A new review has been published highlighting different studies’ findings on the use of various 

 among breastfeeding mothers, with a detailed discussion provided on each medication’s transference to breast milk, blood serum levels in infants, potential adverse events among neonates, and other clinical considerations.

These data were all authored by a team of investigators, led by Carli D. Needle, an MD candidate at The Ronald O. Perelman Department of Dermatology at New York University’s Grossman School of Medicine. Needle et al noted that alopecia areata, androgenetic alopecia (AGA), and cicatricial alopecia can each lead to negative physical symptoms and notable psychological distress among patients and women in particular.

“Given the limited research in this area and the importance of avoiding interruptions in alopecia treatment, this review aims to help guide clinicians in choosing safe and appropriate hair loss therapies for women during lactation,” Needle and coauthors wrote.

The trial investigators carried out their literature searches using the Scopus, PubMed, and Web of Science databases. Searches were done only in English. Existing safety databases such as the Drugs and Lactation Database (LactMed) and the United States Food and Drug Administration (FDA) Drug Database were also used by the team, and any primary literature cited by these databases was further examined when accessible. Terms included the medication names and classes assessed by this review, as well as “lactation” and “breastfeeding.” Searches were done from November 2024 - December 2024.

The investigators noted the increasing systemic and topical medication use in alopecia treatment. The hair regrowth medication minoxidil is generally classified as low-risk during lactation, with oral being documented in breastfeeding mothers without complications. Nevertheless, because of possible transmission through skin contact or milk, cautious utilization of minoxidil is still being advised, especially in premature infants or neonates.

Needle and coauthors highlighted that Janus kinase inhibitors (JAKi), which reduce inflammation by targeting T-cell signaling pathways, are among some of the most effective. Approved JAKis for alopecia areata include baricitinib, deuruxolitinib, and ritlecitinib. As a result of their small molecular size, JAK inhibitors can pass into breast milk, contributing to concerns about infant exposure.

Tofacitinib appears in human breast milk within hours of ingestion, leading to current guidelines to avoid breastfeeding while implementing it. For other JAKis, such as baricitinib and ritlecitinib, lactation safety data are limited, though pharmacokinetic modeling suggests drug levels fall below clinical significance within several half-lives. Given uncertainty, those using such drugs are typically advised to pause breastfeeding during active JAKi use.

Needle and colleagues pointed to a variety of other research, noting different recommendations based on the drugs available for alopecia. Methotrexate, for example, only enters breast milk in small amounts but its active metabolite can linger in neonatal tissues as a result of immature infant kidney function. Even low levels of exposure is linked to potential developmental toxicity, so methotrexate is contraindicated during breastfeeding.

Other data highlighted by the investigative team included diphencyprone (DPCP), a topical option often used in alopecia areata that also acts as a contact allergen, triggering localized immune responses to encourage hair regrowth. Despite noted minimal systemic absorbtion, rare reports of DPCP entering circulation do exist. The lack of robust data, the team suggest, suggests a need for caution until further research is available.

The investigators further highlighted azathioprine that is now applied in autoimmune dermatologic conditions, noting that most experts recommend waiting a few hours after dosing before breastfeeding to allow peak concentrations of the medication to subside. They further pointed to cyclosporine, adding that variable transmission into breast milk has been observed with the drug and largely depends on the formulation. Generally, cyclosporine is considered compatible with breastfeeding, though infants should be monitored for potential adverse effects.

The Excimer laser, a narrow-band ultraviolet B (NB-UVB) therapy used to manage autoimmune scalp conditions, was noted as effective and generally safe, though folate supplementation was highlighted as necessary for consideration in postpartum mothers given this treatment. Needle et al pointed to data suggesting poor absorbtion of topical vitamin D analogues like calcipotriene during lactation, but noted that oral vitamin D is safe up to 10,000 IU daily, and supplementation in the mother may benefit infants given low levels of breast milk vitamin D.

For androgenetic alopecia, spironolactone is an anti-androgen agent that appears in breast milk only in trace amounts and has not been linked to infant harm. In a similar vein, topical clascoterone was shown to have lower systemic absorption, though safety during lactation was noted as not well established. Other findings in the review suggest that progestin-only pills, particularly drospirenone, have no adverse effects among breastfed infants when introduced after 6 weeks postpartum.

Other topical treatments like ketoconazole 2% shampoo, often implemented in scalp inflammation, were noted as safe resulting from their negligible levels of systemic absorption. Low-level laser therapy (LLLT), frequently utilized in hair regrowth procedures, is also regarded as safe during lactation due to its noninvasive nature and lack of drug interaction. Platelet-rich plasma (PRP) was shown by the investigators' review to pose minimal risk for breastfed infants. Some natural or plant-based therapies, including saw palmetto and rosemary oil, had less data and were not recommended.

For scarring (cicatricial) alopecias, topical tacrolimus is considered to be safe due to limited systemic absorption, though available data suggests direct contact with the infant skin should be avoided. Hydroxychloroquine was noted by Needle et al as being excreted in small amounts into breast milk, though it has not been linked to harms among infants. The antibiotic doxycycline was shown by the team to generally be safe for short-term use during lactation.

They highlighted that mycophenolate mofetil is not considered safe during breastfeeding given the high transfer into milk and risks linked to its use such as infections or developmental delays. Pioglitazone, a metabolic agent, is also shown to have produced harmful effects in animal studies and should be avoided. The investigators did, however, highlight the safety of low-dose naltrexone, sometimes used off-label for inflammatory conditions, which has shown minimal transmission into milk.

Clindamycin and rifampicin, both antibiotics used for inflammatory scalp conditions, are compatible with breastfeeding. However, Needle and coauthors did note that infants should be monitored for any GI symptoms. Retinoids like isotretinoin and acitretin were noted as being contraindicated given their high risk of toxicity and birth defects. In contrast, topical retinoids were shown to be likely safe.

The review also highlighted tumor necrosis factor (TNF) inhibitors such as adalimumab, primarily utilized in resistant inflammatory alopecias, which data suggest do appear in breast milk at very low levels. The protein molecules are broken down in an infant’s gut and are not absorbed systemically, making them compatible with breastfeeding.

“Although breastfeeding confers well-established health benefits, some individuals may choose to prioritize treatment for alopecia over continued breastfeeding, especially when effective therapies are not fully validated as compatible with lactation,” they wrote.

 “It is therefore crucial for providers to understand the risk of systemic absorption…in order to make informed decisions and safe recommendations to breastfeeding patients.”

CD Needle, AL Brinks, CA Kearney, et al. “Alopecia Treatments in Breastfeeding: Safety and Clinical Considerations,” International Journal of Dermatology (2025): 1–20, 

N Hunt and S McHale. “The Psychological Impact of Alopecia,” BMJ 331, no. 7522 (2005): 951–953, 

Articles

A recent review examines the safety of alopecia treatments for breastfeeding mothers, focusing on drug transfer to breast milk, infant serum levels, and potential neonatal adverse events. The review highlights the need for clinicians to make informed decisions about alopecia therapies during lactation, considering the limited research available. Various treatments, including minoxidil, JAK inhibitors, methotrexate, and others, are discussed in terms of their safety profiles and recommendations for breastfeeding mothers. The review emphasizes the importance of understanding systemic absorption risks to provide safe treatment options for lactating patients.

This review provides guidance to clinicians in choosing effective and safe alopecia therapies during breastfeeding periods.

Safety Considerations Highlighted for Alopecia Treatments During Breastfeeding

Aimee Shu, MD | Image Credit: Stanford Medicine

Results from a 3-year phase 3 trial have indicated a sustained response to palopegteriparatide (TransCon PTH) therapy in adults with 

Announced by Ascendis Pharma on July 14, 2025, palopegteriparatide continued to provide durable responses in adults with hypoparathyroidism, regardless of whether it was post-surgical, autoimmune, genetic, or idiopathic. Biochemistries, kidney function, and quality of life were all significantly improved.

Hypoparathyroidism, a rare endocrine disease caused by insufficient levels of parathyroid hormone (PTH), the main regulator of phosphate and calcium balance. The disease acts directly on bones and the kidney and indirectly on the intestine. Several short-term and long-term complications, such as neuromuscular irritability, renal complications, extra-skeletal calcifications, and cognitive impairment, have been associated with hypoparathyroidism. Post-surgical hypothyroidism accounts for 70-80% of cases.

“We are pleased to report these latest data from our second clinical trial of TransCon PTH showing sustained efficacy and improvements across key health and quality of life measures, beginning at the earliest timepoints in the Phase 3 PaTHway trial and continuing through three years of treatment,” said Aimee Shu, MD, executive vixce president of Endocrine & Rare Disease Medical Science and chief medical officer at Ascendis Pharma. “These responses, including normalization of skeletal dynamics with significant and clinically meaningful improvements in kidney function, demonstrate the long-term benefits of this treatment option for the vast majority of adults with hypoparathyroidism, regardless of their disease etiology.”

The new data comes from Week 156 of the Phase 3 randomized, double-blind, placebo-controlled PaTHway trial, which consisted of a 26-week trial of 82 adults with chronic hypoparathyroidism followed by an open-label extension period through Week 182. The initial 26-week blinded period saw patients randomized in a 3:1 ratio to either palopegteriparatide or placebo. Investigators assessed their renal function by estimated glomerular filtration rate (eGFR). Safety assessments included 24-hour urine-calcium and treatment-emergent adverse events (TEAEs).

Hypoparathyroidism symptoms, as well as functioning and well-being, were measured via the Hypoparathyroidism Patient Experience Scale (HPES). The trial exhibited a high retention rate, with 73 of the initial 82 patients (89%) completing the full trial.

At the end of Week 156, a total of 64 participants (88%) had normal albumin-adjusted serum calcium levels. Additionally, 70 (96%) were no longer reliant on conventional therapy, which was defined as taking <600 mg/day of calcium and not taking active vitamin D. Improvements in eGFR were also sustained through Week 156: mean eGFR increased by 8.76 mL/min/1.73 m2 across all patients and by 13.98 mL/min/1.73 m2 in patients with baseline eGFR <60.

Continued improvements were reported from baseline through Week 156. Palopegteriparatide was well-tolerated and exhibited no new safety signals. TEAEs were mild to moderate, and no serious events or discontinuations from the trial were due to the study drug.

Palopegteriparatide has already been approved by the US Food and Drug Administration (FDA) to treat hypoparathyroidism in August of 2024, under the name YORVIPATH. Also developed by Ascendis Pharma, this treatment was a prodrug of parathyroid hormone (PTH[1-34]), administered once daily.

The approval came in response to a New Drug Application including data from the phase 2 PaTH Forward and the first portion of the phase 3 PaTHway trial. At the time, palopegteriparatide was the first and only treatment for hypoparathyroidism in adults.

New 3-Year Phase 3 Data Confirmed Sustained Response to TransCon PTH (Palopegteriparatide) Therapy in Adults with Hypoparathyroidism, Including Improvements in Biochemistries, Kidney Function, and Quality of Life. Ascendis Pharma. July 14, 2025. Accessed July 14, 2025. https://investors.ascendispharma.com/news-releases/news-release-details/new-3-year-phase-3-data-confirmed-sustained-response-transconr

FDA Approves YORVIPATH (Palopegteriparatide) as the First and Only Treatment for Hypoparathyroidism in Adults. Ascendis Pharma. August 12, 2024. Accessed July 14, 2025. https://investors.ascendispharma.com/news-releases/news-release-details/fda-approves-yorvipathr-palopegteriparatide-first-and-only

A 3-year phase 3 trial demonstrated that palopegteriparatide (TransCon PTH) provides sustained benefits for adults with hypoparathyroidism, improving biochemistries, kidney function, and quality of life. The trial included 82 adults, with 89% completing the study. By Week 156, 88% achieved normal serum calcium levels, and 96% were off conventional therapy. The treatment was well-tolerated, with no serious adverse events. Palopegteriparatide, approved by the FDA in 2024 as YORVIPATH, remains the only treatment for adult hypoparathyroidism, offering significant long-term benefits across various etiologies.

Already approved by the FDA based on data from the first half of the PaTHway trial, 3-year extended results have indicated lasting efficacy.

Palopegteriparatide Provides Sustained Response in Adults with Hypoparathyroidism

Liver Lineup: Progress, Policy, and Barriers in Hepatitis C Elimination

Liver Lineup: Updates & Unfiltered Insights

, hosts Kimberly Brown, MD, a professor of Medicine at Michigan State University and Wayne State University, associate medical director of the Henry Ford Hospital Transplant Institute, and medical director of Transplant Outreach Services at Henry Ford Hospital, and Nancy Reau, MD, a professor of internal medicine, the Richard B. Capps Chair of Hepatology, associate director of solid organ transplantation, and the section chief of hepatology at Rush University Medical Center, discuss the progress and persistent challenges in eliminating 

With highly effective, short-course oral therapies now available, Brown and Reau emphasize that curing HCV is more achievable than ever. The discussion explores the major policy, clinical, and structural milestones enabling this effort—and the critical gaps in diagnosis, treatment access, and health policy that still impede progress.

Reau opens by emphasizing the revolutionary nature of curative HCV therapies, which not only improve individual health outcomes but also reduce transmission, presenting a rare opportunity for public health impact on a global scale. She and Brown discuss how national and international efforts, including World Health Organization goals and US legislation, have aligned to prioritize viral hepatitis elimination.

Specifically, the hosts discuss the role of the US Preventive Services Task Force and the Affordable Care Act in establishing HCV screening as a covered preventive service. Outlining the evolution from birth cohort screening to universal screening for adults 18 and over, Reau and Brown discuss a recent legal challenge to the Affordable Care Act’s preventive service mandate that threatened access to HCV screening. The Supreme Court’s 6–3 decision to uphold this provision was, in their view, a critical win for public health and HCV elimination.

Despite these advances, both experts acknowledge major challenges remain in the HCV care cascade. Many patients are lost between screening and cure, often due to provider restrictions, system fragmentation, and lack of prioritization. They emphasize the need for government-backed elimination efforts, drawing lessons from successful national programs in countries like Egypt and Georgia.

The conversation also underscores the role of grassroots advocacy, emphasizing the critical role clinicians and patients alike can play in supporting federal hepatitis elimination legislation. Most importantly, they encourage patients to share their stories with legislators—a strategy proven effective in other public health movements, including HIV.

Reau additionally calls upon listeners to write to their local senators to support bipartisan legislation from senators Bill Cassidy (R-LA) and Chris Van Hollen (D-MD) to eliminate hepatitis C using the following link: 

Ask Senators to Cosponsor the Cure Hepatitis C Act

Editors’ note: Relevant Disclosures for 

 include AbbVie, Gilead, Salix, Arbutus, and VIR. Relevant disclosures for 

 include Mallinckrodt Pharmaceuticals, Gilead, Salix, Intercept, Ipsen, and Madrigal.

Podcasts

Hosts Kimberly Brown and Nancy Reau discuss policy, clinical, and structural milestones enabling HCV elimination efforts and critical gaps impeding progress.

At the 2025 Southern California Psychiatry Conference at Huntington Beach, CA, from July 11 – 12, Jonathan Meyer, MD, presented on muscarinics and 

, a brand under MJH Life Sciences, Meyer, a voluntary clinical professor at the University of California, San Diego, discussed what’s new in tardive dyskinesia, when to switch medications, and how the only effective treatment for this condition is VMAT2 inhibitors.

In this Q&A, Meyer emphasized the importance of making sure you diagnose tardive dyskinesia correctly, not mixing up tardive dyskinesia with Parkinsonism. Medications for Parkinsonism worsen tardive dyskinesia symptoms, and vice versa. Only 2 FDA-approved medications for tardive dyskinesia sit on the market—tetrabenazine and valbenazine—both vesicular monoamine transporter 2 (VMAT2) inhibitors.

 The big thing that's new is not the medications. We've had two FDA-approved treatments in 2017, but in the early days when they're just approved, I think the focus was more on detecting tardive dyskinesia. We've come to appreciate that it's not just the movements, it's the functional impact, the impact on the person's well-being, the impact on psychosocial functioning.

A big aspect of what I'll be covering today is really how to use some of these newer instruments that have been developed to help you figure out for your patients with TD, how it interferes with what they do on a day-to-day basis, not just physically, but psychologically and socially.

If you have a patient and you're giving the medication for TD, and you don't see that they're improving, what are some of the things that clinicians should be thinking about?

 Well, for one thing, you want to make sure that you have the right diagnosis. There are sometimes movements [that] can happen to people on psychotropic [medications], which may lead the clinician to think they have tardive dyskinesia.

A classic example is a form of Parkinsonism, in which the person has jaw tremors, because it's in this area, we often would assume it's tardive dyskinesia, and most of the time, you're right…if they've been exposed to a D2 blocker, but in this case, it's actually a form of Parkinsonism. The medicines [that] make Parkinsonism better tend to make TD worse. Conversely, for people with Parkinsonism, the medicines for TD tend to make those symptoms worse.

If you assume, though, that you have the correct diagnosis, the most important thing is making sure the person's taking the medication and that you've maximized the dose. If there is no response whatsoever on the maximal dose of one medication, there's really no harm in trying the other one. We only have 2 options right now, which are FDA-approved, but there are a subset of people with TD who don't get adequate improvement with either of the 2 FDA-licensed medications. Those are the types of people who you may refer to a neurologist for further evaluation and treatment.

Between the two, how should a clinician decide which one they're going to start trying? Is there a rhyme or reason to it?

 There really often isn't. One of them has a bit more of a titration schedule, which is tetrabenazine. Does that always cause a problem? Not necessarily. There are actually some people who prefer a lower initiation schedule.

Valbenazine is easier to initiate. 40 milligrams is the starting dose, and it's actually a very effective dose. I say to clinicians: you need to know how to use both, simply because insurance, more than anything, may dictate what you have access to. They are both effective.

We don't have any head-to-head data. There's inferential data from imaging studies that maybe you might get more VMAT2 occupancy, perhaps at the maximal dose of valbenazine versus the maximal dose of tetrabenazine. I can't promise there's always a clinical correlate for that, but it emphasizes a point of [knowing] how to use both. Maybe somebody will respond better, or perhaps a differential tolerability to one or the other.

Any closing thoughts that you want to share with clinicians?

 The only effective treatments for tardive dyskinesia are the VMAT2 inhibitors. In the old days, people used to throw medicines like benztropine against all movement disorders with the D2 blockade. We now know that they're not effective for TD, and in fact, they tend to make it worse.

The only thing I'll say about that is, if you have people on anticholinergics at some point in their treatment, if they have TD, you want to slowly taper them off to allow the VMAT2 inhibitor to give you your maximum benefit for their movements, most importantly, to improve their quality of life related to their tardive dyskinesia.

Jonathan Meyer, MD, presented insights on tardive dyskinesia (TD) at the 2025 Southern California Psychiatry Conference. He emphasized the importance of accurate diagnosis, distinguishing TD from Parkinsonism, as treatments for one can exacerbate the other. The only FDA-approved treatments for TD are VMAT2 inhibitors, tetrabenazine and valbenazine. Meyer highlighted the need to assess the functional impact of TD on patients' lives and suggested trying both medications if one proves ineffective. He advised tapering off anticholinergics to maximize the benefits of VMAT2 inhibitors.

Discover the latest insights on tardive dyskinesia treatment, diagnosis, and the role of VMAT2 inhibitors in enhancing patient well-being.

What’s New in Tardive Dyskinesia, With Jonathan Meyer, MD

Hypercortisolism in Patients with Treatment-Resistant Type 2 Diabetes, with Richard Auchus, MD, PhD

, Richard Auchus, MD, PhD, presented the results of his deeper examination of the participants of the CATALYST trial for management of 

CATALYST was a phase 4, 2-part, multicenter trial; part 1 examined the prevalence of hypercortisolism in a population of roughly 1000 patients over 36 sites across the US. Each patient had hemoglobin A1c >7.5%, despite using several glucose-lowering therapies such as glucagon-like peptide-1 receptor agonists (GPL-1 RAs). Investigators administered a 1 mg dexamethasone suppression test, the results of which indicated 24% of participants had hypercortisolism.

Part 2 of CATALYST was a randomized, double-blind, placebo-controlled study of mifepristone (Korlym) in select patients from part 1. Patients were randomized to either mifepristone or placebo; the former cohort exhibited a salutary response on glucose, with A1c lowering by roughly 1.5% and roughly 1.3% relative to placebo.

Auchus and colleagues conducted a deeper examination of the patient characteristics highlighted in CATALYST, who had an A1c between 7.5% and 11.5%. Investigating the results from the dexamethasone suppression test, the team stratified patients into 3 major categories: cortisol <1.2, cortisol 1.2-1.8, and cortisol >1.8 after dexamethasone. Auchus and colleagues found substantial worsening of disease, disease control, and comorbidities associated with greater amounts of cortisol after dexamethasone.

“We found that 25% of them failed the dexamethasone suppression test, indicating some form of hypercortisolemia,” Auchus said. “And ‘failed’ conventionally is 1.8 mcg/dL or higher of serum cortisol after the 1mg test. But if you take truly normal people, their cortisol normally suppresses to zero. A couple of groups have looked at what the normal range is for dexamethasone suppression tests in people who are at low suspicion of hypercortisolism, and it turns out that the +2 standard deviation is about 1.2 mcg/dL.”

“Now, we didn’t test the 1.2 to 1.8 people,” Auchus told 

. “So what would happen if we treated those people? And you could also take this one step further and say, ‘What would happen if we treated the people who were less than 1.2?’ I think these are the sort of questions that we need to address.”

Auchus spoke to the lack of variance in response between cohorts. He addressed the alternative approach taken when studying mifepristone and hypercortisolism’s impact on T2D.

“I think it’s comforting but vexing in that the test is an easy way to find people who should respond well, but the reason they respond and the underlying reason that their cortisol doesn’t suppress completely doesn’t seem to matter,” Auchus said. “And it’s a little different than the way we’ve normally thought about it.”

Auchus also mentioned barriers to implementation, chiefly the lack of comfort in drugs like mifepristone and cortisol-directed therapy at large.

“They’ve generally been boutique drugs that only a few endocrinologists use, who specialize in Cushing’s and pituitary centers, adrenal centers,” Auchus said. “I think a barrier to implementation is the comfort level of the average endocrinologist in using cortisol-directed therapy.”

Auchus advised clinicians to keep the possibility of secondary causes in mind when investigating a patient’s treatment-resistant diabetes or high blood pressure. He encouraged broader screening and earlier consideration of alternative causes.

“When the usual things don’t work, don’t keep banging your head against the wall,” Auchus said. “Think about secondary causes. Cortisol and aldosterone are two of the first things you should be thinking of.”

DeFronzo RA, Auchus RJ, Bancos I, et al. Study protocol for a prospective, multicentre study of hypercortisolism in patients with difficult-to-control type 2 diabetes (CATALYST): prevalence and treatment with mifepristone. BMJ Open. 2024;14(7):e081121. Published 2024 Jul 16. doi:10.1136/bmjopen-2023-081121

Diabetes Care Publishes Results from Prevalence Phase of Corcept’s CATALYST Trial in People with Difficult-to-Control Type 2 Diabetes. Corcept Therapeutics. April 21, 2025. Accessed July 14, 2025. https://ir.corcept.com/news-releases/news-release-details/diabetes-care-publishes-results-prevalence-phase-corcepts

Videos

Auchus discusses his recent presentation on the CATALYST trial, investigating the characteristics of patients with difficult-to-treat T2D because of hypercortisolism.

Image Credit: US Food and Drug Administration

 has approved an update to the VARIPULSE Platform’s irrigation flow rate, which is designed to optimize irrigation and support consistent successful operations with low adverse event rates.

Announced on July 14, 2025, by parent company Johnson & Johnson MedTech, the approval follows the significant milestone of >10,000 VARIPULSE procedures across all approved countries. The platform has also maintained a neurovascular adverse event rate of <.5% - although the release notes this statistic is calculated from internal customer reported data/complaints rather than a prospective clinical investigation. The rate reported is preliminary and pending publication.

More than 8 million people in the US and 50 million globally experience 

; 1 in 4 adults ≥40 years of age are at risk of development. However, 1 in 3 are unaware of the condition. Catheter ablation is a safe and effective method of restoring incorrect electrical signals in the heart when traditional therapies are incapable of generating change.

“With a growing prevalence of atrial fibrillation around the world, innovative solutions are critical in expanding options for patients and helping electrophysiologists treat AFib effectively and efficiently,” said Andrea Natale, MD, executive medical director, Texas Cardiac Arrythmia Institute, St. David’s Medical Center. “The VARIPULSE Platform enables efficient procedures with a favorable safety profile, allowing me to treat more patients and get them back to their normal lives.”

The VARIPULSE device is a Pulsed Field Ablation (PFA) system which was initially approved for drug refractory paroxysmal atrial fibrillation on November 7, 2024. It combines PFA therapy with the CARTO 3 system, the world’s leading 3D electroanatomical cardiac mapping system. The device provides real-time visualization of catheter positioning while delivering treatment confidence through tissue proximity indication and lesion tagging.

As treatment is delivered through tissue proximity and lesion tagging, electrophysiologists receive critical feedback for lesion durability and long-term outcomes with the platform. VARIPULSE could provide a comprehensive solution to address both routine and complex AF ablations, according to Johnson & Johnson MedTech.

The VARIPULSE Platform’s initial approval in 2024 was based on 12-month outcome data from the prospective, non-randomized, multi-center admIRE trial, which consisted of 291 patients from 30 US healthcare centers. By week 12, all patients achieved acute procedural success, including 98% with first-pass isolation recorded per vein. Roughly 85% of patients reached peak primary effectiveness when 73-96 applications were given per vein with few adverse events observed.

“By learning from real-world experience and working closely with clinicians, we are continuously enhancing our technologies to improve patient care,” said Michael Bodner, company group chair, electrophysiology and neurovascular, Johnson & Johnson MedTech. “This update to the VARIPULSE Platform reflects our ongoing commitment to lead the evolution of PFA through meaningful, data-driven improvements that advance product performance and build procedural confidence.”

The Platform includes the VARIPULSE Catheter, TRUPULSE Generator, and CARTO 3D Mapping System VARIPULSE Software. It is available for use in the US and several other nations including Europe, China, and Canada.

Johnson & Johnson Receives FDA Approval for Updated VARIPULSE Platform Irrigation Rate. J&J MedTech. July 14, 2025. Accessed July 14, 2025. 

https://www.jnjmedtech.com/en-US/news-events/johnson-johnson-receives-fda-approval-updated-varipulse-platform-irrigation-rate

MedTech J & J. Johnson & Johnson Medtech receives FDA approval for the VARIPULSETM pulsed field ablation platform for the treatment of atrial fibrillation. PR Newswire. November 7, 2024. Accessed July 14, 2025. 

https://www.prnewswire.com/news-releases/johnson--johnson-medtech-receives-fda-approval-for-the-varipulse-pulsed-field-ablation-platform-for-the-treatment-of-atrial-fibrillation-302298232

Iapoce C. FDA Approves VARIPULSE Platform for Treatment of Atrial Fibrillation. 

. November 7, 2024. Accessed July 14, 2025. 

https://www.hcplive.com/view/fda-approves-varipulse-platform-for-treatment-of-atrial-fibrillation

The FDA has approved an update to the VARIPULSE Platform's irrigation flow rate, enhancing its operational consistency and safety profile. This follows over 10,000 procedures performed globally, with a neurovascular adverse event rate of less than 0.5%. The VARIPULSE Platform, a Pulsed Field Ablation system, is used for treating atrial fibrillation, a condition affecting millions worldwide. It integrates with the CARTO 3 system for real-time visualization and feedback, supporting both routine and complex ablations. The platform's initial approval was based on successful outcomes from the admIRE trial.

The previously approved technology has already accomplished over 10,000 procedures for patients with various heart diseases, primarily including atrial fibrillation.

FDA Approves Updated VARIPULSE Platform Irrigation Flow Rate for Heart Disease

Concurrent Lifestyle Intervention Enhances Semaglutide Weight Loss, with Qiaochu Xue, PhD, MPH

Concurrent lifestyle intervention was associated with greater weight loss in people with overweight or obesity receiving semaglutide treatment and less regain following discontinuation.

These findings were from an emulated trial from data from the VA MOVE! Program, a Diabetes Prevention Program (DPP)-style lifestyle intervention (LI) led by Hui Shao, MD, PhD, associate professor in the Hubert Department of Global Health, and the School of Public Health at Emory University. They were presented by Qiaochu Xue, PhD, MPH, Post-Doctoral Fellow at the Emory Global Diabetes Research Center,at the 

2025 American Diabetes Association (ADA) Scientific Sessions

The analysis included 2,403 participants from VA MOVE! who initiated semaglutide from 2019 to 2024 that were matched 1:3 to those without LI, using high-dimensional propensity score matching to balance baseline characteristics. Xue and colleagues used generalized mixed-effects models to assess body weight trajectories from semaglutide initiation through 12 months following discontinuation.

The investigators found that individuals with concurrent LI achieved greater weight loss before semaglutide discontinuation (-8.3% vs. -7.4%, 

<.001). Furthermore, at 12 months following discontinuation, LI participants had greater net weight loss (-5.8%) compared to nonparticipants (-3.3%; 

"Most of the phase 3 clinical trials have reported that semaglutide has some weight loss effect for most of the type 2 diabetes patients, or even overweight or obesity patients, but we don't know if during their semiglutide usage period if adding the MOVE program, that combined lifestyle intervention and the medication will increase the weight loss benefits,” Xue told 

Xue Q, Li P, Staton E, et al. 2199-LB: Weight Loss Maintenance following Semaglutide Discontinuation—The Role of Concurrent Lifestyle Intervention. 

. 2025;74(Supplement_1). doi: 10.2337/db25-2199-lb

Lifestyle intervention yielded greater maintained weight loss 12 months after discontinuing semaglutide than without.

Baxdrostat, a potential first-in-class aldosterone synthase inhibitors (ASI) for the treatment of difficult-to-control 

, has achieved the primary endpoint of statistically significant systolic blood pressure (SBP) reduction in its phase 3 BaxHTN trial.

Announced by parent company AstraZeneca on July 14, 2025, the results of BaxHTN indicate the potential of baxdrostat to lower aldosterone content, preventing dysregulation, which has been cited as a leading cause of hypertension. Uncontrolled hypertension was defined as being persistent despite lifestyle changes and/or the use of ≥2 medications, while resistant hypertension remains elevated despite ≥3 treatments.

“Many people continue to struggle with high blood pressure that is hard to control, even when taking multiple medications,” said Bryan Williams, MD, chair of medicine at University College London, and the primary investigator in BaxHTN. “The highly promising BaxHTN Phase III results show that once-daily baxdrostat on top of standard of care can meaningfully lower systolic blood pressure and offer a potential new treatment approach for controlling hypertension, the leading risk factor for cardiovascular disease.”

Baxdrostat is a highly selective and potent oral small molecule that inhibits ASI, an enzyme responsible for the synthesis of aldosterone in the adrenal gland. Baxdrostat significantly reduced aldosterone levels without impacting cortisol levels in a range of doses during prior trials.

BaxHTN consisted of 3 components supporting the primary efficacy endpoint of difference in mean change from baseline in seated SBP at the end of a 12-week, double-blind, placebo-controlled period. Patients were randomized in a 1:1:1 ratio to receive baxdrostat 2mg, 1mg, or placebo once daily. Efficacy persistence was analyzed through a randomized withdrawal period from Week 24 to 32. Roughly 300 patients treated with baxdrostat 2mg were randomized in a 2:1 ratio to either receive baxdrostat 2mg or placebo for the 8 weeks; SDP at the end of this period was compared with placebo and the baxdrostat 2mg dose group. Long-term safety was assessed at the end of Week 52 compared to a standard of care arm.

BaxHTN was commenced after positive results from phase 2 trials in 2022 and 2023, coined BrigHTN and HALO, respectively. The former indicated an association between baxdrostat and an 11 mmHg placebo-adjusted SDP decline without impacting cortisol levels. The 12-week study included 275 patients, with 248 completing the trial; no serious adverse events were attributed to baxdrostat.

However, the HALO trial in 2023 failed to achieve its endpoint of placebo-corrected SBP change in any of the 3 baxdrostat doses (.5mg, 1mg, and 2mg). Investigators noted several limitations, including a relatively small population, suboptimal adherence, and assessment of the primary endpoint at 8 rather than 12 weeks. HALO did indicate similar safety data to BrigHTN, noting only 2 of 248 patients experienced serious adverse events.

In their press release, AstraZeneca described plans to present data from the BaxHTN trial in a late-breaking Hot Line session at the European Society of Cardiology Congress in August of 2025 and will share the results with regulatory authorities worldwide.

“We are very excited with the BaxHTN Phase III results, which show statistically significant and clinically meaningful reductions in systolic blood pressure,” said Sharon Barr, executive vice president of BioPharmaceuticals R&D. “These findings provide compelling evidence of baxdrostat’s potential to address a critical unmet need by targeting aldosterone dysregulation, bringing a novel mechanism to a field that has seen little innovation in over two decades.”

Baxdrostat met the primary and all secondary endpoints in BaxHTN Phase III trial in patients with uncontrolled or treatment resistant hypertension. AstraZeneca. July 14, 2025. Accessed July 14, 2025. https://www.astrazeneca.com/media-centre/press-releases/2025/baxdrostat-met-primary-and-all-secondary-endpts-in-baxhtn-phiii-trial.html

Phase 2 Data Shows Promise for Baxdrostat in Treatment-Resistant Hypertension. 

. November 7, 2022. Accessed July 14, 2025. https://www.hcplive.com/view/phase-2-data-shows-promise-for-baxdrostat-in-treatment-resistant-hypertension

Campbell P. HALO Trial: Baxdrostat is Well-Tolerated, But Misses Mark in Uncontrolled Hypertension. 

. March 7, 2023. Accessed July 14, 2025. https://www.hcplive.com/view/halo-trial-baxdrostat-is-well-tolerated-but-misses-mark-in-uncontrolled-hypertension

Baxdrostat, an aldosterone synthase inhibitor, has shown promise in treating difficult-to-control hypertension by achieving significant systolic blood pressure reduction in the Phase 3 BaxHTN trial. The trial demonstrated baxdrostat's ability to lower aldosterone levels without affecting cortisol, offering a potential new treatment for hypertension, a major cardiovascular risk factor. Despite previous mixed results in Phase 2 trials, the BaxHTN trial's success highlights baxdrostat's potential to address unmet needs in hypertension management. AstraZeneca plans to present these findings at the European Society of Cardiology Congress.

BaxHTN trial results showed baxdrostat led to a significant reduction of systolic blood pressure compared to placebo, with a favorable safety profile.

Baxdrostat Meets Efficacy Endpoint in Phase 3 Trial for Resistant Hypertension

New data from the phase 2a SPARK trial suggest baxdrostat, a highly selective, second-generation, nonimidazole aldosterone synthase inhibitor, may offer a promising treatment option for patients with primary aldosteronism.

“Recommended therapies for primary aldosteronism have changed little over the past several decades and are completely effective in only a minority of patients,” Morris Brown, MD, FRCP, FMedSci, FRS, a professor of endocrine hypertension at Queen Mary University and clinical pharmacologist at Barts Health NHS Trust, and colleagues wrote, citing the potential advantages of selective aldosterone synthase inhibitors over other existing drugs and their ability to target the root cause of primary aldosteronism.

While 2 first-generation aldosterone synthase inhibitors were previously studied over 4 or 8 weeks in patients with primary aldosteronism and led to modest reductions in blood pressure, these findings were attributed to elevations in the plasma 11-deoxycorticosterone level, and neither drug has advanced into a pivotal trial for the treatment of primary aldosteronism. To date, spironolactone remains the only licensed therapy.

A multicenter, open-label, prospective study of baxdrostat, a highly selective, second-generation, nonimidazole aldosterone synthase inhibitor, SPARK enrolled patients with hypertension and primary aldosteronism diagnosed according to the Endocrine Society guidelines. Participants started treatment with baxdrostat at a dose of 2 mg per day for the first 4 weeks; the dose was then increased monthly to 4 or 8 mg per day on the basis of the blood-pressure measurement and the absence of unacceptable adverse events.

The primary endpoints were change in systolic blood pressure from baseline to week 12 and safety. Patients were offered the opportunity to continue into an active extension period from week 12 through week 72.

A total of 15 patients with a mean systolic blood pressure of 151.5±13.5 and diastolic blood pressure of 90.3±8.8 mm Hg were enrolled and completed part 1 of the study. At week 12, results showed systolic blood pressure was reduced in all 15 patients by a mean of 24.9 mm Hg (95% confidence interval [CI], 19.0 to 30.8). Hypokalemia was corrected in all 5 patients who had the condition, and no serious adverse events occurred during part 1 of the study.

At week 12, diastolic blood pressure decreased by a mean 10.6±9.0 mm Hg. The blood-pressure target, <140/90 mm Hg, was reached in 11 of the 15 patients (73%; 95% CI, 45 to 92). Investigators noted the plasma aldosterone-to-renin ratio was substantially reduced in all the patients by a median of 97.3% (interquartile range, 84.3 to 98.9), and the target aldosterone–renin ratio (<15, with aldosterone measured in nanograms per deciliter and renin in nanograms per milliliter per hour) was reached in 14 of the 15 patients (93%; 95% CI, 68 to 100).

Further analysis revealed plasma and 24-hour urinary aldosterone levels decreased by 90.9% (95% CI, 73.9 to 92.9) and 91.6% (95% CI, 89.6 to 94.3), respectively, at week 12. Investigators pointed out the reciprocal rise in plasma renin activity was more gradual, with an increase by a factor of 1.8 (95% CI, 0.5 to 8.5) at week 12 and an increase by a factor of 6.0 (95% CI, 2.0 to 16.3) at week 72.

In contrast, they noted the serum 11-deoxycorticosterone level peaked early, with an increase by a factor of 11.5 (95% CI, 6.2 to 16.9) at week 8; the level then decreased by approximately 50% by week 36. The mean plasma cortisol level was 7.0±3.1 μg per deciliter at baseline and 9.3±3.8 μg per deciliter at week 12.

A total of 14 patients continued into part 2 of the study, 4 of whom received the 8-mg dose of baxdrostat and discontinued the treatment before 72 weeks.

While investigators acknowledged the lack of a placebo-control group precluded precise quantification of the effects of baxdrostat, they noted the reductions in systolic blood pressure of 25 mm Hg are rare. Additionally, they pointed out the median 97% reduction in the aldosterone–renin ratio exceeded the reductions observed after surgical removal of a culprit adrenal gland and note initial, marked increases in the 11-deoxycorticosterone level may exceed protein-binding capacity and delay maximal mineralocorticoid inhibition.

Furthermore, investigators describe the subsequent decline in 11-deoxycorticosterone and persistent aldosterone suppression after baxdrostat withdrawal as predicted consequences of a maladaptive response to salt, which has been hypothesized to be involved in the pathogenesis and reversal of primary aldosteronism.

“In our study involving 15 patients with primary aldosteronism, treatment with baxdrostat resolved or reduced the severity of hypertension, excessive aldosterone production, and hypokalemia,” investigators concluded.

Turcu AF, Freeman MW, Bancos I, et al. Phase 2a Study of Baxdrostat in Primary Aldosteronism. The New England Journal of Medicine. 

Primary Aldosteronism Foundation. How is PA Treated? Accessed July 14, 2025. 

https://primaryaldosteronism.org/medical-option/

Baxdrostat, a second-generation aldosterone synthase inhibitor, shows promise for treating primary aldosteronism, a condition with limited effective therapies. In a phase 2a trial, baxdrostat significantly reduced systolic blood pressure and corrected hypokalemia in patients. The study demonstrated a substantial reduction in the aldosterone-to-renin ratio and plasma aldosterone levels, with no serious adverse events reported. Although lacking a placebo-control group, the trial's results suggest baxdrostat's potential to address hypertension and excessive aldosterone production in primary aldosteronism patients.

Treatment with baxdrostat resolved or reduced the severity of hypertension, excessive aldosterone production, and hypokalemia in the phase 2a SPARK trial.

Phase 2a Baxdrostat Data Show Promise for Primary Aldosteronism

Dual biologic therapy may be effective and generally well-tolerated in treating refractory inflammatory skin conditions such as 

, new findings suggest, although it carries a moderate risk of infection.

This finding and others were the conclusions that resulted from a recent systematic review on dual biologic therapy use in skin disease. These data were authored by such investigators as Eric McMullen, MD, of the University of Toronto Department of Medicine’s Division of Dermatology.

McMullen and his coauthors highlighted that dual biologic therapy, a process involving the concurrent use of biologic treatments, is an approach for refractory cases of 

 individuals living with comorbid inflammatory conditions who are in need of additional therapies.

“This systematic review aims to document, synthesize and critically appraise the current literature on dual biologic therapy in inflammatory skin diseases,” McMullen and colleagues wrote.

The trial investigators used 5 databases—including Embase, MEDLINE, CENTRAL, Scopus, and Web of Science—for their comprehensive literature search, conducted across these databases' inceptions through March 2024. The team used a search strategy that involved both subject headings and keywords related to various types of biologic agents, inflammatory dermatologic conditions, and combination (dual) biologic use.

The review adhered to PRISMA 2020 guidelines and was registered with PROSPERO.

 McMullen et al maintained a set of criteria for inclusion, looking only at studies assessing the safety and effectiveness of dual biologic therapy in skin diseases that were also written in English. 40 studies were found to have met these criteria, encompassing data from 106 total patients, 59.4% of whom were labeled as female.

Among these trial subjects, the investigators noted the mean age across the cohort as 47.1 years, with ages ranging from 10 - 79 years. Before initiating dual biologic therapy, patients assessed in these studies had failed an average of 1.3 topical drugs, 2.4 non-biologic systemic drugs, and 2.1 biologic monotherapies.

The most frequently reported biologic pairing was found by the investigative team to be omalizumab alongside rituximab, which accounted for 25.7% of cases. This was mostly observed in those showing treatment-resistant bullous pemphigoid. The next most common biologic combination was omalizumab and secukinumab, among 16.5%, which is implemented for refractory chronic spontaneous urticaria (CSU) and psoriasis. 

All 106 of these individuals showed demonstrated clinical response to the dual biologic agent regimens. The most prevalent conditions treated among these subjects included bullous pemphigoid among 28.3%, CSU among 35.8%, psoriasis among 23.6%, and atopic dermatitis among 9.4%. It was noted that 30.2% of patients initiated dual therapy after being prompted by an inadequate response to single-agent biologic treatment, while others required combination biologics as a result of coexisting inflammatory diseases. These were both dermatologic (35.8%) and non-dermatologic (34.0%).

McMullen and coauthors noted that the mean follow-up period of 14.7 months saw 78.3% of patients report no adverse events. Among those who did, the most frequent were non-severe infections (10.4%). Loss of therapeutic response took place in 4 of the study subjects. Serious adverse outcomes included a single case of respiratory failure and 1 fatality in a patient with multiple comorbid conditions—acute lymphoblastic leukemia, bullous pemphigoid, renal failure, sepsis, and graft-versus-host disease. 9 patients had infections, with a notable link to therapies involving ustekinumab or TNF inhibitors being observed by the investigative team.

A notable therapeutic approach for resistant CSU and psoriasis involved co-administration of anti-IgE and anti-IL-17 agents. Such biologics act on separate yet potentially synergistic immunological pathways. IL-17A, a cytokine elevated in psoriasis, can promote IgE class switching and IgE-secreting cell differentiation when stimulated via anti-CD40 and anti-IL-4 pathways. Given that IL-17A may contribute both to psoriatic inflammation and to IgE-driven allergic responses, dual iIL-17A and IgE pathway inhibition could allow for enhanced clinical efficacy.

This systematic review underscores dual biologic therapy's potential in helping achieve clinical responses with an acceptable safety profile in individuals living with inflammatory diseases impacting the skin. However, a 10.4% infection rate was noted by the investigators as raising questions about increased susceptibility due to compounded immunosuppression and impaired immune surveillance.

“Distinct and complementary mechanisms such as IL-17 and anti-IgE in psoriasis and CSU highlight these promising findings, yet current evidence is limited by small sample sizes and likely publication bias,” they concluded.

 “Future studies should prioritize larger studies, extended follow-up periods and refined patient selection criteria to better assess the efficacy and safety of dual biologic therapy.”

McMullen E, Croitoru D, Piguet V, et al. Efficacy and safety of dual biologic therapy in inflammatory skin diseases: A systematic review. J Eur Acad Dermatol Venereol. 

Page MJ, McKenzie JE, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021; 372:n71.

Dual biologic therapy shows promise in treating refractory inflammatory skin conditions like psoriasis, with a generally acceptable safety profile, though it carries a moderate infection risk. A systematic review analyzed 40 studies involving 106 patients, revealing that dual biologic regimens, such as omalizumab with rituximab, effectively manage conditions like bullous pemphigoid and chronic spontaneous urticaria. Despite a 10.4% infection rate, the therapy's potential is highlighted, though further research with larger sample sizes and longer follow-up is needed to better understand its efficacy and safety.

This systematic review evaluated current research on dual biologic treatments in patients living with inflammatory skin conditions.

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