Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

Exploratory post hoc analyses from the phase 3 MODIFY trial suggested a possible signal among participants with reduced kidney function at baseline, while no statistically significant renal benefit was observed with lucerastat in adults with 

Although the trial was not designed or powered to assess renal endpoints, lucerastat was associated with numerically higher eGFR changes compared with placebo over 6 months, with interpretation limited by the short duration of the controlled phase.

“MODIFY is the largest randomized trial performed in Fabry disease to date and included a broad spectrum of participants with Fabry disease, including male and female participants, individuals with classic and nonclassic disease, and participants who were enzyme replacement therapy–naïve or previously treated,” wrote study investigator Derralynn Hughes, professor of experimental hematology at University College London, director of research and innovation at the Royal Free London, and co-clinical director of the North Central London Cancer Alliance, and colleagues.

Fabry disease is a rare, genetic disorder caused by pathogenic variants in the 

 gene, which encodes the α-galactosidase A enzyme. Deficiency of this enzyme leads to lysosomal accumulation of globotriaosylceramide, which contributes to multisystem involvement, including renal injury characterized by glomerulosclerosis and tubular atrophy. Over time, this process can result in proteinuria, declining kidney function, and progression to end-stage renal disease requiring dialysis or kidney transplantation.

In patients with Fabry disease and renal involvement, major therapeutic goals include stabilizing or slowing eGFR decline and delaying progression from 

Lucerastat is an oral glucosylceramide synthase inhibitor under investigation as a substrate reduction therapy designed to reduce glucosylceramide synthesis and thereby limit downstream globotriaosylceramide accumulation.

Hughes and colleagues evaluated lucerastat in MODIFY, a 6-month, prospective, double-blind, placebo-controlled, randomized phase 3 clinical trial designed to assess the efficacy, safety, and tolerability of lucerastat monotherapy in adults with Fabry disease. Participants were randomized across 49 sites in 14 countries, including North America, Europe, and Australia.

The primary objective of MODIFY was to evaluate the effect of lucerastat on neuropathic pain. Prespecified secondary endpoints included assessments of renal function and cardiac parameters. An ongoing open-label extension study is evaluating the long-term safety and tolerability of lucerastat for up to 72 months.

A total of 118 participants were enrolled, with 117 receiving at least 1 dose of study treatment. Overall, 109 participants completed the 6-month double-blind phase, 107 entered the open-label extension, and 78 remained ongoing at the 18-month interim analysis.

The least squares mean (LSM) eGFR slope (mL/min/1.73 m² per month) was +0.26 in the lucerastat group compared with +0.08 in the placebo group, corresponding to annualized changes of approximately +3.12 and +0.96 mL/min/1.73 m² per year, respectively. The LSM treatment difference was not statistically significant (LSM difference, 0.19; 95% Confidence Interval [CI], -0.40 to 0.78; 

Changes in the urine albumin-to-creatinine ratio from baseline were not normally distributed. Therefore, investigators analyzed log-transformed data, where LSM exhibited a percentage change difference of +16.2% (95% CI, -23.9 to 77.3; 

 = .4875), indicating no significant difference between treatment groups, according to investigators.

In a post hoc analysis stratified by sex, investigators did not observed a difference in mean eGFR change from baseline between treatment groups. A slight increase in eGFR was observed among male participants, while female participants showed no significant change from baseline.

In an exploratory, post hoc subgroup analysis of participants with impaired renal function at baseline (screening eGFR <90 mL/min/1.73 m²; n = 40), mean eGFR increased by 3.8 mL/min/1.73 m² from baseline to month 6 in the lucerastat group (n = 27), compared with a decrease of 1.6 mL/min/1.73 m² in the placebo group (n = 13). Investigators did not report any notable changes among participants without baseline renal impairment (n = 77).

“Although the study was not designed to evaluate the impact of lucerastat on renal function because of the short duration of the controlled phase, results from MODIFY and its long-term extension suggest a possible effect on renal outcomes, particularly among patients with greater medical need, such as those with reduced renal function at baseline,” investigators concluded.

Nordbeck P, Ozlem Goker-Alpan, Bernat JA, et al. Lucerastat, an oral therapy for Fabry disease: results from a pivotal randomized phase 3 study and its open-label extension. 

. Published online January 10, 2026. doi:

https://doi.org/10.1038/s41467-025-68256-5

Sunder-Plassmann G. Renal manifestations of Fabry disease. PubMed. Published 2006. 

https://www.ncbi.nlm.nih.gov/books/NBK11571/

Articles

Lucerastat, an oral glucosylceramide synthase inhibitor, was evaluated in the phase 3 MODIFY trial for its efficacy, safety, and tolerability in adults with Fabry disease. Although the trial was not designed to assess renal endpoints, exploratory analyses suggested a potential renal benefit, particularly in participants with reduced kidney function at baseline. The trial's primary focus was on neuropathic pain, with secondary endpoints including renal function. Despite the lack of statistically significant findings, the results indicate a possible effect on renal outcomes, warranting further investigation in long-term studies.

Post hoc MODIFY data showed no significant eGFR or UACR benefit with lucerastat, though exploratory signals appeared in patients with baseline renal impairment.

Clinical

clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

News

news page, resources on the topics of disease- and specialty-specific medical news and expert insight can be found. Content includes articles, interviews, videos, podcasts, and breaking news on health care research, treatment, and drug development.

Nephrology

The HCPLive nephrology page is a resource for medical news and expert insights on kidney disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in nephrology, and more.

Chronic Kidney Disease

RDR Alert®

The Rare Disease Report page is a resource for medical news and expert insights on rare diseases. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for sickle cell disease, multiple myeloma, and more.

Phase 3 MODIFY Shows No Significant Renal Benefit With Lucerastat in Fabry Disease

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

Analysis Shows Childhood Overweight and Obesity Influence Dyslipidemia, Diabetes, NAFLD Risk | Image Credit: Pexels

A significant portion of US children aged 6-17 with overweight and obesity have borderline or abnormal cardiometabolic risk markers for 

, and non-alcoholic fatty liver disease, with higher body mass index (BMI) measures correlating to a greater likelihood of abnormal lab values, according to a recent study.

Obesity and severe obesity have been rising steadily across the country since 1980; in 2017 and 2018, >4.5 million children and adolescents had severe obesity. In 2000, the Centers for Disease Control and Prevention (CDC) released a series of BMI-for-age growth charts, which were based on data from 1963-1980. However, these charts did not extend beyond the 97th percentile. To that end, the CDC developed new percentiles, aiming to evaluate and monitor very high BMI values. These charts were released in 2022 and form the backbone of the present study.

“It is well established that many youths with obesity have cardiometabolic risk factors, but research to date has not yet assessed risk by CDC’s extended BMI percentiles (BMIp),” Samantha Pierce, MPH, an epidemiologist at the CDC, and colleagues wrote. “Understanding what thresholds of extended BMIp are associated with obesity-related comorbidities is important for both clinical practice and the health services research field.”

Pierce and colleagues collected data from IQVIA’s Ambulatory Electronic Medical Record (AEMR)-US database, including laboratory test results and medication orders. Patient data was then cleaned cross-sectionally, excluding outlier values, including height-for-age 

-score < -4 or >10, or BMI <150 kg/m2. BMI was categorized based on the CDC’s extended BMIp: <5th percentile (underweight), ≥5th to <85th (healthy weight), ≥85th to <95th (overweight), and 4 obesity subcategories, including 95th to <98th (moderate or class 1 obesity), 98th to <99th, 99th to <99.9th, and ≥99.9th percentile.

Ultimately, a total of 282,709 patients were included in the study; all patients were aged 6-17 years and had a BMI ≥85th percentile for sex and age in 2022. Patients were excluded if they had a prescription for a statin, insulin, or other diabetes medication, among other conditions. Pierce and colleagues extracted nonmissing, nonzero results for 6 laboratory tests, including total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides. HbA1c was used for diabetes lab tests, and alanine aminotransferase for nonalcoholic fatty liver disease.

Ultimately, among the 282,709 patients included, roughly 43% had BMIp 85th to <95th (overweight), 32% had BMIp ≥95th to <98th, and 10% had BMIp ≥98th to <99th. The remaining 15% had BMIp ≥99th percentile. Males had a higher proportion in the 95th to <98th percentile than females (34% vs 30%) but a lower proportion in the 85th to <95th percentile (40% vs 46%) (

Overall, patients in higher extended BMIp categories had a higher prevalence of borderline or abnormal HbA1c (aPR range: 1.46 to 2.79), ALT (aPR range: 1.58 to 2.59), triglycerides (aPR range: 1.24 to 1.46), total cholesterol (aPR range: 1.11 to 1.23), HDL-C (aPR range: 1.4 to 1.94), and LDL-C (aPR range: 1.23 to 1.55). Dose-response relationships were also observed for several cardiometabolic biomarkers, and similar patterns were found for abnormal lab values.

“Understanding what thresholds of BMIp are associated with these chronic disease markers can facilitate clinical practice, including identifying patients at highest risk and informing when to escalate evaluation or treatment of children and adolescents with excess weight,” Pierce and colleagues wrote.

Pierce SL, Porter RM, Kompaniyets L, He S, Goodman AB. Examining biomarkers for dyslipidemia, diabetes, and NAFLD by CDC’s 2022 extended BMI percentiles in US youth aged 6–17 years. 

Centers for Disease Control and Prevention. CDC Extended BMI-for-Age Growth Charts. CDC. September 2, 2024. Accessed January 16, 2026. 

https://www.cdc.gov/growthcharts/extended-bmi.htm

A recent study highlights the prevalence of borderline or abnormal cardiometabolic risk markers among US children aged 6-17 with overweight and obesity. The study utilized the CDC's 2022 extended BMI-for-age growth charts to assess the correlation between high BMI percentiles and cardiometabolic comorbidities. Data from 282,709 patients revealed that higher BMI percentiles were associated with increased prevalence of abnormal lab values for dyslipidemia, diabetes, and non-alcoholic fatty liver disease. The findings underscore the importance of identifying BMI thresholds linked to chronic disease markers to inform clinical practice.

Recent research shows a substantial portion of US youths have increased risk of cardiometabolic diseases due to obesity and overweight.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Dyslipidemia

Analysis Shows Childhood Overweight and Obesity Influence Dyslipidemia, Diabetes, NAFLD Risk

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

New findings suggest a newly-developed topical antioxidant combination of vitamins C and E with ferulic acid may increase wound healing speed and reduce common post-laser complications following ablative CO₂ treatment for those with 

These data were authored by several investigators, including Wei Zhang, MD, the chief physician at the Shanghai Skin Disease Hospital. Zhang and coauthors’ analysis pointed to previous clinical research on a combination treatment of acne scars using vitamin C, vitamin E, and ferulic acid.

However, the investigative team noted a lack of post-laser recovery data with this formulation in previous studies. They sought to expand upon their findings with this analysis.

“To address this gap, this trial aims to assess the postoperative reparative effects of an antioxidant serum, known as CE Ferulic serum, after ablative fractional CO2 laser treatment in the Chinese population with atrophic acne scars compared with a placebo comparator (normal saline),” Zhang and colleagues wrote.

Using a randomized, investigator-blinded, split-face controlled study design, the investigative team set out to assess post–laser wound recovery among patients using this topical antioxidant serum. Enrollment of participants in the trail occurred over a 60-day period between December 2020 - January 2021, with Zhang et al recruiting adults between 18 - 50 years of age who presented with moderate-to-severe atrophic facial acne scarring.

Scar severity was determined by the investigators via the échelle d’évaluation clinique des cicatrices d’acné (ECCA) system of grading. This classification system features a range of scores, with 16 - 45 being considerate moderate and 46 - 80 being considered severe. Participants deemed eligible were randomly assigned in a split-face design to receive CE Ferulic on 1 side of the face and normal saline on the opposite side. This process took place immediately following ablative CO₂ laser resurfacing.

Application of both of these treatments were applied by Zhang and colleagues for a total duration of 14 days, with the investigators assessing outcomes being blinded to treatment allocation. Those taking part were additionally stratified into subgroups with the team based on application frequency. Some of these subjects received the assigned product once-per-day and others received the treatment twice daily. All throughout the 14-day follow-up period, they assessed multiple parameters related to wound healing and skin barrier function.

The primary marker of acne wound recovery was determined to be scabbing status at the 7-day mark. In their secondary assessments, Zhang and coauthors looked into shifts in erythema index (EI), melanin index (MI), transepidermal water loss (TEWL), and hydration of the skin. They did not aim to directly assess improvement in acne scar appearance. There were 64 patients included by the investigative team in the final analysis.

Findings on Topical Antioxidant Treatment

At Day 7, complete scab detachment was significantly increased in the topical antioxidant–treated side compared with the saline-treated control side of patients’ faces. Specifically, rates were 60.9% versus 34.4%, respectively (

 = .0026). Erythema and pigmentation reductions were consistently greater on the intervention side, as evidenced by significantly lower EI and MI values at the 3, 7, and 14-day marks (

 < .0001 for all comparisons). By Day 14, the CE Ferulic–treated skin also was shown to have superior ability to retain moisture and preserve its barrier integrity. This, Zhang et al highlighted, suggested significantly improved skin hydration (

 = .0246) compared with the control side.

“In conclusion…[we] found that a combination of vitamin C, E, and ferulic acid helped to improve wound healing, reduce erythema and melanin levels, and maintain skin barrier function following ablative fractional CO2 laser treatment compared with normal saline, suggesting its potential to promote skin repair and prevent post-inflammatory hyperpigmentation,” they concluded.

Shi Y, Xu S, Zhang W. Reparative Effects of a Topical Antioxidant Serum Containing Vitamin C, Vitamin E, and Ferulic Acid After Ablative Fractional CO2 Laser Treatment for Atrophic Acne Scars: A Randomized, Investigator-Blinded, Split-Face, Controlled Trial. J Cosmet Dermatol. 2026 Jan;25(1):e70634. 

Lin FH, Lin JY, Pinnell SR, et al. Ferulic acid stabilizes a solution of vitamins C and E and doubles its photoprotection of skin. J Invest Dermatol. 2005 Oct;125(4):826-32. doi: 10.1111/j.0022-202X.2005.23768.x. PMID: 16185284.

A newly-developed topical antioxidant serum combining vitamins C, E, and ferulic acid has shown promise in enhancing wound healing and reducing post-laser complications in patients with atrophic acne scars. A randomized, investigator-blinded, split-face controlled study involving 64 participants demonstrated that the serum significantly improved scab detachment, reduced erythema and pigmentation, and enhanced skin hydration and barrier function compared to a saline placebo. These findings suggest the potential of this antioxidant formulation to promote skin repair and prevent post-inflammatory hyperpigmentation following ablative fractional CO₂ laser treatment.

Investigators assessed the post-procedure reparative impact of a combination of vitamin C, E, and ferulic acid treatment in patients in China with atrophic acne scars.

Acne

The HCPLive acne page is a resource for medical news and expert insights on dermatological disease. This page features expert-led coverage, articles, videos, and research on the therapies and development of treatments for chronic acne, and more.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

Topical Antioxidant Serum May Be Effective in Treating Atrophic Acne Scars

Julia E. M. Upton, MD, MPH, from the Food Allergy and Anaphylaxis Program at The Hospital for Sick Children in Toronto

Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

very low–dose oral immunotherapy (VLOIT) can both meaningfully and safely increase tolerated doses across multiple nuts

In 18 children allergic to 2 to 5 nuts, a low, slow escalation strategy to a 30 mg per nut maintenance dose led to significant gains in reaction thresholds by 18 months, with mean tolerated doses reaching 1000 mg. Most participants achieved at least a 5-fold increase over baseline, and many tolerated amounts associated with protection from accidental exposure. Adherence approached 100%.

VLOIT demonstrated safety and tolerability, with no epinephrine use, serious adverse events, or hospitalizations reported during the study. Adverse effects were generally mild, most commonly abdominal pain or transient oral discomfort during home dosing. Immunologic outcomes aligned with clinical improvements, including reductions in skin prick test wheal sizes, decreases in allergen-specific IgE, and increases in IgG4 blocking antibodies.

In the Q&A that follows, study investigator Julia E. M. Upton, MD, MPH, from the Food Allergy and Anaphylaxis Program at The Hospital for Sick Children in Toronto, explains the rationale behind selecting a 30 mg per nut maintenance dose and why this threshold may be sufficient for real-world protection against accidental exposures. She also discusses how the safety profile compares with that of higher-dose OIT, how immunologic changes are tracked with clinical outcomes, and what the findings mean for the quality of life in families managing multiple food allergies. Upton also outlines ongoing and future trials aimed at defining the minimal effective dose needed to balance efficacy, safety, and treatment burden.

 How do you determine that a 30 mg per nut maintenance dose would be sufficient for meaningful desensitization?

 We picked 30 mg of each nut protein as the amount for maintenance dosing because it is easily measurable and is 1/10 of a commonly used dose. We looked at how well it worked with food challenges. At the start of the study, we fed the nuts to the children under medical supervision. We proved they were allergic to peanuts and that they reacted to 444 mg or less. We started with tiny amounts and increased to about 30 mg protein of each nut with up doses about every 2 months. For peanut butter, this would be about 1/32 tsp of peanut butter. We then fed them again, 18 months after starting oral immunotherapy, to see how much they could safely eat.

 The study reports that most participants tolerated 5 times their baseline dose or ≥ 300 mg per nut. How significant is this increase in tolerated dose for day-to-day allergy management and accidental exposure risk?

 We know from other studies that, if a person can safely eat about 1 peanut (about 300 mg), then they have an extremely low chance of having accidental exposure reactions because most foods do not accidentally contain this amount. So being able to safely eat 300 mg provides the reassurance that an accidental exposure reaction is very unlikely. Hopefully, this gives children and families some peace of mind and helps to lessen the fear around food.

 How does the safety profile of VLOIT compare to traditional high-dose OIT protocols in children?

 In this multi-nut study, no child required [an] epinephrine autoinjector with dosing at home. This study does not compare to higher doses. In a different study, we had children randomly assigned to peanut OIT up to 30 mg maintenance, 300 mg maintenance doses, or avoidance. The safety analyses in that study found that the children assigned to 30 mg had fewer systemic allergic reactions and a trend toward fewer withdrawals (0 in the 30 mg group and 3 in the 300 mg group).

 How well did reductions in skin prick test wheal size align with clinical outcomes?

 The skin prick tests to the treated nuts also decreased over the 18 months. We also saw other immunological improvements: IgG4 went up, and the basophil activation test showed reduced degranulation. Overall, the immunological tests supported what we observed clinically: that very low dose OIT works to increase how much nut protein a child can safely ingest.

 How do improvements in social and dietary restrictions per parent-reported FAQLQs translate to practical benefits for families managing multiple food allergies?

 The main objective of this study was to see whether these low doses could increase the amount of food a child with a nut allergy could safely eat. Food allergy is so important for quality of life that we explored QOL. We performed this QOL survey at the start and at the end. Importantly, the QOL survey at the end was administered before they knew their food challenge result, which, for most, showed they could eat far more nuts safely than at the start of the study. It is reassuring that we saw some quality of life improvements just from eating the tiny amounts in the study, before they knew what they had achieved for desensitization. We want children and their families to feel safe and confident, and we are encouraged we saw some improvements in these scales even in this small study.

 How important is the ongoing trial comparing 30 mg versus 300 mg peanut OIT in determining the optimal minimal dose for efficacy?

 The ongoing trial with our group and Montreal Children's Hospital is more rigorous to examine safety and efficacy because the children are assigned to 30 mg or 300 mg in a blinded and randomized trial, and the food challenges are also performed in a rigorous, blinded, and placebo-controlled manner. This multi-nut trial shows that multi-nut allergies can be safely treated for many, even if only using a small amount of nut butters and with up-dosing visits spread out to every two months. Together, these studies may help to allow OIT to be delivered in a way that reduces the burden on the families and the health-care system with fewer visits, less taste aversion, less systemic allergic reactions, and hopefully more adherence and improvements to quality of life.

 What is next for future research on this topic?

 We will soon report our 21-month outcome experience with our randomized trial of 30 and 300 mg maintenance doses. We have also implemented 30 mg as our initial maintenance dosing in our food immunotherapy clinics, and we are in the process of collecting our real-world experience with this dosing.

Derman C. HCPLive. Very Low-Dose OIT Safely Increases Multi-Nut Tolerance in Young Children. Published on January 9, 2026. Accessed on January 16, 2026. 

https://www.hcplive.com/view/very-low-dose-oit-safely-increases-multi-nut-tolerance-young-children

Upton JEM, Li CH, Berenjy A, et al. Safety and Efficacy of Very Low-Dose Multi-Nut Oral Immunotherapy in Children. 

. 2025;15(12):e70125. doi:10.1002/clt2.70125

A recent study indicates that very low-dose oral immunotherapy (VLOIT) can significantly and safely increase tolerance to multiple nuts in children with food allergies. Involving 18 children allergic to 2-5 nuts, the study used a low, slow escalation strategy to a 30 mg per nut maintenance dose, resulting in substantial increases in reaction thresholds by 18 months. VLOIT showed a favorable safety profile, with no serious adverse events. Immunologic improvements correlated with clinical outcomes, and quality of life enhancements were reported. Ongoing trials aim to optimize dosing for efficacy and safety.

Upton discusses an open-label trial showing a 30 mg per nut very low-dose oral immunotherapy strategy increased multi-nut tolerance and remained safe in children.


Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Food Allergy

VLOIT Boosts Multi-Nut Tolerance in Children, With Julia E. M. Upton, MD, MPH

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration (FDA) clearance of Medtronic’s MiniMed Go Smart Multiple Daily Injection app for use by pediatric and adult patients with type 1 diabetes or type 2 diabetes, the approvals of Neurolief’s ProlivRx brain neuromodulation therapy for adults with major depressive disorder (MDD) who did not respond to ≥ 1 antidepressant and Emergent BioSolutions’ supplemental New Drug Application (sNDA) for over-the-counter naloxone HCl Nasal Spray 4 mg (Narcan) to be packaged in a new carrying case to improve ease of transport and usability, extension of the review timeline for Travere Therapeutics’ sNDA for sparsentan (Filspari) for focal segmental glomerulosclerosis (FSGS), and request to remove information regarding the risk of suicidal ideation and behavior (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications that include such language.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of January 11, 2025—let’s jump in!

FDA Clears MiniMed Go Smart MDI App for Adults and Children with T1D, T2D

On January 12, 2026, the FDA granted 510(k) clearance to Medtronic’s MiniMed Go Smart Multiple Daily Injection (MDI) app for use by patients with type 1 diabetes or type 2 diabetes aged ≥7 years, as well as for children between 2-6 years under adult supervision.

The MiniMed Go Smart MDI system integrates the InPen smart insulin pen with the Instinct sensor developed by Abbott, all of which are connected through the MiniMed Go app. The system provides users with missed dose alerts to minimize glucose highs, action-oriented guidance in the event of a missed or miscalculated dose, and a dose calculator to simplify dose decision-making.

FDA Approves ProlivRx, First At-Home Neuromodulation Device for MDD

On January 12, 2026, the FDA approved Neurolief’s ProlivRx, the first at-home, physician-directed brain neuromodulation therapy for adults with MDD who did not respond to ≥ 1 antidepressant. The therapy can be delivered at home under physician supervision, eliminating the access and operational challenges of clinic-based treatments.

The approval was supported by clinical evidence from the MOOD Study, a randomized, controlled, multicenter clinical trial, evaluating ProlivRx in MDD with inadequate response to antidepressant medications.

FDA Requests Removal of Suicidal Ideation and Behavior Warning From GLP-1 RA Therapies

On January 13, 2026, the FDA requested the removal of information regarding the risk of suicidal ideation and behavior (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications that included such language. Affected products include liraglutide (Saxenda), semaglutide (Wegovy), and tirzepatide (Zepbound). The action follows a comprehensive FDA review that found no increased risk of SI/B associated with the use of GLP-1 RA medications.

FDA Extends Sparsentan (Filspari) sNDA Review for Focal Segmental Glomerulosclerosis

On January 13, 2026, Travere Therapeutics announced the FDA extension of the review timeline for the Company’s sNDA of sparsentan (Filspari) for FSGS. The Agency moved the Prescription Drug User Fee Act (PDUFA) target action date, which was expected on January 13, 2026, to April 13, 2026. No additional information relating to the safety or manufacturing of the drug was requested.

FDA Approves New Narcan Packaging, Aiming to Boost Carry Rates

On January 14, 2026, the FDA approved Emergent BioSolutions’ sNDA for over-the-counter (OTC) naloxone HCl Nasal Spray 4 mg (Narcan) to be packaged in a new carrying case to improve ease of transport and usability.

The new case includes 2 blister packs, each enclosed with Quick Start Guide, and is designed to be compact, discreet and durable, with the goal of making naloxone more readily carried and available. The new design aims to reduce the stigma often associated with carrying naloxone and to increase its rates of carry and chances of its use in emergencies.

The FDA has recently cleared Medtronic's MiniMed Go Smart MDI app for pediatric and adult diabetes patients, enhancing insulin management. Neurolief's ProlivRx, an at-home neuromodulation device for major depressive disorder, received FDA approval, offering a new treatment avenue for patients unresponsive to antidepressants. The FDA also requested the removal of suicidal ideation warnings from GLP-1 RA therapies, citing no increased risk. Additionally, the FDA extended the review timeline for Travere Therapeutics' sparsentan for FSGS and approved new Narcan packaging to improve accessibility and usability.

Stay updated with the latest healthcare breakthroughs, including FDA approvals and clearances, in this week’s essential news roundup.

Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

Obesity Management

Obesity Management condition center page, resources on the topics of medical news and expert insight into clinical weight management can be found. Content includes articles, interviews, videos, podcasts, and breaking news on obesity research, treatment, and drug development.

The HCPFive: Top News for Healthcare Providers from the Week of 01/11

Videos

Wang discusses results from a recent study, comparing multiple forms of intravenous and oral iron supplements in female patients with heavy menstrual bleeding.

Hematology

Anemia

IV Iron Dextran is the Most Cost-Effective Treatment for Iron Deficiency Anemia in HMB, With Daniel Wang

Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

Higher accuracy lung biopsy could make a strong impact on lung cancer diagnoses and outcomes.

Lung Cancer

Pulmonology

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

FDA News

FDA Clears LEADOPTIK's LIA System for Higher-Accuracy Lung Biopsy 

In this analysis, the rates of survival of primary cutaneous melanoma were evaluated based on the delay of definitive surgery.

Melanoma Surgery Delay After 4 Weeks Post-Diagnosis Decreases Survival Rates

Nancy Reau, MD, is Professor of Internal Medicine, Richard B. Capps Chair of Hepatology, Associate Director of Solid Organ Transplantation, and Section Chief of Hepatology at Rush University Medical Center.

Podcasts

Reau and Brown discuss emerging research in liver transplantation and hepatocellular carcinoma from AASLD The Liver Meeting 2025.

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

Liver Lineup: Updates & Unfiltered Insights

Introducing Liver Lineup: Updates & Unfiltered Insights — an exciting new podcast delivering timely, candid perspectives on the most pressing topics in the fast-moving world of hepatology. Created by Nancy Reau, MD, and Kimberly Brown, MD, and hosted by HCPLive, this series dives into the cutting edge of liver disease research, clinical care, and real-world practice.

Hepatology

Liver Lineup: Bridging Innovation and Practice in Liver Transplant and HCC Care

In children with CKD and iron deficiency anemia, iron polymaltose complex improved hemoglobin and TSAT, while liposomal iron was better tolerated.


Iron Polymaltose Complex Outperforms Liposomal Iron in Pediatric CKD Anemia

A 12-week study found that combining CBT with quetiapine lowered suicide risk more than quetiapine alone in adults with depressive or bipolar disorders.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

Adding CBT to Quetiapine Significantly Reduces Suicide Risk in Mood Disorders

Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

Diana Isaacs, PharmD, and Natalie Bellini, DNP, review tech updates from Sequel Med Tech, Diabeloop, and Medtronic.

Type 2 Diabetes

Type 1 Diabetes

Diabetes Dialogue

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives is a monthly podcast hosted by Diana Isaacs, PharmD, and Natalie Bellini, DNP, aimed at providing a regular roundup of the latest clinically applicable insights across diabetes and metabolic diseases, with a focus on leveraging technology to improve care.

Strategic Alliance Partnership

Diabetes Dialogue: Tech Updates on Twiist, MiniMed Go, and More

Sidhartha Sinha, MD, is an assistant professor of gastroenterology and hepatology at Stanford University.

Sinha explains current unmet needs in mild Crohn’s, the shortcomings of steroids for these patients, and what benefits a fasting-mimicking diet may offer.

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

Inflammatory Bowel Disease

On the HCPLive inflammatory bowel disease page, resources on the topics of medical news and expert insight into IBD can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBD and more.

When Medications Fall Short: Exploring Diet in Mild Crohn’s Disease, With Sidhartha Sinha, MD

A population-based analysis suggests age and sex specific eGFR percentiles and a web-based calculator can identify CKD risk before diagnostic thresholds. 


Age, Sex Specific eGFR Percentiles May Enable Earlier CKD Detection

This study analyzed the Chronic Urticaria Registry (CURE), evaluating CSU treatment patterns and looking into unmet needs in real-world practice.

Urticaria

The HCPLive urticaria page is a comprehensive resource for clinical news and insights on chronic idiopathic urticaria and chronic spontaneous urticaria. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for urticaria, and more.

Latest News

Phase 3 MODIFY Shows No Significant Renal Benefit With Lucerastat in Fabry Disease

Analysis Shows Childhood Overweight and Obesity Influence Dyslipidemia, Diabetes, NAFLD Risk

Topical Antioxidant Serum May Be Effective in Treating Atrophic Acne Scars

VLOIT Boosts Multi-Nut Tolerance in Children, With Julia E. M. Upton, MD, MPH

The HCPFive: Top News for Healthcare Providers from the Week of 01/11