Rachael Sood, NP, is a diabetes nurse practitioner and Owner and CEO of The Diabetes Collective.

FDA Proposes Exclusion of Multiple GLP-1 RAs from Bulks List, With Raechel Sood, NP

 semaglutide, tirzepatide, and liraglutide from the 503B bulks list.

The 503B bulks list collects bulk drug substances for compounding by outsourcing facilities, according to the conditions of section 503B of the Federal Food, Drug, and Cosmetic Act. These facilities can rarely compound drugs with these substances unless they appear on the list, or if the drug is on the FDA’s drug shortage list.

“Compounded medications have been around for a very long time,” Rachael Sood, NP, founder and chief executive officer of the Diabetes Collective and a speaker and clinical expert for Sanofi, Eli Lilly, Dexcom, and more, told 

 in an exclusive interview. “We’ve been using them in different spaces, not just in GLP-1s. This is not the first time, but there has certainly been some overuse and abuse, I believe, of some privileges and mass production of these medications, which can put patients at harm. The FDA is trying to take precautions.”

This announcement comes on the heels of a statement on April 1, 2026, in which the FDA clarified its policies for compounders as the national shortage of GLP-1 drugs and components stabilized. The statement emphasized the strict criteria for compounded drugs, including that the drug is compounded based on a received prescription and that the manufacturer does not compound drugs considered to be essentially copies of commercially available products.

From 2022 until February of 2025, the US experienced a nationwide shortage of semaglutide products, specifically Ozempic and Wegovy. This was largely attributed to increased demand, given the drugs’ efficacy and popularity following their release into the market. Prior research indicated that semaglutide prescription fills rose by roughly 442% between January 2021 and December 2023. During this shortage, pharmacies across the country created lower-cost, compounded versions of Ozempic and Wegovy, operating under an exception to produce copies of these drugs.

On February 21, 2025, the FDA announced the resolution of this shortage after reviewing data from Novo Nordisk regarding its production and inventory of Ozempic and Wegovy. Since then, the drugs have shown no sign of further shortages, and the release of multiple alternative GLP-1 RA treatments has provided a plethora of alternatives should the issue arise again. Sood also addressed this, commenting on the unlikelihood of needing compounded therapies to account for similar shortages in the future.

“During the shortage, I would switch doses around. I would either increase or decrease a dose. I would try to go to a different pharmacy, I would change a medication we have,” Sood said. “We have 13, 14, maybe 15 different GLP-1s to prescribe now; we don’t have very many shortages of many of these medications, and now that we have so many options, I don’t really see this being a problem.”

Notably, this present announcement is not final – the FDA encourages parties to submit comments via the docket by June 29, 2026. According to the release, the FDA will consider these comments before a final determination is announced.

Editors’ Note: Sood reports no relevant disclosures.

US Food and Drug Administration. FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List. April 30, 2026. Accessed May 1, 2026. 

https://content.govdelivery.com/accounts/USFDA/bulletins/41537f8

US Food and Drug Administration. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. April 1, 2026. Accessed May 1, 2026. 

https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize

Billingsley A. Is Semaglutide in Shortage? The Latest on Ozempic and Wegovy Availability. 

. August 18, 2025. Accessed May 1, 2026. 

https://www.goodrx.com/classes/glp-1-agonists/semaglutide-shortage?srsltid=AfmBOorCqzazDrEXShxG2U7I3iOpYR7DXNspvQx0wpfw6xRG1rOGtZqW

US Food and Drug Administration. Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Ozempic and Wegovy). February 21, 2025. Accessed May 1, 2026. 

https://www.fda.gov/media/185526/download

Videos

Sood shares her thoughts on the recent announcement by the FDA, limiting pharmacies’ ability to compound semaglutide, tirzepatide, and liraglutide from bulk substances.

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

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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.

Type 2 Diabetes

Pranav Garimella, MBBS, MPH, is chief medical officer of the American Kidney Fund.

Professor of Medicine and Renal Division Chief at the University of Pennsylvania Perelman School of Medicine

John Cijan He, MD, PhD, is a Professor of Medicine and Pharmacological Sciences and Chief of the Division of Nephrology at the Icahn School of Medicine at Mount Sinai.

Katalin Susztak, MD, PhD, is a Professor of Medicine and Genetics at the University of PennsylvaniaKatalin Susztak, MD, PhD, is a Professor of Medicine and Genetics at the University of Pennsylvania

Kristin Meliambro, MD, is an Associate Professor in the Department of Medicine, Division of Nephrology at the Icahn School of Medicine at Mount Sinai.

APOL1-Mediated Kidney Disease: From Genetic Discovery to the Edge of Precision Medicine


A decade and a half after APOL1 was linked to kidney disease, clinicians are still grappling with misdiagnosis, unpredictable progression, and uneven access to genetic insight, just as targeted therapies begin to emerge.

Kirk Campbell, MD, Professor of Medicine and Chief of the Renal Division at the University of Pennsylvania Perelman School of Medicine.

Pranav Garimella, MD, Chief Medical Officer of the American Kidney Fund,

Katalin Susztak, MD, PhD, is a Professor of Medicine and Genetics at the University of Pennsylvania

John Cijan He, MD, PhD, Professor of Medicine and Pharmacological Sciences and Chief of the Division of Nephrology at the Icahn School of Medicine at Mount Sinai

A Genetic Discovery That Reshaped Kidney Disease Risk

In the span of roughly 16 years, APOL1 has moved from evolutionary curiosity to one of the most important genetic risk factors in nephrology.

The G1 and G2 variants, enriched in populations with West and Central African ancestry, rose in frequency because they confer protection against 

 infection. Today, they are recognized as among the strongest common genetic risk factors for kidney disease.

Approximately one-third of African Americans carry at least one high-risk APOL1 variant, and about 14% carry the high-risk genotype—two risk alleles in combinations such as G1/G1, G2/G2, or G1/G2. Globally, more than 100 million people in sub-Saharan Africa are estimated to carry two risk variants, with frequencies reaching 37% in parts of Ghana and 50% in southeastern Nigeria.

“It is a long time,” said Campbell. “But the fact that it took 13 years from the discovery of APOL1 kidney disease genetic association to the first proof-of-concept APOL1 inhibitor efficacy report should be celebrated.”

At the same time, Campbell emphasized ongoing uncertainty:

“There are still no approved APOL1-specific therapies, no consensus on population screening, limited ability to predict who among carriers will progress, and unresolved questions about ‘second hits,’” he said.

Rethinking a Default Diagnosis: Hypertension as Explanation — or Misclassification

Before APOL1 can be treated, it must be recognized—and that remains a persistent challenge.

Hypertensive nephrosclerosis has long served as a default diagnosis for chronic kidney disease in patients with hypertension, particularly Black patients. But emerging evidence suggests this label often obscures more specific and potentially treatable disease.

One biopsy-based study found that clinical criteria for nephrosclerosis had a sensitivity of just 0.13. Even optimized algorithms only reached 0.19, and roughly 40% of clinically diagnosed cases were found to have alternative diagnoses such as glomerulonephritis or interstitial nephritis.

Clinicians increasingly caution against treating hypertension as the primary explanation by default. “Hypertensive nephrosclerosis is often a diagnosis of exclusion,” Garimella noted. “Some patients labeled that way actually have APOL1-associated kidney disease, FSGS, or another primary kidney disorder.”

The reframing has clinical and psychological implications. Elevated blood pressure may in some cases be a consequence rather than a cause of kidney disease.

“Sometimes patients feel that explanation doesn’t fully make sense, especially if their hypertension hasn’t seemed severe,” Meliambro observed. “Recognizing that there may have been more going on can be validating rather than implying they did something wrong.”

The data on blood pressure management remain nuanced. Some studies show intensive blood pressure control does not necessarily slow progression in high-risk APOL1 carriers, while other data suggest a survival benefit with more intensive control compared with standard targets.

The introduction of a dedicated ICD code for APOL1-mediated kidney disease represents an important structural shift, enabling more precise diagnosis, counseling, and trial referral.

The Core Problem: Risk Without Prediction

While identifying APOL1 risk variants is now straightforward, predicting outcomes remains the central clinical challenge.

Carriers of two high-risk alleles face an estimated 15%–20% lifetime risk of kidney disease—meaning roughly 80% will never develop kidney failure.

“This represents a major knowledge gap,” Susztak explained. “If you receive a genotype result, you start asking: should I be doing something specific to prevent disease?”

Traditional risk models have not resolved this. Polygenic risk scores have failed to improve prediction in APOL1 high-risk individuals. Clinical risk scores based on eGFR, proteinuria, age, and sex perform well in established disease but are not clinically meaningful in preserved kidney function, she said.

“Some work has suggested that the G1/G1 genotype might be associated with a higher risk of decline in GFR and also a younger age of developing kidney disease,” Meliambro noted, adding that this requires further validation. High-risk genotype is still defined as any two risk alleles.

To address this gap, researchers turned to proteomics.

In a study of approximately 1,400 African American individuals from the Penn Medicine Biobank—many with preserved kidney function and no proteinuria at baseline—researchers analyzed roughly 7,700 circulating proteins.

Using machine learning, they identified nine proteins that, combined with clinical variables, formed the APOL1 Proteomic Risk Score (APRS), achieving a time-dependent AUC of 86.5%.

Individuals in the highest-risk quintile had approximately a 60% probability of progressing to dialysis or transplant over 10 years, while those in the lowest-risk quintile had less than a 1% risk. The score outperformed both the Kidney Failure Risk Equation and polygenic risk scores.

“Some of these proteins are related to tissue damage in the kidney that is not reflected in creatinine levels or urinary protein,” Susztak said. “For example, markers like MMP7 and matrix proteins may reflect fibrosis or injury that isn’t detected with standard tests.”

Others reflect inflammatory and endothelial pathways.

The score has been validated in external cohorts, including UK Biobank and NIH-supported data, but remains a research tool.

“We need to incorporate this biomarker into clinical trials and demonstrate that it is actionable,” she said. “Currently, we can treat the disease but not cure it.”

What APOL1 Biology Is Revealing About Early Kidney Injury

Beyond prediction, APOL1 research is reshaping understanding of early disease biology.

“In African American patients, we know the APOL1 gene is a high-risk gene for what we call APOL1-mediated glomerular disease, which is essentially like FSGS,” said He. “When this gene is highly expressed, it can cause podocyte injury through specific cellular pathways.”

“Some of these proteins are related to tissue damage in the kidney that is not reflected in creatinine levels or urinary proteins,” Susztak said.

“Other proteins are linked to inflammation. APOL1 is strongly regulated by inflammation, so individuals with higher inflammatory states may be at greater risk.”

“And there are a few proteins related to endothelial injury that we are still working to understand.”

Together, these findings suggest injury may precede traditional clinical markers such as proteinuria or eGFR decline.

From Biology to Therapy: Precision Medicine Takes Shape

Mechanistic insight has enabled targeted drug development.

“Based on that mechanism, therapies have been developed to block the pathways activated by APOL1,” He said. “These inhibitors have shown promising results in reducing proteinuria in phase 2 studies, with ongoing phase 3 trials.”

Inaxaplin directly targets APOL1 pore formation in podocytes.

“This is a very specific, targeted therapy that inhibits the pore-forming function of the APOL1 protein,” Meliambro said. “It represents a true example of precision medicine in nephrology.”

Other approaches include antisense oligonucleotides and anti-inflammatory strategies.

Despite therapeutic advances, management remains standard CKD care.

“A two-risk-variant APOL1 genotype raises concern for progressive disease,” Garimella explained. “But the treatment backbone remains standard CKD care.”

That includes RAAS blockade, SGLT2 inhibitors when appropriate, blood pressure control, statins, and avoidance of nephrotoxins.

“APOL1 testing is worth considering when the result can change follow-up, trial eligibility, transplant donor counseling, or future targeted-treatment decisions,” Campbell said. “But it should come with counseling, and it should never replace a full kidney-disease workup.”

“Awareness only matters if it changes decisions such as diagnosis, counseling, testing, referral, or follow-up,” Garimella said.

The ICD code for APOL1-mediated kidney disease may help translate awareness into action.

Barriers to Integration and Uneven Adoption

Despite availability of testing, adoption remains inconsistent.

“It’s not necessarily ordering the test—it’s interpreting and explaining the results,” Meliambro said.

Barriers include lack of guidelines, limited genetic counseling infrastructure, and patient concerns about privacy and discrimination.

Equity Will Define the Impact of Precision Medicine

“Equitable access would require more than drug approval,” Campbell said. “It would require payer coverage for testing, counseling, nephrology referral, and medication.”

“Otherwise, we risk repeating the same inequities,” he said. “Patients with better access get tested and treated, while underserved populations remain underdiagnosed.”

The decision to hold a major consensus meeting in Accra reflects the field’s shifting center of gravity.

“This is a rapidly evolving field,” Meliambro said. “There has been substantial research progress. But there are still many unresolved questions—especially around predicting disease progression and translating this knowledge into improved patient outcomes.”

“There is significant investment and enthusiasm,” she added. “Hopefully that will lead to meaningful breakthroughs in the near future.”

Campbell reports relevant disclosures with NIH, National Kidney Foundation. Garimella reports relevant disclosures with NIH. Meliambro reports no relevant disclosures identified. Susztak reports relevant disclosures with NIH. He reports no relevant disclosures identified.

Genovese G, Friedman DJ, Ross MD, et al. Association of trypanolytic ApoL1 variants with kidney disease in African Americans. Science. 2010;329(5993):841-845. doi:10.1126/science.1193032

Tzur S, Rosset S, Shemer R, et al. Missense mutations in the APOL1 gene are highly associated with end stage kidney disease risk previously attributed to the MYH9 gene. Hum Genet. 2010;128(3):345-350. doi:10.1007/s00439-010-0861-0

Friedman DJ, Pollak MR. APOL1 nephropathy: from genetics to clinical applications. Clin J Am Soc Nephrol. 2021;16(2):294-303. doi:10.2215/CJN.15161119

Gbadegesin RA, Ulasi I, Ajayi S, et al. APOL1 bi- and monoallelic variants and chronic kidney disease in West Africans. N Engl J Med. 2025;392:228-238. doi:10.1056/NEJMoa2403840

Hallan S, Øien CM, Garborg K, et al. Hypertensive nephrosclerosis: wider kidney biopsy indications may be needed to improve diagnostics. J Intern Med. 2021;289(4):527-540. doi:10.1111/joim.13146

Ojo A, Ulasi I, Freedman BI, et al. APOL1 kidney disease: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. Kidney Int. Published online June 23, 2025. doi:10.1016/j.kint.2025.04.029

Li C, et al. Proteomic risk score for early prediction of kidney disease progression in individuals with APOL1 high-risk genotypes. Nat Med. Published online April 15, 2026. doi:10.1038/s41591-026-04337-2

Egbuna O, Zimmerman B, Manos G, et al. Inaxaplin for proteinuric kidney disease in persons with two APOL1 variants. N Engl J Med. 2023;388(11):969-979. doi:10.1056/NEJMoa2202396

Vertex Pharmaceuticals Incorporated. Vertex advances inaxaplin (VX-147) into phase 3 portion of adaptive phase 2/3 clinical trial for the treatment of APOL1-mediated kidney disease. Press release. April 1, 2024. Accessed May 1, 2026. https://news.vrtx.com/news-releases/news-release-details/vertex-advances-inaxaplin-vx-147-phase-3-portion-adaptive-phase

Vertex Pharmaceuticals Incorporated. Vertex announces key advancements across kidney portfolio. Press release. September 25, 2025. Accessed May 1, 2026. https://news.vrtx.com/news-releases/news-release-details/vertex-announces-key-advancements-across-kidney-portfolio

Maze Therapeutics. Maze Therapeutics doses first patient in phase 2 HORIZON clinical trial evaluating MZE829 as a potential treatment for APOL1 kidney disease. Press release. February 7, 2025. Accessed May 1, 2026. https://ir.mazetx.com/news-releases/news-release-details/maze-therapeutics-doses-first-patient-phase-2-horizon-clinical

Maze Therapeutics. Maze Therapeutics announces positive topline data from phase 2 HORIZON trial of MZE829. Press release. March 25, 2026. Accessed May 1, 2026. https://ir.mazetx.com/news-releases/news-release-details/maze-therapeutics-announces-positive-topline-data-phase-2

Articles

APOL1 G1/G2 variants, selected for trypanosome resistance, are prevalent in people with West/Central African ancestry and drive substantial CKD and FSGS risk, yet progression remains poorly predictable. Hypertensive nephrosclerosis frequently misclassifies underlying glomerular or interstitial disease, prompting calls for more precise workups and use of the new APOL1-mediated kidney disease ICD code. A nine-protein APOL1 Proteomic Risk Score stratifies 10-year kidney failure risk far better than existing models. Targeted APOL1 inhibitors (eg, inaxaplin) and other modalities are advancing, while equitable access to testing, counseling, and therapy lags.

APOL1 research is driving precision nephrology, but prediction gaps and equity challenges still limit clinical impact.

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.

Strategic Alliance Partnership

APOL1-Mediated Kidney Disease: From Genetic Discovery to the Edge of Precision Medicine

Physician and CEO, Chicago Allergy Center, and board director at American Lung Association

BGF Triple Therapy FDA Approval Expands Asthma Options for Underserved Patients, With Juanita Mora, MD

The FDA's April 28, 2026 approval of budesonide/glycopyrrolate/formoterol fumarate (BGF; Breztri Aerosphere, AstraZeneca) for 

 maintenance in patients aged 12 years and older marks the first time a single-inhaler triple combination therapy has been available in the United States for this indication.

caught up with Juanita Mora, MD, an allergist-immunologist at Chicago Allergy Center, attending physician at Advocate Illinois Masonic Medical Center in Chicago, Illinois, and board director of American Lung Association, to learn more about the approval, which she sees as an overdue expansion of options for a large and underserved patient population.

BGF combines budesonide, an inhaled corticosteroid (ICS), with formoterol fumarate, a long-acting β₂-agonist (LABA), and glycopyrrolate, a long-acting muscarinic antagonist (LAMA), delivered via pressurized metered-dose inhaler using AstraZeneca's Aerosphere co-suspension technology. The addition of the LAMA to the established ICS/LABA backbone provides a complementary bronchodilatory mechanism through anticholinergic airway smooth muscle relaxation, addressing both the inflammatory and obstructive components of asthma in a single device. Breztri was previously approved for chronic obstructive pulmonary disease (COPD) in adults in July 2020, giving the regimen a substantial real-world safety and efficacy track record — a feature Mora noted provides additional confidence as the drug transitions into the asthma setting.

The approval was supported by data from the KALOS and LOGOS trials, twin phase 3, randomized, double-blind, double-dummy, multicenter studies enrolling approximately 4,300 patients with asthma inadequately controlled on medium- or high-dose ICS/LABA therapy, with treatment durations of 24 to 52 weeks. The least squares mean differences in morning pre-dose trough FEV₁ and FEV₁ AUC₀₋₃ over 24 weeks for BGF 28.8 μg versus the pooled budesonide–formoterol comparators were 76 mL (95% CI, 57–94; 

 <.0001), respectively. In the primary pooled exacerbation analysis, BGF 28.8 μg reduced the annualized severe exacerbation rate versus the combined budesonide–formoterol arms (incidence rate ratio, 0.86; 95% CI, 0.76–0.97; 

 = .012) and versus the suspension formulation specifically (IRR, 0.82; 95% CI, 0.71–0.94; 

 = .0043). Investigators noted that benefits were observed regardless of recent exacerbation history, suggesting BGF may be appropriate for escalation without requiring a preceding acute episode on ICS/LABA. The most common adverse events were nasopharyngitis, pneumonia, and headache; no treatment-related deaths occurred.

Mora framed the clinical significance of the approval around access as much as mechanism. An estimated 27 million Americans have asthma, with a substantial proportion — representing as many as half of those on existing inhaled maintenance therapy — remaining inadequately controlled on dual ICS/LABA regimens. For patients in that group who have not yet been able to see a specialist and initiate biologic therapy, BGF provides an additional pharmacologic option within the inhaled maintenance category that can be initiated and managed in primary care or general allergy settings. She emphasized this pathway as especially relevant for Hispanic and other underserved communities with limited specialty access, a patient population she serves directly in Chicago and one she has described as bearing a disproportionate burden of poorly controlled asthma.

“I think it's going to really especially for patients who maybe don't have as much access to a specialist where they can get a biologic,” Mora said. “[It’s] a wonderful option to open the doors for better control of our asthmatics.”

Mora has no relevant disclosures to report.

AstraZeneca. FDA approves BREZTRI AEROSPHERE® (budesonide/glycopyrrolate/formoterol fumarate) for asthma. Press release. April 28, 2026.

Bateman ED, O'Byrne PM, Rabe KF, et al. Budesonide/glycopyrronium/formoterol fumarate dihydrate versus budesonide/formoterol in patients with inadequately controlled asthma (KALOS and LOGOS): two multicentre, randomised, double-blind, double-dummy, phase 3 studies. 

. 2026. doi:10.1016/S2213-2600(25)00457-6

The first single-inhaler ICS/LABA/LAMA combination for asthma adds a mechanistically distinct bronchodilator to a well-established inhaled backbone.

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.

Chelsie Derman is an associate editor for 

who covers allergy and  psychiatry. 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.

 was defined by regulatory expansion, early-stage innovation, and emerging questions around how patients access mental health care. The US Food and Drug Administration (FDA) expanded the label for lumateperone (Caplyta) to include relapse prevention in schizophrenia. A White House executive order accelerated psychedelic research through coordinated action with the FDA and Drug Enforcement Administration (DEA), while clinical trials advanced rapid-acting and mechanism-driven approaches such as GH001. At the same time, increasing reliance on ChatGPT for mental health guidance raised new ethical and clinical oversight concerns for psychiatrists.

This month in review spotlights the 5 top psychiatry news stories in April 2026.

FDA Update: Extended Lumateperone Label for Schizophrenia

Lumateperone sNDA Approved with Relapse Prevention Data in Schizophrenia

The FDA approved a supplemental New Drug Application (NDA) for lumateperone, expanding its schizophrenia label to include relapse prevention. In the randomized withdrawal phase 3 trial, patients stabilized on lumateperone 42 mg had a 63% lower relapse risk versus placebo (HR, 0.37; 

 =.0002), with 84% remaining relapse-free at 6 months. Johnson & Johnson reported favorable time to relapse and discontinuation outcomes.

White House Push for Psychedelic Research

White House Order Accelerates Psychedelic Research for Mental Illness, With Gus Alva, MD

A White House executive order signed by Donald Trump on April 18, 2026, directs the FDA and DEA to accelerate psychedelic research for serious mental illness, including breakthrough therapy pathways, national priority vouchers, and ≥ $50 million in federal funding. In an 

 interview, Gus Alva, MD, of ATP Clinical Research, highlighted 5-HT2A–mediated neuroplasticity and models such as REBUS as potential mechanisms. Evidence from psilocybin (TRD) and MDMA (PTSD) trials shows promise, though blinding challenges, safety risks, and psychotherapy confounders remain key limitations.

Your Patient's New Therapist Is an AI. Now What?

As patients increasingly use ChatGPT for mental health advice, psychiatrists and ethicists warn of clinical and ethical risks. Richard Miller (Elwyn Adult Behavioral Health) noted AI may deliver decontextualized or misleading guidance, while Dominic Sisti (University of Pennsylvania) raised concerns about self-harm queries, privacy, and the need for guardrails. Darlene King (University of Texas Southwestern Medical Center) likened AI advice to that of an uninformed friend.

Despite risks, AI tools show promise in screening, biomarker-guided treatment, and documentation. Experts recommend clinicians proactively discuss AI use and maintain a “human-in-the-loop” approach.

Patients Bring ChatGPT to Psychiatry Visits, With Richard Miller, MD

AI in Psychiatry Raises Ethics Questions With Dominic Sisti, PhD

Single-Day GH001 for TRD Shows Rapid Response, With Michael E. Thase, PhD

In a phase 2b trial, single-day inhaled GH001 demonstrated rapid, clinically meaningful antidepressant effects in treatment-resistant depression (TRD), with significant MADRS improvement by day 8 (−15.5; 

<.001) and 57.5% remission vs 0% with placebo. In an 

 interview, Michael E. Thase (Perelman School of Medicine at the University of Pennsylvania) highlighted GH001’s individualized, single-day dosing (6 mg, 12 mg, 18 mg) and rapid onset within 1 week.

Effects were short-lived (9-14 minutes), with outpatient feasibility. Safety was favorable, with no serious adverse events. Durability data suggest intermittent retreatment approximately every 6 weeks may maintain response.

Kv7 Channel Modulator Azetukalner May Improve Anhedonia, With James Murrough, MD, PhD

At the Anxiety and Depression Association of America (ADAA) 2026 meeting, phase 2 data showed the Kv7 channel opener azetukalner may improve anhedonia in major depressive disorder (MDD) despite missing its primary neuroimaging endpoint. In the randomized trial (n = 60), ventral striatal activation did not differ from placebo, but MADRS and SHAPS outcomes numerically favored azetukalner with low discontinuation rates. James Murrough (Icahn School of Medicine at Mount Sinai) emphasized Kv7 (KCNQ) channels as targets for reward circuitry and stress resilience.

Regulatory momentum and early clinical innovation shaped April 2026 psychiatry developments. Lumateperone gained an FDA label expansion for schizophrenia relapse prevention, supported by a randomized-withdrawal phase 3 hazard ratio of 0.37 versus placebo. Federal action also intensified interest in psychedelics, outlining FDA/DEA coordination, expedited pathways, and dedicated funding while highlighting unresolved trial-design and safety challenges. Concurrently, patient use of generative AI for mental health guidance prompted calls for guardrails and clinician engagement. Phase 2 signals for GH001 and azetukalner suggested rapid antidepressant and anhedonia effects.

FDA expands lumateperone for relapse prevention in schizophrenia, White House boosts psychedelics research, and AI reshapes psychiatry care debates in April 2026.

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.

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.

5 Psychiatry Headlines You Missed in April 2026

Victoria Johnson joined MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and is now an assistant managing editor for HCPLive and RheumatologyLive. She doesn’t have enough time for her numerous hobbies. You can reach her at vjohnson@mjhlifesciences.com.

April 2026 was a consequential month for pulmonology, defined above all by the continued consolidation of tozorakimab's phase 3 program and a regulatory milestone that reshapes the inhaled therapy landscape in 

. AstraZeneca's IL-33 inhibitor added a third positive pivotal trial to its LUNA program with the MIRANDA readout, which tested the drug on a more frequent 2-week dosing interval and extended the exacerbation reduction signal to former and current smokers alike, regardless of eosinophil level or lung function severity — a population breadth that separates it mechanistically from the type 2–restricted biologics that currently dominate chronic obstructive pulmonary disease (COPD) prescribing. LUNA program chief investigator Frank Sciurba, MD, joined 

 to contextualize the results and explain why the IL-33 pathway's dual-form inhibition may address COPD drivers that prior biologics cannot reach.

On the asthma side, the month closed with the FDA approval of budesonide/glycopyrrolate/formoterol fumarate (BGF; BREZTRI Aerosphere) as the first single-inhaler ICS/LABA/LAMA triple combination for patients aged 12 and older — a decision grounded in the phase 3 KALOS and LOGOS data published in 

, which showed a pooled 76 mL improvement in trough FEV₁ and a reduction in severe exacerbations over dual therapy. The approval arrives alongside growing pipeline momentum: Sanofi's bispecific lunsekimig, targeting both TSLP and IL-13, posted positive phase 2 results across asthma and chronic rhinosinusitis with nasal polyps earlier in the month, though a concurrent atopic dermatitis study missed its primary endpoint — a mixed but directionally encouraging readout for a mechanism that could eventually offer a single-agent alternative to sequential biologic escalation.

Check out this April 2026 pulmonology month in review for a recap of HCPLive's coverage of the top news and research from the past few weeks:

FDA Approves BGF Triple Therapy for Asthma in Patients 12 and Older

The FDA approved budesonide/glycopyrrolate/formoterol fumarate (BREZTRI Aerosphere; AstraZeneca) on April 28 as the first single-inhaler fixed-dose triple-combination maintenance therapy for asthma in patients aged 12 years and older, marking the drug's second approved indication following its 2020 clearance for COPD. The approval was supported by the phase 3 KALOS and LOGOS trials, in which BGF demonstrated statistically significant improvements in trough FEV₁ and FEV₁ AUC₀₋₃ over dual ICS/LABA therapy at 24 weeks, along with reductions in severe exacerbation rates.

Lunsekimig Meets End Points in Asthma and CRSwNP, Misses in Atopic Dermatitis

Sanofi's lunsekimig, a bispecific Nanobody construct targeting both TSLP and IL-13, met its primary and key secondary endpoints in the phase 2b AIRCULES trial in moderate-to-severe asthma and in the phase 2a DUET trial in chronic rhinosinusitis with nasal polyps, though it did not meet its primary endpoint in the exploratory phase 2b VELVET study in atopic dermatitis. Full efficacy data from all 3 studies have not yet been disclosed, and Sanofi has characterized respiratory indications as the primary development focus, with 2 phase 3 COPD trials and a high-risk asthma study currently underway.

BGF Triple Therapy Improves Lung Function in Phase 3 Uncontrolled Asthma Controls

Full results from the phase 3 KALOS and LOGOS trials, published in 

, showed that BGF 320/28.8/9.6 µg improved trough FEV₁ by a pooled least squares mean of 76 mL (95% CI, 57–94 mL; 

 <.001) and FEV₁ AUC₀₋₃ by 90 mL over dual ICS/LABA at 24 weeks in patients with asthma inadequately controlled on medium- or high-dose ICS/LABA therapy. Benefits in lung function and severe exacerbation reduction were observed regardless of prior exacerbation history across the approximately 4,300 randomized patients, supporting BGF as a viable escalation option before or independent of a preceding acute episode.

Phase 3 MIRANDA: Tozorakimab Reduces COPD Exacerbations

AstraZeneca announced April 20 that tozorakimab met its primary endpoint in the phase 3 MIRANDA trial, reducing the annualized rate of moderate-to-severe COPD exacerbations compared with placebo in former smokers and in the overall population — including current smokers across all eosinophil levels and lung function severity stages — with patients receiving 300 mg subcutaneously every 2 weeks on top of inhaled standard of care. The result marks the third consecutive positive phase 3 readout in the LUNA program, extending the exacerbation reduction signal from OBERON and TITANIA to a more frequent dosing regimen and further consolidating the evidence base ahead of anticipated regulatory submissions.

Reducing COPD Exacerbations With Tozorakimab, With Frank Sciurba, MD

Frank Sciurba, MD, professor of Pulmonary and Critical Care Medicine at the University of Pittsburgh and chief investigator of the LUNA program, discussed the clinical significance of tozorakimab's positive phase 3 program, explaining that the IL-33 inhibitor's unique ability to block both the reduced and oxidized forms of IL-33 positions it to address type 1, 2, and non-type 2 inflammatory pathways simultaneously — a mechanistic distinction from existing COPD biologics that require eosinophilic phenotyping. Sciurba noted that up to half of patients with COPD continue to experience exacerbations on standard inhaled therapy, underscoring the magnitude of the unmet need that a biomarker-agnostic agent could begin to address pending regulatory review.

April 2026 highlighted two major pulmonary inflection points: expansion of IL-33 inhibition in COPD and the first FDA-cleared single-inhaler triple therapy for asthma. Tozorakimab delivered a third positive phase 3 result in MIRANDA, extending exacerbation reduction to broad COPD subgroups including current smokers, independent of eosinophils and lung-function severity, on a q2w regimen. In asthma, FDA approved budesonide/glycopyrrolate/formoterol (BGF) for patients ≥12 years, supported by KALOS/LOGOS lung-function gains and fewer severe exacerbations. Sanofi’s bispecific lunsekimig showed phase 2 respiratory efficacy despite an atopic dermatitis miss.

April 2026 saw new data from pivotal clinical trials and a new approval in asthma.

Asthma

The HCPLive asthma page is a comprehensive resource for clinical news and insights on asthmatic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for allergic and severe asthma, and more.

COPD

COPD condition center page, resources on the topics of medical news and expert insight into chronic obstructive pulmonary disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COPD research, treatment, and drug development.

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