How Envudeucitinib May Fit Into the Evolving Oral Psoriasis Landscape, With Andrew Blauvelt, MD, MBA

2026 American Academy of Dermatology (AAD) Annual Meeting

 held in Denver, Colorado, from March 27-31, marked a watershed moment for the oral psoriasis treatment landscape, with late-breaking phase 3 data presented for 2 next-generation TYK2 inhibitors — envudeucitinib and zasocitinib — arriving just weeks after the FDA approval of icotrokinra (Icotyde), the first oral IL-23 receptor antagonist approved for moderate to severe plaque psoriasis. Andrew Blauvelt, MD, MBA, owner of Blauvelt Consulting, in Annapolis, Maryland, and a principal investigator on the ONWARD program, spoke about where envudeucitinib fits in the context of this rapidly expanding field. 

Blauvelt characterized envudeucitinib as a second-generation TYK2 inhibitor specifically engineered for complete 24-hour target coverage — distinct from the first approved agent in the class, deucravacitinib — and the only TYK2 inhibitor to date shown to achieve maximal inhibition over a full dosing interval in humans. The ONWARD1 and ONWARD2 trials together enrolled more than 1,700 adults with moderate to severe plaque psoriasis, randomized 2:1:1 to envudeucitinib 40 mg twice daily, placebo, or the active comparator apremilast, with co-primary endpoints of PASI 75 and static Physician's Global Assessment (sPGA) 0/1 at week 16. Both studies met all primary and secondary endpoints with high statistical significance versus placebo (

 <.0001). At week 16, approximately 74% to 75% of envudeucitinib-treated patients achieved PASI 75 and 59% achieved sPGA 0/1. Response continued to deepen through week 24, at which point approximately 80% achieved PASI 75, approximately 65% achieved PASI 90, and more than 40% achieved PASI 100 — complete skin clearance. Envudeucitinib outperformed apremilast on all PASI endpoints at week 24 (

 <.0001), with separation from placebo on PASI 90 observed as early as week 4. The safety profile was favorable and consistent with phase 2 findings, with nasopharyngitis and upper respiratory tract infection the most common adverse events and notably no lipid signal of the type observed in earlier deucravacitinib studies.

Zasocitinib, Takeda's once-daily investigational TYK2 inhibitor, presented concurrent phase 3 data from the LATITUDE PsO 3001 and 3002 trials at the same meeting. In those studies, 71.4% and 69.2% of zasocitinib-treated patients achieved sPGA 0/1 at week 16 versus 10.7% and 12.6% with placebo (

 <.001), with PASI 75 responses observed as early as week 4 and more than 90% of week 40 responders maintaining response through week 60. Also arriving just before AAD, icotrokinra received FDA approval on March 18, 2026 as the first targeted oral peptide to precisely block the IL-23 receptor, with approval based on the phase 3 ICONIC program in approximately 2,500 patients. In the ICONIC-ADVANCE head-to-head studies, approximately 70% of patients achieved IGA 0/1 and 55% achieved PASI 90 at week 16, with icotrokinra demonstrating superiority over deucravacitinib at weeks 16 and 24.

Blauvelt placed these 3 agents in direct relation to one another, noting that the best IL-23 and IL-17 biologics likely still represent the ceiling for skin clearance. For patients prioritizing maximum efficacy, he would continue to favor those agents; however, for the many patients who prefer oral therapy and the many clinicians who remain reluctant to prescribe biologics, he characterized icotrokinra, envudeucitinib, and zasocitinib as agents that will move immediately to the top of the oral treatment hierarchy. He noted that dosing may be an early point of practical differentiation — zasocitinib and icotrokinra are once daily, while envudeucitinib is currently dosed twice daily, though Alumis has indicated plans to develop an extended-release once-daily formulation. He also raised the possibility that performance in psoriatic arthritis could ultimately drive prescribing choices among these agents if data reveal meaningful differences in joint outcomes. An NDA submission for envudeucitinib is planned for the second half of 2026.

Blauvelt’s disclosures include Abbvie, Almirall, Alumis, Amgen, AnaptysBio, Apogee Therapeutics, Arcutis Biotherapeutics, Eli Lilly, Incyte, Janssen, LEO Pharma, Lipidio Pharma, Novartis, Oruka Therapeutics, Pfizer, Regeneron Pharmaceuticals, Sanofi, Sun Pharma, Takeda, and UCB.

Blauvelt A, Sofen H, Armstrong A, et al. Envudeucitinib (ESK-001) in moderate-to-severe plaque psoriasis: 24-week results from the randomized, double-blind, active comparator- and placebo-controlled, phase 3 ONWARD1 and 2 studies. Presented at: AAD Annual Meeting; Denver, Colorado; March 27-31, 2026.

Alumis Inc. Alumis' envudeucitinib delivers early and robust improvements in skin clearance, quality of life and psoriasis symptoms in two phase 3 trials, underscoring its potential as a leading oral therapy for plaque psoriasis. Press release. March 28, 2026. Accessed March 28, 2026. 

https://investors.alumis.com/news-releases/news-release-details/alumis-envudeucitinib-delivers-early-and-robust-improvements

Gooderham M, et al. Once-daily oral zasocitinib demonstrates rapid and reproducible skin clearance with a consistent safety profile in moderate-to-severe plaque psoriasis: results from two randomized phase 3 trials (LATITUDE-PsO-3001 and 3002). Presented at: AAD Annual Meeting; Denver, Colorado; March 27-31, 2026.

Johnson & Johnson. FDA approval of ICOTYDE™ (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide. Press release. March 18, 2026. Accessed March 28, 2026. 

https://www.investor.jnj.com/investor-news/news-details/2026/FDA-approval-of-ICOTYDE-icotrokinra-ushers-in-new-era-for-first-line-systemic-treatment-of-plaque-psoriasis-with-a-targeted-oral-peptide/default.aspx

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Phase 3 ONWARD data for the investigational TYK2 inhibitor envudeucitinib join a rapidly crowding oral psoriasis space.


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March brought a series of notable developments in endocrinology, with regulatory milestones and clinical trial advances continuing to reshape the treatment landscape across diabetes, obesity, and rare endocrine disorders. From first-in-class therapies to innovations in drug delivery, the month underscored a growing emphasis on improving both clinical outcomes and patient experience.

Several key approvals highlighted progress in areas of unmet need, including the first treatment for cerebral folate deficiency and an expanded indication for setmelanotide in acquired hypothalamic obesity. At the same time, the US Food and Drug Administration (FDA) clearance of a smaller, smartphone-controlled insulin pump and the approval of once-weekly insulin icodec signal a shift toward more convenient, patient-centered diabetes management.

Meanwhile, emerging data from trials of next-generation incretin-based therapies and investigational approaches like islet transplantation continue to push the boundaries of what’s possible in metabolic disease care.

Here’s a look at the key endocrinology headlines from March 2026 you may have missed:

FDA Approves Leucovorin Calcium (Wellcovorin) Tablets as First Cerebral Folate Deficiency Treatment

On March 10, 2026, the FDA approved GSK’s leucovorin calcium (Wellcovorin) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (CFD-FOLR1), making it the first treatment for the rare genetic condition of cerebral folate deficiency. The approval was based on a systematic review of the published literature on the topic, including published case reports with patient-level information, as well as mechanistic data.

Interim Results from ACCESS Program of Aleniglipron Shows Weight Loss Efficacy

On March 16, 2026, Structure Therapeutics reported positive topline results from the ACCESS clinical program, investigating aleniglipron for patients with obesity or overweight and ≥1 weight-related comorbidity. The ACCESS program includes 44-week data from the phase 2 ACCESS II study and interim data from an ongoing body composition study, as well as the ACCESS open-label extension study.

Diabetes Dialogue: GLP-1 RA News & Updates in March 2026

This episode features discussion around 3 recent announcements from Novo Nordisk, Eli Lilly, and Structure Therapeutics. 

Tegoprubart Enables Insulin Independence in Type 1 Diabetes Islet Transplant Study

On March 16, 2026, Eledon Pharmaceuticals announced updated results from an investigator-initiated trial of 12 adults with long-standing type 1 diabetes undergoing allogeneic islet transplantation who received tegoprubart as part of a calcineurin inhibitor-free immunosuppression regimen. The pilot study, conducted at the University of Chicago Medicine Transplant Institute, showed tegoprubart enabled insulin independence and strong glycemic control in adults with long-standing type 1 diabetes undergoing islet transplantation.

Tegoprubart Improves Glycemic Control Following Islet Transplantation for T1D, With Piotr Witkowski, MD, PhD

FDA Clears MiniMed Flex, A Smaller and Smartphone-Controlled Insulin Pump

On March 18, 2026, the FDA cleared MiniMed’s MiniMed Flex™, a next-generation discreet, smartphone-controlled insulin pump designed to fit seamlessly into everyday life. The product is about half the size of the MiniMed™ 780G pump and roughly the size of 2 stacked insulin vials. It is cleared for individuals ≥ 7 years of age with type 1 diabetes and for individuals ≥ 18 years of age with insulin-requiring type 2 diabetes.

Retatrutide Delivers A1C Reduction, Weight Loss in Phase 3 TRANSCEND-T2D-1 Trial

On March 19, 2026, Eli Lilly and Company announced positive topline results from the phase 3 TRANSCEND-T2D-1 trial assessing the efficacy and safety of retatrutide, an investigational first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, as an adjunct to diet and exercise in people with type 2 diabetes and inadequate glycemic control. In the study, retatrutide met the primary and all key secondary endpoints, delivering superior A1C reduction and weight loss at 40 weeks compared to placebo, using both the efficacy and treatment-regimen estimands.

FDA Approves Setmelanotide (Imcivree) for Acquired Hypothalamic Obesity

On March 19, 2026, the FDA approved an expanded indication for setmelanotide (Imcivree) to treat acquired hypothalamic obesity in adults and pediatric patients aged 4 years and older. The approval makes setmelanotide the first and only FDA-approved therapy for this rare condition, which is characterized by accelerated and sustained weight gain following injury to or dysfunction of the hypothalamus.

FDA Approves Insulin Icodec (Awiqli) as First Once-Weekly Basal Insulin for Type 2 Diabetes

On March 26, 2026, the FDA approved insulin icodec-abae (Awiqli) injection 700 units/mL, the first and only once-weekly basal insulin available in the US, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The decision makes insulin icodec the first new class of basal insulin to reach US patients in more than 2 decades.

March 2026 endocrinology updates include key FDA approvals, advances in diabetes and obesity therapies, and innovations in insulin delivery and rare disease care.

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7 Endocrinology Headlines You Missed in March 2026

Clinical Presentation of Hypercortisolism

In this episode, ‘Clinical Presentation of Hypercortisolism,’ the expert faculty discuss the evolving understanding of hypercortisolism beyond its classic clinical presentation, emphasizing its variable manifestations and significant cardiometabolic impact. While traditional teaching has focused on recognizable Cushingoid features such as moon face, central obesity, and dorsocervical fat pads, the panelists highlight that many patients, particularly those with resistant hypertension or diabetes, do not exhibit these hallmark signs. This variability contributes to under recognition in clinical practice, especially among cardiologists who may not routinely consider hypercortisolism in patients without physical features.

The expert panel further explores how excess cortisol functions as a metabolic condition along a continuum, rather than a binary diagnosis. They discuss how varying levels of cortisol dysregulation can lead to a range of adverse outcomes, including hypertension, hyperglycemia, cardiovascular disease, atrial fibrillation, and bone loss. The faculty also note emerging evidence suggesting that cortisol contributes to insulin resistance, visceral fat accumulation, and muscle effects, reinforcing its broad systemic impact.

Importantly, the panelists underscore that individual responses to cortisol excess can differ widely, making hypercortisolism a highly heterogeneous condition. Overall, the discussion highlights the need for increased awareness of non-classic presentations and a greater appreciation of hypercortisolism as a clinically relevant contributor to cardiometabolic disease.

The next episode in this series, ‘Evolving Hypercortisolism Screening and Diagnosis,’ features the panelists discussing how emerging data are reshaping screening approaches for hypercortisolism, particularly in patients with resistant hypertension. The panel highlights a shift toward simpler diagnostic strategies and increased recognition of potentially reversible endocrine causes of cardiovascular disease.

This episode explores how hypercortisolism extends beyond classic Cushingoid features, highlighting its variable presentation and role as a continuum of cortisol-driven cardiometabolic disease that is often underrecognized in clinical practice.

Video Series

Neurological and Psychiatric Manifestations in Wilson Disease

In this episode, 'Neurological and Psychiatric Manifestations in Wilson Disease,' the panelists explore the complex and often nonspecific neurological and psychiatric landscape of Wilson disease. Dr. Peter Hedera describes the condition as a "great imitator" because it frequently mimics more common movement disorders such as Parkinson's disease, dystonia, and essential tremor. This clinical overlap often leads to significant diagnostic delays, sometimes lasting two years or longer. The experts stress that a high index of suspicion is required for any patient under the age of 40 or 50 presenting with unexplained movement symptoms.

The discussion also delves into the psychiatric side of the disease, noting that approximately 10% of patients may present with psychosis. This can create a diagnostic trap where neuroleptic treatments for psychiatric symptoms cause extrapyramidal side effects that further mask the underlying Wilson disease. In pediatric populations, the panelists shift the focus to neuropsychiatric indicators, such as sudden changes in school performance, cognitive shifts, or hyperkinetic movements like chorea.

Finally, the panel addresses the overlap between hepatic and neurological symptoms. While adults frequently show signs of both, pediatric patients under age 10 rarely exhibit neurological symptoms. However, that frequency increases to roughly 30% in adolescents. The experts conclude that while the coexistence of elevated liver enzymes and movement disorders is a major red flag, clinicians must rely on thorough laboratory confirmation to navigate these overlapping clinical presentations and ensure the best patient outcomes through early diagnosis.

The next episode in this series, 'Understanding Pathophysiology and Copper Transport in Wilson Disease,' features the panelists advancing their conversation on Wilson disease and focusing on the genetic and cellular mechanisms of the condition. Dr. Peter Hedera explains how mutations in the ATP7B gene disrupt copper homeostasis, leading to toxic accumulation in the liver and brain.

Panelists discuss the often misdiagnosed neurological and psychiatric manifestations of Wilson disease, highlighting its overlap with common movement and mental health disorders, the need for high clinical suspicion, and the importance of early diagnosis through careful evaluation of overlapping symptoms.

EPI Across Disease States: Identifying High-Risk Patients

This episode focuses on the full spectrum of clinical conditions that warrant high suspicion for EPI. Jennifer Geremia leads with the primary pancreatic risk factors: chronic pancreatitis (with or without confirmatory imaging), recurrent acute pancreatitis regardless of etiology, prior pancreatic surgeries such as the Whipple procedure, cystic fibrosis, and pancreatic cancer. She notes that patients with these primary conditions are frequently under-screened and undertreated, even when the risk is well established.

The discussion expands to non-primary pancreatic conditions. The panelists highlight that celiac disease, type 2 diabetes, and Crohn's disease should also raise EPI suspicion—not because of direct pancreatic damage, but due to the shared mechanisms of malabsorption and maldigestion. Lifestyle factors such as smoking and heavy alcohol use are identified as important aggravators in the right clinical context.

A particularly valuable clinical insight emerges around severe acute pancreatitis and disconnected duct syndrome. Sarah Enslin notes that patients labeled simply as "acute" may actually have significant parenchymal loss and thus EPI—yet this is often missed because the framing remains acute rather than chronic. Dr. Kaul clarifies that typical mild acute pancreatitis does not routinely lead to EPI; it is the severe cases with significant parenchymal destruction that carry the highest risk.

The episode closes with a discussion of surgical and procedural risk factors: bariatric surgery (especially gastric bypass), small bowel resection for any cause (including IBD), and all foregut surgeries. The panel also spotlights pancreatic cancer patients—both surgical and non-surgical—as a special and complex high-risk population in whom EPI can be easily obscured by oncologic therapies and their side effects.

EPI Unmet Needs: Barriers to Diagnosis and Long-Term Consequences

," the panel explores the significant gaps in EPI diagnosis and the downstream consequences of untreated disease on patient quality of life and health.

Panelists discuss the wide range of pancreatic and non-pancreatic conditions that increase suspicion for exocrine pancreatic insufficiency to improve identification of high-risk patients.

James Murrough, MD, PhD, from the Icahn School of Medicine at Mount Sinai.

Phase 2 data presented at ADAA 2026 suggest azetukalner may improve anhedonia in MDD, even though the trial did not meet its primary neuroimaging endpoint.

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

Panelists discuss the often subtle and asymptomatic hepatic presentations of Wilson disease, emphasizing the importance of early detection, awareness of advanced complications, and maintaining clinical suspicion to prevent progression to severe liver outcomes.

Hepatic Symptoms and Clinical Presentations of Wilson Disease

The panel discusses how hypercortisolism presents variably beyond classic Cushingoid features, emphasizing it as a spectrum of metabolic dysfunction with serious cardiovascular and systemic impacts.

Hypercortisolism Prevalence in Cardiovascular Practice

Panelists discuss recognizing the varied and often atypical symptoms of exocrine pancreatic insufficiency to improve early diagnosis and clinical awareness.

EPI Explained: Recognizing Symptoms and the Road to Diagnosis

Extension data from BE HEARD showed that patients with shorter disease duration and lower baseline severity achieved higher response rates than those with longstanding, more severe disease.


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BE HEARD: Bimekizumab 3-Year Data Support Earlier Intervention HS, With Raj Chovatiya, MD, PhD

Alex Hillenbrand is an assistant editor for 

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HCPLive’s editorial team has compiled 5 of the most informative discussions, along with key data from the WCN. 

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WCN 2026 Recap: 5 Key Updates in Kidney Disease to Know 

Andrew Yockey, PhD, assistant professor at the University of Mississippi.

Yockey discusses why girls, older teens, and multiracial youth remain at greater risk for depression despite overall post-pandemic improvements.

Sex, Age, Racial Disparities Persist in Adolescent Depression, With Andrew Yockey, PhD

March 2026 cardiology updates feature key ACC.26 data, new guidelines, and advances in PAH, AF, hypertension, and lipid management.

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7 Cardiology Headlines You Missed in March 2026

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.

FDA approvals, at-home neuromodulation, phase 3 psychedelic data, and rising AI therapy use impacted the psychiatry field in the first quarter of 2026.

Q1 2026 Recap: Psychiatry News and Updates

Narendra Singh, MD, is an assistant professor at Mercer University Atlanta Campus and the director of clinical research at NSC Cardiology.

Singh discusses his analysis of all 3 parts of the NODE-301 phase 3 trial, investigating the recently approved CBB’s potential risk of hypotension.

Latest News

How Envudeucitinib May Fit Into the Evolving Oral Psoriasis Landscape, With Andrew Blauvelt, MD, MBA

7 Endocrinology Headlines You Missed in March 2026

Clinical Presentation of Hypercortisolism

Neurological and Psychiatric Manifestations in Wilson Disease

EPI Across Disease States: Identifying High-Risk Patients