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7 Endocrinology Headlines You Missed in March 2026

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

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.

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

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.

Related: 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.


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