Endocrinology Month in Review: May 2025

May 2025 was a high-impact month in endocrinology, with major developments in obesity treatment, adrenal care, and diabetes technology. Novo Nordisk’s oral semaglutide NDA signals a new chapter in weight management, while SURMOUNT-5 data reinforced tirzepatide’s lead in the obesity space.

In pediatric endocrinology, crinecerfont showed promise in reducing steroid burden for CAH, and a new hydrocortisone oral solution offers better dosing precision for adrenal insufficiency. Meanwhile, the Diabetes Dialogue podcast delivered timely insights on automated insulin delivery, inhaled insulin, and the latest tech advances shaping diabetes care.

Here's a roundup of the most important updates in endocrinology from May 2025.

Endocrinology Pipeline and Regulatory Updates

FDA Accepts NDA Submission for Oral Semaglutide 25 mg

On May 2, 2025, Novo Nordisk announced the FDA accepted its NDA for a once-daily 25 mg oral formulation of semaglutide (Wegovy) for chronic weight management in adults with obesity or overweight and at least one comorbidity. Based on Phase 3 OASIS 4 trial results, the oral formulation showed significant weight reduction in patients without diabetes. According to Novo Nordisk, this could be the first oral GLP-1 therapy approved for obesity, offering a new option for individualized care. The submission also supports risk reduction of major adverse cardiovascular events. An FDA decision is expected in Q4 2025.

SURMOUNT-5: Tirzepatide (Zepbound) Proves Benefit over Semaglutide (Wegovy) for Obesity

On May 11, 2025, Eli Lilly released full data from the SURMOUNT-5 trial showing tirzepatide (Zepbound) led to significantly greater weight loss than semaglutide (Wegovy) in adults with obesity. Based on 72-week results, tirzepatide reduced body weight by 20.2% compared to 13.7% with semaglutide, and more patients achieved ≥25% weight loss. According to Eli Lilly, these findings confirm tirzepatide’s role as a leading treatment option for obesity management. Both drugs had similar safety profiles, with mostly gastrointestinal side effects. Results were presented at ECO 2025 and published in The New England Journal of Medicine.

Crinecerfont Reduces Steroid Use for Pediatric CAH in Phase 3 Analysis

On May 8, 2025, Neurocrine Biosciences announced exploratory Phase 3 CAHtalyst Pediatric data showing crinecerfont (CRENESSITY) reduced glucocorticoid dosing while maintaining or improving androgen levels in children with classic congenital adrenal hyperplasia (CAH). Based on subgroup analyses, benefits were consistent across demographics and baseline hormone levels. According to Neurocrine, crinecerfont may help reduce long-term complications of steroid overuse while managing hormonal imbalances. The drug, approved by the FDA in December 2024, is the first CRF1 receptor antagonist for CAH in patients aged 4 and older. Crinecerfont was well-tolerated across the trial population.

FDA Approves Hydrocortisone Oral Solution for Adrenal Insufficiency

On May 28, 2025, Eton Pharmaceuticals announced FDA approval of hydrocortisone (KHINDIVI) oral solution for pediatric patients aged 5 and older with adrenocortical insufficiency. Based on the need for accurate, individualized dosing, the 1 mg/mL liquid formulation offers an alternative to pill-splitting and is the first FDA-approved hydrocortisone oral solution. According to Eton, KHINDIVI supports precise titration critical for children’s growth and clinical outcomes. The ready-to-use solution requires no mixing or refrigeration and will be distributed through Anovo Specialty Pharmacy. It complements Eton’s existing ALKINDI SPRINKLE granule formulation.

Diabetes Dialogue

During May, cohosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, recorded 7 episodes tackling the latest updates in diabetes care, including a plethora of updates in diabetes technology, a breakdown of the SURMOUNT-5 trial, a recap of the American Academy of Endocrinology meeting, and special guest episodes spotlighting Luna Automated Insulin Delivery system, the iLet Bionic Pancreas, and inhaled insulin.

Diabetes Dialogue May 2025 Episodes:

• Diabetes Dialogue: INHALE-3 Trial and Afrezza, With Roy Beck, MD, PhD
• Diabetes Dialogue: AACE 2025 Recap (Featured Below)
• Diabetes Dialogue: Real-World Impact of iLet Bionic Pancreas, With Steven Russell, MD, PhD
• Diabetes Dialogue: Luna Automated Insulin Delivery, With Jon Brilliant and John Sjölund
• Diabetes Dialogue: Tirzepatide vs Semaglutide for Obesity, Understanding SURMOUNT-5
• Diabetes Dialogue: Dexcom G7, Libre App, and Medtronic Simplera Sync