Q1 2025 Recap: Endocrinology News and Updates

The field of endocrinology, particularly diabetes care, has surged forward in recent years, reshaping patient outcomes with groundbreaking therapies and technology. From pharmacotherapy advances transcending the public consciousness to continuous glucose monitoring to AI-driven insulin delivery, innovation has redefined what is possible.

Q1 2025 was no exception—building on this momentum, the field has witnessed further refinement in personalized medicine, historic drug approvals, and enhanced integration of digital health solutions. To celebrate the end of Q1 2025, HCPLive Endocrinology has created a recap of the news and updates capturing headlines during the first 3 months of 2025.

In our recap, we spotlight 5 regulatory updates from the US Food and Drug Administration (FDA) and other government entities, our 5 most popular trial announcement articles, and 3 key insights from top experts featured within our coverage.

Q1 2025 Regulatory Updates in Endocrinology

FDA Announces End to Shortage of Semaglutide Products (Ozempic, Wegovy)

On February 21, 2025, Novo Nordisk announced that the FDA has declared the shortage of semaglutide injection (Ozempic) and semaglutide 2.4 mg (Wegovy) officially resolved. Based on current and projected demand, the available US supply now meets regulatory standards, though some supply chain disruptions may persist. The FDA has set transition periods for compounders to cease production of semaglutide copies, with deadlines of April 22 and May 22, 2025, for different compounding facilities.

FDA Approves Semaglutide (Ozempic) for Type 2 Diabetes, Chronic Kidney Disease

On January 28, 2025, Novo Nordisk announced FDA approval of semaglutide (Ozempic) to reduce the risk of kidney disease worsening, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD).

Based on the phase 3b FLOW trial, semaglutide demonstrated a 24% relative risk reduction in major kidney disease events and a 29% reduction in cardiovascular death compared to placebo. According to Novo Nordisk, this approval makes semaglutide the most broadly indicated GLP-1 receptor agonist in its class.

HHS Targets 15 Drugs for Medicare Part D Negotiations, Including Semaglutide

On January 17, 2025, HHS announced 15 additional drugs covered under Medicare Part D that will undergo price negotiations in 2025, with new prices taking effect in 2027 under the Inflation Reduction Act.

The selected drugs, including semaglutide (Ozempic, Wegovy) linagliptin (Tradjenta), and sitagliptin/metformin (Janumet; Janumet XR). This marks the second round of Medicare drug price negotiations, following the first cycle’s agreements, which take effect in 2026.

FDA Accepts NDA for Relacorilant for Endogenous Hypercortisolism

On March 3, 2025, Corcept Therapeutics announced the FDA's acceptance of a New Drug Application for relacorilant, a selective cortisol modulator for endogenous hypercortisolism (Cushing’s syndrome).

Based on data from the phase 3 GRACE trial, relacorilant demonstrated significant improvements in blood pressure and glucose metabolism without adrenal insufficiency or other hormone-related adverse effects. The FDA has set a PDUFA target action date of December 30, 2025.

FDA Accepts Finerenone sNDA for Heart Failure, Grants Priority Review

On March 17, 2025, Bayer announced the FDA’s acceptance of a supplemental New Drug Application for finerenone (Kerendia) in heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF), granting it Priority Review.

Based on the phase 3 FINEARTS-HF trial, finerenone demonstrated a 16% reduction in cardiovascular death and heart failure events compared to placebo. Already approved for chronic kidney disease in people with type 2 diabetes, finerenone could offer an additional treatment option for a population with high hospitalization and mortality rates if approved.

Q1 2025 Trial Announcements in Endocrinology

Enobosarm Protects Lean Mass in Topline Phase 2b Trial Results

On January 27, 2025, Veru Pharmaceuticals announced positive Phase 2b trial results for enobosarm in older adults using semaglutide for weight loss.

Based on trial data, enobosarm reduced lean mass loss by 71% versus placebo and preserved physical function while enhancing fat loss. Safety data remains blinded, but no major concerns have emerged. Veru plans to meet with the FDA to advance enobosarm as a body composition therapy for older patients on GLP-1 RAs.

Monlunabant Misses Primary Endpoint in Phase 2 Diabetic Kidney Disease Trial

On February 5, 2025, Novo Nordisk announced the phase 2 trial of monlunabant in diabetic kidney disease did not meet its primary endpoint for urine albumin-creatinine ratio (uACR) improvement.

The trial evaluated once-daily 10 mg and 25 mg doses over 16 weeks, with monlunabant showing mild to moderate gastrointestinal and neuropsychiatric side effects. According to a press release, Novo Nordisk is assessing the drug’s future clinical development following these results.

Semaglutide 7.2 mg Displays 20.7% Weight Loss in Phase 3b STEP UP Trial

On January 17, 2025, Novo Nordisk announced the phase 3b STEP UP trial demonstrated superior weight loss with semaglutide 7.2 mg compared to semaglutide 2.4 mg (Wegovy) and placebo in adults with obesity.

Patients on semaglutide 7.2 mg achieved a 20.7% weight reduction at 72 weeks, with 33.2% losing at least 25% of their body weight. Novo Nordisk plans to present full results at a scientific conference in 2025, with additional trial data in type 2 diabetes expected soon.

CagriSema Yields Nearly 16% Weight Loss in Phase 3 REDEFINE 2 Trial

On March 10, 2025, Novo Nordisk announced CagriSema, a fixed-dose combination of cagrilintide and semaglutide, achieved superior weight loss in adults with obesity or overweight and type 2 diabetes in the phase 3 REDEFINE 2 trial.

Patients receiving CagriSema experienced a 15.7% weight reduction at 68 weeks compared to 3.1% with placebo, with a majority reaching at least 5% weight loss. Novo Nordisk plans to seek regulatory approval in early 2026, with full trial results to be presented later in 2025.

Eneboparatide Hits Primary Phase 3 Endpoint for Hypoparathyroidism

On March 17, 2025, AstraZeneca announced eneboparatide (AZP-3601) met the primary endpoint in the phase 3 CALYPSO trial, significantly normalizing serum calcium levels in adults with chronic hypoparathyroidism.

The investigational PTH receptor 1 agonist demonstrated a tolerable safety profile and will continue to be studied until 52 weeks to further assess its risk-benefit profile. Eneboparatide has received FDA Fast Track and Orphan Drug Designations, with full data expected to be presented at upcoming medical meetings.

Q1 2025 Expert Perspectives in Endocrinology

Understanding Semaglutide for Diabetes and CKD, with Pranav Garimella, MBBS, MPH

Pranav Garimella, MBBS, MPH, chief medical officer of the American Kidney Fund, reacts to and offers perspective on the potential downstream effect of the FDA’s approval of semaglutide (Ozempic) for treatment of chronic kidney disease and type 2 diabetes.

Diabetes Dialogue: Impact of NovoCare Pharmacy, LillyDirect Self Pay on GLP-1 RA Access

In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, break down what the latest developments in the GLP-1 RA affordability and accessibility battles mean for providers and patients as the field enters the post-shortage era.

Diabetes Dialogue: Understanding Control-IQ+ AID Algorithm with Laurel Messer, PhD, RN

In this episode of Diabetes Dialogue, hosts speak with Laurel Messer, PhD, RN, senior director of medical affairs at Tandem Diabetes Care, about the latest advancements in Control-IQ+, the company’s next-generation automated insulin delivery (AID) technology, on the heels of Tandem’s March 18, 2025 announcement that the Control-IQ+ hybrid closed-loop algorithm was now available for use in adults with type 2 diabetes aged 18 years or older alongside people with type 1 diabetes aged 2 years or older.