Q1 2026 Recap: Endocrinology News and Updates

Endocrinology is off to a stellar start in 2026, with a first quarter packed full of major FDA approvals and trial results. Orforglipron, now approved for type 2 diabetes (T2D), demonstrated some of its best trial performance in February, while the investigational triple agonist retatrutide demonstrated solid safety data in the same disease. Meanwhile, the US Food and Drug Administration (FDA) fired off a volley of approvals, covering the first once-weekly basal insulin for T2D, inhaled insulin powder for type 1 diabetes (T1D), and setmelanotide for the rare and previously poorly-managed acquired hypothalamic obesity.

With so much practice-changing news arriving over the last 3 months, HCPLive has collected 9 of the most impactful headlines from this first quarter. Catch up on any big news you may have missed below:

FDA News

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 as the first and only once-weekly basal insulin for the improvement of glycemic control as an adjunct to diet and exercise in patients with T2D. Under the brand name Awiqli, this is the first new class of basal insulin to reach US patients in over 2 decades. The approval was based on the ONWARDS clinical program, including 4 clinical trials evaluating insulin icodec against standard once-daily basal insulins.

FDA Approves Setmelanotide (Imcivree) for Acquired Hypothalamic Obesity

On March 19, 2026, the FDA announced its approval of an expanded indication for setmelanotide, allowing its use for the treatment of hypothalamic obesity in adults and pediatric patients aged ≥4 years. Based on data from the phase 3 TRANSCEND trial, which demonstrated setmelanotide’s greater body mass index (BMI) reducing capacity compared to placebo, setmelanotide is a major step forward for a historically rare disease with very few options for treatment.

FDA Approves Updated Starting Dose Guidelines for Inhaled Insulin Powder (Afrezza)

On January 26, 2026, parent company MannKind Corporation announced the FDA’s approval of an updated label for insulin human inhalation powder (Afrezza), providing guidance for starting doses when switching from multiple daily injections or insulin pump mealtime therapy in patients with T1D. The decision was in part due to the phase 4 INHALE-3 trial, which demonstrated improved postprandial glucose outcomes after converting to inhaled insulin with the new dose.

FDA Clears MiniMed Go Smart MDI App for Adults and Children with T1D, T2D

On January 12, 2026, Medtronic’s MiniMed go Smart Multiple Daily Injection app was approved for the use of patients aged ≥7 years with T1D or T2D, as well as for children between 2-6 years with adult supervision. The device integrates the InPen smart insulin pen and the Instinct sensor, both of which were developed by Abbott, to provide users with missed dose alerts to minimize glucose highs, action-oriented guidance in the event of a missed or miscalculated dose, and a dose calculator to help simplify decision-making.

Trial Results

VESPER-3: Positive Results of Long-Term GLP-1 PF’3944 in Overweight and Obesity Without T2D

Pfizer’s investigational ultra-long-acting, fully biased GLP-1 RA displayed substantial weight loss compared to placebo in patients with overweight or obesity but without T2D. VESPER-3, an ongoing 64-week trial, includes 4 separate titration and dosage arms and a placebo comparator. By week 28, arm 1 saw a 10% placebo-adjusted weight loss, while arm 3 exhibited 12.3%. Pfizer has announced that full data from the trial will be presented on June 6 at the American Diabetes Association’s 86th Scientific Sessions.

ACHIEVE-3: Orforglipron Achieves Superiority to Oral Semaglutide in Poorly Controlled T2D

Eli Lilly announced detailed results from ACHIEVE-3 on February 26, 2026. The trial demonstrated orforglipron’s superiority to oral semaglutide for the treatment of T2D inadequately controlled with metformin. Orforglipron led to an A1c reduction of 2.2% in the 36 mg treatment arm and by 1.9% in the 12 mg arm, compared to 1.1% and 1.4% in semaglutide 7 mg and 14 mg. Similarly, patients given orforglipron saw a body weight reduction of 9.2% in the 36 mg arm and 6.7% in the 12 mg arm, compared to 3.7% and 5.3% in the semaglutide 7 mg and 14 mg arms, respectively.

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

The TRANSCEND-T2D-1 trial data, published on March 19, 2026, demonstrated Eli Lilly’s groundbreaking GIP/GLP-1/glucagon triple agonist and its efficacy as an adjunct to diet and exercise in patients with T2D and inadequate glycemic control. 3 separate doses of retatrutide were pitted against placebo in adults with T2D – patients given the 12 mg dose lost an average of 28.7% of their body weight at 68 weeks. Full data will be presented at the American Diabetes Association conference in June 2026.

Podcast Updates

Diabetes Dialogue: Orforglipron, Retatrutide, and Other GLP-1 Updates

In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss an onslaught of news regarding GLP-1 RAs and similar medications. Orforglipron’s exceptional results from ACHIEVE-3, retatrutide’s superiority to placebo in T2D, and early phase 2 data on Novo Nordisk’s investigative triple agonist UBT251 take center stage as Isaacs and Bellini cover the expanding landscape of these practice-changing medications.

Diabetes Dialogue: Oral Ozempic and the Risks of Compounding Formulas

In this episode, Isaacs and Bellini cover a landscape of oral GLP-1s, between Ozempic, Wegovy, and Rybelsus – the latter now known as Ozempic as well. Additionally, the cohosts discuss the controversy surrounding Hims and Hers, a nutrition/lifestyle company marketing lower-cost, compounded oral GLP-1s. The company is currently facing down a lawsuit by Novo Nordisk, given that they potentially infringed upon the latter’s proprietary SNAC technology. Isaacs and Bellini warn that similar formulations to the Hims and Hers line may lack regulatory oversights, potentially resulting in direct risk to patients.