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Catch up on major trial results, key FDA decisions, and more.
The tail end of May 2026 saw a surge in endocrinology news, between major trial results and groundbreaking decisions from the US Food and Drug Administration (FDA). Between inhaled insulin’s approval for pediatric patients with type 1 (T1D) and type 2 diabetes (T2D) and topline data from SYNCHRONIZE-1 and TRIUMPH-1, the last 30 days have seen significant shifts all across endocrinology.
As we enter June, the editorial team at HCPLive has collected 7 of the most impactful headlines in endocrinology from last month. Catch up on any major news you may have missed below:
On May 29, 2026, the FDA approved MannKind’s inhaled insulin, Afrezza, for pediatric patients aged between 4 and 17 years with T1D or T2D. The decision came in response to positive endpoint data from the INHALE-1 study – despite failing to achieve its primary noninferiority endpoint of HbA1c reduction, the trial did demonstrate the safety of Afrezza among pediatric patients. This, taken in conjunction with existing safety data from adult trials, led to the FDA’s approval of the new indication.
On May 21, 2026, the FDA accepted a supplemental New Drug Application for finerenone, which could expand its indication to adults with T1D and chronic kidney disease. The administration also granted Bayer’s supplemental application Priority Review, based in large part on results from the FINE-ONE phase 3 trial, in which patients treated with finerenone saw significantly reduced urine albumin-to-creatinine ratio (UACR) compared with placebo after 6 months.
On May 14, 2026, the EndoTool IV Cloud, a cloud-based version of Glooko’s intravenous insulin dosing decision-support platform, received FDA clearance via the 510(k) pathway. Designed to assess individualized insulin doses among hospitalized patients to support clinicians during inpatient care, the device is expected to launch commercially in the US before the end of 2026.
Patients with congenital adrenal hyperplasia (CAH) who received crinecerfont demonstrated substantially lower glucocorticoid doses and reduced symptoms compared to those receiving placebo, according to 2-year data from the CAHtalyst Pediatric study. In an interview with HCPLive, Patricia Fechner, MD, attending physician at Seattle Children’s Hospital and a professor of pediatrics at the University of Washington School of Medicine, discusses the implications of this study for a condition often limited by the risks of glucocorticoid treatment.
Boehringer Ingelheim released topline results from the phase 3 SYNCHRONIZE-1 trial in May 2026 highlighting survodutide’s substantial weight loss outcomes in patients with obesity and overweight without T2D. The investigational glucagon-GLP-1 receptor dual agonist has already received Fast Track designation in May of 2021 and Breakthrough therapy designation in September of 2024. In an interview with HCPLive, Carel le Roux, PhD, MSC, director of the Metabolic Medicine Group at the University College of Dublin School of Medicine and global coordinating investigator of the study, highlights the weight loss dependent benefits of survodutide and the possibility of weight loss independent benefits upon further research.
Retatrutide, Eli Lilly’s investigative triple GLP-1/GIP/glucagon agonist, demonstrated substantial weight reduction among patients with overweight or obesity and ≥1 weight-related comorbidity, according to topline data from the TRIUMPH-1 trial. A total of 2339 participants were randomly assigned to 1 of 4 separate doses of retatrutide, all of which demonstrated body weight reductions >15%, versus 2.2% with placebo. Full data from the study will be presented at the American Diabetes Association (ADA) Scientific Sessions 2026 in June.
In this special in-studio episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the trials, presentations, and discussions they’re looking forward to at ADA 2026. Isaacs and Bellini highlight the myriad GLP-1 RA therapies expected to dominate the conference, as well as pointing out new insulin titration tools driven by continuous glucose monitor (CGM) such as Dexcom’s Smart Basal feature. The hosts express their excitement for the variety of updates to be presented at the conference in June.