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Catch up on key FDA approvals, major trial updates, and critical clinician insights from the last 3 months.
Endocrinology made some substantial progress over the last 3 months, between new treatments approved by the US Food and Drug Administration (FDA) and key trial readouts across the spectrum of care. From diabetes and obesity to cardiovascular complications, several major facets of endocrinology saw major upgrades through new medications or topline evidence from new programs.
As we enter the fourth and final quarter of 2026, catch up on any headlines you may have missed with our quarter in review now:
Finerenone saw a label expansion approved by the FDA on September 17, 2026, marking the first new treatment option for chronic kidney disease (CKD) associated with T1D in >30 years. According to the announcement from Bayer, the approval was granted through the priority review system and was based on data from the FINE-ONE trial. This program saw finerenone outperform placebo in reducing the urine albumin-to-creatinine ratio over 6 months.
On August 28, the FDA approved tirzepatide for cardiovascular disease risk in patients with type 2 diabetes, based on the SURPASS-CVOT trial. Parent company Eli Lilly positioned this trial as a higher evidentiary bar, comparing tirzepatide to dulaglutide, which holds an established cardiovascular indication. Tirzepatide ultimately displayed noninferiority for a composite of cardiovascular death, heart attack, or stroke, allowing the FDA to provide clinicians with a new option for managing these events in this population with increased risk.
On September 14, 2026, the FDA cleared the Mint insulin patch pump from Beta Bionics, a 2-piece reusable and disposable system designed to be smaller than the leading Omnipod 5. Each patch is designed for 3 days of wear with a 12-hour grace period and contains a 200-unit insulin reservoir. Additionally, the pump will receive firmware updates over the air, avoiding the issue of phone re-pairing. Mint is expected to be commercially available in the first quarter of 2027.
The TRIUMPH-1 study has demonstrated retatrutide’s substantial efficacy in reducing weight in obesity, improving pain in knee osteoarthritis, and reducing apnea-hypopnea events in obstructive sleep apnea. The GLP-1/GIP/glucagon triple agonist demonstrated its overwhelming efficacy, with body weight loss of roughly 25% at the highest dose compared with placebo. Additionally, retatrutide’s safety data was consistent with prior phase 2 trials, with the most common adverse events mild to moderate in severity.
AT278, an investigational U500 rapid-acting insulin aspart formulation being developed by Arecor Therapeutics, demonstrated substantially greater glucose reduction among patients with T2D, regardless of body mass index. This phase 1 glucose clamp trial compared AT278 to InsAsp-U100 and HumIns-U500, ultimately displaying significantly faster insulin absorption. Thomas Pieber, MD, discusses the implications of this finding with HCPLive following the trial’s readout.
An investigational combination of eloralintide and tirzepatide, dubbed EloraTZP, significantly outperformed tirzepatide alone in patients with obesity or overweight and T2D. In a phase 2b trial presented at the European Association for the Study of Diabetes (EASD) 2026 Annual Meeting, EloraTZP led to substantially greater body weight and A1c reductions at 48 weeks, with all EloraTZP dose combinations meeting all primary and secondary endpoints.
In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the FDA’s approval of weekly insulin efsitora alfa. The duo expressed excitement for the new option, while also noting the potential barriers of education regarding loading doses, concentrated pen conversions, and coverage, as insulin icodec saw similar gaps following its launch earlier in 2026.
In this episode of Diabetes Dialogue, Isaacs and Bellini discuss the TRIUMPH-2 and TRIUMPH-3 trials, which examined retatrutide’s capacity to reduce weight and improve glycemic control in patients with T2D. The trials, comparing retatrutide to placebo, resulted in major weight loss efficacy data and substantial reductions in triglycerides, non-HDL-C, and systolic blood pressure. Although gastrointestinal effects were common across both trials, Isaacs and Bellini conclude that retatrutide is a significantly promising new option for weight loss, and express their anticipation for its progress through the pipeline.