6 Endocrinology Headlines You Missed in October 2025

Endocrinology has been on an upward track for most of 2025, and October has continued this trend. With crucial approvals from the US Food and Drug Administration (FDA) and key trial results for investigational new therapies, the industry is making great strides as we approach the end of the year.

The FDA’s approval of oral semaglutide 7 mg and 14 mg has revolutionized the already rapidly evolving GLP-1 field. Results from the DREAMS-3 trial have highlighted the superiority of mazdutide, a new GLP-1/glucagon dual receptor agonist, compared to semaglutide in type 2 diabetes (T2D). Inhaled insulin (Afrezza) from MannKind Corporation is moving towards approval with the FDA’s acceptance of its biologics license application for adolescents with type 1 diabetes (T1D) or T2D.

With so many updates over the course of the month, the editorial team at HCPLive has collected 6 of the most important headlines from October. Check them out below.

FDA Approvals

FDA Accepts Inhaled Insulin (Afrezza) sBLA for Pediatric Diabetes

On October 13, MannKind Corporation announced the FDA acceptance of their supplemental biologics license application for insulin human Inhalation Powder in children and adolescents with T1D or T2D. This application was supported by data from the phase 3 open-label INHALE-1 study, which saw the difference in mean HbA1c change between groups exceed the prespecified non-inferiority margin compared to daily injections of basal insulin. The FDA has assigned Afrezza a Prescription Drug User Fee Act target action date of May 29, 2026.

FDA Approves Oral Semaglutide (Rybelsus) for CV Risk Reduction in Type 2 Diabetes

On October 17, the FDA approved semaglutide 7 mg and 14 mg for cardiovascular risk reduction in patients with T2D, irrespective of prior cardiovascular events. This groundbreaking decision marks the first approval of an oral GLP-1 receptor agonist, opening an entirely new pathway for treatment of both cardiovascular and obesity-related diseases.

Trial Results

Mazdutide Demonstrates Superiority to Semaglutide in Type 2 Diabetes and Obesity

Data from the DREAMS-3 trial has shown the superiority of mazdutide, Innovent Biologics, Inc.’s investigative GLP-1/glucagon dual receptor agonist, to semaglutide in patients with T2D and comorbid obesity. Mazdutide afforded greater benefits in HbA1c and body weight reduction during the trial; coupled with its favorable safety profile, the drug has the capacity for applications in a range of other diseases and clinical fields.

FORWARD: Zimislecel Relieves Insulin Dependence in Patients with T1D with Michiel Nijhoff, MD

Zimislecel treatment during the FORWARD trial has led to meaningful continuous glucose monitor (CGM) metric improvements and reduced insulin dependence in patients with T1D, impaired hypoglycemic awareness, and severe hypoglycemic events. This investigative allogeneic stem cell-derived, fully differentiated, insulin-producing islet cell therapy may be capable of restoring a patient’s glucose regulating capabilities.

Key Studies

Adolescent Hyperglycemia in Type 1 Diabetes May Increase Adult Neuropathy Risk

Research from the University of Michigan Health has indicated that poor blood sugar control in children with T1D may be directly associated with increased risks of neuropathy in adulthood. Specifically, investigators noted a correlation between deviation from mean childhood HbA1c and increased neuropathy risk.

Normal Glucose Regulation May More Effectively Prevent T2D Than Weight Loss

In a post hoc analysis of the Prediabetes Lifestyle Intervention Study, investigators have demonstrated the achievability of prediabetes remission without gaining or losing weight. Additionally, prediabetes remission without weight loss may be protective from T2D development, as well as being associated with higher insulin sensitivity and improved insulin secretion.