Q3 2025 Recap: Endocrinology News and Updates

The third quarter of 2025 was a very active period for endocrinology. Major regulatory updates from the US Food and Drug Administration (FDA), major trial updates for investigative therapies, and new guidelines for diabetes during pregnancy have opened the way for exciting new progress across the sphere.

The FDA granted De Novo classification to the Biolinq Shine, the first needle-free glucose monitor, which opens up an entirely new pathway for monitoring type 1 diabetes (T1D) and type 2 diabetes (T2D).

Additionally, Q3 saw the positive endpoint of REGEN-007, testing an autologous cellular therapy in both diabetes and chronic kidney disease, and of ACHIEVE-3, which indicated the superiority of orforglipron to semaglutide across a variety of doses.

The editorial team at HCPLive has collected some of the most impactful headlines from Q3 of 2025 – check them out below:

FDA News

FDA Grants Atumelnant Orphan Drug Designation for Congenital Adrenal Hyperplasia

After positive topline results from Crinetics Pharmaceuticals, Inc.’s phase 2 TouCAHn trial, during which atumelnant demonstrated rapid, substantial, and sustained reductions in androstenedione, the FDA granted Orphan Drug Designation to the investigational therapy on August 21, 2025. Congenital adrenal hyperplasia (CAH) is a significant unmet need due to severely limited treatment options; atumelnant, the only small molecule adrenocorticotropic hormone receptor agonist in development, may revolutionize treatment.

FDA Grants De Novo Classification to Needle-Free Glucose Monitor

Biolinq Shine, the first wearable glucose biosensor to not require a needle for sensor placement, has received De Novo classification, providing a path towards scaling a new generation of wearable sensors. The device, a patch on the forearm, displays real-time glucose feedback via a color-coded LED display. The technology for monitoring blood glucose without a needle may lead to a slew of new, less invasive products to help patients with T1D and T2D manage their diseases.

FDA Approves Paltusotine (Palsonify) As First Once-Daily, Oral Acromegaly Treatment

Acromegaly treatment typically involves repeated injections and major lifestyle sacrifices; paltusotine, the first oral, once-daily selectively targeted somatostatin receptor type 2 agonist, may provide an effective and convenient alternative treatment method. The FDA granted approval after paltusotine proved its superiority to placebo in reducing IGF-1 levels in patients with acromegaly who were medication naïve. According to the release from parent company Crinetics, paltusotine is expected to be available in the US in early October.

Trial Updates

ACHIEVE-3: Orforglipron Superior to Semaglutide for Type 2 Diabetes in Phase 3 Trial

Announced on September 17, 2025, by parent company Eli Lilly, ACHIEVE-3 showed orforglipron’s superior reduction of A1C in patients with T2D compared to oral semaglutide. The lowest dose of 6 mg still outperformed semaglutide, while the highest, at 36 mg, helped roughly 3 times as many participants equalize their blood sugar versus the highest dose of oral semaglutide.

SURPASS-PEDS: Tirzepatide Achieves Superiority to Placebo in Adolescent T2D

Eli Lilly’s Mounjaro, a dose of tirzepatide, was first approved by the FDA in May 2022 as an injection to improve glycemic control in adult patients with T2D. Presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2025, the SURPASS-PEDS trial proved tirzepatide’s superiority in improving both A1C and body mass index versus placebo in adolescents with T2D. Given the comparatively limited treatment options for children with T2D, an expanded indication could ease the more aggressive disease course they often face.

Rilparencel Improves eGFR Slope in Phase 2 CKD, Diabetes REGEN-007 Trial

ProKidney Corp announced on July 8, 2025 that rilparencel, their investigational autologous cellular therapy which received Regenerative Medicine Advanced therapy designation from the FDA in October of 2021, has improved eGFR slope in patients with T2D and advanced chronic kidney disease. Rilparencel is currently under investigation in the ongoing phase 3 REGEN-006 trial, aiming to demonstrate the drug’s potential to preserve kidney function in the same patient group.

Diabetes Dialogue: Results of ATTAIN-1 and STEP UP Phase 3 Trials

ATTAIN-1 saw the success of orforglipron, an investigational, oral GLP-1 RA that could revolutionize obesity treatment, in total weight loss compared to placebo in patients with obesity. STEP-UP proved the safety and efficacy of semaglutide 7.2 mg in adults with obesity, a significantly higher dose than currently approved by the FDA. In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the implications of these groundbreaking trials.

New Guidelines

Diabetes Dialogue: 2025 Guideline Updates for Diabetes & Pregnancy

In July 2025, the Journal of Clinical Endocrinology & Metabolism released the Preexisting Diabetes in Pregnancy guidelines, a list of methods by which clinicians can improve outcomes in pregnant individuals with T1D or T2D. In this episode of Diabetes Dialogue, cohosts Natalie Bellini, DNP, and Diana Isaacs, PharmD, break down each of the 10 core guidelines in the release and how it may change treatment paradigms.