Endocrinology in 2025: Year in Review

Endocrinology experienced staggering growth across the board in 2025. Glucagon-like peptide-1 (GLP-1) receptor agonists have led the charge against type 2 diabetes (T2D) and obesity, while also evolving into a key component in the management of chronic kidney disease (CKD) and cardiovascular complications associated with these conditions. Additionally, US Food and Drug Administration (FDA) approvals for the Biolinq Shine and Dexcom’s G7 15 Day continuous glucose monitoring system (CGM) are beginning to address the day-to-day challenges faced by many patients with both type 1 diabetes (T1D) and T2D.

With so much movement in the sphere in the last 12 months, it was challenging to keep up with every bit of news coming out. The editorial team at HCPLive has put together a highlight reel of the 13 most impactful headlines in the endocrinology space from 2025 – catch up on some of the news you may have missed below.

FDA News

FDA Approves Semaglutide (Ozempic) for Type 2 Diabetes, Chronic Kidney Disease

On January 28, 2025, the FDA approved semaglutide to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular disease death in patients with T2D and CKD. The decision was based on the phase 3b FLOW kidney outcomes trial, which highlighted semaglutide’s superior 24% relative risk reduction of all 3 endpoints compared to placebo when added to standard care.

FDA Clears Dexcom G7 15 Day CGM System

On April 10, 2025, the FDA granted clearance to the Dexcom G7 15-day CGM system for patients with diabetes aged ≥18 years. With this approval, the G7 CGM is the longest-lasting CGM system, with 15.5 days of wear and best-in-class accuracy with a mean absolute relative difference of 8%. The device offers a waterproof sensor, direct connectivity to Apple watches, and automated activity logging, accompanied by a 12-hour grace period for transition for sensor replacement.

FDA Approves Label Expansion for Osilodrostat for Cushing's Syndrome

On April 16, 2025, parent company Recordati announced the FDA’s approval of a label extension for osilodrostat to treat endogenous hypercortisolemia in adults with Cushing’s syndrome who cannot undergo surgery or for whom it was not curative. The decision was based on the phase 3 LINC 3 study, which saw 137 patients with persistent or recurrent Cushing’s disease treated with twice-daily osilodrostat exhibit a rapid reduction in mean 24-hour urinary free cortisol concentration.

FDA Approves Lonapegsomatropin-tcgd (Skytrofa), Formerly TransCon hGH, for Adult Growth Hormone Deficiency

Lonapegsomatropin-tcgd received FDA approval on July 28, 2025, to replace endogenous growth hormone in adults with growth hormone deficiency (GHD). This approval was based on data from foresiGHt, a phase 3 randomized clinical trial comparing weekly lonapegsomatropin-tcgd to weekly placebo and daily somatropin. After analysis, investigators saw lonapegsomatropin-tcgd showed superiority in reducing trunk fat and increasing total body lean mass at week 38 versus placebo. It was also safe and well-tolerated, with no discontinuations related to the study drug.

FDA Grants De Novo Classification to Needle-Free Glucose Monitor

On September 25, 2025, the FDA granted De Novo Classification to the Biolinq Shine, the first wearable glucose biosensor that does not require a needle for sensor placement. The device makes use of a microsensor array, which is up to 20 times more shallow than conventional glucose sensors, and aims to combine glucose, activity, and sleep information into a single device with autonomous operation. The Biolinq Shine takes the form of a patch placed on the forearm, displaying real-time glucose feedback via a primary color-coded LED display.

Trial Updates and New Guidelines

Oral GLP-1 Orforglipron Hits Target in Phase 3 Diabetes Trial

Results from the ACHIEVE-1 trial, published on April 17, 2025, displayed the efficacy and safety of oral orforglipron for adults with T2D inadequately controlled by diet and exercise. The once-daily GLP-1 receptor agonist lowered A1c by an average of 1.3-1.6% from a baseline of 8%, with >65% of individuals on the highest dose achieved A1c ≤6.5% - which is below the American Diabetes Association (ADA)’s threshold for diabetes. Patients also experienced an average weight loss of 16 lbs at the highest orforglipron dose, and parent company Eli Lilly noted no sign of a weight plateau by the end of the study.

CATALYST Trial: Mifepristone Improves Glycemic Control in Type 2 Diabetes with Hypercortisolism

Data from the phase 4 CATALYST trial showed the efficacy of mifepristone in improving glycemic control, reducing body weight, and decreasing waist circumference in patients with hypercortisolism and T2D. Mifepristone was associated with a least-squares mean difference in HbA1c of -1.3% compared to placebo, and secondary outcomes also suggested use was associated with weight loss and waist circumference reduction compared to placebo.

SURMOUNT-5: Tirzepatide (Zepbound) Proves Benefit over Semaglutide (Wegovy) for Obesity

Full data from the SURMOUNT-5 was released on May 11, 2025, highlighting tirzepatide’s more substantial weight reduction compared to semaglutide in patients with overweight and obesity. The trial enrolled 751 patients, who were randomly assigned in a 1:1 ratio to the maximum tolerated dose of either tirzepatide or semaglutide. Patients treated with tirzepatide exhibited a 20.2% reduction in body weight, compared to 13.7% with semaglutide. Similarly, absolute weight loss was greater with tirzepatide, at 22.8 kg versus 15 kg. Both medications also had consistent safety profiles.

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

The phase 3 SURPASS-PEDS trial was presented at the European Association for the Study of Diabetes Annual Meeting 2025, highlighting tirzepatide’s efficacy compared to placebo in patients 10-18 years with T2D inadequately controlled with metformin, basal insulin, or both. Investigators found that pooled tirzepatide doses from the trial lowered A1c by an average of 2.2% from baseline, and 86.1% of patients assigned to tirzepatide 10 mg achieved a target A1c of ≤6.5%. Tirzepatide also led to meaningful improvements in BMI, with improvements continuing through a long-term extension of 52 weeks.

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

On September 18, 2025, Eli Lilly announced the results from their phase 3 ACHIEVE-3 trial, which proved orforglipron’s superiority to semaglutide in T2D inadequately controlled with metformin. The trial included 4 active treatment arms, aiming to assess glycemic control and weight loss; by 52 weeks, orforglipron met the primary and all key secondary endpoints across both treatment arms. Orforglipron 12 mg lowered A1c by an average of 1.9%, while the 36 mg dose lowered it by 2.2%, compared to 1.1% and 1.4% with oral semaglutide at 7 mg and 14 mg, respectively. Orforglipron was also superior to oral semaglutide for weight loss, with orforglipron recipients losing an average of 14.6 lbs (12 mg) and 19.7 lbs (36 mg) compared to 7.9 and 11 lbs with oral semaglutide at 7 and 14 mg, respectively.

Podcasts/Feature Content

Diabetes Dialogue: 2025 Guideline Updates for Diabetes & Pregnancy

In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discussed the July 2025 Preexisting Diabetes in Pregnancy guidelines. Comprised of 10 key recommendations aimed at improving outcomes in pregnant individuals with type 1 or 2 diabetes, these guidelines included discontinuing GLP-1 RAs prior to conception, avoidance of metformin during pregnancy due to concerns of fetal outcomes, and the use of a hybrid closed-loop insulin delivery system rather than standard pumps.

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

In this episode of Diabetes Dialogue, Isaacs and Bellini covered the results of the ATTAIN-1 and STEP UP clinical trials, both of which had been presented at the European Association for the Study of Diabetes 2025 Conference. They discuss the success of orforglipron, a non-peptide GLP-1 receptor agonist, in patients with obesity or overweight and without diabetes – orforglipron’s status as an oral rather than injected GLP-1 was a key focus of the discussion. Additionally, the STEP UP trial investigating semaglutide 7.2 mg in adults with obesity marks a meaningful success for a substantially higher dose than what has been approved by the FDA.

Diabetes Dialogue: Therapeutic Updates from the ADA 2026 Standards of Care

In this episode of Diabetes Dialogue, Isaacs and Bellini cover the recently released 2026 ADA Standards of Care, emphasizing therapeutic changes that may be practice-changing. GLP-1 RAs are now recommended for both heart failure and CKD, and the Standards have added time-in-range goals to glucose monitoring alongside A1c targets. Additionally, Isaacs and Bellini express their excitement over the first-ever recommendation for GLP-1 RAs in patients with T1D and obesity, describing it as a major step forward, albeit a first one.