Hormonal Disorders in 2025: Year in Review

Despite being a relatively quiet year for hormonal disorders in terms of groundbreaking new research, the US Food and Drug Administration (FDA) has been very active over the last 12 months, with new approvals and revisions to old therapies. Hormone replacement therapy (HRT) for both men and women has evolved significantly after a long period of stagnation, and everything from growth hormone deficiency (GHD) to adrenal insufficiency has seen major new therapeutic options added to their treatment repertoires.

With the end of the year rapidly approaching, the editorial team at HCPLive has collected 9 of the most impactful headlines across hormonal disorders from 2025. Catch up on any news you may have missed below.

FDA News

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

On July 28, 2025, the FDA approved lonapegsomatropin-tcgd for adult GHD, based on data from the phase 3 foresiGHt clinical trial. The somatropin prodrug achieved superiority in trunk fat reductions and body lean mass increase from baseline when compared to placebo. Additionally, lonapegsomatropin-tcgd appeared safe and well-tolerated for the duration of the trial, with no discontinuations related to the study drug.

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

On September 25, 2025, Crinetics Pharmaceuticals announced the FDA’s approval of paltusotine for first-line treatment of adults with acromegaly who had an inadequate response to surgery or who are unable to undergo surgery. The selectively targeted somatostatin receptor type 2 agonist is now the first once-daily oral treatment approved for this condition – the approval was based on data from the phase 3 PATHFNDR-1 and PATHFNDR-2 trials. In both, paltusotine displayed rapid onset, reliable biochemical control, and sustained efficacy for the duration.

FDA Approves Hydrocortisone Oral Solution for Adrenal Insufficiency

On May 28, 2025, the FDA approved hydrocortisone oral solution for pediatric patients ≥5 years with adrenocortical insufficiency, addressing administration and dosing accuracy in patients who may have difficulty swallowing pills or with special administration needs. Adrenal insufficiency is a rare but serious condition, decreasing the production of aldosterone and cortisol via reduced adrenal gland function and potentially leading to high morbidity and mortality. This new treatment provides an additional option to meet the needs of both clinicians and patients.

Trial Updates and New Guidelines

FDA initiates removal of boxed warnings, requests updated labeling for menopausal hormone therapy

On November 10, 2025, the FDA and the US Department of Health and Human Services announced their plan to revise safety labeling for menopausal hormone therapy, also known as hormone replacement therapy. After reevaluating data from the original Women’s Health Initiative (WHI) trial, which was conducted in the 1990s, both agencies determined that the substantially older patient group from WHI does not properly represent the average age of menopause onset in the US. To this end, the FDA requested several labeling changes, including the removal of language in boxed warnings related to cardiovascular disease, breast cancer, and dementia, as well as adding WHI data for women aged 50-59 years.

FDA issues labeling changes for testosterone products following TRAVERSE, postmarket studies

On March 3, 2025, the FDA issued a class-wide labeling change for testosterone products, based on new findings from the phase 4 TRAVERSE trial and from required postmarket ambulatory blood pressure monitoring studies. These postmarket trials resulted in suggestions to add product-specific information on increased blood pressure and a new warning about increased blood pressure for testosterone products without a current warning, while TRAVERSE led to the FDA suggesting retaining “limitation of use” language for age-related hypogonadism and removing language from the boxed warning related to increased risk of adverse cardiovascular outcomes, as well as posting the results of TRAVERSE on the products directly.

Mohit Khera, MD, recaps key takeaways from FDA panel on TRT for men

Mohit Kera, Md, MBA, MPH, sat down with Urology Times in December of 2025 to address the recent FDA panel on labeling of testosterone replacement therapy (TRT) for men. The panel was a turning point in TRT, marking the beginning of the FDA revisiting historical and long-standing perspectives on testosterone. Key points from the panel included outdated label language and reconsidering testosterone’s classification as a Schedule III controlled substance.

Feature Content/Podcasts

Crinecerfont Shows Lasting Efficacy in Treating Adult CAH, with Richard Auchus, MD, PhD

Data from year 1 of the phase 3 CAHtalyst clinical trial, investigating crinecerfont in adult patients with congenital adrenal hyperplasia, were presented at ENDO 2025, showing the drug’s efficacy in reducing excessive adrenal androgen production and thereby reducing the amount of glucocorticoid treatment necessary to return patients to equilibrium. CAHtalyst compared crinecerfont to placebo, with the former providing a 27.3% reduction in glucocorticoid doses compared to 10.3% in the latter.

Karyn S. Eilber, MD, shares her reaction to genitourinary syndrome of menopause guidelines

The 2025 American Urological Association Annual Meeting saw the release of the “Genitourinary Syndrome of Menopause: AUA/SUFU (Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction/American Urogynecologic Society) Guideline,” which described in detail the symptoms and physical changes caused by declining estrogen and androgen concentrations in the genitourinary tract during menopause. Karen Eilber, MD, discusses the importance of a full, complete diagnosis of these symptoms so that treatment strategies can be undertaken in the future.

Diabetes Dialogue: CATALYST Trial, Mifepristone, and Hypercortisolism in T2D, with John Buse, MD, PhD

In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, spoke with John Buse, MD, PhD, about the phase 4 CATALYST trial, which suggests that mifepristone substantially improves glycemic control, reduces body weight, and lowers waist circumference in patients with hypercortisolism and difficult-to-control type 2 diabetes. While part 1 of the trial saw patients undergo dexamethasone suppression testing to identify hypercortisolism, part 2 randomized 136 patients to either mifepristone or placebo for 24 weeks. Despite the drug’s proven efficacy, however, 49% of patients discontinued therapy, compared to 18% in placebo.