Top 5 Trending FDA Approvals of 2025

The US saw several new and expanded FDA indications this year. The top 5 most-read FDA approvals on AJMC.com included 4 novel therapies and 1 expanded indication, reflecting the growing number of treatment options available to patients across the health care continuum.

Here are the top 5 FDA approval articles from 2025; keep up with all FDA approvals here.

This article highlights several newly approved therapies that expand treatment options across multiple disease states. | Image Credit: Tada Images - stock.adobe.com

5. FDA Approves First New Class of Oral Antibiotics for Uncomplicated UTIs in Nearly 30 Years

In March, the FDA approved gepotidacin (Blujepa; GSK) for the treatment of uncomplicated urinary tract infections (uUTIs) in female patients 12 years and older, introducing the first new class of oral antibiotics for this condition in nearly 30 years. The approval was supported by positive results from the phase 3 EAGLE-2 (NCT04020341) and EAGLE-3 (NCT04187144) trials, which compared the efficacy and safety of oral gepotidacin with that of the antibiotic nitrofurantoin in adolescent and adult female patients with uUTIs.

In EAGLE-2, therapeutic success was observed in 50.6% of patients receiving gepotidacin and 47.0% of those treated with nitrofurantoin (adjusted difference, 4.3%; 95% CI, –3.6 to 12.1). EAGLE-3 yielded similar results, with therapeutic success rates of 58.5% for gepotidacin and 43.6% for nitrofurantoin (adjusted difference, 14.6%; 95% CI, 6.4-22.8). Based on these results, gepotidacin was deemed noninferior to nitrofurantoin in both trials and demonstrated superiority in EAGLE-3.

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4. FDA Expands Semaglutide Use for CV, Kidney Risks in T2D, CKD

One of the first FDA actions in 2025 was expanding semaglutide (Ozempic; Novo Nordisk) indications to include patients with type 2 diabetes and chronic kidney disease, making it the only glucagon-like peptide-1 receptor agonist approved to reduce cardiovascular risks and slow kidney disease progression when added to standard care. The decision was supported by the phase 3b FLOW (NCT03819153) trial, which found that once-weekly semaglutide injections reduced the risk of both cardiovascular disease (CVD) and adverse kidney outcomes. Specifically, patients in the treatment group exhibited a 24% lower risk of multiple adverse kidney outcomes, including progressive and end-stage kidney disease, along with a nearly 5% lower risk of CVD-related death over 3 years compared with the placebo group.

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3. FDA Approves Nerandomilast for Idiopathic Pulmonary Fibrosis

In October, the FDA approved nerandomilast (Jascayd; Boehringer Ingelheim) for adults with idiopathic pulmonary fibrosis (IPF), marking the first approval of a novel IPF therapy in more than 10 years. The decision was supported by data from the phase 3 FIBRONEER-IPF trial (NCT05321069) and Trial 2 (NCT04419506), both of which showed that nerandomilast slowed lung function decline compared with placebo.

In FIBRONEER-IPF, patients receiving nerandomilast experienced significantly less decline in absolute forced vital capacity (FVC) from baseline compared with the placebo group. The adjusted mean FVC decline was –106 mL in the 18-mg group and –122 mL in the 9-mg group, compared with –170 mL in the placebo group. In Trial 2, patients treated with nerandomilast had a 91-mL decline in FVC at 12 weeks.

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2. Brensocatib Becomes First FDA-Approved Therapy for Bronchiectasis

This past summer, the FDA approved brensocatib (Brinspuri; Insmed) for the treatment of non–cystic fibrosis bronchiectasis, making it both the first therapy approved for this patient population and the first dipeptidyl-peptidase-1 inhibitor approved to treat a neutrophil-mediated disease. The approval was supported by data from the phase 3 ASPEN trial (NCT04594369), which randomly assigned adults (1:1:1) and adolescents (2:2:1) with bronchiectasis to once-daily brensocatib at either 10 mg or 25 mg or to placebo. The trial showed that brensocatib reduced the annualized rate of exacerbations compared with placebo, with the 25-mg dose also associated with a smaller decline in lung function.

Specifically, annualized pulmonary exacerbation rates were 1.02 with 10 mg, 1.04 with 25 mg, and 1.29 with placebo, yielding rate ratios (RRs) of 0.79 (95% CI, 0.68-0.92; adjusted P = .004) for 10 mg and 0.81 (95% CI, 0.69-0.94; adjusted P = .005) for 25 mg vs placebo. At week 52, 48.5% of patients treated with brensocatib remained exacerbation-free vs 40.3% treated with placebo. The RRs for remaining exacerbation-free were 1.20 (95% CI, 1.06-1.37; adjusted P = .02) for 10 mg and 1.18 (95% CI, 1.04-1.34; adjusted P = .04) for 25 mg.

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1. Suzetrigine: First-in-Class Nonopioid Pain Therapy Is Approved by FDA

The top-trending approval occurred in January and was granted to suzetrigine (Journavx; Vertex Pharmaceuticals), a novel oral, nonopioid, highly selective NaV1.8 pain signal inhibitor, for the treatment of adults with moderate to severe acute pain. Supported by data from multiple clinical trials, suzetrigine is both the first agent in the selective NaV1.8 pain signal inhibitor class and the first new drug approved for acute pain in more than 20 years. The approval, offering patients an effective nonopioid alternative, came just a week after Purdue Pharma and the Sackler family settled opioid-related lawsuits for $7.4 billion.

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