Cardiology Month in Review: May 2025

Amid the dynamic and fast-paced landscape of cardiovascular medicine, May 2025 delivered a mix of promising advances and sobering setbacks across the pipeline, regulatory, and clinical arenas. This month in review highlights the most important developments shaping current and future care for patients with cardiometabolic disease.

FDA Updates in Cardiology

FDA Accepts NDA Submission for Oral Semaglutide 25 mg

On May 2, 2025, Novo Nordisk announced the FDA accepted its NDA for a once-daily 25 mg oral formulation of semaglutide (Wegovy) for chronic weight management in adults with obesity or overweight. Based on Phase 3 OASIS 4 trial results, the pill showed significant efficacy in reducing weight in patients with at least one comorbidity. According to Novo Nordisk, this could become the first oral GLP-1 therapy approved for obesity treatment. The drug also aims to reduce cardiovascular risk in patients with established heart disease. The FDA decision is expected in Q4 2025.

FDA Approves 12.5 mg Chlorthalidone Tablets for Hypertension

On May 6, 2025, PRM Pharma announced FDA approval of 12.5 mg chlorthalidone tablets (HemiClor) for treating adults with hypertension. Based on data from trials like ALLHAT and SHEP, the low-dose formulation supports guideline-recommended strategies to reduce cardiovascular risk. According to PRM Pharma, HemiClor offers clinicians more flexibility when initiating or adjusting hypertension therapy. The 12.5 mg dose may also help minimize side effects like hypokalemia, especially in older adults. Tablets will be available nationwide beginning this month.

MAR001 Cuts Remnant Cholesterol, Triglycerides by 50% in Phase 2a Trial

On May 7, 2025, Marea Therapeutics announced Phase 2a data showing that MAR001, a first-in-class monoclonal antibody targeting ANGPTL4, significantly reduced remnant cholesterol and triglycerides by over 50% compared to placebo. Based on these results, MAR001 could offer a new option for patients with ASCVD who remain at risk despite standard care. According to Marea, the drug was well-tolerated and showed no serious safety concerns. The company plans to begin Phase 2b development in Q2 2025.

Pipeline News

Obicetrapib Achieves Robust LDL-C Reductions in Phase 3 ASCVD Trials

On May 7, 2025, NewAmsterdam Pharma announced Phase 3 results showing once-daily oral obicetrapib significantly reduced LDL-C in ASCVD patients inadequately managed with standard therapy. Based on the BROADWAY and TANDEM trials, obicetrapib reduced LDL-C by over 30% alone and nearly 50% when combined with ezetimibe. According to NewAmsterdam, the drug also lowered lipoprotein(a) by 45% and showed a trend toward reducing cardiovascular events. These findings support global regulatory filings and reflect obicetrapib’s potential as an effective oral adjunct to statins. A decision will follow results from the ongoing PREVAIL outcomes trial.

Olezarsen Cuts Triglyceride Levels at 6 Months in Essence Study

On May 19, 2025, Ionis Pharmaceuticals announced that olezarsen significantly reduced triglyceride levels in the Phase 3 Essence trial for patients with moderate hypertriglyceridemia (HTG) at risk for ASCVD. Based on 6-month data, 50 mg and 80 mg monthly doses cut triglycerides by nearly 60%, with most patients reaching normal levels. According to Ionis, these results support expanding olezarsen’s use beyond its current approval for familial chylomicronemia syndrome. The therapy was well-tolerated, with mostly mild injection site reactions reported. Additional pivotal trial results are expected later in 2025 to support a potential sNDA for severe HTG.

Birtamimab Misses Primary Phase 3 Endpoint for AL Amyloidosis

On May 23, 2025, Prothena announced that birtamimab failed to meet the primary endpoint in the Phase 3 AFFIRM-AL trial for AL amyloidosis, leading to the termination of its development and open-label extension. Based on trial results showing no significant survival benefit or improvement in secondary outcomes, the company will reduce operating costs and implement major workforce cuts. According to Prothena, despite prior FDA Fast Track and Orphan Drug designations, discontinuing birtamimab is the most appropriate course. The drug was designed to clear amyloid deposits contributing to organ failure in AL amyloidosis. Additional pipeline updates are expected later this year.

Don’t Miss a Beat

This episode of Don’t Miss a Beat centers on the evolving treatment landscape for transthyretin amyloid cardiomyopathy (ATTR-CM) with special guest Ahmad Masri, MD. Hosts Muthiah Vaduganathan, MD, MPH, a cardiologist and codirector of the Center for Cardiometabolic Implementation Science at Brigham and Women’s Hospital, and Steve Greene, MD, an advanced heart failure specialist at Duke University School of Medicine, are joined by Masri, who serves as the director of the HCM and Amyloid Program at Oregon Health & Science University, to discuss the rapid therapeutic advances in ATTR-CM and the emerging questions shaping real-world clinical practice.