Q1 2025 Recap: Cardiology News and Updates

The landscape of cardiovascular medicine continues to evolve rapidly, with Q1 2025 delivering significant regulatory, clinical, and strategic developments. Novel therapeutics, key trial milestones, and expert insights are reshaping how clinicians understand and manage cardiovascular risk, disease progression, and rare disorders.

Clinicians and researchers alike are navigating a pivotal moment in cardiology, as therapies once considered experimental enter practice and diagnostics grow more precise.. This momentum is underscored by a mix of long-awaited approvals and strategic trial decisions that reflect both scientific progress and real-world clinical needs.

This quarter, the HCPLive Cardiology team highlighted 6 major regulatory updates from the US Food and Drug Administration (FDA), 5 major clinical trial headlines, and 3 expert-driven perspectives, including two episodes of our flagship cardiology podcast, Don’t Miss a Beat.

Q1 2025 Regulatory Updates in Cardiology

FDA Grants 510(k) Clearance to First Lp(a) Blood Test in Molar Units

On January 29, 2025, the FDA awarded 510(k) clearance to the first blood test for the US market to measure lipoprotein (a) [Lp(a)] in molar units. Granted to Roche, the regulatory agency suggested the Tina-quant® Lipoprotein (a) Gen.2 Molarity assay could benefit the assessment of lipid metabolism disorders and atherosclerotic cardiovascular disease (ASCVD) risk in conjunction with clinical evaluation and other lipoprotein tests.

FDA Approves Chenodiol Tablets for Cerebrotendinous Xanthomatosis

On February 21, 2025, the FDA approved chenodiol tablets (Ctexli) for adults with cerebrotendinous xanthomatosis (CTX), based on positive data from the Phase 3 RESTORE study showing a statistically significant reduction in bile alcohols. Awarded to Mirum Pharmaceuticals, the approval marked the first ever for the rare genetic lipid storage disease.

FDA Approves Tenecteplase (TNKase) for Acute Ischemic Stroke

On March 3, 2025, the FDA approved tenecteplase (TNKase) for adults with acute ischemic stroke (AIS), marking the first medicine approved for stroke in nearly 30 years. Genentech’s tenecteplase, a tissue plasminogen activator, clot-dissolving, thrombolytic medicine, is administered as a single intravenous bolus, with the company announcing plans for a 25 mg vial configuration later this year.

FDA Approves First Generic of Rivaroxaban (Xarelto) for CAD, PAD

On March 4, 2025, the FDA approved the first generic formulation of rivaroxaban (Xarelto) 2.5 mg tablets to reduce cardiovascular risk in adults with coronary artery disease (CAD) and major thrombotic vascular events in adult patients with peripheral artery disease (PAD). Anticoagulants, including rivaroxaban, are commonly prescribed in the US, and a generic approval could directly impact patient access and well-being.

FDA Approves Vutrisiran (AMVUTTRA) for ATTR-CM

On March 20, 2025, the FDA approved the supplemental New Drug Application (sNDA) for vutrisiran (AMVUTTRA) for treatment of cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM). With a previous indication for polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN), Alnylam’s vutrisiran became the first approved RNAi therapeutic targeted to reduce cardiovascular mortality, cardiovascular hospitalizations, and urgent heart failure visits in ATTR-CM.

FDA Issues CRL for Etripamil Nasal Spray (Cardamyst) in PSVT

On March 28, 2025, the FDA issued a Complete Response Letter (CRL) to the NDA for etripamil nasal spray (Cardamyst), targeted for the treatment of paroxysmal supraventricular tachycardia (PSVT). The denial did not raise concerns on the clinical safety or efficacy of etripamil nasal spray, but cited 2 key Chemistry, Manufacturing and Controls issues to be addressed by Milsetone Pharmaceuticals.

Q1 2025 Trial Announcements in Cardiology

Merck Halts Phase 3 HYPERION Trial of Sotatercept for Final Analysis

On January 30, 2025, Merck announced it would stop the Phase 3 HYPERION trial evaluating sotatercept-csrk (WINREVAIR) in adults with recently diagnosed pulmonary arterial hypertension (PAH) and proceed with final analysis. The company attributed the trial's halt to the efficacy benefit of sotatercept in the PAH clinical development program, including the STELLAR and ZENITH studies, which led to a loss of clinical equipoise in HYPERION.

Study Finds Icosapent Ethyl Can Reduce Cardiovascular Risk, Even in Well-Controlled LDL-C

Analysis of the multicenter, randomized, double-blind, placebo-controlled REDUCE-IT trial showed the benefit of icosapent ethyl (Vascepa) regardless of low-density lipoprotein cholesterol (LDL-C) levels at baseline. Icosapent ethyl offered benefit for those with LDL-C <55 mg/dL, achieving a statistically significant 34% reduction in cardiovascular event risk.

Lorundrostat Significantly Lowers Blood Pressure in Key Hypertension Trials

On March 10, 2025, Mineralys Therapeutics announced the promising efficacy and safety of lorundrostat in the pivotal Phase 3 Launch-HTN and Phase 2 Advance-HTN trials evaluating the treatment for uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). The oral aldosterone synthase inhibitor achieved statistically significant and clinically meaningful reductions in systolic blood pressure with a favorable safety and tolerability profile.

Olpasiran Reduces Oxidized Phospholipids on ApoB in OCEAN(a)-DOSE Trial

Olpasiran, a small interfering RNA inhibitor of lipoprotein(a) [Lp(a)], sustained a significant reduction in oxidized phospholipids associated with apoliprotein B (OxPL-apoB), but not high-sensitivity interleukin 6 (hs-IL-6) or C-reactive protein (hs-CRP), in the Phase 2 OCEAN(a)-DOSE trial. Previous results from the OCEAN(a)-DOSE trial showed increased olpasiran doses reduced circulating Lp(a) levels by ≥95% in individuals with atherosclerotic cardiovascular disease (ASCVD).

Q1 2025 Expert Perspectives in Cardiology

MOMENTUM Examines Hypercortisolism in Hypertension, with Deepak L. Bhatt, MD, MPH, MBA

On March 10, 2025, Corcept Therapeutics announced the launch of the MOMENTUM clinical trial to establish the prevalence of endogenous hypercortisolism (Cushing’s syndrome) in patients with resistant hypertension. Deepak L. Bhatt, MD, MPH, MBA, director of the Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at Icahn School of Medicine at Mount Sinai, explained the importance of the MOMENTUM trial in a recent interview with HCPLive Cardiology.

Don't Miss a Beat: STRIDE and SOUL Trials at ACC.25

At the American College of Cardiology (ACC) 2025 Annual Scientific Sessions, 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, tackled a pair of late-breaking trials at the meeting, STRIDE and SOUL.

Don't Miss a Beat: Treatment Sequencing in New Era of Heart Failure Management

In a second episode of Don’t Miss a Beat from ACC.25, hosts explored the evolving landscape of heart failure with preserved ejection fraction (HFpEF) treatment, focusing on implementation of combination therapies and the transition from a previously limited treatment landscape to an era with multiple therapeutic options.