CMHC Pulse Blog

The first half of 2025 has brought an impressive wave of progress in cardiometabolic and renal care, with the U.S. Food and Drug Administration (FDA) granting approvals to several novel therapies and expanded indications. These approvals address a broad spectrum of conditions, including hypertension, diabetes, chronic kidney disease, stroke, and cardiovascular risk reduction—diseases that collectively represent some of the most burdensome and costly challenges in modern medicine. What sets this period apart is not just the volume of approvals, but the diversity and innovation of the treatments themselves: wearable drug delivery systems, biosimilar insulin, triple-combination antihypertensives, and the first stroke medication in nearly three decades. As clinicians and patients alike seek more personalized, efficient, and accessible care, these advances offer meaningful solutions to unmet needs across the cardiometabolic spectrum.

Below, we summarize the key FDA approvals from January through July 2025 that are poised to reshape clinical practice and improve patient outcomes.

Ozempic (semaglutide)

• Approval Date: January 2025
• New Indication: Reduction of risk of worsening kidney disease and cardiovascular complications
• Why It Matters: Ozempic becomes the first GLP-1 receptor agonist approved for the prevention of kidney disease progression—a milestone for patients with type 2 diabetes and chronic kidney disease.
• Company: Novo-Nordisk

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Merilog (insulin aspart-szjj) Injection

• Approval Date: February 2025
• Indication: Diabetes Mellitus
• Why It Matters: As a biosimilar to NovoLog (insulin aspart),  Merilog provides a cost-effective, rapid-acting insulin option for both adult and pediatric patients with diabetes mellitus.
• Company: sanofi-aventis U.S. LLC

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TNKase (tenecteplase)

• Approval Date: March 2025
• New Indication: FDA Approves Genentech’s TNKase® in Acute Ischemic Stroke in Adults
• Why It Matters: TNKase offers a simpler, faster alternative to existing stroke treatments with a single five-second IV bolus. This approval is the first for a stroke drug in nearly three decades.
• Company: Genentech

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Arbli (losartan potassium) Oral Suspension

• Approval Date: March 2025
• Indication: High Blood Pressure, Diabetic Kidney Disease
• Why It Matters: Arbli is the first FDA-approved oral liquid formulation of the approved angiotensin II receptor blocker losartan, and is used for the treatment of hypertension and diabetic nephropathy.
• Company: Scienture Holdings, Inc.

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HemiClor (chlorthalidone) Tablets

• Approval Date: March 2025
• Indication: High Blood Pressure
• Why It Matters: HemiClor, a thiazide-like diuretic, offers a low-dose option for the treatment of hypertension in adults, to lower blood pressure.
• Company: PRM Pharma, LLC

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Vanrafia (atrasentan) Tablets

• Approval Date: April 2025
• Indication: Immunoglobulin A Nephropathy
• Why It Matters: Vanrafia, an endothelin A receptor antagonist, is specifically approved to reduce proteinuria—an important biomarker of disease progression in IgA nephropathy.
• Company: Novartis Pharmaceuticals Corporation

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Yutrepia (treprostinil) Inhalation Powder – formerly LIQ861

• Approval Date: May 2025
• Indication: Pulmonary Arterial Hypertension (PAH); Pulmonary Hypertension Associated with Interstitial Lung Disease
• Why It Matters: Yutrepia offers a dry powder inhalation formulation of the prostacyclin mimetic treprostinil, streamlining treatment for patients managing chronic pulmonary vascular diseases.
• Company: Liquidia Technologies, Inc.

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Widaplik (amlodipine, indapamide and telmisartan) Tablets – formerly GMRx2

• Approval Date: June 2025
• Indication: High Blood Pressure
• Why It Matters: Widaplik is a fixed-dose, triple-combination pill and the first FDA-approved triple-combination medication for use as an initial therapy for the treatment of hypertension .
• Company: George Medicines

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Cardiometabolic and Cardiorenal Therapeutics   

These 2025 approvals reflect a clear trend: innovation in cardiometabolic and cardiorenal medicine is accelerating—not only through the development of new drugs but through better delivery mechanisms, affordability improvements, and formulation updates that make therapies more patient-friendly. 

The 20th Annual Cardiometabolic Health Congress (Oct. 23–25, 2025, in Boston, MA) features distinguished CMHC faculty sharing the latest updates and insights on these groundbreaking developments.

Join us at the 20th Annual CMHC for comprehensive FDA updates, instructive patient case studies, late-breaking trial data, and more.

Don’t miss this opportunity to enhance your clinical practice and advance patient care.

Learn more and register now for the 20th Annual CMHC.