The U.S. Food and Drug Administration has approved Cytokinetics’ oral drug Myqorzo for the treatment of a rare heart condition, the company confirmed on Friday.
Myqorzo is approved for patients with obstructive hypertrophic cardiomyopathy (oHCM). In this condition, the heart muscle thickens abnormally, restricting blood flow. As a result, patients often experience shortness of breath, chest pain, fatigue, and dizziness.
Hypertrophic cardiomyopathy affects roughly one in every 500 people in the United States. A significant proportion of these patients have the obstructive form of the disease.
A Major Milestone for Cytokinetics
Myqorzo represents Cytokinetics’ first FDA-approved medicine. It is also only the second drug in its class to receive US clearance. Importantly, it targets the underlying disease mechanism rather than just managing symptoms.
The drug belongs to a class known as cardiac myosin inhibitors. It works by reducing excessive heart muscle contraction, thereby improving blood flow and relieving symptoms. Cytokinetics said Myqorzo will become available in the United States in the second half of January. However, the FDA has required the strongest safety warning due to the potential risk of heart failure.
It took 27 years, but Cytokinetics secured its first U.S. drug approval. https://t.co/RIi1dM4nbN
— STAT (@statnews) December 19, 2025Because of this risk, Myqorzo will be dispensed only under a Risk Evaluation and Mitigation Strategy (REMS) program. This system ensures careful monitoring and appropriate use in eligible patients.
How Myqorzo Compares to Existing Therapy
Myqorzo is in the same drug class as Bristol Myers Squibb’s Camzyos, which gained FDA approval in 2022 and carries similar safety warnings. According to Mizuho analyst Salim Syed, Myqorzo appears safer and easier to use. He noted that convenience could play a key role, especially for doctors and patients who are new to cardiac myosin inhibitors.
Read: FDA Approves Apple Watch’s Hypertension Detection Feature
The active ingredient in Myqorzo, aficamten, showed strong results in late-stage clinical trials. Studies found that it improved exercise capacity and reduced symptoms more effectively than the standard blood pressure medication metoprolol. Cytokinetics said it will announce Myqorzo’s list price before launch. The company expects pricing to align closely with Camzyos.
With FDA approval secured, Myqorzo offers a new, disease-focused option for patients with obstructive hypertrophic cardiomyopathy. Its arrival marks a significant advance in treatment and a major step forward for Cytokinetics.
