News | FDA | July 14, 2026

FDA Clears Atrium Therapeutics' IND Application for Cardiomyopathy Drug

Atrium receives FDA clearance of investigational new drug application for ATR 1072 for treating  PRKAG2 syndrome.

FDA Clears Atrium Therapeutics' IND Application for Cardiomyopathy Drug

July 14, 2026 — Atrium Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application allowing the company to move forward with its Corventis Phase 1/2 clinical trial designed to evaluate ATR 1072 for the treatment of Protein Kinase AMP-activated non-catalytic subunit Gamma 2 (PRKAG2) syndrome.

“PRKAG2 syndrome and other rare genetic cardiomyopathies represent a profound unmet need — these are progressive, life-altering and life-threatening diseases that often strike early, affect multiple members of the same family, and have no approved therapy to address their root cause,” said Kathleen Gallagher, president and chief executive officer, Atrium Therapeutics. “FDA clearance of our IND and the launch of the Corventis Phase 1/2 trial reinforce our team's ability to move with speed on behalf of patients with the goal of delivering potential disease-modifying treatments.”

Corventis is a Phase 1/2 open-label, multicenter clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ATR 1072. The study will enroll approximately 37 participants across two parts: Part A, multiple ascending dose cohorts to characterize safety and support dose selection, and Part B, a single-arm expansion cohort at the recommended Phase 2 dose to further evaluate safety and efficacy trends in cardiac structure and function.

Clinical site initiation activities are currently underway, and Atrium expects the first participant to be enrolled by the end of 2026. Initial trial data demonstrating proof of concept is anticipated in the second half of 2027.

 

Atrium FCA IDE

 


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