Adagio Medical (ADGM) FDA Approvals

Adagio Medical's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Adagio Medical (ADGM). Over the past two years, Adagio Medical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as FULCRUM-VT. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

FULCRUM-VT FDA Regulatory Events

FULCRUM-VT is a drug developed by Adagio Medical for the following indication: for Ventricular Tachycardia. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Enrollment Update - October 1,2025

• Drug: FULCRUM-VT
• Announced Date: October 1, 2025
• Indication: for Ventricular Tachycardia

Adagio Medical Holdings, Inc announced the completion of enrollment of the FULCRUM-VT Pivotal U.S. Food and Drug Administration ("FDA") Investigational Device Exemption ("IDE") study evaluating the Company's vCLASTM Cryoablation System ("vCLAS" or "vCLAS System") for ablation of monomorphic ventricular tachycardia (MMVT).

Adagio Medical Holdings announced it has finished enrolling 208 patients in the FULCRUM-VT pivotal IDE study of its vCLAS™ Cryoablation System, a novel ultra-low temperature technology for treating monomorphic ventricular tachycardia (MMVT). This single-arm, multi-center trial across 20 sites in the U.S. and Canada will assess safety and effectiveness for scar-mediated, sustained MMVT in patients with structural heart disease. The main goal is six-month freedom from recurrent MMVT without increasing antiarrhythmic drugs. Study findings will support a pre-market approval application, targeting completion of the PMA process by late 2026. The vCLAS System is already available for MMVT treatment in Europe and select regions but remains investigational in the United States. Adagio plans to use these results to bring its purpose-built cryoablation technology to a large population of VT patients seeking more effective treatment options.

Enrollment took only 11 months, underscoring strong interest in this VT-specific ablation method among leading heart centers.

Adagio Medical FDA Events - Frequently Asked Questions

Has Adagio Medical received FDA approval?

As of now, Adagio Medical (ADGM) has not received any FDA approvals for its therapy in the last two years.

What drugs has Adagio Medical submitted to the FDA?

In the past two years, Adagio Medical (ADGM) has reported FDA regulatory activity for FULCRUM-VT.

What is the most recent FDA event for Adagio Medical?

The most recent FDA-related event for Adagio Medical occurred on October 1, 2025, involving FULCRUM-VT. The update was categorized as "Enrollment Update," with the company reporting: "Adagio Medical Holdings, Inc announced the completion of enrollment of the FULCRUM-VT Pivotal U.S. Food and Drug Administration ("FDA") Investigational Device Exemption ("IDE") study evaluating the Company's vCLASTM Cryoablation System ("vCLAS" or "vCLAS System") for ablation of monomorphic ventricular tachycardia (MMVT)."

What conditions do Adagio Medical's current drugs treat?

Currently, Adagio Medical has one therapy (FULCRUM-VT) targeting the following condition: for Ventricular Tachycardia.