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Milestone Pharmaceuticals Announces First European Study Participant Enrolled in ReVeRA-301 Phase 3 Clinical Trial

Globe Newswire•09/10/2026•08:00 ET
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Key Highlights

  • ➤First European patient enrolled in Milestone’s ReVeRA-301 Phase 3 AFib-RVR trial
  • ➤ReVeRA-301 targets approximately 150 AFib-RVR patients with treated events
  • ➤Trial evaluates FDA-approved 70 mg repeat-dose etripamil regimen
  • ➤U.S. enrollment began August 2026 and expanded to Canada
  • ➤Primary endpoint measures ventricular-rate reduction within 30 minutes

Expert Statements

David Bharucha, Chief Medical Officer of Milestone Pharmaceuticals

“Enrollment of the first patient in Europe represents continued progress in the global execution of ReVeRA-301 as we advance our pivotal Phase 3 program”

David Bharucha, Chief Medical Officer of Milestone Pharmaceuticals

“WCN brings an established network of experienced cardiovascular investigators, and our collaboration during the successful Phase 2 ReVeRA study in AFib-RVR provides a strong foundation for this next stage of clinical development.”

David Bharucha, Chief Medical Officer of Milestone Pharmaceuticals

“We look forward to building on that experience as we evaluate etripamil as a potential self-administered, ambulatory-setting treatment for patients experiencing AFib-RVR.”

Martin Hemels, Cardiologist and Chair of WCN, the Dutch Cardiovascular Investigator Network

“The enrollment of the first European patient in ReVeRA-301 marks an important milestone in advancing a new potential treatment for patients with AFib-RVR.”

Martin Hemels, Cardiologist and Chair of WCN, the Dutch Cardiovascular Investigator Network

“This innovative study explores a novel approach that could help patients receive effective treatment earlier and potentially avoid hospital visits.”

Martin Hemels, Cardiologist and Chair of WCN, the Dutch Cardiovascular Investigator Network

“We are proud that the Dutch WCN network can support both participating sites and Milestone Pharmaceuticals in bringing this exciting trial to patients.”

MONTREAL and CHARLOTTE, N.C., Oct. 09, 2026 (GLOBE NEWSWIRE) -- Milestone(®) Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that the first European patient has been enrolled in ReVeRA-301, its ongoing Phase 3 pivotal trial evaluating etripamil nasal spray for the treatment of atrial fibrillation with rapid ventricular rate (AFib-RVR). The study participant was enrolled at a site within the Dutch Cardiovascular Investigator Network (WCN) in the Netherlands as enrollment advances toward the study’s target of approximately 150 AFib-RVR patients with treated AFib-RVR events. ReVeRA-301 is evaluating the same 70 mg repeat-dose regimen that is U.S. Food and Drug Administration (FDA)-approved for the treatment of paroxysmal supraventricular tachycardia (PSVT) as CARDAMYST(®) (etripamil) nasal spray.

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