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Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia. NODE-301 Trial

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Trial Profile

Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia. NODE-301 Trial

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 09 Sep 2026

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At a glance

  • Drugs Etripamil (Primary)
  • Indications Paroxysmal supraventricular tachycardia
  • Focus Registrational; Therapeutic Use
  • Acronyms NODE-301; RAPID
  • Sponsors Milestone Pharmaceuticals

Most Recent Events

  • 03 Sep 2026 According to a Milestone Pharmaceuticals media release, based on data from the pivotal global Phase III RAPID study and the Phase III JX02002 study the National Medical Products Administration (NMPA), China approved etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) in adults.
  • 13 May 2026 According to a Milestone Pharmaceuticals media release, MAA was accepted by EMA and European decision on approval is expected by the first half of 2027.
  • 23 Mar 2026 According to Everest medicines media release, the NDA for etripamil nasal spray was accepted by the NMPA on January 17, 2025 based on data from the pivotal global Phase 3 RAPID study and the China Phase 3 JX02002 study. Approval is expected in Q3 2026.

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