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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: 13 Jan 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

  • 06 Jan 2026 According to a Milestone Pharmaceuticals media release, announced the acceptance of a Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) seeking the approval of etripamil nasal spray and the decision on approval is expected by the first quarter of 2027. The MAA is based upon data from obust clinical trial program based on data from more than 1,800 participants and more than 2,000 episodes of PSVT and this study.
  • 13 Dec 2025 According to a Milestone Pharmaceuticals media release, U.S. Food and Drug Administration (FDA) approved its first commercial product, CARDAMYST™ (etripamil) nasal spray, a prescription medication for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.
  • 11 Jul 2025 According to a Milestone Pharmaceuticals media release, Company announced that the U.S. Food and Drug Administration (FDA) has accepted for review company's response to issues raised in the Complete Response Letter (CRL) for CARDAMYS (etripamil) nasal spray for the treatment of patients with paroxysmal supraventricular tachycardia (PSVT). The FDA has assigned a new Prescription Drug User Fee Act (PDUFA) target action date of December 13, 2025.

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