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Etripamil

Phase 3FDA approved

Atrial Fibrillation | Small molecule | Cardiovascular |Milestone Pharmaceuticals Inc.|Trials Updated: Oct 7, 2026

Etripamil development status

FDA approval on record Dec 12, 2025 as Cardamyst
Approval holderMilestone Pharms Usa
ApplicationNDA218571
Highest phase Phase 3
Registered trials 4 across 1 sponsor since Nov 2014

Label indication CARDAMYST is indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. CARDAMYST is a calcium channel blocker indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults ( 1 ). FDA label

Etripamil target and mechanism

Molecular targetCAV1
ModalitySmall molecule

Also known as MSP-2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment1,018

FDA Designations

No designations recorded

Etripamil clinical trials

Etripamil · 3 trials · 2 indications

Phase 3 1Phase 2 2
NCT06716021ReVeRA-301: Etripamil in Atrial Fibrillation Phase 3Atrial Fibrillation
RECRUITING750 Analytics
PHASE3RECRUITING
ReVeRA-301: Etripamil in Atrial Fibrillation Phase 3
Atrial FibrillationUnlock trial analytics

Study Endpoints

Primary Endpoints

Demonstrate the efficacy of etripamil NS over placebo in patients with AF.
30 minutes from first drug administration

The maximum reduction in ventricular rate, measured from ECG CMS recordings, within 30 minutes from first drug administration

The Maximum Reduction in Ventricular Rate, Measured on Holter Monitoring, Within 60 Minutes From Drug Administration.
60 minutes post drug administration

Baseline ventricular rate is defined as the average heart rate over 5 minutes immediately prior to drug administration. Nadir is defined as the lowest moving average heart rate over 5 minutes recorded in the 60 minutes post drug administration.

The Percentage of Subjects Successfully Converted From PSVT to Sinus Rhythm Within 15 Minutes of Study Drug Administration
Within 15 minutes of study drug administration

The primary efficacy endpoint was the rate of successful PSVT conversion to sinus rhythm lasting at least 30 seconds within 15 minutes of study drug administration after a minimum of 5 minutes in sustained PSVT.

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPatients will self-administer an initial dose of placebo for a perceived episode of AF with RVR, followed by an optional second dose 10 minutes later if symptoms persist.
EtripamilEXPERIMENTALPatients will self-administer an initial dose of etripamil for a perceived episode of AF with RVR, followed by an optional second dose 10 minutes later if symptoms persist.

Interventions

NameTypeDescription
PlaceboDRUGThe formulation of placebo will consist of water, sodium acetate, disodium EDTA, and sulfuric acid to reproduce the same pH as the etripamil formulation.
EtripamilDRUGThe formulation of etripamil is for IN administration and will consist of etripamil, water, acetic acid, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid. The dose of etripamil to be evaluated in this study is 70 mg with an optional second dose of 70 mg 10 minutes after the first dose if symptoms persist.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: 1. Age 18 years and over. 2. Provision of written informed consent. 3. Documented history of symptomatic AF (paroxysmal, persistent, or permanent) with a ventricular rate of ≥110 bpm. * Documentation: electrocardiogram (ECG) tracing (including 12-lead ECG or ECG strip) showi...

Countries:United StatesCanadaNetherlands
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Competitive Landscape -Atrial Fibrillation 159 trials

Recent Changes (Last 90 Days)

LOWOct 7, 2026NCT06716021lastUpdatePostDate: changed
LOWOct 7, 2026NCT06716021lastUpdatePostDate: changed
LOWSep 23, 2026NCT06716021lastUpdatePostDate: changed
LOWSep 23, 2026NCT06716021lastUpdatePostDate: changed
LOWSep 9, 2026NCT06716021Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 9, 2026NCT06716021Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 17, 2026NCT06716021lastUpdatePostDate: changed
LOWAug 17, 2026NCT06716021lastUpdatePostDate: changed

Frequently asked questions about Etripamil

What is Etripamil?

Etripamil is an investigational small molecule developed by Milestone Pharmaceuticals Inc. (ticker: MIST) for cardiovascular conditions. It is being studied in atrial fibrillation and paroxysmal supraventricular tachycardia (PSVT). Etripamil is currently in Phase 3 clinical development and is not approved for commercial use.

What is Etripamil used for?

Etripamil is being developed to treat atrial fibrillation and paroxysmal supraventricular tachycardia (PSVT), two heart rhythm disorders. In PSVT, the goal is conversion of the arrhythmia to normal sinus rhythm. In atrial fibrillation, it is being evaluated in Phase 3 and earlier studies. It remains investigational.

What does Etripamil target?

Etripamil targets CAV1. CAV1 is a calcium channel, and Etripamil is a small molecule designed to act on this target. This mechanism underlies its development for cardiovascular rhythm conditions such as atrial fibrillation and paroxysmal supraventricular tachycardia (PSVT).

Who makes Etripamil?

Etripamil is developed by Milestone Pharmaceuticals Inc., which trades under the ticker MIST. The company is advancing the drug as a nasal spray formulation, referenced as Etripamil Nasal Spray 70mg, across cardiovascular indications including atrial fibrillation and paroxysmal supraventricular tachycardia (PSVT).

What phase is Etripamil in?

Etripamil is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 program includes the ReVeRA-301 trial in atrial fibrillation, which is currently recruiting, while earlier Phase 2 studies in atrial fibrillation and PSVT have been completed.

What clinical trials is Etripamil in?

Etripamil has been studied in three registered trials. NCT06716021 (ReVeRA-301) is a recruiting Phase 3 trial in atrial fibrillation with 750 participants across the United States, Canada, and the Netherlands. NCT04467905 (ReVeRA-201) was a completed Phase 2 atrial fibrillation trial, and NCT02296190 was a completed Phase 2 PSVT trial.