Drugs / Etripamil

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed paroxysmal atrial fibrillation 2 milestones
Filed EU (EMA) TACHYMIST paroxysmal atrial fibrillation 2026-01-06

“today announced the acceptance of a Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) seeking the approval of etripamil nasal spray” milestonepharma.com ↗

Filed China (NMPA) — paroxysmal atrial fibrillation 2025-01-17

“In China, the New Drug Application (NDA) for etripamil nasal spray was accepted by the National Medical Products Administration (NMPA) on January 17, 2025.” milestonepharma.com ↗

“The New Drug Application for etripamil for PSVT in China is currently under review by China’s National Medical Products Administration (NMPA).” milestonepharma.com ↗

Approved Indication not stated 1 milestone
Approved US (FDA) CARDAMYST — 2025-12-12 fda.gov ↗

Trials 10

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT05511870 Mar 2023 — Corxel Pharmaceuticals Completed No outcome recorded
Phase 23 trials · 2 met primary
Phase 2 NCT05763953 Dec 2023 → Jun 2027 expected cardiac rhythm disease Milestone Pharmaceuticals Inc. Recruiting No outcome recorded
Phase 2 NCT04467905 Nov 2020 → Aug 2023 atrial fibrillation Milestone Pharmaceuticals Inc. Completed Met primary
Phase 2 NCT02296190 Mar 2015 → Dec 2016 cardiac rhythm disease Milestone Pharmaceuticals Inc. Completed Met primary
Phase 36 trials
Phase 3 NCT06716021 Jan 2027 → Jan 2029 expected atrial fibrillation Milestone Pharmaceuticals Inc. Not yet recruiting No outcome recorded
Phase 3 NCT05410860 Jun 2022 → Aug 2024 cardiac rhythm disease Corxel Pharmaceuticals Completed No outcome recorded
Phase 3 NCT04952610 Dec 2021 → Apr 2026 cardiac rhythm disease Milestone Pharmaceuticals Inc. Completed No outcome recorded
Phase 3 NCT04072835 Sep 2019 → Jan 2023 cardiac rhythm disease Milestone Pharmaceuticals Inc. Completed No outcome recorded
Phase 3 NCT03635996 Dec 2018 → Nov 2020 cardiac rhythm disease Milestone Pharmaceuticals Inc. Terminated No outcome recorded
Phase 3 NCT03464019 Jun 2018 → Jan 2023 cardiac rhythm disease Milestone Pharmaceuticals Inc. Terminated No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2026-09-03 Milestone Pharmaceuticals Inc. Regulatory Milestone Pharmaceuticals Announces NMPA Approval of Etripamil Nasal Spray for PSVT in China, Marking First Regulatory Approval of Etripamil Outside of the United States milestonepharma.com ↗
Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that China’s National Medical Products Administration (NMPA) has approved etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) in adults.
2026-03-31 Milestone Pharmaceuticals Inc. Regulatory Milestone Pharmaceuticals Announces that CARDAMYST™ (etripamil) Nasal Spray is Available on Express Scripts Commercial National Formularies milestonepharma.com ↗
Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that Express Scripts, one of the nation’s largest pharmacy benefit managers, has added CARDAMYST™ (etripamil) nasal spray to its commercial national formularies, effective March 27, 2026.
2026-03-16 Milestone Pharmaceuticals Inc. Results Milestone Pharmaceuticals to Present Data on CARDAMYST™ (etripamil) Nasal Spray at the 2026 American College of Cardiology Annual Scientific Session milestonepharma.com ↗
2026-01-06 Milestone Pharmaceuticals Inc. Regulatory Milestone Pharmaceuticals Announces Acceptance of Marketing Authorization Application for Etripamil Nasal Spray in PSVT by the European Medicines Agency milestonepharma.com ↗

All press releases naming this drug 8 releases

DateIssuerRelease

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 12 sources stand behind the page.

FieldValueCited text
Known as Etripamil ClinicalTrials.gov intervention name — accepted as the source's own label NCT05763953 ↗
9

NCT03635996 ↗

NCT04072835 ↗

NCT04952610 ↗

NCT05511870 ↗

NCT04467905 ↗

NCT06716021 ↗

NCT05410860 ↗

NCT03464019 ↗

NCT02296190 ↗

Known as (-)-MSP-2017 ChEMBL registry synonym — accepted as the source's own label CHEMBL3707312 ↗
Known as Etripamilo ChEMBL registry synonym — accepted as the source's own label CHEMBL3707312 ↗
Known as MS)-MSP-2017 ChEMBL registry synonym — accepted as the source's own label CHEMBL3707312 ↗
Action Inhibit “a short-acting calcium-channel blocker” PMID 30049309 ↗ Jul 2018
Modality Small molecule — CHEMBL3707312 ↗
Route Intranasal “intranasal administration via 4 prefilled Aptar Pharma Unit-Dose Spray devices” NCT02296190 ↗