Product Description
Mechanisms of Action: Calcium Channel Blocker
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Topical, Nasal
FDA Designation: *
Approval Status: Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Milestone
Company Location:
Company Founding Year: 1997
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Brazil, Canada, China, Colombia, Germany, Netherlands, Spain, United States
Active Clinical Trial Count: 8
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Milestone presented P2 Tachycardia, Paroxysmal results on 2025-11-10 for Etripamil
- FDA accepted response to CRL for etripamil nasal spray, sets new PDUFA target date of December 13, 2025. Company strengthens balance sheet for commercialization.
- PDUFA target date for Cardamyst nasal spray for PSVT: March 27, 2025, with FDA NDA review ongoing. Commercial launch prep in progress.
Highest Development Phases
Phase 3: Tachycardia, Paroxysmal|Tachycardia, Supraventricular|Tachycardia, Ventricular
Phase 2: Atrial Fibrillation
Phase 1: Healthy Volunteers
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2022-500319-38-00 |
MSP-2017-1265 | P2 |
Recruiting |
Tachycardia, Ventricular|Tachycardia, Supraventricular|Tachycardia, Paroxysmal |
2027-06-30 |
2025-05-02 |
Treatments |
|
2022-001854-49 |
2022-001854-49 | P2 |
Completed |
Atrial Fibrillation |
2023-08-10 |
2025-06-30 |
Treatments |
|
NCT05410860 |
JX02002 | P3 |
Completed |
Tachycardia, Paroxysmal|Tachycardia, Supraventricular|Tachycardia, Ventricular |
2024-08-02 |
11% |
2024-12-27 |
Primary Endpoints|Study Completion Date |
NCT04072835 |
The NODE-303 Study | P3 |
Completed |
Tachycardia, Ventricular|Tachycardia, Paroxysmal|Tachycardia, Supraventricular |
2023-01-26 |
16% |
2024-05-25 |
|
2018-000308-41 |
2018-000308-41 | P3 |
Completed |
Tachycardia, Paroxysmal|Tachycardia, Ventricular|Tachycardia, Supraventricular |
2023-01-20 |
26% |
2025-07-04 |
Treatments |
NCT05511870 |
JX02001 | P1 |
Completed |
Tachycardia, Supraventricular|Tachycardia, Ventricular|Tachycardia, Paroxysmal |
2023-03-26 |
69% |
2023-04-11 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2019-001857-13 |
2019-001857-13 | P3 |
Active, not recruiting |
Tachycardia, Paroxysmal|Tachycardia, Ventricular|Tachycardia, Supraventricular |
2022-04-09 |
2022-03-13 |
Treatments |
|
CTR20221959 |
CTR20221959 | P1 |
Completed |
Healthy Volunteers |
2023-03-26 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |