Overview
Etripamil has been used in trials studying the treatment of Paroxysmal Supraventricular Tachycardia (PSVT).
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Etripamil (CARDAMYST™): A Comprehensive Monograph on a Novel, Patient-Administered Therapy for Paroxysmal Supraventricular Tachycardia
I. Executive Summary
Etripamil is an investigational, small molecule drug being developed by Milestone Pharmaceuticals as a novel, short-acting, non-dihydropyridine L-type calcium channel blocker.[1] It is formulated as an intranasal spray intended for patient self-administration, representing a potential paradigm shift in the management of acute cardiovascular conditions.[4]
The core therapeutic proposition of Etripamil is to provide a rapid, on-demand treatment for episodes of paroxysmal supraventricular tachycardia (PSVT), particularly atrioventricular (AV)-nodal dependent forms such as atrioventricular nodal re-entrant tachycardia (AVNRT) and atrioventricular re-entrant tachycardia (AVRT).[2] Its development is aimed at empowering patients to manage their condition in a medically unsupervised, at-home setting, thereby reducing the burden of symptoms and the need for urgent medical care.[4]
The mechanism of action involves the selective inhibition of slow inward calcium channels in the AV node. This action slows AV nodal conduction and prolongs the refractory period, which effectively interrupts the re-entrant electrical circuit responsible for the tachycardia and restores normal sinus rhythm.[2]
The clinical development program has yielded robust evidence supporting its efficacy. The pivotal Phase 3 RAPID trial demonstrated a statistically significant and clinically meaningful benefit, with 64.3% of patients receiving Etripamil converting to sinus rhythm within 30 minutes, compared to 31.2% in the placebo group.[7] Subsequent large-scale safety studies have reported a median time to conversion of approximately 17 minutes.[9]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/04 | Phase 3 | Not yet recruiting | |||
2023/03/10 | Phase 2 | Recruiting | |||
2022/08/23 | Phase 1 | Completed | Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. | ||
2022/06/08 | Phase 3 | Completed | Corxel Pharmaceuticals | ||
2021/07/07 | Phase 3 | ENROLLING_BY_INVITATION | |||
2020/07/13 | Phase 2 | Completed | |||
2019/08/28 | Phase 3 | Completed | |||
2018/08/17 | Phase 3 | Terminated | |||
2018/03/13 | Phase 3 | Terminated | |||
2014/11/20 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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