Primary completion· ClinicalTrials.gov
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM
Aficamten History and Updates
27 events · 2021 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
2
FDA Approvals
0
Label Revisions
25
Trial Milestones
0
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-10Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Aficamten since 2021, drawn from openFDA, ClinicalTrials.gov, and PubMed.
All published updates (5)
2026
- Results postedAficamten for oHCM Shows Superior Peak Oxygen Uptake vs. Metoprolol· Jun 9, 2026
- Results postedAficamten Phase 3 Trial Shows Significant oHCM Symptom and Exercise Improvement· Mar 3, 2026
2025
- FDA approvalMyqorzo (Aficamten) Receives Initial FDA Approval as New Molecular Entity· Dec 19, 2025
- Primary completionAficamten Phase 3 Study for oHCM in Chinese Patients Completes· Oct 20, 2025
- Primary completionAficamten Phase 3 Trial for oHCM Completes Primary Data Collection· Feb 28, 2025
Upcoming & expected milestones
Primary completion· ClinicalTrials.gov
Mavacamten to Aficamten Transition in Patients With Obstructive Hypertrophic Cardiomyopathy
Primary completion· ClinicalTrials.gov
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
Primary completion· ClinicalTrials.gov
A Study to Evaluate the Effect of Aficamten in Pediatric Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM).
Past events
2026
Results posted· ClinicalTrials.gov
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM
Trial registered· ClinicalTrials.gov
Mavacamten to Aficamten Transition in Patients With Obstructive Hypertrophic Cardiomyopathy
Results posted· ClinicalTrials.gov
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM
FDA approval (supplemental)· FDA
Sponsor: CYTOKINETICS. Class: REMS.
2025
FDA approval· FDA
Sponsor: CYTOKINETICS. Class: Type 1 - New Molecular Entity.
Primary completion· ClinicalTrials.gov
An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM
Primary completion· ClinicalTrials.gov
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM
2024
Trial started· ClinicalTrials.gov
A Study to Evaluate the Effect of Aficamten in Pediatric Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM).
Trial registered· ClinicalTrials.gov
A Study to Evaluate the Effect of Aficamten in Pediatric Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM).
2023
Primary completion· ClinicalTrials.gov
Study to Evaluate the Effect of Aficamten Administration on QT/QTc Interval
Trial started· ClinicalTrials.gov
An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM
Primary completion· ClinicalTrials.gov
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM
Trial registered· ClinicalTrials.gov
An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM
Trial registered· ClinicalTrials.gov
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM
Trial started· ClinicalTrials.gov
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM
Trial registered· ClinicalTrials.gov
Study to Evaluate the Effect of Aficamten Administration on QT/QTc Interval
Trial started· ClinicalTrials.gov
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM
Trial started· ClinicalTrials.gov
Study to Evaluate the Effect of Aficamten Administration on QT/QTc Interval
Trial registered· ClinicalTrials.gov
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM
2022
Trial started· ClinicalTrials.gov
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM
Trial registered· ClinicalTrials.gov
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM
2021
Trial started· ClinicalTrials.gov
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
Trial registered· ClinicalTrials.gov
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
Sources
FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.