Trial Profile
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 05 Mar 2024
Price :
$35
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At a glance
- Drugs Omecamtiv mecarbil (Primary)
- Indications Chronic heart failure
- Focus Registrational; Therapeutic Use
- Acronyms GALACTIC-HF
- Sponsors Amgen; Cytokinetics
- 27 Feb 2024 According to a Cytokinetics media release, Received the Day 180 List of Outstanding Issues from the European Medicines Agency (EMA) regarding the Marketing Authorization Application (MAA) for omecamtiv mecarbil during Q4 2023, and submitted responses during Q1 2024. The company expect the Committee for Medicinal Products for Human Use (CHMP) to issue an opinion regarding the MAA for omecamtiv mecarbil in Q2 2024.
- 01 Jan 2024 Results assessing the safety and efficacy of omecamtiv mecarbil published in the Journal of Cardiac Failure.
- 04 May 2023 According to a Cytokinetics media release, insights from this study presented at Journal of the American College of Cardiology: Heart Failure.