Clinical Trials

Omecamtiv mecarbil has been evaluated across multiple Phase 1, 2, and 3 clinical trials sponsored by Cytokinetics for the treatment of heart failure, chronic heart failure with reduced ejection fraction, left ventricular systolic dysfunction, and myocardial ischemia. These studies range from pharmacokinetic and safety assessments in healthy volunteers to large-scale outcome evaluations in patient populations. Although numerous protocols are completed or actively recruiting, certain studies have been terminated or withdrawn, including post-trial access protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06736574 RECRUITING
Heart Failure; Heart Failure With Reduced Ejection Fraction
Cytokinetics
 2024-12-19 PHASE3
NCT04464525 WITHDRAWN
Chronic Heart Failure With Reduced Ejection Fraction
Cytokinetics
 2020-12-18 PHASE3
NCT03759392 COMPLETED
Heart Failure With Reduced Ejection Fraction
Cytokinetics
 2019-04-09 PHASE3
NCT04464525 Withdrawn
Chronic Heart Failure With Reduced Ejection Fraction
Cytokinetics
 2020-12-18 Phase 3
NCT02929329 COMPLETED
Heart Failure
Cytokinetics
 2017-01-06 PHASE3
NCT04175808 COMPLETED
QT Intervals Changes; QTc Intervals Changes
Cytokinetics
 2019-11-14 PHASE1
NCT02695420 COMPLETED
Heart Failure With Reduced Ejection Fraction
Cytokinetics
 2016-04-14 PHASE2
NCT02601001 COMPLETED
Healthy Volunteer
Cytokinetics
 2015-11-13 PHASE1
NCT02601001 Completed
Healthy Volunteer
Cytokinetics
 2015-11-13 Phase 1
NCT01786512 COMPLETED
Modified Release Oral Formulation; Left Ventricular Systolic Dysfunction; Chronic Heart Failure; History of Chronic Heart Failure; Left Ventricular Ejection Fraction; Pharmacokinetics; Echocardiogram
Cytokinetics
 2013-02-26 PHASE2
NCT01300013 COMPLETED
Heart Failure
Cytokinetics
 2011-04 PHASE2
NCT01077167 WITHDRAWN
Heart Failure
Cytokinetics
 2010-07 PHASE2
NCT01300013 Completed
Heart Failure
Cytokinetics
 2011-04 Phase 2
NCT01077167 Withdrawn
Heart Failure
Cytokinetics
 2010-07 Phase 2
NCT00941681 COMPLETED
Heart Failure
Cytokinetics
 2009-04 PHASE2
NCT00624442 COMPLETED
Heart Failure
Cytokinetics
 2007-04 PHASE2
NCT00682565 COMPLETED
Heart Failure; Myocardial Ischemia; Angina Pectoris
Cytokinetics
 2008-04 PHASE2
NCT00748579 TERMINATED
Heart Failure
Cytokinetics
 2008-09 PHASE2
NCT01380223 COMPLETED
Heart Failure
Cytokinetics
 2005-08 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-28)

Check the Omecamtiv mecarbil (CK-1827452) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Omecamtiv mecarbil selectively binds to cardiac myosin within the sarcomere, accelerating productive phosphate release and enhancing actin-myosin cross-bridge cycling without elevating intracellular calcium concentrations. This biochemical action prolongs systolic ejection duration and increases stroke volume, thereby improving overall cardiac efficiency in clinical conditions such as chronic heart failure with reduced ejection fraction.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.