Danicamtiv (MYK-491) Clinical Trials

Size	Price	Qty
5mg	USD 359
25mg	USD 970

Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 3 evaluate the clinical development of danicamtiv in healthy participants and patients with heart failure with reduced ejection fraction, dilated cardiomyopathy, and primary familial or genetic dilated cardiomyopathy. Sponsored by organizations including Bristol-Myers Squibb, MyoKardia, Inc., and Kardigan, Inc., trial statuses encompass completed early-phase safety and pharmacokinetic evaluations, ongoing recruiting late-phase studies, and a small subset of terminated trials. Ultimately, these investigations aim to establish the safety, pharmacokinetics, and therapeutic efficacy of danicamtiv in heart failure populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07771465	RECRUITING	Symptomatic Genetic Dilated Cardiomyopathy (DCM)	Kardigan, Inc.	2026-08-26	PHASE3
NCT07210723	RECRUITING	Symptomatic Genetic Dilated Cardiomyopathy	Kardigan, Inc.	2026-02-13	PHASE2; PHASE3
NCT05952089	COMPLETED	Heart Failure With Reduced Ejection Fraction	Bristol-Myers Squibb	2023-08-17	PHASE1
NCT04572893	TERMINATED	Primary Familial Dilated Cardiomyopathy	Bristol-Myers Squibb	2020-08-04	PHASE2
NCT06027437	COMPLETED	Healthy Volunteers	Bristol-Myers Squibb	2023-09-05	PHASE1
NCT05806359	COMPLETED	Healthy Volunteers	Bristol-Myers Squibb	2023-03-31	PHASE1
NCT05162222	COMPLETED	Healthy Participants	Bristol-Myers Squibb	2021-12-15	PHASE1
NCT03447990	COMPLETED	Heart Failure With Reduced Ejection Fraction; Dilated Cardiomyopathy	Bristol-Myers Squibb	2018-02-06	PHASE1; PHASE2
NCT03447990	Completed	Heart Failure With Reduced Ejection Fraction\|Dilated Cardiomyopathy	Bristol-Myers Squibb	2018-02-06	Phase 1\|Phase 2
NCT03062956	COMPLETED	Dilated Cardiomyopathy	MyoKardia, Inc.	2017-01-16	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-09-02)

Check the Danicamtiv (MYK-491) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Danicamtiv functions as a selective cardiac myosin activator that directly binds to the cardiac myosin head, enhancing cross-bridge turnover and increasing myocardial sarcomeric contractility. By bolstering systolic cardiac function and improving stroke volume, this target engagement directly counters the impaired contractile state characteristic of heart failure with reduced ejection fraction and dilated cardiomyopathy.

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>).