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MYK-224

Phase 2

Undisclosed | Small molecule | Other |Bristol-Myers Squibb Company|Trials Updated: Jul 30, 2026

MYK-224 development status

Highest phase Phase 2 (NCT05556343)
Phase scored for BMYPhase 1
Registered trials 9 across 1 sponsor since Mar 2022

MYK-224 target and mechanism

Molecular targetCardiac Myosin
Target classProtein
ModalitySmall molecule

Also known as BMS-986435

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials4
Total Enrollment315

FDA Designations

No designations recorded

MYK-224 clinical trials

MYK-224 · 4 trials · 3 indications

Phase 2 1Phase 1 3
NCT06122779Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)Heart Failure
ACTIVE NOT_RECRUITING227 Analytics
PHASE2ACTIVE NOT_RECRUITING
Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment emergent adverse events (TEAEs)
Up to approximately 24 weeks
Incidence of serious adverse events (SAEs)
Up to approximately 24 weeks
Incidence of AEs leading to treatment discontinuation
Up to approximately 20 weeks
Maximum observed concentration (Cmax)
Up to 45 days
Time to maximum observed concentration (Tmax)
Up to 45 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Up to 45 days
Maximum observed plasma concentration (Cmax)
Up to 72 days
Time of maximum observed concentration (Tmax)
Up to 72 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Up to 72 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Up to 36 days

Secondary Endpoints

Summary of plasma concentrations of MYK-224
Up to approximately 20 weeks
Metabolite profiling of BMS-986435 in plasma, urine, and feces
Up to 45 days
Number of participants with adverse events (AEs)
Up to 45 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BMS-986435EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
MYK-224EXPERIMENTAL -
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -
Arm 3EXPERIMENTAL -
Arm 4EXPERIMENTAL -
Arm 1: MYK-224EXPERIMENTAL -
Arm 2: MYK-224 + ItraconazoleEXPERIMENTAL -
Arm 3: MYK-224 + VerapamilEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986435DRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
MYK-224DRUGSpecified dose on specified days
ItraconazoleDRUGSpecified dose on specified days
VerapamilDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range40 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites86

Inclusion Criteria \- Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability. Exclusion Criteria * Participants must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy or infiltrative/storage disorder such as cardiac amyloidosis, or any...

Countries:United StatesArgentinaCanadaChinaIsraelItalyJapanPolandSouth KoreaSpainUnited Kingdom
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Recent Changes (Last 90 Days)

MEDIUMJul 30, 2026NCT06122779Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 30, 2026NCT06122779Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about MYK-224

What is MYK-224?

MYK-224 is an investigational small molecule developed by Bristol-Myers Squibb Company (NYSE: BMY). It is a Phase 1 clinical candidate that targets cardiac myosin. The specific therapeutic indication for MYK-224 has not been disclosed. It has been studied in three completed Phase 1 trials involving healthy volunteers.

What does MYK-224 target?

MYK-224 targets cardiac myosin, a protein essential for heart muscle contraction. By interacting with cardiac myosin, the drug is designed to modulate contractility. This mechanism is being explored in early-stage clinical development. The target class is a protein, and the molecule is a small chemical entity.

Who is developing MYK-224?

MYK-224 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. Bristol-Myers Squibb is the sponsor of the clinical trials evaluating MYK-224.

What phase is MYK-224 in?

MYK-224 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. Three Phase 1 trials have been completed, with a total enrollment of 88 participants. The trials were randomized, double-blind, and controlled.

What clinical trials is MYK-224 in?

MYK-224 has been evaluated in three completed Phase 1 trials: NCT05686096, an ADME study in healthy volunteers; NCT05405543, a safety and drug levels study in healthy Japanese participants; and NCT05304533, a drug interaction study with itraconazole and verapamil in healthy participants. All trials were conducted in the United States.

Is MYK-224 the same as BMS-986435?

Yes, BMS-986435 is an alternative name for MYK-224. The ADME study NCT05686096 refers to the drug as BMS-986435, while other trials use MYK-224. Both names refer to the same investigational small molecule developed by Bristol-Myers Squibb.