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danicamtiv

Phase 3

Symptomatic Genetic Dilated Cardiomyopathy | Small molecule | Rare Disease |Kardigan, Inc.|Trials Updated: Oct 5, 2026

danicamtiv development status

Highest phase Phase 3
Registered trials 7 across 2 sponsors since Oct 2020

danicamtiv target and mechanism

Molecular targetMYH7, MYH6, MYH7B, MYL3, MYL2, MYL7
Target classActivator
ModalitySmall molecule
ChEMBLCHEMBL4594304

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment664

FDA Designations

No designations recorded

danicamtiv clinical trials

danicamtiv · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT07771465A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated CardiomyopathySymptomatic Genetic Dilated Cardiomyopathy (DCM)
RECRUITING332 Analytics
PHASE3RECRUITING
A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Symptomatic Genetic Dilated Cardiomyopathy (DCM)
NCT07771465332
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Study Endpoints

Primary Endpoints

Frequency and severity of treatment-emergent adverse events (TEAEs)
61 months
Frequency and severity of adverse events of special interest (AESIs)
61 months
Frequency and severity of serious adverse events (SAEs)
61 months
Frequency and severity of disease-related events (DREs)
61 months
Frequency of abnormal findings from physical examination
61 months
Frequency of abnormal findings from vital signs
61 months
Frequency of abnormal findings from 12-lead electrocardiograms (ECGs)
61 months
Frequency of abnormal findings from clinical laboratory assessments
61 months
Part 1: Change from Baseline (Day 1) to Week 26 in left atrial function index in Cohort 1
26 weeks
Part 2: Change from Baseline (Day 1) to Week 26 in peak VO2 in Cohort 1
26 weeks

Secondary Endpoints

Change from Baseline (Day 1) to Week 26, Months 18, 30, 42, 54, 60, and 61 in cardiac structure, function, and size using Transthoracic Echocardiogram (TTE)
61 months
Change from Baseline (Day 1) to Week 26, Months 12, 18, 24, 30, 36, 42, 48, 54, 60, and 61 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-23 CSS)
61 months
Change from Baseline (Day 1) to Week 26, Months 12, 18, 24, 30, 36, 42, 48, 54, 60, and 61 in EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Utility Score
61 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DanicamtivEXPERIMENTAL -
placeboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
DanicamtivDRUGDanicamtiv will be administered twice daily for up to 5 years
PlaceboDRUGPlacebo will be administrated twice daily for up to 26 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites78

Inclusion Criteria: 1. Completed 24 weeks of blinded study treatment (corresponding to the Week 26 Visit in DAN-301) and planned assessments in Part 1 or Part 2 of the DAN-301 study. 2. If sexually active, must use a highly effective birth control method from the Screening Visit through 3 months af...

Countries:United StatesBelgiumDenmarkFranceHungaryItalyNetherlandsPolandSpainSwedenUnited Kingdom
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