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Danicamtiv · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Danicamtiv | EXPERIMENTAL | - |
| placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Danicamtiv | DRUG | Danicamtiv will be administered twice daily for up to 5 years |
| Placebo | DRUG | Placebo will be administrated twice daily for up to 26 weeks |
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...
Danicamtiv is an investigational small molecule developed by Kardigan, Inc. for symptomatic genetic dilated cardiomyopathy, a rare disease in which the heart muscle is weakened and enlarged. It is being studied in Phase 3 clinical development and is designed as an activator of cardiac myosin proteins.
Danicamtiv is being developed to treat adults with symptomatic genetic and familial dilated cardiomyopathy, a rare inherited form of heart muscle disease. The clinical program enrolls adults 18 years and older with symptomatic disease and uses biomarker selection to identify appropriate patients for treatment.
Danicamtiv targets cardiac myosin heavy and light chain proteins, specifically MYH7, MYH6, MYH7B, MYL3, MYL2, and MYL7. It acts as an activator of these targets, a mechanism intended to modulate the heart's contractile machinery in dilated cardiomyopathy.
Danicamtiv is being developed by Kardigan, Inc., which trades under the ticker KARD. The company is running the clinical program for the drug in symptomatic genetic and familial dilated cardiomyopathy across sites in the United States and several European countries.
Danicamtiv is in Phase 3 clinical development. It is investigational and is being evaluated in a Phase 3 long-term safety and efficacy study alongside a Phase 2 efficacy and safety study, both currently recruiting participants.
Danicamtiv is being studied in two recruiting trials: NCT07771465, a Phase 3 study of long-term safety and efficacy in adults with symptomatic genetic and familial dilated cardiomyopathy, and NCT07210723, a Phase 2 efficacy and safety study in the same condition. Both are randomized, double-blind, placebo-controlled, and enroll 332 participants each.