Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants or Other Causalities

Phase 2 Terminated 41 enrolled Bristol-Myers Squibb

NaSequentialOpen-labelTreatment

Summary

The purpose of this Phase 2a study is to establish safety and preliminary efficacy of treatment with danicamtiv in patients with primary dilated cardiomyopathy (DCM) due to MYH7 or TTN variants or other causalities.

Timeline

Start: 2020-08-04
Primary completion: 2024-02-22
Completion: 2024-02-22

Outcome

Outcome not reported

Stopped (Business): “Business objectives have changed”

Publications

Lakdawala NK, Hershberger RE, Garcia-Pavia P, Elliott PM, Ginns J, Meder B, Solomon S, Cunningham JW, Gimeno JR, Barriales-Villa R, Adler E, Gerull B, Pereira NL, Halliday BP, Li W, Jarugula P, Maruyama S, Mohran SE, Papadaki M, Anto AR, Anderson RL, Rodriguez HM, Del Rio CL, Edelberg JM, Kurio G, Maya J, Januzzi JL. Danicamtiv, a Selective Agonist of Cardiac Myosin, for Dilated Cardiomyopathy: A Phase 2 Open-Label Trial. J Am Coll Cardiol. 2025 Dec 23;86(25):2598-2612. doi: 10.1016/j.jacc.2025.09.1511. Epub 2025 Sep 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Danicamtiv	Small molecule	10 mg	Oral
Subject	Danicamtiv	Small molecule	50 mg	Oral