Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CK-4021586 · 1 trial · 1 indication
Incidence of early drug discontinuation observed during dosing of CK 4021586 in patients with HFpEF
Incidence of left-ventricular ejection fraction (LVEF) \< 40% observed during dosing of CK-4021586 in patients with HFpEF
Incidence of adverse events observed during dosing of CK-4021586 in patients with HFpEF
| Arm | Type | Description |
|---|---|---|
| CK-4021586 - Cohort 1 | EXPERIMENTAL | Participants may receive 150 mg or 300 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total. |
| Placebo - Cohort 1 | PLACEBO_COMPARATOR | Participants will receive placebo daily for up to 12 weeks. |
| CK-4021586 - Cohort 2 | EXPERIMENTAL | Participants may receive 300 mg or 450 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total. |
| Placebo - Cohort 2 | PLACEBO_COMPARATOR | Participants will receive placebo daily for up to 12 weeks. |
| CK-4021586 - Cohort 3 | EXPERIMENTAL | Participants may receive 450 mg or 600 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total. |
| Placebo - Cohort 3 | PLACEBO_COMPARATOR | Participants will receive placebo daily for up to 12 weeks. |
| Name | Type | Description |
|---|---|---|
| CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg) | DRUG | CK-4021586 administered orally |
| Placebo to match CK-4021586 | DRUG | Placebo administered orally |
Inclusion Criteria: * Males and females ≥ 40 years and ≤ 85 years of age at screening. * Diagnosed with HF with NYHA functional class II or III. * Screening echocardiography with LVEF ≥ 60%. * Screening NT-proBNP ≥ 300 pg/mL for participants in sinus rhythm and ≥ 900 pg/mL for participants with com...
CK-4021586 is an investigational small molecule being developed by Cytokinetics, Incorporated for symptomatic heart failure with preserved ejection fraction, or HFpEF. It is currently in Phase 2 clinical development and has not been approved by the FDA. It is being studied in a placebo-controlled trial called AMBER-HFpEF.
CK-4021586 is being studied for the treatment of symptomatic heart failure with preserved ejection fraction (HFpEF), a form of heart failure in which the heart's pumping function appears preserved but patients experience symptoms. It is investigational and has not been approved for any indication. The Phase 2 AMBER-HFpEF trial is evaluating its safety and tolerability in this population.
CK-4021586 targets cardiac myosin, a protein that drives heart muscle contraction. By acting directly on cardiac myosin, the drug is designed to modulate the contractile machinery of the heart. This mechanism is being explored in symptomatic heart failure with preserved ejection fraction, where impaired cardiac relaxation and contraction contribute to symptoms.
CK-4021586 is being developed by Cytokinetics, Incorporated, a biopharmaceutical company traded on the Nasdaq under the ticker CYTK. Cytokinetics is focused on cardiovascular therapeutics and is running the Phase 2 AMBER-HFpEF trial of CK-4021586 in the United States.
CK-4021586 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The ongoing Phase 2 trial, AMBER-HFpEF, is currently recruiting participants and is designed to assess safety and tolerability in patients with symptomatic heart failure with preserved ejection fraction.
CK-4021586 is being evaluated in one active clinical trial, NCT06793371, also known as AMBER-HFpEF. This Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled trial assessing safety and tolerability in symptomatic heart failure with preserved ejection fraction. It is recruiting in the United States and plans to enroll 60 participants aged 40 years and older.