Approval Probability
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Omecamtiv Mecarbil Matrix F1 Formulation · 1 trial · 7 indications
| Arm | Type | Description |
|---|---|---|
| Dose-escalation Cohort 1: Placebo | PLACEBO_COMPARATOR | Participants received placebo tablets twice a day (BID) for 7 days. |
| Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1 | EXPERIMENTAL | Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days. |
| Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2 | EXPERIMENTAL | Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days. |
| Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2 | EXPERIMENTAL | Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days. |
| Dose-escalation Cohort 2: Placebo | PLACEBO_COMPARATOR | Participants received placebo tablets twice a day for 7 days. |
| Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1 | EXPERIMENTAL | Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days. |
| Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2 | EXPERIMENTAL | Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days. |
| Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2 | EXPERIMENTAL | Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days. |
| Expansion Phase: Placebo | PLACEBO_COMPARATOR | Participants received placebo tablets twice a day for 20 weeks. |
| Expansion Phase: Omecamtiv Mecarbil 25 mg M-F1 | EXPERIMENTAL | Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day for 20 weeks. |
| Expansion Phase: OM M-F1 PK-based Titration | EXPERIMENTAL | All participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day. At week 8 the dose escalated to 50 mg twice a day if the week 2 predose plasma concentration of OM was less than the predefined cutoff of 200 ng/mL. |
| Name | Type | Description |
|---|---|---|
| Omecamtiv Mecarbil Matrix F1 Formulation | DRUG | Modified release tablets for oral administration |
| Omecamtiv Mecarbil Matrix F2 Formulation | DRUG | Modified release tablets for oral administration |
| Placebo | DRUG | Modified release tablets matching to omecamtiv mecarbil |
| Omecamtiv Mecarbil Swellable Core Technology F2 | DRUG | Modified release tablets for oral administration |
Inclusion Criteria: * History of chronic heart failure (HF), defined as requiring treatment for HF for a minimum of 4 weeks prior to screening * Treated with stable, optimal pharmacological therapy for ≥ 4 weeks * History of left ventricular ejection fraction (LVEF) ≤ 40% * Elevated N-terminal proh...
Omecamtiv Mecarbil Matrix F1 Formulation is an investigational small molecule being developed for the modified release oral formulation of a treatment for chronic heart failure with left ventricular systolic dysfunction. It is being studied in patients with a history of chronic heart failure and reduced left ventricular ejection fraction.
Omecamtiv Mecarbil Matrix F1 Formulation is being developed by Cytokinetics, Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol CYTK. The company is conducting clinical research on this cardiovascular small molecule.
Omecamtiv Mecarbil Matrix F1 Formulation is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed, and no active trials are currently ongoing.
Omecamtiv Mecarbil Matrix F1 Formulation was studied in the COSMIC-HF trial, registered as NCT01786512. This was a Phase 2, randomized, double-blind, placebo-controlled study that enrolled 544 participants across multiple countries, including the United States, Australia, Belgium, Bulgaria, Canada, Czechia, Germany, Hungary, Italy, Lithuania, Netherlands, Poland, and the United Kingdom.
Omecamtiv Mecarbil Matrix F1 Formulation is not the same as COSMIC-HF. COSMIC-HF is the name of the clinical trial, formally titled 'Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure,' which evaluated this drug. The trial was completed and included 544 participants.