Drugs / Omecamtiv Mecarbil
Omecamtiv Mecarbil
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed advanced heart failure 1 milestone | |||||
| Filed | EU (EMA) | — | advanced heart failure | 2023-03-01 | “The European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA) for omecamtiv mecarbil for the treatment of advanced or worsening HFrEF.” cytokinetics.com ↗ |
| Filed symptomatic heart failure 4 milestones | |||||
| Filed | China (NMPA) | — | symptomatic heart failure | 2023-03-01 | “the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People’s Republic of China has accepted the submission of the New Drug...” cytokinetics.com ↗ |
| Rejected (CRL) | US (FDA) | — | symptomatic heart failure | 2023-02-28 | “the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for omecamtiv mecarbil” cytokinetics.com ↗ “FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for omecamtiv mecarbil” cytokinetics.com ↗ |
| Filed | US (FDA) | — | symptomatic heart failure | 2022-04-03 | “The U.S. Food and Drug Administration (FDA) accepted and filed our New Drug Application (NDA) for omecamtiv mecarbil” cytokinetics.com ↗ “The FDA has accepted for filing the NDA for omecamtiv mecarbil based on the results from GALACTIC-HF” cytokinetics.com ↗ |
| Filed | US (FDA) | — | symptomatic heart failure | 2022-02-04 | “FDA has accepted and filed the company’s New Drug Application (NDA) for omecamtiv mecarbil” cytokinetics.com ↗ |
| Rejected Indication not stated 1 milestone | |||||
| Refused (EMA) | EU (EMA) | Kinharto | — | 2024-05-07 | europa.eu ↗ |
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04175808 | Nov 2019 → Mar 2020 | — | Cytokinetics | Completed | No outcome recorded |
| Phase 1 | NCT02601001 | Nov 2015 → Jan 2016 | — | Cytokinetics | Completed | No outcome recorded |
| Phase 1 | NCT01380223 | Aug 2005 → Apr 2006 | heart failure | Cytokinetics | Completed | No outcome recorded |
| Phase 28 trials · 3 met primary · 1 missed | ||||||
| Phase 2 | NCT02695420 | Apr 2016 → Apr 2017 | symptomatic heart failure | Cytokinetics | Completed | Met primary |
| Phase 2 | NCT01786512 | Feb 2013 → Jul 2015 | left ventricular failure | Cytokinetics | Completed | Met primary |
| Phase 2 | NCT01300013 | Apr 2011 → Apr 2013 | heart failure | Cytokinetics | Completed | Missed primary |
| Phase 2 | NCT01077167 | Jul 2010 → May 2011 | heart failure | Cytokinetics | Withdrawn | No outcome recorded |
| Phase 2 | NCT00941681 | Apr → Oct 2009 | heart failure | Cytokinetics | Completed | No outcome recorded |
| Phase 2 | NCT00748579 | Sep → Nov 2008 | heart failure | Cytokinetics | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00682565 | Apr → Nov 2008 | heart failure, myocardial ischemia | Cytokinetics | Completed | No outcome recorded |
| Phase 2 | NCT00624442 | Apr 2007 → Feb 2009 | heart failure | Cytokinetics | Completed | Met primary |
| Phase 33 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT06736574 | Dec 2024 → Sep 2027 expected | symptomatic heart failure | Cytokinetics | Recruiting | No outcome recorded |
| Phase 3 | NCT03759392 | Apr 2019 → Nov 2021 | symptomatic heart failure | Cytokinetics | Completed | Missed primary |
| Phase 3 | NCT02929329 | Jan 2017 → Sep 2020 | heart failure | Cytokinetics | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT04464525 Background | Dec 2020 → Nov 2026 | congestive heart failure | Cytokinetics | Withdrawn | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 36
| Date | Issuer | Release |
|---|---|---|
| 2024-11-16 | Cytokinetics | Results Cytokinetics Presents Additional Data From GALACTIC-HF at the American Heart Association Scientific Sessions 2024 cytokinetics.com ↗
A post-hoc analysis from GALACTIC-HF supports the potential efficacy of omecamtiv mecarbil irrespective of age, including in patients with severe heart failure. |
| 2023-03-01 | Cytokinetics | Regulatory Cytokinetics Reports Fourth Quarter 2022 Financial Results cytokinetics.com ↗
Company Received Complete Response Letter from FDA for New Drug Application for Omecamtiv Mecarbil |
| 2023-02-28 | Cytokinetics | Regulatory Cytokinetics Receives Complete Response Letter From FDA for New Drug Application for Omecamtiv Mecarbil cytokinetics.com ↗ |
| 2022-12-13 | Cytokinetics | Regulatory Cytokinetics Announces Outcome of FDA Advisory Committee Vote On Omecamtiv Mecarbil cytokinetics.com ↗ |
| 2022-11-07 | Cytokinetics | Results Cytokinetics Presents New Data at the American Heart Association Scientific Sessions 2022 cytokinetics.com ↗ |
| 2022-08-04 | Cytokinetics | Regulatory Cytokinetics Reports Second Quarter 2022 Financial Results cytokinetics.com ↗
Advisory Committee Meeting to Review NDA for Omecamtiv Mecarbil Scheduled for December 13, 2022; PDUFA Target Action Date Set for February 28, 2023 |
| 2022-06-24 | Cytokinetics | Regulatory Cytokinetics Announces Date for FDA Advisory Committee Meeting to Review New Drug Application for Omecamtiv Mecarbil cytokinetics.com ↗
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has informed the company that the previously announced meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the New Drug Application for omecamtiv mecarbil is currently scheduled for December 13, 2022. |
| 2022-06-17 | Cytokinetics | Regulatory Cytokinetics Provides Regulatory Update for Omecamtiv Mecarbil cytokinetics.com ↗
After an initial review of the company’s submission, FDA has communicated that the additional data provided constitutes a major amendment to the NDA and has extended the PDUFA date by three months to February 28, 2023 to provide time for a full review of the submission. |
| 2022-05-23 | Cytokinetics | Results Cytokinetics Announces Data From REDWOOD-HCM OLE and GALACTIC-HF Presented as Late Breaking Science Presentations at the European Society of Cardiology Heart Failure 2022 Congress cytokinetics.com ↗
Analyses from GALACTIC-HF Show Patients with Low Blood Pressure Have Increased Treatment Effect |
| 2022-05-17 | Cytokinetics | Regulatory Cytokinetics Provides Regulatory Update Related to New Drug Application for Omecamtiv Mecarbil cytokinetics.com ↗
FDA Plans to Convene Advisory Committee Meeting |
| 2022-04-03 | Cytokinetics | Results Cytokinetics Announces Results From METEORIC-HF and Additional Data From GALACTIC-HF Presented at the American College of Cardiology 71st Annual Scientific Session cytokinetics.com ↗ |
| 2022-02-15 | Cytokinetics | Results Cytokinetics Announces Topline Results From METEORIC-HF cytokinetics.com ↗
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced topline results from METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), a Phase 3 clinical trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction (HFrEF). |
| 2022-02-04 | Cytokinetics | Regulatory Cytokinetics Announces FDA Acceptance of New Drug Application for Omecamtiv Mecarbil for the Treatment of Heart Failure With Reduced Ejection Fraction cytokinetics.com ↗
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food & Drug Administration (FDA) has accepted and filed the company’s New Drug Application (NDA) for omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin activator, for the treatment of heart failure with reduced ejection fraction (HFrEF). |
| 2021-11-15 | Cytokinetics | Results Cytokinetics Announces Additional Results from GALACTIC-HF Presented at American Heart Association Scientific Sessions 2021 cytokinetics.com ↗
Analysis from GALACTIC-HF Shows Treatment with Omecamtiv Mecarbil Associated with Significant Reduction in the Risk of Stroke |
| 2021-09-12 | Cytokinetics | Results Cytokinetics Announces Results From REDWOOD-HCM and GALACTIC-HF Presented in Late Breaking Clinical Trial Session at the HFSA Annual Scientific Meeting cytokinetics.com ↗
Additional Results from GALACTIC-HF Show Effect of Treatment with Omecamtiv Mecarbil in Black Patients Consistent with Overall Population and White Patients |
| 2021-06-30 | Cytokinetics | Results Cytokinetics Announces Additional Results From GALACTIC-HF Presented at the European Society of Cardiology Heart Failure 2021 cytokinetics.com ↗ |
| 2021-05-17 | Cytokinetics | Results Cytokinetics Announces Secondary Analysis of GALACTIC-HF Presented in Late Breaking Clinical Trial Session at the American College of Cardiology 70th Annual Scientific Session and Published in the Journal of American College of Cardiology cytokinetics.com ↗
Analysis Shows Treatment Effect of Omecamtiv Mecarbil Increased Progressively as Baseline Ejection Fraction Decreased |
| 2020-12-07 | Cytokinetics | Results Cytokinetics Announces Additional Results From GALACTIC-HF Presented at the 17th Global Cardiovascular Clinical Trialists cytokinetics.com ↗
These additional data from GALACTIC-HF suggest that omecamtiv mecarbil may provide a new treatment option for this critical population of patients. |
| 2020-11-13 | Cytokinetics | Results Cytokinetics Announces Results From GALACTIC-HF Presented at Late Breaking Clinical Trial Session at the American Heart Association Scientific Sessions and Published in the New England Journal of Medicine cytokinetics.com ↗
Trial Met Primary Composite Endpoint of Reduction in Heart Failure Events or Cardiovascular Death; Did Not Meet Secondary Endpoints Including Reduction in Cardiovascular Death |
| 2020-10-08 | Cytokinetics | Results Amgen, Cytokinetics and Servier Announce Topline Results From GALACTIC-HF, a Phase 3 Trial of Omecamtiv Mecarbil in Patients With Heart Failure cytokinetics.com ↗
No reduction in the secondary endpoint of CV death was observed. |
| 2020-10-05 | Cytokinetics | Results Cytokinetics Announces Data From Two Presentations at the HFSA Virtual Annual Scientific Meeting 2020 cytokinetics.com ↗
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that new data were presented at the Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting 2020. |
| 2020-05-08 | Cytokinetics | Regulatory FDA Grants Fast Track Designation For Omecamtiv Mecarbil In Heart Failure cytokinetics.com ↗
Amgen (NASDAQ:AMGN) and Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for omecamtiv mecarbil, a novel selective cardiac myosin activator, also known as a cardiac myotrope,1 being developed for the potential treatment of chronic heart failure with reduced ejection fraction (HFrEF). |
| 2020-03-30 | Cytokinetics | Results Correction: Cytokinetics Announces Baseline Characteristics from GALACTIC-HF at ACC.20/WCC Virtual cytokinetics.com ↗
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that patient baseline characteristics and demographics from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 event driven cardiovascular outcomes clinical trial of omecamtiv mecarbil, were published during the American College of Cardiology 69th Annual Scientific Session together with the World Congress of Cardiology (ACC.20/WCC). |
| 2019-11-18 | Cytokinetics | Results New Results From COSMIC-HF Presented At AHA 2019 Show Treatment Of Heart Failure Patients With Omecamtiv Mecarbil Was Associated With Neutral Or Improved Measures Of Diastolic Function cytokinetics.com ↗
The results show that, in addition to increasing the pumping action of the heart (systolic function), omecamtiv mecarbil did not change and for some measures was consistent with improvement of the heart's diastolic function, or ability to relax between heartbeats, |
| 2019-03-18 | Cytokinetics | Results Cytokinetics Announces Presentation of Additional Results From COSMIC-HF at ACC.19 cytokinetics.com ↗
There were no statistically significant differences in the effects of treatment with omecamtiv mecarbil between subjects with and without atrial fibrillation (AF) on cardiac function, including systolic ejection time and stroke volume, as well as ventricular volumes, heart rate, and NT-proBNP in patients. |
| 2017-11-13 | Cytokinetics | Results Cytokinetics Announces Additional Results From COSMIC-HF at the American Heart Association Scientific Sessions 2017 cytokinetics.com ↗
In this post-hoc responder analysis, the proportion of patients achieving various thresholds in the percent reduction of NT-proBNP were larger in patients who received omecamtiv mecarbil than in patients who received placebo. |
| 2017-09-18 | Cytokinetics | Results Cytokinetics Announces Presentation of Additional Results From COSMIC-HF at the HFSA 21st Annual Scientific Meeting cytokinetics.com ↗
Effects of Omecamtiv Mecarbil Were Similar in Patients with Ischemic and Non-Ischemic Heart Failure |
| 2017-08-02 | Cytokinetics | Results Cytokinetics Announces Positive Results From Phase 2 Clinical Trial of Omecamtiv Mecarbil in Japanese Patients With Heart Failure cytokinetics.com ↗
Cytokinetics, Incorporated (Nasdaq:CYTK) today announced that the Phase 2 clinical trial of omecamtiv mecarbil in Japanese patients with heart failure has met its pharmacokinetic primary endpoint and demonstrated statistically significant improvements in systolic ejection time (SET), a secondary endpoint. |
| 2017-05-01 | Cytokinetics | Results Cytokinetics Announces Results from Dose Escalation Phase of COSMIC-HF Presented at Heart Failure 2017 cytokinetics.com ↗
The results were presented in a Rapid Fire Abstracts session by John Teerlink, M.D., professor of Clinical Medicine at the University of California San Francisco and director of Heart Failure at the San Francisco Veterans Affairs Medical Center. |
| 2017-03-20 | Cytokinetics | Results Cytokinetics Announces Additional Results From COSMIC-HF Presented at ACC.17 cytokinetics.com ↗
The results presented showed that omecamtiv mecarbil improved myocardial deformation, a marker of myocardial function that has been related to outcomes. |
| 2016-11-30 | Cytokinetics | Results The Lancet Publishes Results From COSMIC-HF Trial Showing Omecamtiv Mecarbil Significantly Improved Cardiac Function in Patients With Chronic Heart Failure cytokinetics.com ↗
Amgen (NASDAQ:AMGN) and Cytokinetics, Inc. (NASDAQ:CYTK) today announced The Lancet published results from a Phase 2 clinical trial evaluating omecamtiv mecarbil in patients with chronic heart failure. |
| 2016-11-14 | Cytokinetics | Results Cytokinetics Announces Presentation of Additional Results From COSMIC-HF at the AHA Annual Scientific Meeting cytokinetics.com ↗
The results presented show that omecamtiv mecarbil improved left atrial (LA) structure and function in patients with chronic heart failure with reduced systolic function. |
| 2016-09-19 | Cytokinetics | Results Cytokinetics Announces Presentation of Additional Results From COSMIC-HF at the HFSA Annual Scientific Meeting cytokinetics.com ↗
The results presented show that omecamtiv mecarbil may improve symptoms in patients with moderate to severe heart failure symptoms versus placebo after 20 weeks of double-blind treatment, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS), one of the sub-domains of a self-administered questionnaire that measures quality-of-life in patients with heart failure. |
| 2016-05-23 | Cytokinetics | Results Cytokinetics Announces Presentation of Additional Results From COSMIC-HF at Heart Failure 2016 Congress cytokinetics.com ↗
The results presented showed that omecamtiv mecarbil improved left ventricular (LV) systolic function, LV end-diastolic volume and NT-proBNP over time, suggesting potentially favorable ventricular remodeling and progressive reduction in myocardial wall stress. |
| 2015-11-08 | Cytokinetics | Results Amgen and Cytokinetics Announce Late-Breaking Presentation of COSMIC-HF Trial at AHA Scientific Sessions 2015 cytokinetics.com ↗
The trial met its primary pharmacokinetic objective and demonstrated statistically significant improvements in all pre-specified secondary measures of cardiac function in the treatment group employing pharmacokinetic-based dose titration. |
| 2015-10-27 | Cytokinetics | Results Amgen and Cytokinetics Announce Positive Top-Line Results From COSMIC-HF, a Phase 2 Trial of Omecamtiv Mecarbil in Patients With Chronic Heart Failure cytokinetics.com ↗ |
All press releases naming this drug 52 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Omecamtiv Mecarbil | “investigating the effects of omecamtiv mecarbil (formerly CK-1827452), given intravenously for 2, 24, or 72 h to patients with stable heart failure and left ventricular...” PMID 21856481 ↗ Aug 2011 |
| Known as | CK-1827452 | “investigating the effects of omecamtiv mecarbil (formerly CK-1827452), given intravenously for 2, 24, or 72 h to patients with stable heart failure and left ventricular...” PMID 21856481 ↗ Aug 2011 |
| Known as | Omecamtiv mecarbilo | ChEMBL registry synonym — accepted as the source's own label CHEMBL1800955 ↗ |
| Action | Activate | “The effects of the cardiac myosin activator, omecamtiv mecarbil, on cardiac function in systolic heart failure” PMID 21856481 ↗ Aug 2011 |
| Modality | Small molecule | “Omecamtiv mecarbil (AMG 423, CK-1827452) is a novel small molecule” NCT01786512 ↗ |
| Route | Intravenous | “I.V. infusion for 2 hours at 24mg/hr followed by 18 hours at 6mg/hr” NCT00682565 ↗ |