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Omecamtiv mecarbil FDA Approval Status

FDA Approved: No
Generic name: omecamtiv mecarbil
Company: Cytokinetics, Inc.
Treatment for: Heart Failure with Reduced Ejection Fraction

Omecamtiv mecarbil is a first in class, small molecule cardiac myosin activator in development for the treatment of heart failure with reduced ejection fraction (HFrEF).

  • Omecamtiv mecarbil is designed to increase the number of active actin-myosin cross bridges during each cardiac cycle and consequently augment the impaired contractility that is associated with heart failure with reduced ejection fraction (HFrEF).
  • The FDA has assigned the NDA a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2022.

Development timeline for omecamtiv mecarbil

Feb 28, 2023Cytokinetics Receives Complete Response Letter From FDA for New Drug Application for Omecamtiv Mecarbil
Dec 13, 2022Cytokinetics Announces Outcome of FDA Advisory Committee Vote On Omecamtiv Mecarbil
May 17, 2022Cytokinetics Provides Regulatory Update Related to New Drug Application for Omecamtiv Mecarbil
Feb  4, 2022Cytokinetics Announces FDA Acceptance of New Drug Application for Omecamtiv Mecarbil for the Treatment of Heart Failure With Reduced Ejection Fraction
Oct  8, 2020Amgen, Cytokinetics And Servier Announce Topline Results From GALACTIC-HF, A Phase 3 Trial Of Omecamtiv Mecarbil In Patients With Heart Failure
May  8, 2020FDA Grants Fast Track Designation For Omecamtiv Mecarbil In Heart Failure
Nov 18, 2019New 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
Jul 15, 2019Cytokinetics Announces Completion of Enrollment in GALACTIC-HF, Phase 3 Clinical Trial of Omecamtiv Mecarbil in Patients With Heart Failure

Further information

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