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Deramiocel - Capricor Therapeutics

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Drug Profile

Deramiocel - Capricor Therapeutics

Alternative Names: Allogeneic adult stem cell therapy for myocardial infarction - Capricor; Allogeneic cardiosphere-derived cells - Capricor; Allogeneic CDCs - Capricor; Allogenic derived cells - Capricor; CAP-1002

Latest Information Update: 07 Oct 2025

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At a glance

  • Originator Capricor
  • Developer Capricor; Capricor Therapeutics; Medical University of South Carolina
  • Class Exosome therapies; Stem cell therapies
  • Mechanism of Action Cell replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Duchenne muscular dystrophy
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Duchenne muscular dystrophy
  • Phase II COVID 2019 infections
  • Phase I/II Cardiomyopathies
  • Discontinued Heart failure; Myocardial infarction

Most Recent Events

  • 25 Sep 2025 Capricor Therapeutics completes a Type A meeting with the US FDA to pave the way for potential approval of Deramiocel in Duchenne muscular dystrophy, securing alignment on key regulatory and clinical endpoints
  • 25 Aug 2025 Capricor Therapeutics scheduled a Type A meeting with the US FDA to discuss the regulatory path for its Biologics License Application (BLA) for Deramiocel for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy
  • 11 Aug 2025 Capricor Therapeutics plans a Type A meeting with the US FDA to discuss the regulatory path for its Biologics License Application (BLA) for Deramiocel for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy in August 2025

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