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JRM 001

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Drug Profile

JRM 001

Alternative Names: JRM-001

Latest Information Update: 13 Mar 2025

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At a glance

  • Originator Gene Techno Science; Japan Regenerative Medicine
  • Developer Metcela
  • Class Cardiovascular 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 - Hypoplastic left heart syndrome
  • New Molecular Entity No

Highest Development Phases

  • Phase III Hypoplastic left heart syndrome

Most Recent Events

  • 25 Feb 2025 JRM 001 receives Orphan Drug status for Hypoplastic left heart syndrome in Japan
  • 25 Feb 2025 JRM 001 receives Sakigake Designation System for Regenerative Medicine Product from the Ministry of Health Labour & Welfare (MHLW) for Hypoplastic left heart syndrome in Japan prior to February 2025
  • 31 Jan 2025 Metcela receives acceptance for a clinical trial amendment notification from Pharmaceuticals and Medical Devices Agency (PMDA) in Japan

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