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Forzinity

Forzinity is a mitochondrial-targeted therapy for Barth syndrome in patients weighing 30 kg or more. It stabilizes mitochondrial function to improve energy production and muscle strength, administered via subcutaneous injection.

The information outlined in the molecule details section below would help you evaluate Para IV filing opportunities early to secure a first-to-file advantage.

Molecule Details :

  • Molecule Name :

    Elamipretide

  • Innovator :

    STEALTH BIOTHERAPEUTICS INC

  • Approval Date :

    19-Sep-25

  • NCE-1 Date :

    19-Sep-29

  • NCE Date :

    19-Sep-30

  • Dosage Form :

    Subcutaneous Solution

  • Strength :

    EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML)

  • Therapeutic Category :

    Mitochondrial Dysfunction Agent

  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2025 :

    NA

  • 2026 :

    NA

  • 2027 :

    NA

  • 2028 :

    NA

  • 2029 :

    NA

  • 2030 :

    NA

  • 2031 :

    NA
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