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Modeyso

Modeyso is an oral protease activator approved for adults and children with recurrent H3 K27M-mutant diffuse midline glioma (DMG), a rare and aggressive brain tumor. By activating mitochondrial caseinolytic protease P (ClpP) and antagonizing dopamine D2 receptors, it induces stress-response pathways, apoptosis, and restoration of histone H3 trimethylation, ultimately slowing tumor growth. Taken once weekly on an empty stomach, Modeyso provides a systemic, non-invasive treatment option in an area where effective therapies have historically been limited.

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 :

    Dordaviprone
  • Innovator :

    CHIMERIX INC
  • Approval Date :

    06-Aug-25
  • NCE-1 Date :

    06-Aug-29
  • NCE Date :

    06-Aug-30
  • Dosage Form :

    Oral Capsule
  • Strength :

    EQ 125MG BASE
  • Therapeutic Category :

    Anticancer
  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2025 :

    3
  • 2026 :

    47
  • 2027 :

    107
  • 2028 :

    180
  • 2029 :

    235
  • 2030 :

    298
  • 2031 :

    364
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