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Ibtrozi

Ibtrozi is a targeted oral therapy for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer. This selective ROS1 tyrosine kinase inhibitor received FDA approval in June 2025 with breakthrough therapy designation. Features enhanced CNS penetration for improved efficacy against brain metastases compared to earlier ROS1 inhibitors.

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 :

    Taletrectinib
  • Innovator :

    NUVATION BIO INC
  • Approval Date :

    11-Jun-25
  • NCE-1 Date :

    11-Jun-29
  • NCE Date :

    11-Jun-30
  • Dosage Form :

    Oral Capsule
  • Strength :

    EQ 200MG BASE
  • Therapeutic Category :

    Anticancer
  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2025 :

    9
  • 2026 :

    56
  • 2027 :

    126
  • 2028 :

    207
  • 2029 :

    298
  • 2030 :

    386
  • 2031 :

    471
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