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Revtorpyk

Hormone receptor-positive, HER2-negative breast cancer remains challenging once resistance to endocrine therapy develops. Revtorpyk (gedatolisib) introduces another targeted option by blocking the PI3K/AKT/mTOR (PAM) pathway, one of the key drivers of tumor growth and treatment resistance.

Approved by the FDA in combination with fulvestrant, Revtorpyk is indicated for patients with locally advanced or metastatic disease following endocrine therapy. Unlike many pathway-directed therapies that focus only on patients with a PIK3CA mutation, Revtorpyk expands treatment possibilities for those without that mutation.

With its unique positioning, Revtorpyk is expected to attract attention in future oncology studies. Monitoring its market performance, exclusivity, and sourcing availability will be increasingly relevant for clinical trial teams and companies evaluating future filing opportunities.

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 :

    Gedatolisib
  • Innovator :

    CELCUITY INC
  • Approval Date :

    14-Jul-26
  • NCE-1 Date :

    14-Jul-30
  • NCE Date :

    14-Jul-31
  • Dosage Form :

    Intravenous Powder
  • Strength :

    180MG/VIAL
  • Therapeutic Category :

    PI3K/AKT/mTOR (PAM) Inhibitor
  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2026 :

    44
  • 2027 :

    349
  • 2028 :

    625
  • 2029 :

    903
  • 2030 :

    1229
  • 2031 :

    1668
  • 2032 :

    2056
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