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Komzifti

Komzifti is an advanced anticancer therapy developed for the treatment of adults with relapsed or refractory Acute Myeloid Leukemia (AML) harboring a susceptible Nucleophosmin 1 (NPM1) mutation. It is specifically indicated for patients who have no satisfactory alternative treatment options, addressing a critical unmet medical need in high-risk AML management.

Designed to target the molecular pathways driven by NPM1 mutations, Komzifti provides a focused therapeutic approach aimed at improving disease control in a population with limited clinical responses to conventional regimens. Its formulation and mechanism are optimized to support enhanced antileukemic activity while maintaining rigorously monitored safety and quality standards.

Komzifti serves as a promising option for clinicians seeking mutation-specific therapy in relapsed or refractory AML, offering renewed possibility in cases where traditional treatments have proven insufficient.

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 :

    Ziftomenib
  • Innovator :

    KURA ONCOLOGY INC
  • Approval Date :

    13-Nov-25
  • NCE-1 Date :

    13-Nov-29
  • NCE Date :

    13-Nov-30
  • Dosage Form :

    Oral Capsule
  • Strength :

    200MG
  • Therapeutic Category :

    Anticancer
  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2025 :

    NA
  • 2026 :

    69
  • 2027 :

    202
  • 2028 :

    397
  • 2029 :

    623
  • 2030 :

    978
  • 2031 :

    1,370
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