Product Pipeline

Continuously evaluating innovative ways to overcome diseases

Program
Preclinical
Phase 1
Phase 2
Registrational
FDA Review
Phase
  • ONC201
    Registrational
    H3 K27M-mutant glioma (orphan drug designation)

    The FDA has granted ONC201 Fast Track Designation for the treatment of adult recurrent H3 K27M-mutant high-grade glioma, Rare Pediatric Disease Designation for treatment of H3 K27M-mutant glioma, and Orphan Drug Designations for the treatment of glioblastoma and for the treatment of malignant glioma.

  • ONC201
    Phase 2
    Neuroendocrine Tumors (PCPG)

    ONC201 is in a phase 2 trial to treat Neuroendocrine Tumors (Pheochromocytoma/paraganglioma).

  • DSTAT for
    Registrational
    Acute Myeloid Leukemia (AML) (orphan drug designation)

    DSTAT is in development for the first-line treatment of AML. DSTAT has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration for the treatment of AML. View clinical trial results.

  • ONC206
    Phase 1
    Solid tumors

    The first-in-human ONC206 clinical trial for adults with recurrent primary central nervous system tumors is ongoing at the National Institute of Health.

  • ONC212
    PreClinical
    IND-enabling studies

    A $3.4 million grant awarded to Brown University supports completion of ONC212 IND-enabling studies and a first-in-human clinical trial.