Product Pipeline

Continuously evaluating innovative ways to overcome diseases

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

    The FDA has granted dordaviprone (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.

  • Dordaviprone ONC201
    Phase 2
    Phase 2 (Mid)
    IITs – signal finding, multiple oncology indications/combinations

    ONC201 is in multiple signal finding oncology indications/combinations

  • ONC206
    Phase 1
    Phase 1 (Late)
    Central Nervous System tumors

    Phase 1 trials are enrolling dose escalation cohorts that have explored multiple doses and schedules in adult and pediatric patients with CNS tumors. ONC206 has been well tolerated at doses delivering exposures that demonstrate efficacy in nonclinical models.

  • ONC206
    PreClinical (Early)
    PreClinical
    Non-Central Nervous System tumors
  • ONC212
    PreClinical (Early)
    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.

  • CMX521
    PreClinical (Early)
    PreClinical
    Novel coronaviruses

    Preclinical efficacy data generated using CMX521 as a potential prophylactic and treatment of SARS-CoV-2 (COVID-19) infection in collaboration and the Rapidly Emerging Antiviral Drug Development Initiative (READDI)