Product Pipeline

The FDA has accepted the New Drug Application (NDA) for Accelerated Approval review of ONC201 (dordaviprone). A six-month FDA review period is now underway, with a potential PDUFA action date of August 18, 2025.

ONC201 is in multiple signal finding oncology indications/combinations

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.

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

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)