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Ojemda (TOVORAFENIB)
Ojemda (generic name: TOVORAFENIB) is a Kinase Inhibitor [EPC] Small molecule drug developed by Day One Biopharms. It is currently FDA-approved (first approved 2024) for relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF V600 mutation.
Ojemda works by blocking the BRAF protein, which is a key driver of cancer cell growth and survival.
Ojemda is a small molecule inhibitor of the RAF serine/threonine protein kinase. It is being studied in clinical trials for various conditions, including Hairy Cell Leukemia, Low-grade Glioma, and Recurrent Langerhans Cell Histiocytosis.
At a glance
| Generic name | TOVORAFENIB |
|---|---|
| Sponsor | Day One Biopharms |
| Drug class | Kinase Inhibitor [EPC] |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2024 |
Mechanism of action
Tovorafenib is a Type II RAF kinase inhibitor of mutant BRAF V600E , wild-type BRAF , and wild-type CRAF kinases. Tovorafenib exhibited antitumor activity in cultured cells and xenograft tumor models harboring BRAF V600E and V600D mutations, and in a xenograft model harboring a BRAF fusion.
Approved indications
- relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement
- relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF V600 mutation
Common side effects
- Rash
- Fatigue
- Viral infection
- Vomiting
- Pyrexia
- Headache
- Hemorrhage
- Dry skin
- Constipation
- Nausea
- Dermatitis acneiform
- Upper respiratory tract infection
Drug interactions
- Moderate and Strong CYP2C8 Inhibitors
- Moderate and Strong CYP2C8 Inducers
- CYP3A Substrates
- Hormonal contraceptives
- Tovorafenib
- CYP3A substrates (other than hormonal contraceptives)
- Moderate CYP2C8 inhibitors
- Strong CYP2C8 inhibitors
- Moderate CYP2C8 inducers
- Strong CYP2C8 inducers
- CYP3A substrates (hormonal contraceptives)
- CYP3A substrates (other than hormonal contraceptives)
Key clinical trials
- A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis (PHASE2)
- Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia (PHASE1,PHASE2)
- Tovorafenib for Treatment of Craniopharyngioma in Children and Young Adults (PHASE2)
- A Study to Assess a Medicine Called Tovorafenib in Japanese Children and Young Adults With Brain Tumours (PHASE1)
- DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2) (PHASE3)
- DAY101 In Gliomas and Other Tumors (PHASE1)
- Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG) (PHASE2)
- Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ojemda CI brief — competitive landscape report
- Ojemda updates RSS · CI watch RSS
- Day One Biopharms portfolio CI
Frequently asked questions about Ojemda
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Related
- Drug class: All Kinase Inhibitor [EPC] drugs
- Manufacturer: Day One Biopharms — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement
- Indication: Drugs for relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF V600 mutation
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing