OJEMDA (tovorafenib) · DAY ONE BIOPHARMS
Ojemda is a kinase inhibitor used for children and infants as young as six months who have low-grade glioma that has returned or failed to respond to previous therapies. It helps patients whose tumors carry specific genetic markers, including BRAF fusions, rearrangements, or V600 mutations. This medication offers a targeted approach for managing these specific pediatric brain tumors.
How OJEMDA Works
This medication works by inhibiting Type II RAF kinases, specifically targeting mutant BRAF V600E along with wild-type BRAF and CRAF. By blocking these specific proteins, the drug interferes with the signaling that promotes cancer growth, leading to antitumor activity in tumors with BRAF mutations or fusions.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2024-04-23
- Patent Cliff
- 2035
- Routes
- ORAL
- Dosage Forms
- TABLET, FOR SUSPENSION
OJEMDA Approval History
What OJEMDA Treats
1 indicationsOJEMDA is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Low-Grade Glioma
OJEMDA Target & Pathway
ProTarget
A kinase in the MAPK signaling pathway that regulates cell growth. BRAF mutations (especially V600E) occur in melanoma, colorectal, and thyroid cancers, causing uncontrolled cell proliferation. Inhibiting mutant BRAF blocks this aberrant growth signal.
OJEMDA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to OJEMDA
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05828069 | NCI-2022-06282 NCI-2022-06282, ANHL2121 | Ph 2 | recruiting | A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis |
| NCT06965114 | NCI-2025-03281 NCI-2025-03281, 10664 | Ph 1, Ph 2 | recruiting | Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia |
| NCT07441707 | CLIN-60310-450 | Ph 1 | recruiting | A Study to Assess a Medicine Called Tovorafenib in Japanese Children and Young Adults With Brain Tumours |
| NCT05465174 PNOC029 | 210828 NCI-2022-05356 | Ph 2 | recruiting | Tovorafenib for Treatment of Craniopharyngioma in Children and Young Adults |
| NCT07206849 | CONNECT TarGeT-B R01FD008167 | Ph 2 | not yet recruiting | Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG) |
| NCT05566795 | DAY101-002 2022-001363-27 | Ph 3 | active not recruiting | DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2) |
| NCT04985604 results posted | DAY101-102a 2021-003768-29 | Ph 2 | terminated | Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors |
| NCT07121829 | DAY101-102b 2021-003768-29 | Ph 1 | terminated | Tovorafenib (DAY101) or in Combination With Pimasertib for Participants With Melanoma and Other Solid Tumors |
| NCT04775485 FIREFLY-1 | DAY101-001/PNOC026 | Ph 2 | recruiting | A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OJEMDA FDA Label Details
Indications & Usage
FDA Label (PDF)OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). OJEMDA is a kinase inhibitor indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatri...
OJEMDA Patents & Exclusivity
Patents (2 active)
Exclusivity
Pro Intelligence Preview
Deep insights for OJEMDA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 4 active patents
Trial Analysis
- • 9 total trials
- • Stage: Growth
Competitive Landscape
- • 2 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment