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Drug

Tovorafenib

Approved · EMA
Late-stage development

Also known as Ojemda.

RxNorm2682434ChEMBLCHEMBL3348923UNIIZN90E4027M
8
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase I, Open-label, Single-arm, Multicentre Study to Evaluate the Safety and Pharmacokinetics of Tovorafenib in Japanese Paediatric Participants With BRAF-altered Recurrent or Progressive Low-grade Glioma

Clinical trial2026-07-01Results expected Q3 2030 · ClinicalTrials.gov

Phase 2 Study of Tovorafenib (DAY101) in Relapsed and Refractory Langerhans Cell Histiocytosis

Clinical trial2026-06-17Results expected Q3 2028 · ClinicalTrials.gov

A Phase 1 Study of Combination Tovorafenib (DAY101) and Rituximab Treatment in Relapsed or Refractory Classical Hairy Cell Leukemia and Phase 2 Randomized Study Comparing Tovorafenib (DAY101) and Rituximab With Cladribine and Rituximab for Front-Line Treatment of Classical Hairy Cell Leukemia

Clinical trial2026-06-03Results expected Q1 2030 · ClinicalTrials.gov

LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients With Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy

Clinical trial2026-05-14Results expected Q2 2027 · ClinicalTrials.gov

Tovorafenib for the Treatment of Newly Diagnosed or Recurrent Craniopharyngioma in Children and Young Adults

Clinical trial2026-04-23Results expected Q1 2027 · ClinicalTrials.gov

Approval: Ojemda (EMA)

Regulatory2026-04-20EMA

A Phase 2 Study of Tovorafenib in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG), Which Harbor Alterations in the Mitogen-Activated Protein Kinase (MAPK) Pathway

Clinical trial2026-04-08Results expected Q2 2030 · ClinicalTrials.gov

VICTORY: A Pilot Study to Investigate Safety and Efficacy of Weekly Combination of Intravenous Vinblastine With Oral Type II RAF Inhibitor Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas

Clinical trial2025-05-15Results expected Q1 2027 · ClinicalTrials.gov

FIREFLY-1: A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients With RAF-Altered, Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors

Clinical trial2025-04-10Results expected Q2 2027 · ClinicalTrials.gov

A Phase 1b/2, Subprotocol of DAY101 in Combination With Pimasertib for Patients With Recurrent, Progressive, or Refractory Solid Tumors and MAPK Pathway Aberrations

Clinical trial2024-12-18Terminated · ClinicalTrials.gov

A Phase 2, Subprotocol of DAY101 Monotherapy for Patients With Recurrent, Progressive, or Refractory Solid Tumors With MAPK Pathway Aberrations

Clinical trial2024-07-08Terminated · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Tovorafenib
Aliases & brands
Ojemda
RxNorm CUI
2682434
ChEMBL ID
CHEMBL3348923
UNII
ZN90E4027M
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2026-04-20
Latest approval
2026-04-20
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2026-04-20Approval
Approval: Ojemda (EMA)
Indication: Ojemda is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low-grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or… Show full indication

Ojemda is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low-grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies (for biomarkers-based patient selection, see section 4.2)

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

10 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
10
registered trials across all phases
8
Active studies
7
Recruiting
1
Late-stage (III+)
2
Discontinued
PHASE DISTRIBUTIONn = 10
Early Phase 11Phase 12Phase 1 / 21Phase 25Phase 31

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients With Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy

Active, not recruitingPH IIIDay One Biopharmaceuticals, Inc.n=4182031
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.