Ojemda

(Tovorafenib)

ApprovedSmall molecule

Ojemda is a small molecule that works as a RAF Inhibitor.[2] It is being used across 7 indications, with its most advanced program in Approved.[1]

Ojemda is one of 136 small molecule programs targeting Glioblastoma. It is currently in Approved.

Indications

Total Trials

Active Trials

135

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

GlioblastomaApproved

Low Grade GliomaActive, not recruiting

Recurrent Langerhans Cell HistiocytosisRecruiting

High Grade GliomaNot yet recruiting

Hairy Cell LeukemiaRecruiting

GliomaRecruiting

CraniopharyngiomaRecruiting

GlioblastomaApproved

Approved

Low Grade GliomaPhase 1

Active, not recruiting

Recurrent Langerhans Cell HistiocytosisPhase 2

Recruiting

High Grade GliomaPhase 2

Not yet recruiting

Hairy Cell LeukemiaPhase 2

Recruiting

GliomaPhase 3

Recruiting

CraniopharyngiomaPhase 2

Recruiting

Competition

Competitive Landscape

160 competitors in Glioblastoma

#DrugCompanyPhaseTrials

Avastin

Roche

Phase 3

58 2

Ojemda

Day One Biopharmaceuticals

Approved

11 3

Keytruda

Merck & Co.

Phase 3

24 4

Opdivo

Bristol-Myers Squibb

Phase 3

18 5

Temodar

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Yervoy

11 7

Ceenu

AAzurity Pharmaceuticals

Phase 3

21 8

Antabuse

Teva

Phase 3

5 9

Zejula

GGlaxo Dba Glaxosmithkline

Phase 3

4 10

Feraheme

AAzurity Pharmaceuticals

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Glioma

NCT04775485

Q1 2028

Phase 2Recruiting

Craniopharyngioma

NCT05465174

Q3 2028

Phase 2Recruiting

Recurrent Langerhans Cell Histiocytosis

NCT05828069

Q1 2029

Phase 1Recruiting

Low Grade Glioma

NCT06381570

Clinical

Trials by Indication[1]

Glioma3 trials

A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors

Recruiting· Day One Biopharmaceuticals logo

Day One Biopharmaceuticals·Phase 2·NCT04775485·141 enrolled

Expanded Access Program (EAP) for Tovorafenib (DAY101) in RAF-Altered, Relapsed or Refractory Low-Grade Glioma

Approved for marketing· Day One Biopharmaceuticals logo

Day One Biopharmaceuticals··NCT05760586

DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)

Recruiting· Day One Biopharmaceuticals logo

Day One Biopharmaceuticals·Phase 3·NCT05566795·400 enrolled

Melanoma2 trials

Tovorafenib (DAY101) or in Combination With Pimasertib for Participants With Melanoma and Other Solid Tumors

Terminated· Day One Biopharmaceuticals logo

Day One Biopharmaceuticals·Phase 1·NCT07121829·44 enrolled

Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors

Terminated· Day One Biopharmaceuticals logo

Day One Biopharmaceuticals·Phase 2·NCT04985604·23 enrolled

Low Grade Glioma2 trials

Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas

Recruiting·DDaniel Morgenstern·Phase 1·NCT06381570·57 enrolled

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

Active, not recruiting· Ipsen logo

Ipsen·Phase 1·NCT07441707·6 enrolled

Craniopharyngioma1 trial

Tovorafenib for Treatment of Craniopharyngioma in Children and Young Adults

Recruiting·SSabine Mueller, MD, PhD·Phase 2·NCT05465174·57 enrolled

Recurrent Langerhans Cell Histiocytosis1 trial

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

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05828069·48 enrolled

2 more indications

High Grade Glioma1 trial

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

Not yet recruiting·NNationwide Children's Hospital·Phase 2·NCT07206849·79 enrolled

Hairy Cell Leukemia1 trial

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

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT06965114·84 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 23, 2024

OJEMDA

NDA NDA217700

Apr 23, 2024

OJEMDA

NDA NDA218033

Jun 26, 2024

OJEMDA

NDA NDA217700

Jun 26, 2024

OJEMDA

NDA NDA218033

Aug 27, 2025

OJEMDA

NDA NDA217700

Aug 27, 2025

OJEMDA

NDA NDA217700

Aug 27, 2025

OJEMDA

NDA NDA217700

Aug 27, 2025

OJEMDA

NDA NDA218033

Aug 27, 2025

OJEMDA

NDA NDA218033

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Tovorafenib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tovorafenib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tovorafenib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA217700). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Ojemda. U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Tovorafenib. U.S. National Library of Medicine.
[7]
SEC EDGAR — Day One Biopharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: RAF Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Day One Biopharmaceuticals

Patent Landscape[5]

Patent Cliff

Aug 4, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8293752Aug 4, 2031

10426782Jun 23, 2035

Key Publications[6]

Tovorafenib in Relapsed Pediatric Low-Grade Glioma: FIREFLY-1

N Engl J MedJan 25, 2024DOI: 10.1056/NEJMoa2310334

Ojemda

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q1 2028

Q3 2028

Q1 2029

Trials by Indication[1]

Glioma3 trials

Melanoma2 trials

Low Grade Glioma2 trials

Craniopharyngioma1 trial

Recurrent Langerhans Cell Histiocytosis1 trial

High Grade Glioma1 trial

Hairy Cell Leukemia1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Key Publications[6]

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