Drugs / Tovorafenib
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved · conditional | EU (EMA) | Ojemda | — | 2026-04-20 | europa.eu ↗ |
| Label expansion | US (FDA) | OJEMDA | — | 2025-08-27 | fda.gov ↗ |
| Approved | US (FDA) | OJEMDA | — | 2024-04-23 | fda.gov ↗ |
Trials 15 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06381570 | Mar 2024 → Mar 2027 expected | low grade glioma | Daniel Morgenstern | Recruiting | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT07441707 | Mar 2026 → Jul 2030 expected | low grade glioma | Ipsen | Recruiting | No outcome recorded |
| Phase 1 | NCT07121829 | May 2022 → Dec 2024 | colorectal cancer, malignant pancreatic neoplasm, melanoma, non-small cell lung carcinoma +1 | Day One Biopharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT03429803 | Feb 2018 → Dec 2025 | low grade glioma | Karen D. Wright MD | Completed | No outcome recorded |
| Phase 1 | NCT02723006 | Jun 2016 → May 2018 | melanoma | Millennium Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT02327169 | Jan 2015 → Jul 2018 | neoplastic disease or syndrome | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01425008 | Sep 2011 → Apr 2017 | melanoma | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06965114 | May 2026 → Mar 2030 expected | hairy cell leukemia | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT07206849 | May 2026 → May 2030 expected | diffuse intrinsic pontine glioma, grade III glioma, high grade astrocytic tumor, metastatic malignant neoplasm in the brain | Nationwide Children's Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05828069 | Mar 2024 → Sep 2028 expected | Langerhans cell histiocytosis | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05465174 | Sep 2022 → Mar 2027 expected | craniopharyngioma | Sabine Mueller, MD, PhD | Recruiting | No outcome recorded |
| Phase 2 | NCT04985604 | Jul 2021 → Jul 2024 | colorectal cancer, non-small cell lung carcinoma, pancreatic acinar cell carcinoma, pilocytic astrocytoma +4 | Day One Biopharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT04775485 | Apr 2021 → May 2027 expected | low grade glioma | Day One Biopharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05566795 | Feb 2023 → Jun 2027 expected | childhood low-grade glioma | Day One Biopharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05760586 | — | low grade glioma | Day One Biopharmaceuticals, Inc. | Approved for marketing | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-04-22 | Ipsen | Ojemda® approved in the European Union as the first targeted therapy in relapsed or refractory pediatric low-grade glioma regardless of BRAF alteration ipsen.com ↗ |
| 2026-02-27 | Ipsen | Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma ipsen.com ↗ |
| 2024-07-25 | Ipsen | Ipsen and Day One enter into exclusive ex-U.S. licensing agreement to commercialize tovorafenib for the most common childhood brain tumor ipsen.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tovorafenib | “The name of the study drug involved in this study is: • Tovorafenib/DAY101 (formerly TAK-580, MLN2480)” NCT03429803 ↗ |
| Known as | BIIB-024 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3348923 ↗ |
| Known as | DAY101 | “Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors” NCT04985604 ↗ |
| Known as | MLN2480 | “The type II RAF inhibitor, tovorafenib (formerly DAY101, TAK-580, MLN2480), has shown promising activity and good tolerability in patients with BRAF-altered pLGG in the phase 2...” PMID 38291372 ↗ Jan 2024 |
| Known as | Ojemda | ChEMBL registry synonym — accepted as the source's own label CHEMBL3348923 ↗ |
| Known as | TAK-580 | “The type II RAF inhibitor, tovorafenib (formerly DAY101, TAK-580, MLN2480), has shown promising activity and good tolerability in patients with BRAF-altered pLGG in the phase 2...” PMID 38291372 ↗ Jan 2024 |
| Action | Inhibit | “MLN2480 (an Oral A-, B-, and CRAF Inhibitor)” NCT02327169 ↗ |
| Modality | Small molecule | — CHEMBL3348923 ↗ |
| Route | Oral | “participants will receive MLN2480 orally in escalating doses every other day or once weekly for three weeks of a 28-day cycle.” NCT01425008 ↗ |
| Target | CRAF | “MLN2480 (an Oral A-, B-, and CRAF Inhibitor)” NCT02327169 ↗ |