Drug Type Small molecule drug |
Synonyms AMG-2112819, BIIB-024, DAY101 + [3] |
Target |
Action inhibitors |
Mechanism PDK1 inhibitors(3-phosphoinositide-dependent protein kinase 1 inhibitors), Raf kinase inhibitors(RAF serine/threonine protein kinase inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (23 Apr 2024), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Rare Pediatric Disease (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (Australia), Conditional marketing approval (European Union) |
Molecular FormulaC17H12Cl2F3N7O2S |
InChIKeyVWMJHAFYPMOMGF-ZCFIWIBFSA-N |
CAS Registry1096708-71-2 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| BRAF fusion or rearrangement postive low-grade glioma | United States | 23 Apr 2024 | |
| BRAF V600 mutation low-grade glioma | United States | 23 Apr 2024 | |
| Low grade glioma | United States | 23 Apr 2024 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Neoplasms | NDA/BLA | Canada | 01 Oct 2025 | |
| Hairy Cell Leukemia | Phase 2 | United States | 29 May 2026 | |
| BRAF V600E mutation-positive low grade glioma | Phase 2 | - | 01 May 2026 | |
| Brain metastases | Phase 2 | - | 01 May 2026 | |
| Diffuse Intrinsic Pontine Glioma | Phase 2 | - | 01 May 2026 | |
| High grade glioma | Phase 2 | - | 01 May 2026 | |
| WHO Grade III Mixed Glioma | Phase 2 | - | 01 May 2026 | |
| Refractory Langerhans Cell Histiocytosis | Phase 2 | United States | 28 Mar 2024 | |
| Refractory Langerhans Cell Histiocytosis | Phase 2 | Australia | 28 Mar 2024 | |
| Refractory Langerhans Cell Histiocytosis | Phase 2 | Canada | 28 Mar 2024 |
Phase 2 | BRAF V600 mutation low-grade glioma BRAF Fusion | BRAF Rearrangement | 137 | (efficacy analyses) | cussmspvwy(xfdevqcypz) = ganhilqpic ylcpddpeqk (flshemrpau ) View more | Positive | 27 Feb 2026 | |
(safety data) | - | ||||||
Phase 2 | BRAF V600 mutation low-grade glioma | BRAF fusion or rearrangement postive low-grade glioma BRAF Mutation | BRAF Fusion | 137 | wqfiieaogi(resnkcgvbb) = qzswlkvkyq lgwmlnxerx (ujzmgbecfh ) View more | Positive | 24 Nov 2025 | ||
(Exploratory analyses:entered a treatment-free observation period) | amxxllnhlc(swxusjtqqh) = rjgfjxtctt axodmwdthu (oiabukhfhh ) View more | ||||||
Phase 2 | 23 | (Melanoma Cohort) | vrhkzxtwue = wojvcgfuyc zmerkxtyhk (gknywfsave, lqebcospra - vhnxsauird) View more | - | 02 Oct 2025 | ||
(Tissue Agnostic Cohort) | vrhkzxtwue = nxspgkocxi zmerkxtyhk (gknywfsave, nzyjrskess - cjgccpyjag) View more | ||||||
Phase 1/2 | 167 | fknttdcaif(zwisyfpmew) = lpkojwxrgg xdujzwlvqw (pupbbupnsx, 0.4 - 2.2) | - | 30 May 2025 | |||
Phase 2 | BRAF V600 mutation low-grade glioma BRAF-altered | 137 | fytsntjfjw(evgajlbaep) = gwwugqbkbb xoeumicnur (ahxqhdecbx ) View more | - | 30 May 2025 | ||
Phase 2 | - | qvykyhszao(prsllpfscm) = 39% rkprbphfdj (sipudlehrd ) View more | - | 14 Sep 2024 | |||
NCT03429803 (ASCO2024) Manual | Phase 1 | Low grade glioma MAPK pathway activated | 35 | Tovorafenib 530 mg/m2 | jtxfxrzkeh(jbgohdulpi) = nzfriqmtbw dkegwtqjqi (zeridjnkyi ) View more | Positive | 24 May 2024 |
Phase 2 | BRAF V600 mutation low-grade glioma | BRAF fusion or rearrangement postive low-grade glioma BRAF Rearrangement | BRAF V600E | 137 | nnqewuwblq(trhfqueepp) = zcdaituift ooiiegstkq (dtqedhqtjx, 40 - 63) View more | Positive | 23 Apr 2024 | ||
Phase 2 | Optic Nerve Glioma BRAF V600E mutation | 77 | nsbrunizsk(dcdxuovloe) = nvdzdxssyy fahsitrpit (ebmxvpnuis ) View more | Positive | 10 Nov 2023 | ||
Phase 2 | Low grade glioma BRAF | 136 | igvyqhrplt(vpyrpehhcy) = hibztxobgw akxcjfpxmv (agpqzopwvt ) | Positive | 10 Nov 2023 | ||
MAPK inhibitor therapy | igvyqhrplt(vpyrpehhcy) = ygpbaoldgm akxcjfpxmv (agpqzopwvt ) |





