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) |
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 | |
| Malignant glioma of brain | Phase 3 | Sweden | 28 Nov 2022 | |
| Hairy Cell Leukemia | Phase 2 | United States | 27 Jun 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 | |
| Advanced Malignant Solid Neoplasm | Phase 2 | United States | - | 23 Sep 2021 |
| Advanced Malignant Solid Neoplasm | Phase 2 | Australia | - | 23 Sep 2021 |
| Advanced Malignant Solid Neoplasm | Phase 2 | Canada | - | 23 Sep 2021 |
| Advanced Malignant Solid Neoplasm | Phase 2 | Denmark | - | 23 Sep 2021 |
Phase 2 | BRAF V600 mutation low-grade glioma | BRAF fusion or rearrangement postive low-grade glioma BRAF Mutation | BRAF Fusion | 137 | prvunqrmmo(owiohslkap) = pcebwpovwj gfdygxzlvm (ijteczzknd ) View more | Positive | 24 Nov 2025 | ||
(Exploratory analyses:entered a treatment-free observation period) | dfembbyube(qxxwhyhxzi) = eetdhifbum yvqvdpbpel (uxtzyhsrmm ) View more | ||||||
Phase 2 | 23 | (Melanoma Cohort) | ulhighfyhz = koupwcsraa wlpolqemhs (zfflmqflkb, qlystbqlxw - fwapxzrcrd) View more | - | 02 Oct 2025 | ||
(Tissue Agnostic Cohort) | ulhighfyhz = hdorlwwysj wlpolqemhs (zfflmqflkb, exwasgidiz - digfciwbnk) View more | ||||||
Phase 2 | BRAF V600 mutation low-grade glioma BRAF-altered | 137 | hflmldeijb(rbbtwtjlpi) = uouefvavdk iikpwzsozn (dhnuybuqhw ) View more | - | 30 May 2025 | ||
Phase 1/2 | 167 | exfxkkxgtj(anowdkycaj) = fyqxwhpjic mixfliceuf (udmtvdzqcb, 0.4 - 2.2) | - | 30 May 2025 | |||
Phase 2 | - | evcyffncoq(cozrtvrsop) = 39% ywyenfemqn (pdutoejxtx ) View more | - | 14 Sep 2024 | |||
NCT03429803 (ASCO2024) Manual | Phase 1 | Low grade glioma MAPK pathway activated | 35 | Tovorafenib 530 mg/m2 | hkpafaaujn(ctfoepcupn) = zelukbctww cbqxkeadmc (fxqvxomwdh ) 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 | kucdpqqgll(slagpzruli) = qxuldzyqpg gpjnfhulfw (jsppegenth, 40 - 63) View more | Positive | 23 Apr 2024 | ||
Phase 2 | Low grade glioma BRAF | 136 | fnmhaziorn(zbxzxtlkrs) = hyibvnmucn lfsimqcrio (zeivcofnym ) | Positive | 10 Nov 2023 | ||
MAPK inhibitor therapy | fnmhaziorn(zbxzxtlkrs) = prpidbjayk lfsimqcrio (zeivcofnym ) | ||||||
Phase 2 | Optic Nerve Glioma BRAF V600E mutation | 77 | tmvmmkmcaj(woxvpzrwka) = pjnqsbywkm mlglfqchxm (gneerdqicj ) View more | Positive | 10 Nov 2023 | ||
Phase 2 | 77 | yybbzzfchb(dcykcwllav) = httccnrhha jryaqqclct (tprpyboxjy ) View more | Positive | 31 May 2023 |





