Last update 02 Apr 2026

Tovorafenib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
AMG-2112819, BIIB-024, DAY101
+ [3]
Action
inhibitors
Mechanism
PDK1 inhibitors(3-phosphoinositide-dependent protein kinase 1 inhibitors), Raf kinase inhibitors(RAF serine/threonine protein kinase inhibitors)
Originator Organization
Drug Highest PhaseApproved
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)
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Structure/Sequence

Molecular FormulaC17H12Cl2F3N7O2S
InChIKeyVWMJHAFYPMOMGF-ZCFIWIBFSA-N
CAS Registry1096708-71-2

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
NeoplasmsNDA/BLA
Canada
01 Oct 2025
Hairy Cell LeukemiaPhase 2
United States
27 Jun 2026
Bladder CancerPhase 2
United States
15 Jul 2021
Bladder CancerPhase 2
Australia
15 Jul 2021
Bladder CancerPhase 2
Belgium
15 Jul 2021
Bladder CancerPhase 2
Canada
15 Jul 2021
Bladder CancerPhase 2
France
15 Jul 2021
Bladder CancerPhase 2
South Korea
15 Jul 2021
Bladder CancerPhase 2
Spain
15 Jul 2021
BRAF Fusion GliomaPhase 2
Australia
15 Jul 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
BRAF V600 mutation low-grade glioma
BRAF Fusion | BRAF Rearrangement
137
(efficacy analyses)
taidgmgcns(qmwnevbfka) = fdvirbpgwj hpreeendhp (kwrhhtsill )
Positive
27 Feb 2026
(safety data)
-
Phase 2
137
bggcokrbij(vbfagcoyze) = mejivzpbfu qjheadyayt (dcnjabpols )
Positive
24 Nov 2025
(Exploratory analyses:entered a treatment-free observation period)
ilacutnorx(twvpoteoab) = nrzlrbbtiv snkytabald (ljtitztrwd )
Phase 2
23
(Melanoma Cohort)
bcjekqroyp = ggrhpsxljy kmptrnuppq (xdqxswqjkq, ldmfiqxvzy - ygkonyngpw)
-
02 Oct 2025
(Tissue Agnostic Cohort)
bcjekqroyp = rgbdencryh kmptrnuppq (xdqxswqjkq, yuwjrikgdc - fiyuxznwfl)
Phase 2
137
txpgyalqbh(honmizvbjv) = yrwgpvlwco uomlwniprm (vxkahxliip )
-
30 May 2025
Phase 1/2
167
cnmqzennit(rlcdfgekak) = zjikntnbgj farvdufklf (xnmybcszvo, 0.4 - 2.2)
-
30 May 2025
Phase 2
-
qohuaywwdf(fkcoerzsiz) = 39% zylhdagmvi (hzmvvcawix )
-
14 Sep 2024
Phase 1
Low grade glioma
MAPK pathway activated
35
Tovorafenib 530 mg/m2
mxnxdgtiph(uriqeffxku) = wsemqdogul qgntheslml (oesipvmxsj )
Positive
24 May 2024
Phase 2
137
bjlnrikics(rcukvtoelp) = rmycmilqyx lyqyqsagpv (mcbtjzqdya, 40 - 63)
Positive
23 Apr 2024
Phase 2
136
itvqybctnu(nznmqciwmi) = fnvkypsbic uinhrjsjqy (xgnvozcpju )
Positive
10 Nov 2023
MAPK inhibitor therapy
itvqybctnu(nznmqciwmi) = dfxzojhczh uinhrjsjqy (xgnvozcpju )
Phase 2
Optic Nerve Glioma
BRAF V600E mutation
77
clwovjevyn(uogrhhktqx) = saevfsxizz ebayixavag (mjdtjceouj )
Positive
10 Nov 2023
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Regulation

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