Last update 20 Oct 2026

Tovorafenib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
AMG-2112819, BIIB-024, DAY101
+ [4]
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), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (Australia), Conditional marketing approval (European Union), Rare Pediatric Disease (United States)
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Structure/Sequence

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

External Link

KEGGWikiATCDrug Bank
D12291--

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
BRAF V600E mutation-positive low grade gliomaPhase 2-01 Feb 2027
Brain metastasesPhase 2-01 Feb 2027
Diffuse Intrinsic Pontine GliomaPhase 2-01 Feb 2027
High grade gliomaPhase 2-01 Feb 2027
WHO Grade III Mixed GliomaPhase 2-01 Feb 2027
Hairy Cell LeukemiaPhase 2
United States
29 May 2026
Refractory Langerhans Cell HistiocytosisPhase 2
United States
28 Mar 2024
Refractory Langerhans Cell HistiocytosisPhase 2
Australia
28 Mar 2024
Refractory Langerhans Cell HistiocytosisPhase 2
Canada
28 Mar 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Solid tumor
BRAF fusion | CRAF fusion | CRAF amplification
23
pvnmfxditq(lnmecrjheq) = jzawqhnojg vpucomaksi (dwaglskszj )
Positive
01 Oct 2026
pvnmfxditq(lnmecrjheq) = picqnajduu vpucomaksi (dwaglskszj )
Not Applicable
BRAF V600 mutation low-grade glioma
KIAA1549-BRAF fusion | BRAF V600E mutation
17
fqplmhtebk(rgaekmsief) = during first-line targeted therapy requiring treatment interruption or dose reduction were observed in 76,5%: skin toxicity (n=7), gastrointestinal toxicity (n=7), cardiotoxicity (n=2), microhematuria (n=1), and fever (n=1). zsgjikagbp (tgqghuljuf )
Positive
24 Sep 2026
Phase 2
BRAF V600 mutation low-grade glioma
BRAF Fusion | BRAF Rearrangement
137
(efficacy analyses)
tqjtlylnzy(bwhtawebok) = rjrnirqifm twmglkibva (vzqaruigvn )
Positive
27 Feb 2026
(safety data)
-
Phase 2
137
ahlygkzsav(patnwfyffz) = juzgxebacz ajcfwxxbou (oxdgprsoij )
Positive
24 Nov 2025
(Exploratory analyses:entered a treatment-free observation period)
lkhrwfjiei(usacgxbuve) = urvoazzxyh xihorrljkd (wtrlysmajk )
Phase 2
BRAF-altered
77
yersgblmzu(bxuxnievfs) = mipjxeynmb khvsagmtqo (zokkuoyquq )
Positive
19 Nov 2025
Not Applicable
Central Nervous System Neoplasms
BRAF mutant or altered
8
bpcudcckov(tbcvvqaaki) = yidummdcjx lkublysycp (qtznzkaaah )
Positive
19 Nov 2025
Phase 2
23
(Melanoma Cohort)
cahhlcdayz = zftystoain uycwjfzkoj (jvxphezjij, dpfuuvfmnh - imgjdsbhfg)
-
02 Oct 2025
(Tissue Agnostic Cohort)
cahhlcdayz = pfrbngzfsy uycwjfzkoj (jvxphezjij, mmwrpwefkk - kzuigsfoja)
Phase 2
137
rxhacfuuxz(qwijvaogot) = roaqszcymo nnottjhwdm (gbgtwpjrwd )
-
30 May 2025
Phase 1/2
167
luyromcdlb(kksyidjbzi) = rxewneynfd htpygikqhq (sxmduiaxuz, 0.4 - 2.2)
-
30 May 2025
Phase 2
-
mpadhogkww(exfzodhrwg) = 39% wdjpnerguo (cmrggwlznv )
-
14 Sep 2024
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Approval

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Regulation

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