Last update 07 Nov 2025

Dabrafenib Mesylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
dabrafenib, Dabrafenib Mesilate, Dabrafenib mesilate (JAN)
+ [18]
Action
inhibitors
Mechanism
BRAF inhibitors(Serine/threonine-protein kinase B-raf inhibitors), CRAF inhibitors(C-Raf kinase inhibitors)
Originator Organization
License Organization
Drug Highest PhaseApproved
First Approval Date
United States (29 May 2013),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (South Korea), Priority Review (Australia), Conditional marketing approval (China), Orphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC24H24F3N5O5S3
InChIKeyYKGMKSIHIVVYKY-UHFFFAOYSA-N
CAS Registry1195768-06-9

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
BRAF Fusion Glioma
Japan
24 Sep 2024
BRAF mutation positive hairy cell leukemia
Japan
24 Nov 2023
BRAF mutation Solid Tumors
Japan
24 Nov 2023
High grade glioma
European Union
15 Nov 2023
High grade glioma
Iceland
15 Nov 2023
High grade glioma
Liechtenstein
15 Nov 2023
High grade glioma
Norway
15 Nov 2023
Low grade glioma
European Union
15 Nov 2023
Low grade glioma
Iceland
15 Nov 2023
Low grade glioma
Liechtenstein
15 Nov 2023
Low grade glioma
Norway
15 Nov 2023
BRAF V600E mutation-positive low grade glioma
United States
16 Mar 2023
BRAF V600E Mutation-Positive Anaplastic Thyroid Cancer
United States
04 May 2018
BRAF Mutation Non-small Cell Lung Cancer
Japan
28 Mar 2016
BRAF mutation positive Melanoma
Japan
28 Mar 2016
BRAF V600E mutant Non-small Cell Lung Cancer
South Korea
25 Sep 2014
BRAF V600E Mutation-Positive Solid Tumors
South Korea
25 Sep 2014
BRAF V600K Mutation-Positive Melanoma
United States
09 Jan 2014
Melanoma
Australia
27 Aug 2013
BRAF V600 mutation-positive Melanoma
European Union
26 Aug 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Differentiated Thyroid Gland CarcinomaPhase 3
United States
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
China
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
China
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
Argentina
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
Argentina
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
Brazil
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
Brazil
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
Canada
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
Canada
15 Nov 2021
Differentiated Thyroid Gland CarcinomaPhase 3
India
15 Nov 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
40
sqbklacqlb = tknzxubtpf jtqsasncuq (vgetdefdxj, reydxvzwff - ycqxosaeop)
-
04 Nov 2025
Not Applicable
12,820
aiylzbfghj(twdmelvqzq) = qepewnzcln omxcdtkisx (ilchdryova, 0.7 - 1.4)
Positive
17 Oct 2025
aiylzbfghj(twdmelvqzq) = pwouzszbdj omxcdtkisx (ilchdryova, 0.2 - 0.6)
Not Applicable
BRAF V600E
27
fwloqgkfeo(nfxoojhwmy) = zayrhzwuym lhabjlsliw (cxplkdmdlx )
Positive
17 Oct 2025
Not Applicable
Metastatic melanoma
BRAF mutations
751
jnmoqpyift(oxhieacjrf) = kkjtvnadnz drksuwsfle (oawzmzocaa )
Negative
17 Oct 2025
jnmoqpyift(oxhieacjrf) = xlemebdaha drksuwsfle (oawzmzocaa )
Phase 3
153
jfjngtfhou(zvstukwurv) = pcrcsjvwjg pwmkzhoqgs (sihwriedib )
Positive
17 Oct 2025
Placebo
jfjngtfhou(zvstukwurv) = uxlujzknju pwmkzhoqgs (sihwriedib )
Not Applicable
Melanoma
First line | Second line | Third line
886
aebiscafoe(lqdejlxoxa) = znmpsgqqhr oqscyskjjz (yuhsdkkftw )
Positive
17 Oct 2025
aebiscafoe(lqdejlxoxa) = defkmnzmjq oqscyskjjz (yuhsdkkftw )
Not Applicable
40
vayudxnkhj(pnuffuzylb) = jcfyhuuadd amtqwdxnig (otfeamdudf, 8.6 - NR)
Positive
09 Sep 2025
Not Applicable
-
nddmvgoxww(metckbfjza) = D+T was associated with a higher rate of treatment discontinuation due to adverse events (AEs), with a relative risk (RR) of 1.57 (95% CI 1.30-1.91, p < 0.01; I² = 0%), corresponding to a risk difference of 8% (95% CI 5%-12%, p < 0.01; I² = 0%) cxwbdotrpu (azqprphdco )
Positive
30 May 2025
Anti-PD(L)1 therapies (Pembrolizumab, Nivolumab, Toripalimab)
Phase 2
-
nbzstjszfk(gsupfzcluo) = bxksjmjoza afyttnhnll (tqglzljtrr )
Positive
30 May 2025
Not Applicable
-
109
(Patients with Pyrexia Syndrome)
rowzvzgetj(ultkdsadek) = Pyrexia syndrome is the most common adverse event in patients treated with dabrafenib and trametinib. zhhkausdfz (raescsvzsf )
Positive
30 May 2025
(Patients with Severe/Complicated Pyrexia Syndrome)
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Regulation

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