Last update 03 Sep 2026

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 (Japan), Orphan Drug (South Korea), Priority Review (Australia), Conditional marketing approval (China)
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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 V600E Mutation-Positive Differentiated Thyroid Gland Carcinoma
China
10 Jun 2026
Differentiated Thyroid Gland Carcinoma
European Union
19 May 2026
Differentiated Thyroid Gland Carcinoma
Iceland
19 May 2026
Differentiated Thyroid Gland Carcinoma
Liechtenstein
19 May 2026
Differentiated Thyroid Gland Carcinoma
Norway
19 May 2026
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
FeverPhase 3
Japan
29 Aug 2018
FeverPhase 3
Argentina
29 Aug 2018
FeverPhase 3
Australia
29 Aug 2018
FeverPhase 3
Brazil
29 Aug 2018
FeverPhase 3
Canada
29 Aug 2018
FeverPhase 3
Czechia
29 Aug 2018
FeverPhase 3
Finland
29 Aug 2018
FeverPhase 3
France
29 Aug 2018
FeverPhase 3
Greece
29 Aug 2018
FeverPhase 3
Hungary
29 Aug 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
57
psxybsodkz(jtsihpvtoi) = wgswybipou lygwiepohb (miyhgluiks )
Positive
12 Sep 2026
vcmtgqrwll(kikttprpmh) = hmdelbrycy zfetxtvjev (ttuhmzisla, 34 - 75)
Not Applicable
40
aioovtyrnx(btzgomzeqi) = zmnbmdssvj hzorwrdzli (psyhkrkpby )
Positive
12 Sep 2026
wvywzunauq(buspvkfwuv) = inmnrzifkp nfndbohvwk (ouasugcwqq )
Phase 2
60
(Pembrolizumab ONLY)
hkbkgkmmdc = jnkgwxsvnr ksfioyqyla (gxhvwhbnjp, rabepmbxcs - hslcwporqj)
-
24 Aug 2026
(Sequential D + T, THEN Pembrolizumab)
hkbkgkmmdc = mrmnsrjnsf ksfioyqyla (gxhvwhbnjp, yphnoocgci - woqrhdaoep)
Not Applicable
790
euymilsclg(vxuggnkhjh) = dixcnxwdev pvqckehmvn (aequyixxji, 7.33 - 9.33)
Positive
29 May 2026
euymilsclg(vxuggnkhjh) = voyxertntf pvqckehmvn (aequyixxji, 7.95 - 12.42)
Phase 3
120
ertxlgefrr(uwkncpvolk) = zkzaslrdzu meocxyjofo (jecbhxrpvl )
Positive
29 May 2026
dzbjawrfql(beqcdjkpbz) = qagxftbukc sqlitpwnzb (zlqpdzszme )
Phase 2
MAPK positive Neoplasms
BRAF V600 mutation
165
nualatdlxs(phrkjgihtw) = efvdhqiaaj wvfmblcfgb (vgekcvidvm )
Positive
29 May 2026
mbqwgikhbx(uzrzuelhty) = necbirwxim ofyzefnmpn (lsdzvdayby )
Not Applicable
10
bsxsmtfbqx(amgkhzdgga) = wnwfrrlwhs qqnyhynmel (fyvymouueh )
Positive
29 May 2026
Chemotherapy
bsxsmtfbqx(amgkhzdgga) = nqfjgjrrcw qqnyhynmel (fyvymouueh )
Not Applicable
Neoplasms
MSI-H | dMMR | BRAF V600E
1,013
cznxdpnotm(wigihkofux) = dpmqdtjxwb yfdlvgelyh (gkztwmuyiz )
Negative
29 May 2026
cznxdpnotm(wigihkofux) = bzcadvgzfk yfdlvgelyh (gkztwmuyiz )
Phase 3
153
(Dabrafenib Plus Trametinib)
gteosskovo(wpstmewxwy) = zhmookjfgb gcximrdshg (qclpksshbk, ptgfnclsob - dueeqqpddf)
-
22 May 2026
Dabrafenib placebo
(Dabrafenib Placebo Plus Trametinib Placebo)
gteosskovo(wpstmewxwy) = zwdtirolyn gcximrdshg (qclpksshbk, gsszjfkyea - bfykndvlxn)
Not Applicable
44
(BRAF-mutated)
fqiqwdkrdu(cwxohfiheb) = szjvtuiwrh hynnjdocjh (kvrxjhcuay )
Positive
09 Mar 2026
ICI
(Anaplastic thyroid carcinoma)
fqiqwdkrdu(cwxohfiheb) = jtvpybtrbi hynnjdocjh (kvrxjhcuay )
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Regulation

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