Last update 22 Oct 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)
Login to view timeline

Structure/Sequence

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

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
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.
Login
to view more data
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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
61
onohhalgfe(jsomhaoefn) = kprpjguemm lzxokdzsay (wmebadrkiv, 3.4 - 7.8)
Negative
23 Oct 2026
Phase 3
BRAF V600 mutation-positive Melanoma
Adjuvant
BRAF V600-mutant
140
pxkjzsvwlb(fsahjlnwjd) = libomfeohh bxlioohgxo (jfvnkefyqn, 62.2 - 77.7)
Positive
23 Oct 2026
pxkjzsvwlb(fsahjlnwjd) = escufklpmf bxlioohgxo (jfvnkefyqn, 56.9 - 72.2)
Not Applicable
304
xzerjbogrt(xnzpnuqdsa) = ajktkyozby xaqzlqsbnb (aozufzkvgu, 71 - 81)
Positive
23 Oct 2026
eiqrnfpaau(vikbzpkbzr) = gkzqhpbtol jqdltqefwj (hpgtivhvlx, 63 - 71)
Not Applicable
Metastatic melanoma
Second line | First line
424
rukvflghco(afaebvmmum) = vuwfqbdbbs tkaodycifx (vhtpxolbnx )
Positive
23 Oct 2026
rukvflghco(afaebvmmum) = wttrdogfge tkaodycifx (vhtpxolbnx )
Not Applicable
Astrocytoma
First line
BRAF V600E
18
Radiochemotherapy with concurrent and adjuvant temozolomide (TMZ)
wjqdqdmsgv(edpyvthcal) = pzpangynet imraasqgtw (crcbvxmexe )
Positive
24 Sep 2026
Not Applicable
40
uabwjifrty(uafwthrjes) = qzhxcytudh xqpswkbnih (byygzjijbx )
Positive
12 Sep 2026
uybczweqwo(sstidekzjn) = myencdjhrp igqjsibvxj (rqbofxcvas )
Not Applicable
57
nqedghomlb(lbjuqyjoid) = vsbaxmjysy rorwrsgefh (hlgsswbque )
Positive
12 Sep 2026
ismlrdxvev(pbbmrqpmyt) = peintcjmru uhvoktjkkc (lqzertjyak, 34 - 75)
Not Applicable
Melanoma
BRAFV600 突变
28
达拉非尼联合曲美替尼联合替莫唑胺及仑伐替尼
ipttykuuzw(ojcwrjmdhu) = rsuoemubdz qfzihlumpo (colruybrsf )
Positive
11 Sep 2026
Phase 3
532
ggrdcpvkjd(ebxeitqvau) = fqgkyplqln sdacurignf (ancdahcsrb, 41.6 - NE)
Positive
10 Sep 2026
Placebo plus Dabrafenib and Trametinib
ggrdcpvkjd(ebxeitqvau) = mcbrmbqdnt sdacurignf (ancdahcsrb, 30.6 - 56.9)
Phase 2
60
(Pembrolizumab ONLY)
obdzqeqnoh = mqafkoarbd bkkfngxwbb (fgwixqfleh, ttunzxzhwg - vtevrfttqn)
-
24 Aug 2026
(Sequential D + T, THEN Pembrolizumab)
obdzqeqnoh = evjrqmpebw bkkfngxwbb (fgwixqfleh, twxartgnwr - eacvxmytje)
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Hiro LS Researcher
The AI Search Engine Built to Accelerate Biopharma Decisions
Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.
Ask any biopharma research question→
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Discover Synapse Data Servers
Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free