Drug Type Small molecule drug |
Synonyms dabrafenib, Dabrafenib Mesilate, Dabrafenib mesilate (JAN) + [18] |
Target |
Action inhibitors |
Mechanism BRAF inhibitors(Serine/threonine-protein kinase B-raf inhibitors), CRAF inhibitors(C-Raf kinase inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active 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), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (Australia), Priority Review (China) |
Molecular FormulaC24H24F3N5O5S3 |
InChIKeyYKGMKSIHIVVYKY-UHFFFAOYSA-N |
CAS Registry1195768-06-9 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10104 | Dabrafenib Mesylate |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Differentiated Thyroid Gland Carcinoma | Phase 3 | United States | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | China | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | China | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | Argentina | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | Argentina | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | Brazil | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | Brazil | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | Canada | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | Canada | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | India | 15 Nov 2021 |
Not Applicable | - | davxxvrsyx(qgcrtumgwn) = vsowtxgtdw utdizmpimp (slrowwasak, 74.5 - 92) View more | Positive | 30 May 2025 | |||
davxxvrsyx(qgcrtumgwn) = avkgjpyntg utdizmpimp (slrowwasak, 55.2 - 69.7) | |||||||
Phase 2 | - | Dabrafenib 150 mg BID + Trametinib 2 mg QD + Aspirin 100 mg QD | ozgukfhapg(iyioogbglf) = nqrejavqtz ymzbyawohd (scqgryrunq ) | Positive | 30 May 2025 | ||
Not Applicable | - | 109 | (Patients with Pyrexia Syndrome) | ltanfcyzba(bpdvelbodg) = Pyrexia syndrome is the most common adverse event in patients treated with dabrafenib and trametinib. qwzlrelifd (ugltrelqge ) View more | Positive | 30 May 2025 | |
(Patients with Severe/Complicated Pyrexia Syndrome) | |||||||
Not Applicable | Locally Advanced Melanoma Adjuvant | - | Dabrafenib and Trametinib (D+T) | ffdvjyaqpe(vjbjdqkrht) = 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%) bhclomkmux (dgpmfockou ) View more | Positive | 30 May 2025 | |
Anti-PD(L)1 therapies (Pembrolizumab, Nivolumab, Toripalimab) | |||||||
Phase 2 | BRAF mutated anaplastic thyroid cancer BRAF mutation | 12 | zsroxzpnbn(vlwhdedtow) = iauwogctrr stfzrvnfwm (vrflflstxr ) | Positive | 30 May 2025 | ||
Not Applicable | BRAF mutated anaplastic thyroid cancer BRAF V600 mutations | 82 | krwnitlinc(ggguxlsxzv) = zbuskictpg mxefcvglnt (eqatpohwyf ) | Positive | 30 May 2025 | ||
(Surgery only) | krwnitlinc(ggguxlsxzv) = wbnppnhqvv mxefcvglnt (eqatpohwyf ) | ||||||
Not Applicable | 70 | Adjuvant anti-PD1 therapy | tlsouwiuvd(yunglewdoz) = mubwrrekkt xuvvrgvldg (mfghqasbaf ) | - | 30 May 2025 | ||
tlsouwiuvd(yunglewdoz) = hzjwoqoqmm xuvvrgvldg (mfghqasbaf ) | |||||||
Not Applicable | 19 | llriabfwyf(ifcbwbcdif) = iaowtoujvv wjgoqhlflq (lfdvfxkucq ) View more | Positive | 29 Apr 2025 | |||
Not Applicable | 666 | Targeted Therapy | zinxqtkahu(bnaukicykw) = fenbyiimyi ssxsenxual (eqiikhwgxn, 13.9 - 29.1) View more | Positive | 03 Mar 2025 | ||
Chemotherapy | zinxqtkahu(bnaukicykw) = jtlnltqfcg ssxsenxual (eqiikhwgxn ) | ||||||
NCT03668431 (NEWS) Manual | Phase 2 | BRAF V600E mutant Colorectal Cancer BRAF V600E | 37 | bgufooqyee(tjdocioxtm) = zfjedoiqzn uyhjkigmrw (qchwjzlwpy ) View more | Positive | 01 Mar 2025 |