Dabrafenib

Kinase Inhibitor — ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Also known as: dabrafenib mesilate, dabrafenib mesylate, GSK2118436, GSK2118436B, tafinlar

OnpEMA approvedFDA approvedPMDA approvedOrphan designationATC L01EC02

Data last refreshed: 2026-11-10 (DrugCentral release 2024-11-01)

Open interactive profile (3D, safety, PGx)

Key facts

Dabrafenib is an onp drug in the Kinase Inhibitor class catalogued in DrugCentral. It was first approved by the FDA in 2013. Its mechanism of action is classified as Breast Cancer Resistance Protein Inhibitors, Cytochrome P450 2B6 Inducers and Cytochrome P450 2C19 Inducers. DrugCentral lists 55 molecular targets, including BRAF, RIPK3 and CDK16. Recorded indications include Malignant Melanoma with BRAF V600E Mutation and Metastatic malignant melanoma.

Approval status: onp (first approved 2013 by the FDA).
Drug class: Kinase Inhibitor.
Mechanism of action: Breast Cancer Resistance Protein Inhibitors; Cytochrome P450 2B6 Inducers; Cytochrome P450 2C19 Inducers.
Molecular targets: BRAF, RIPK3, CDK16 and CDK2 (55 listed in DrugCentral).
Indications: Malignant Melanoma with BRAF V600E Mutation and Metastatic malignant melanoma.
ATC code: L01EC02 (B-Raf serine-threonine kinase (BRAF) inhibitors).
Molecular formula: C23H20F3N5O2S2; molecular weight 519.56 g/mol.

Indications & contraindications

Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).

Indications (2)

Malignant Melanoma with BRAF V600E Mutation
Metastatic malignant melanoma

Mechanism & targets

Mechanism of action (MoA)	Breast Cancer Resistance Protein Inhibitors; Cytochrome P450 2B6 Inducers; Cytochrome P450 2C19 Inducers; Cytochrome P450 2C8 Inducers; Cytochrome P450 2C9 Inducers; Cytochrome P450 3A4 Inducers; Organic Anion Transporter 1 Inhibitors; Organic Anion Transporter 3 Inhibitors; Organic Anion Transporting Polypeptide 1B1 Inhibitors; Organic Anion Transporting Polypeptide 1B3 Inhibitors; Protein Kinase Inhibitors
Established pharmacologic class	Kinase Inhibitor

Mechanism of action (MoA)

Breast Cancer Resistance Protein Inhibitors; Cytochrome P450 2B6 Inducers; Cytochrome P450 2C19 Inducers; Cytochrome P450 2C8 Inducers; Cytochrome P450 2C9 Inducers; Cytochrome P450 3A4 Inducers; Organic Anion Transporter 1 Inhibitors; Organic Anion Transporter 3 Inhibitors; Organic Anion Transporting Polypeptide 1B1 Inhibitors; Organic Anion Transporting Polypeptide 1B3 Inhibitors; Protein Kinase Inhibitors

Established pharmacologic class

Kinase Inhibitor

Molecular targets (55)

Target	Gene	Action	Activity
Serine/threonine-protein kinase B-raf	BRAF	inhibitor	IC50 9.15
Receptor-interacting serine/threonine-protein kinase 3	RIPK3	unknown	IC50 8.70
Cyclin-dependent kinase 16	CDK16	unknown	Kd 7.89
Cyclin-dependent kinase 2	CDK2	unknown	Kd 7.72
Serine/threonine-protein kinase A-Raf	ARAF	unknown	IC50 7.59
LIM domain kinase 1	LIMK1	unknown	Kd 7.48
Serine/threonine-protein kinase D2	PRKD2	unknown	Kd 7.47
Cyclin-dependent kinase 17	CDK17	unknown	Kd 7.44
Serine/threonine-protein kinase Nek9	NEK9	unknown	Kd 7.28
Non-receptor tyrosine-protein kinase TNK1	TNK1	unknown	Kd 7.18
Receptor-interacting serine/threonine-protein kinase 2	RIPK2	unknown	IC50 7.11
LIM domain kinase 2	LIMK2	unknown	Kd 7.09
Nuclear receptor subfamily 1 group I member 2	NR1I2	unknown	EC50 7.06
Serine/threonine-protein kinase/endoribonuclease IRE2	ERN2	unknown	Kd 6.94
Serine/threonine-protein kinase D3	PRKD3	unknown	Kd 6.92
Cyclin-dependent kinase 4	CDK4	unknown	Kd 6.90
RAF proto-oncogene serine/threonine-protein kinase	RAF1	unknown	IC50 6.82
Mitogen-activated protein kinase kinase kinase MLT	ZAK	unknown	Kd 6.74
Serine/threonine-protein kinase ULK1	ULK1	unknown	Kd 6.73
Abelson tyrosine-protein kinase 2	ABL2	unknown	Kd 6.52

Regulatory approvals (3)

Date	Agency	Marketed as	Applicant	Orphan
2016-03-28	PMDA	—	Novartis Pharma K.K.	Yes
2013-08-26	EMA	—	Novartis Europharm Limited
2013-05-29	FDA	—	NOVARTIS PHARMS CORP	Yes

ATC classification

ATC code	Therapeutic hierarchy
`L01EC02`	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ANTINEOPLASTIC AGENTS › PROTEIN KINASE INHIBITORS › B-Raf serine-threonine kinase (BRAF) inhibitors

Pharmacogenomics

Drug-label and guideline annotations from PharmGKB and CPIC.

EMA label: BRAF · Testing Required
EMA label: HRAS, KRAS, NRAS · Actionable PGx
FDA label: G6PD · Actionable PGx
FDA label: BRAF · Testing Required
FDA label: HRAS, KRAS, NRAS · Actionable PGx
HCSC label: HRAS, KRAS, NRAS · Actionable PGx
HCSC label: BRAF · Testing Required

Reported adverse-event signals

Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.

MedDRA term	LLR
Pyrexia	3757.6
Malignant neoplasm progression	2401.4
Chills	1158.4
Metastases to central nervous system	909.5
Death	819.2
Uveitis	543.0
Visual impairment	397.9
Ejection fraction decreased	390.2
Blood creatine phosphokinase increased	277.4
Panniculitis	265.3
Rash	203.8
Skin toxicity	192.2

Chemical structure

Molecular formula	C₂₃H₂₀F₃N₅O₂S₂
Molecular weight	519.56 g/mol
CAS number	1195765-45-7
InChIKey	BFSMGDJOXZAERB-UHFFFAOYSA-N
PubChem CID	44462760

CC(C)(C)C1=NC(=C(S1)C1=NC(N)=NC=C1)C1=C(F)C(NS(=O)(=O)C2=C(F)C=CC=C2F)=CC=C1

Frequently asked questions

Answers are generated from the structured data on this page, not written by hand.

What is Dabrafenib used for?

DrugCentral lists the following indications for Dabrafenib: Malignant Melanoma with BRAF V600E Mutation and Metastatic malignant melanoma.

How does Dabrafenib work?

Dabrafenib is classified as Breast Cancer Resistance Protein Inhibitors, Cytochrome P450 2B6 Inducers and Cytochrome P450 2C19 Inducers; its molecular targets in DrugCentral include BRAF (inhibitor), RIPK3, CDK16 and CDK2.

When was Dabrafenib first approved?

Dabrafenib was first approved by the FDA in 2013.

What drug class does Dabrafenib belong to?

Dabrafenib is in the Kinase Inhibitor class.

What is the chemical formula of Dabrafenib?

Dabrafenib has the molecular formula C23H20F3N5O2S2 and a molecular weight of 519.56 g/mol.

Browse: all drugs starting with D · drug guides by category · protein targets A–Z.

Sources

DrugCentral drug card 4801 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
ChEMBL CHEMBL2028663 — compound record and bioactivity
PubChem CID 44462760 — chemical identifiers
DrugBank DB08912 — drug record
FDA UNII QGP4HA4G1B — substance identity
DailyMed: FDA labels for Dabrafenib — current prescribing information (label search)
UniProt P15056 (BRAF) — target protein
UniProt Q9Y572 (RIPK3) — target protein
UniProt Q00536 (CDK16) — target protein
UniProt P24941 (CDK2) — target protein
UniProt P10398 (ARAF) — target protein
UniProt P53667 (LIMK1) — target protein
FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral
PharmGKB / CPIC — pharmacogenomic label annotations

How this page is built: methodology · editorial policy & corrections.

For research and educational use only — not medical advice. This page is compiled automatically from public databases. It is not written or reviewed by a clinician. Do not start, stop or change any treatment based on it; consult a qualified healthcare professional. Spotted an error? See our corrections policy or email hello@molforge.ai.