THERAPY DOSSIER · th-8773f8403b72

Dabrafenib

Drug · ATP-competitive BRAF kinase inhibitor, approved 2013, ATC L01EC02, USAN stem -rafenib. Mechanism record is held on the mesylate salt CHEMBL2105729 (parent CHEMBL2028663). 192 ClinicalTrials.gov records match; 7 interventional dabrafenib trials retained, observational registry studies excluded.

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This record is classified as “NO TRAUMA TRANSLATION”. Read the indication and notes below for the specific context.

Evidence & regulatory context

Mechanism: ATP-competitive BRAF kinase inhibitor, approved 2013, ATC L01EC02, USAN stem -rafenib. Mechanism record is held on the mesylate salt CHEMBL2105729 (parent CHEMBL2028663). 192 ClinicalTrials.gov records match; 7 interventional dabrafenib trials retained, observational registry studies excluded.
Target: CHEMBL5145 (BRAF; mechanism annotated against the V600E variant, UniProt P15056)
Injury models: Spinal cord injury
Reported indication: Not recorded
First approval: 2013
Development stage: Not recorded
ChEMBL record: CHEMBL2028663 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: GSK-2118436; GSK2118436A; Tafinlar; Finlee; Dabrafenib mesylate
Note: Not recorded

Clinical trials 7

1 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT06819605 ↗Injury indicationPHASE2/PHASE3not yet recruiting

Neoadjuvant Dabrafenib and Trametinib Before Curettage/Fenestration Surgery in BRAF V600E Mutated Ameloblastoma

Ameloblastoma

Enrolment: 46 · Results not recorded

NCT03784014 ↗PHASE3completed

Molecular Profiling of Advanced Soft-tissue Sarcomas (MULTISARC), Trametinib and Dabrafenib Arm

Soft Tissue Sarcoma

Enrolment: 603 · Results not recorded

NCT07440290 ↗PHASE2/PHASE3not yet recruiting

DETERMINE Platform Trial Arm 07: Dabrafenib With Trametinib in BRAF V600 Mutation-Positive Cancers

Solid Tumour · Haematological Malignancy · Glioma · Thyroid Carcinoma

Enrolment: 30 · Results not recorded

NCT02672358 ↗PHASE2withdrawn

Dabrafenib and Trametinib in Japanese Patients With BRAF V600E Metastatic NSCLC

Non-Small-Cell Lung Cancer

Enrolment: 0 · Results not recorded

NCT04294160 ↗PHASE1terminated

Dose Escalation and Expansion Platform Study of Select Drug Combinations in Advanced BRAF V600 Colorectal Cancer

BRAF V600 Colorectal Cancer

Enrolment: 122 · Results not recorded

NCT04903119 ↗PHASE1recruiting

Nilotinib With Dabrafenib and Trametinib or Encorafenib/Binimetinib in BRAF V600 Mutant Metastatic Melanoma

Metastatic Melanoma · BRAF Gene Mutation

Enrolment: 30 · Results not recorded

NCT02873650 ↗PHASE1terminated

Pharmacokinetics of Dabrafenib in Subjects With Normal and Impaired Hepatic Function

Hepatic Impairment

Enrolment: 5 · Results not recorded

Preclinical evidence 1

1 studies reported at therapy level; 1 evidence entries itemised.

PMID 31817643 ↗2019Reported benefit

B-RAF Inhibitor Dabrafenib Attenuates RIPK3-Mediated Necroptosis and Promotes Functional Recovery after Spinal Cord Injury.

MouseSpinal cord injuryContusionC57BL/6Jfemalen = 12 per group in the locomotor cohort; other per-group n not…Oral gavage100 mg/kg in 200 microlitres of 0.5 per cent hydroxypropyl…4, 24 and 48 hours after injury

Model: Thoracic (T10) contusion spinal cord injury using a modified MASCIS impactor, 10 g rod with 1.5 mm tip dropped from 3 mm

Acute oral dabrafenib reduced RIPK3 and phospho-MLKL expression and necrotic cell numbers, preserved white matter, neurons and axons, shortened motor evoked potential latency and improved locomotor and sensory recovery versus vehicle.

Extraction: extract · Subtype source: rule · Supplied extraction confidence: 0.85. Machine-extracted fields require source verification.

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Dabrafenib