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GSK2118436
GSK2118436 is a BRAF inhibitor Small molecule drug developed by M.D. Anderson Cancer Center. It is currently in Phase 3 development for Metastatic melanoma with BRAF V600E mutation, Unresectable melanoma with BRAF V600E mutation. Also known as: Dabrafenib.
GSK2118436 is a BRAF V600E inhibitor that blocks mutant BRAF kinase signaling in melanoma cells.
GSK2118436 is a BRAF V600E inhibitor that blocks mutant BRAF kinase signaling in melanoma cells. Used for Metastatic melanoma with BRAF V600E mutation, Unresectable melanoma with BRAF V600E mutation.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | GSK2118436 |
|---|---|
| Also known as | Dabrafenib |
| Sponsor | M.D. Anderson Cancer Center |
| Drug class | BRAF inhibitor |
| Target | BRAF V600E |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
GSK2118436 (dabrafenib) selectively inhibits BRAF kinase with high potency against the V600E mutation commonly found in melanoma. By blocking this oncogenic driver mutation, the drug suppresses the MAPK/ERK pathway that promotes melanoma cell proliferation and survival. This targeted approach is particularly effective in BRAF V600E-mutant melanomas.
Approved indications
- Metastatic melanoma with BRAF V600E mutation
- Unresectable melanoma with BRAF V600E mutation
Common side effects
- Hyperkeratosis
- Palmar-plantar erythrodysesthesia
- Pyrexia
- Fatigue
- Headache
- Secondary malignancies
Key clinical trials
- Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma (PHASE1, PHASE2)
- Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial (PHASE1)
- Testing Two Different Treatment Schedules of Dabrafenib and Trametinib for Skin Cancer Which Has Spread (PHASE2)
- Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma (PHASE2)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (PHASE2)
- Testing the Addition of the Anti-cancer Drug, Tazemetostat, to the Usual Treatment (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment (PHASE1, PHASE2)
- Testing Trametinib and Dabrafenib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes (MATCH-Subprotocol H) (PHASE2)
- Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- GSK2118436 CI brief — competitive landscape report
- GSK2118436 updates RSS · CI watch RSS
- M.D. Anderson Cancer Center portfolio CI
Frequently asked questions about GSK2118436
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Related
- Drug class: All BRAF inhibitor drugs
- Target: All drugs targeting BRAF V600E
- Manufacturer: M.D. Anderson Cancer Center — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic melanoma with BRAF V600E mutation
- Indication: Drugs for Unresectable melanoma with BRAF V600E mutation
- Also known as: Dabrafenib
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing