Tafinlar(dabrafenib)
Tafinlar (dabrafenib) is a small molecule pharmaceutical. Dabrafenib was first approved as Tafinlar on 2013-05-29. It is used to treat melanoma in the USA. It has been approved in Europe to treat melanoma. The pharmaceutical is active against serine/threonine-protein kinase B-raf.
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Commercial
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FDA
EMA
Tafinlar
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tafinlar | New Drug Application | 2025-04-07 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DABRAFENIB MESYLATE, TAFINLAR, NOVARTIS | |||
| 2030-03-16 | ODE-428 | ||
| 2026-03-16 | I-908, NP | ||
| 2025-12-22 | PED | ||
| 2025-11-04 | PED | ||
| 2025-10-30 | PED | ||
| 2025-06-22 | I-894 | ||
| 2025-05-04 | ODE-183 | ||
| 2025-04-30 | ODE-182 | ||
| 2024-12-22 | PED | ||
| 2024-06-22 | ODE-147 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Dabrafenib Mesylate, Tafinlar, Novartis | |||
| 11504333 | 2038-06-29 | DP | |
| 10869869 | 2033-08-30 | U-3185 | |
| 8703781 | 2030-10-15 | DS, DP | U-1713, U-2032, U-2296, U-2298, U-3565 |
| 8952018 | 2030-10-15 | U-2027 | |
| 7994185 | 2030-01-20 | DS, DP | U-1406, U-2031, U-2032, U-2296 |
| 8415345 | 2030-01-20 | DS, DP | U-1406, U-2031, U-2032, U-2296 |
| 9233956 | 2029-05-04 | U-1811, U-2031, U-2032, U-2296 | |
| 8835443 | 2025-06-10 | U-2026, U-2027, U-2296, U-2298, U-3565 | |
HCPCS
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Clinical
Clinical Trials
184 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Melanoma | D008545 | — | — | 30 | 46 | 8 | 1 | 23 | 95 |
| Neoplasms | D009369 | — | C80 | 20 | 24 | 2 | 1 | 2 | 44 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | 1 | 12 | 2 | 2 | 1 | 18 |
| Thyroid diseases | D013959 | — | E00-E07 | — | 10 | — | 2 | 1 | 13 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 5 | — | 1 | 4 | 11 |
| Lung neoplasms | D008175 | — | C34.90 | — | 5 | — | 1 | 2 | 8 |
| Glioma | D005910 | EFO_0000520 | — | 2 | 5 | — | 2 | 1 | 8 |
| Glioblastoma | D005909 | EFO_0000515 | — | — | 2 | — | 1 | 2 | 5 |
| Astrocytoma | D001254 | EFO_0000271 | — | — | 2 | — | 1 | 1 | 4 |
| Ganglioglioma | D018303 | — | — | — | 2 | — | 1 | — | 3 |
Show 10 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 5 | 9 | 1 | — | — | 14 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 2 | 4 | 1 | — | 1 | 7 |
| Adamantinoma | D050398 | — | — | — | 4 | 2 | — | — | 5 |
| Ameloblastoma | D000564 | — | — | — | 3 | 2 | — | — | 4 |
| Fever | D005334 | — | R50.9 | — | 2 | 1 | — | — | 3 |
| Hyperthermia | D000084462 | — | — | — | 1 | 1 | — | — | 2 |
| Sarcoma | D012509 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | 7 | — | — | 1 | 9 |
| Cutaneous malignant melanoma | D000096142 | — | — | 4 | 5 | — | — | 1 | 8 |
| Colorectal neoplasms | D015179 | — | — | 2 | 5 | — | — | 1 | 7 |
| Anaplastic thyroid carcinoma | D065646 | — | — | 2 | 5 | — | — | — | 7 |
| Hematologic neoplasms | D019337 | — | — | 2 | 4 | — | — | — | 5 |
| Carcinoma | D002277 | — | C80.0 | — | 3 | — | — | 2 | 5 |
| Multiple myeloma | D009101 | — | C90.0 | 2 | 2 | — | — | — | 4 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | 2 | — | — | — | 3 |
| Papillary thyroid cancer | D000077273 | — | — | — | 2 | — | — | 1 | 3 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 1 | — | — | — | 2 |
Show 27 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | 1 | 2 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | — | — | — | 1 | 2 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | — | — | — | 1 | 2 |
| Renal insufficiency | D051437 | — | N19 | 2 | — | — | — | — | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | — | — | — | — | 1 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | — | — | — | — | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | — | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | — | — | — | — | 1 |
| Primary myelofibrosis | D055728 | — | D47.4 | 1 | — | — | — | — | 1 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 1 | — | — | — | — | 1 |
Show 14 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | — | — | — | — | 2 | 2 |
| Lymphoid leukemia | D007945 | — | C91 | — | — | — | — | 2 | 2 |
| Leukemia | D007938 | — | C95 | — | — | — | — | 1 | 1 |
| Myeloid leukemia | D007951 | — | C92 | — | — | — | — | 1 | 1 |
| Acute disease | D000208 | — | — | — | — | — | — | 1 | 1 |
| Small cell lung carcinoma | D055752 | — | — | — | — | — | — | 1 | 1 |
| Hereditary sensory and autonomic neuropathies | D009477 | — | — | — | — | — | — | 1 | 1 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | — | — | — | 1 | 1 |
| Eunuchism | D005058 | EFO_0007266 | E29.1 | — | — | — | — | 1 | 1 |
| Physiological sexual dysfunction | D012735 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dabrafenib |
| INN | dabrafenib |
| Description | Dabrafenib is an organofluorine compound and antineoplastic agent, used as its mesylate salt in treatment of metastatic melanoma. It has a role as an antineoplastic agent, a B-Raf inhibitor and an anticoronaviral agent. It is a sulfonamide, an organofluorine compound, a member of 1,3-thiazoles and an aminopyrimidine. |
| Classification | Small molecule |
| Drug class | rapidly accelerated fibrosarcoma (RAF) kinase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)(C)c1nc(-c2cccc(NS(=O)(=O)c3c(F)cccc3F)c2F)c(-c2ccnc(N)n2)s1 |
Identifiers
| PDB | — |
| CAS-ID | 1195765-45-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2028663 |
| ChEBI ID | 75045 |
| PubChem CID | 44462760 |
| DrugBank | DB08912 |
| UNII ID | QGP4HA4G1B (ChemIDplus, GSRS) |
Target
Agency Approved
BRAF
BRAF
Organism
Homo sapiens
Gene name
BRAF
Gene synonyms
BRAF1, RAFB1
NCBI Gene ID
Protein name
serine/threonine-protein kinase B-raf
Protein synonyms
94 kDa B-raf protein, B-Raf proto-oncogene serine/threonine-protein kinase (p94), B-Raf serine/threonine-protein, murine sarcoma viral (v-raf) oncogene homolog B1, p94, Proto-oncogene B-Raf, v-raf murine sarcoma viral oncogene homolog B, v-Raf murine sarcoma viral oncogene homolog B1
Uniprot ID
Mouse ortholog
Braf (109880)
serine/threonine-protein kinase B-raf (P28028)
Alternate
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Variants
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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19,625 adverse events reported
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