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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Novartis Pharmaceuticals
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
Trade Name
FDA
EMA
Tafinlar
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tafinlar | New Drug Application | 2020-07-02 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| melanoma | — | D008545 | — |
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
No data
Clinical
Clinical Trials
134 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 | 24 | 35 | 6 | 1 | 13 | 69 | ||
| Neoplasms | D009369 | C80 | 16 | 12 | 1 | 1 | 1 | 28 | |
| Non-small-cell lung carcinoma | D002289 | — | 2 | — | 1 | — | 3 | ||
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | — | 1 | — | 3 | |
| Astrocytoma | D001254 | EFO_0000271 | — | 2 | — | 1 | — | 3 | |
| Neurofibromatosis 1 | D009456 | Q85.01 | 1 | 1 | — | 1 | — | 2 | |
| Oligodendroglioma | D009837 | EFO_0000631 | — | 1 | — | 1 | — | 2 | |
| Ganglioneuroma | D005729 | — | 1 | — | 1 | — | 2 | ||
| Ganglioglioma | D018303 | — | 1 | — | 1 | — | 2 | ||
| Multiple hamartoma syndrome | D006223 | E71.440 | — | 1 | — | 1 | — | 2 |
Show 2 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thyroid neoplasms | D013964 | EFO_0003841 | 1 | 7 | 1 | — | — | 9 | |
| Sarcoma | D012509 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | C90.0 | 2 | 2 | — | — | — | 4 | |
| Anaplastic thyroid carcinoma | D065646 | 1 | 3 | — | — | — | 4 | ||
| Papillary thyroid cancer | D000077273 | — | 2 | — | — | 1 | 3 | ||
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | 2 | — | — | — | 3 |
| Prostatic neoplasms | D011471 | C61 | 1 | 1 | — | — | — | 2 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 1 | — | — | — | 2 |
| Colorectal neoplasms | D015179 | — | 2 | — | — | — | 2 | ||
| Lymphoma | D008223 | C85.9 | — | 2 | — | — | — | 2 | |
| Glioma | D005910 | EFO_0000520 | — | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | HP_0000083 | N19 | 2 | — | — | — | — | 2 |
| Myelodysplastic syndromes | D009190 | D46 | 1 | — | — | — | — | 1 | |
| Myeloid leukemia acute | D015470 | C92.0 | 1 | — | — | — | — | 1 | |
| Hematologic neoplasms | D019337 | 1 | — | — | — | — | 1 | ||
| Castration-resistant prostatic neoplasms | D064129 | 1 | — | — | — | — | 1 | ||
| Non-hodgkin lymphoma | D008228 | C85.9 | 1 | — | — | — | — | 1 | |
| Primary myelofibrosis | D055728 | D47.4 | 1 | — | — | — | — | 1 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | — | — | — | — | 1 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 1 | — | — | — | — | 1 | |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 1 | — | — | — | — | 1 |
Show 8 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Small cell lung carcinoma | D055752 | — | — | — | — | 1 | 1 |
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 | 4XV2 |
| CAS-ID | 1195765-45-7 |
| RxCUI | 1424911 |
| 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
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,562 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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10,694 adverse events reported
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