TAFINLAR

Peak

dabrafenib

NDAORALCAPSULE
Approved
May 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
46

Mechanism of Action

50 values of 0.65, 0.5, and 1.84 nM for BRAF V600E, BRAF V600K, and BRAF V600D enzymes, respectively. Dabrafenib also inhibits wild-type BRAF and CRAF kinases with IC 50 values of 3.2 and 5.0 nM, respectively, and other kinases, such as SIK1, NEK11, and LIMK1 at higher concentrations. Some…

Clinical Trials (5)

NCT07440290Phase 2/3Not Yet Recruiting

DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage/Young Adult Patients With BRAF V600 Mutation-Positive Cancers.

Started Feb 2026
30 enrolled
Haematological MalignancyMalignant NeoplasmLymphoproliferative Disorders+16 more
NCT06262919N/ARecruiting

Special Drug Use-results Surveillance of Tafinlar/Mekinist

Started Feb 2024
110 enrolled
BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor
NCT05868629N/ARecruiting

Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors

Started Feb 2024
40 enrolled
Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors
NCT06079333Phase 2Recruiting

NEO- and Adjuvant Targeted Therapy in Braf-mutated Anaplastic Cancer of the Thyroid (NEO-ATACT Study)

Started Jan 2023
20 enrolled
Anaplastic Thyroid Cancer
NCT06557291N/ACompleted

Relapse-Free Survival With Adjuvant Dabrafenib/Trametinib Therapy in Patients With BRAF V600-mutated Stage III/IV Melanoma

Started Oct 2022
38 enrolled
BRAF V600 Mutated-Stage III/IV Melanoma

Loss of Exclusivity

LOE Date
Feb 28, 2034
97 months away
Patent Expiry
Feb 28, 2034
Exclusivity Expiry
Sep 16, 2030

Patent Records (5)

Patent #ExpiryTypeUse Code
9233956
May 4, 2029
U-2032
9233956*PED
Nov 4, 2029
7994185
Jan 20, 2030
SubstanceProduct
U-2031
8415345
Jan 20, 2030
SubstanceProduct
U-2296
7994185*PED
Jul 20, 2030