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1. 1195768-06-9
2. Dabrafenib (mesylate)
3. Gsk 2118436b
4. Dabrafenib Mesilate
5. Dabrafenib Mesylate [usan]
6. Unii-b6dc89i63e
7. Gsk-2118436 Mesylate
8. Gsk-2118436b
9. Methane Sulfonate Salt
10. Gsk2118436b
11. Gsk2118436 Mesylate
12. B6dc89i63e
13. Chebi:75048
14. Gsk-2118436b Mesylate
15. N-(3-(5-(2-aminopyrimidin-4-yl)-2-(tert-butyl)thiazol-4-yl)-2-fluorophenyl)-2,6-difluorobenzenesulfonamide Methanesulfonate
16. Gsk2118436b, Methane Sulfonate Salt
17. Gsk-2118436 Methanesulfonate Salt
18. Gsk-2118436b Methanesulfonate Salt
19. Gsk2118436 Mesylate;gsk 2118436b
20. Dabrafenib Mesilate (jan)
21. Dabrafenib Mesylate (gsk-2118436)
22. Dabrafenib Mesylate (usan)
23. Dabrafenib Mesilate [jan]
24. Taflinar
25. N-[3-[5-(2-aminopyrimidin-4-yl)-2-tert-butyl-1,3-thiazol-4-yl]-2-fluorophenyl]-2,6-difluorobenzenesulfonamide;methanesulfonic Acid
26. Dabrafenib Methanesulfonate
27. Tafinlar (tn)
28. Gsk2118436 Methane Sulfonate Salt
29. Dabrafenib Monomesylate
30. Gsk 2118436 Mesylate
31. Schembl1127269
32. Chembl2105729
33. Dabrafenib Mesylate [mi]
34. Dtxsid70152500
35. Amy30045
36. Bcp04738
37. Ex-a1559
38. Dabrafenib Mesilate [who-dd]
39. Hy-14660a
40. Mfcd20922872
41. S5069
42. Akos025396661
43. Ccg-270246
44. Cs-1641
45. Dabrafenib Mesylate [orange Book]
46. Ac-31302
47. As-17010
48. Ft-0696677
49. D10104
50. A903491
51. Sr-01000941590
52. Sr-01000941590-1
53. Q27145089
54. Gsk2118436 Ms Salt, Dabrafenib Ms Salt, Gsk2118436a Ms Salt
55. Benzenesulfonamide, N-(3-(5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-4-thiazolyl)- 2-fluorophenyl)-2,6-difluoro-, Methanesulfonate (1:1)
56. Benzenesulfonamide, N-[3-[5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-4-thiazolyl]-2-fluorophenyl]-2,6-difluoro-, Methanesulfonate (1:1)
57. Dabrafenib Mesylaten-[3-[5-(2-aminopyrimidin-4-yl)-2-tert-butyl-1,3-thiazol-4-yl]-2-fluorophenyl]-2,6-difluorobenzenesulfonamide, Methanesulfonic Acid; Dabrafenib Mesylate
58. N-(3-(5-(2-aminopyrimidin-4-yl)-2-(1,1-dimethylethyl)thiazol-4-yl)-2-fluorophenyl)-2,6- Difluorobenzenesulfonamide Monomethanesulfonate
59. N-{3-[5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide Methanesulfonate
60. N-{3-[5-(2-aminopyrimidin-4-yl)-2-tert-butyl-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide Methanesulfonate
1. 1195765-45-7
2. Dabrafenib
Molecular Weight | 615.7 g/mol |
---|---|
Molecular Formula | C24H24F3N5O5S3 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 14 |
Rotatable Bond Count | 6 |
Exact Mass | 615.08916689 g/mol |
Monoisotopic Mass | 615.08916689 g/mol |
Topological Polar Surface Area | 210 Ų |
Heavy Atom Count | 40 |
Formal Charge | 0 |
Complexity | 910 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
* Melanoma:
Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4. 4 and 5. 1).
* Adjuvant treatment of melanoma:
Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.
* Non-small cell lung cancer (NSCLC):
Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.
Treatment of melanoma, Treatment of solid malignant tumours (excluding melanoma)
L01EC02
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm : MIs. MSN Laboratories Private Limited, Unit-II, sv. No, 50, Kardanur (Village), ...
NDC Package Code : 54893-0052
Start Marketing Date : 2016-10-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 50384-6600
Start Marketing Date : 2023-07-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
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Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
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API Imports and Exports
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Details:
Tafinlar is a combination of dabrafenib mesylate and trametinib that targets two different kinases in the RAS/RAF/MEK/ERK pathway. This combination resulted in greater growth inhibition of BRAF V600 mutation-positive tumor cell lines.
Lead Product(s): Dabrafenib Mesylate,Trametinib
Therapeutic Area: Oncology Brand Name: Tafinlar
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2023
Lead Product(s) : Dabrafenib Mesylate,Trametinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Tafinlar is a combination of dabrafenib mesylate and trametinib that targets two different kinases in the RAS/RAF/MEK/ERK pathway. This combination resulted in greater growth inhibition of BRAF V600 mutation-positive tumor cell lines.
Brand Name : Tafinlar
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 16, 2023
Details:
JSI-1187 is a selective and orally administered small molecule inhibitor of ERK1 and ERK2. In preclinical studies, JSI-1187 demonstrated high potency against a variety of tumors with MAPK pathway mutations.
Lead Product(s): JSI-1187,Dabrafenib Mesylate
Therapeutic Area: Oncology Brand Name: JSI-1187
Study Phase: Phase IProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 03, 2023
Lead Product(s) : JSI-1187,Dabrafenib Mesylate
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : JSI-1187 is a selective and orally administered small molecule inhibitor of ERK1 and ERK2. In preclinical studies, JSI-1187 demonstrated high potency against a variety of tumors with MAPK pathway mutations.
Brand Name : JSI-1187
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 03, 2023
Details:
E6201 is an ATP-competitive MEK1 inhibitor that has demonstrated preclinical activity in BRAF V600-mutant melanoma cell lines. E6201 has shown excellent brain distribution characteristics and minimal CNS efflux by transporters at the BBB.
Lead Product(s): E6201,Dabrafenib Mesylate
Therapeutic Area: Oncology Brand Name: E6201
Study Phase: Phase IProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2022
Lead Product(s) : E6201,Dabrafenib Mesylate
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : E6201 is an ATP-competitive MEK1 inhibitor that has demonstrated preclinical activity in BRAF V600-mutant melanoma cell lines. E6201 has shown excellent brain distribution characteristics and minimal CNS efflux by transporters at the BBB.
Brand Name : E6201
Molecule Type : Large molecule
Upfront Cash : Not Applicable
November 30, 2022
Details:
FDA approval was based on clinical efficacy and safety demonstrated in three clinical trials. In Phase II ROAR basket study and NCI-MATCH Subprotocol H study, Tafinlar (dabrafenib mesylate) + Mekinist resulted in overall response rates of up to 80% in patients with BRAF V600E.
Lead Product(s): Dabrafenib Mesylate,Trametinib
Therapeutic Area: Oncology Brand Name: Tafinlar
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 23, 2022
Lead Product(s) : Dabrafenib Mesylate,Trametinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : FDA approval was based on clinical efficacy and safety demonstrated in three clinical trials. In Phase II ROAR basket study and NCI-MATCH Subprotocol H study, Tafinlar (dabrafenib mesylate) + Mekinist resulted in overall response rates of up to 80% in pa...
Brand Name : Tafinlar
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 23, 2022
Details:
Treatment with targeted therapies Tafinlar (dabrafenib)+ Mekinist resulted in 47% ORR versus chemotherapy and reduced risk of progression or death by 69%, showing significant efficacy improvement in patients with BRAF V600 LGG requiring first systemic treatment.
Lead Product(s): Dabrafenib Mesylate,Trametinib
Therapeutic Area: Oncology Brand Name: Tafinlar
Study Phase: Phase II/ Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2022
Lead Product(s) : Dabrafenib Mesylate,Trametinib
Therapeutic Area : Oncology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Novartis Tafinlar® (Dabrafenib) + Mekinist® (Trametinib) Demonstrates Unprecedented Efficacy in ...
Details : Treatment with targeted therapies Tafinlar (dabrafenib)+ Mekinist resulted in 47% ORR versus chemotherapy and reduced risk of progression or death by 69%, showing significant efficacy improvement in patients with BRAF V600 LGG requiring first systemic tr...
Brand Name : Tafinlar
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 06, 2022
Details:
In a paper published by Science Advances, Creighton scientists and students involved in the research found that dabrafenib can be repurposed to prevent cisplatin- and noise-induced hearing loss in mice.
Lead Product(s): Dabrafenib Mesylate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 05, 2021
Lead Product(s) : Dabrafenib Mesylate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Study identifies Repurposed Drug with Potential to Protect Hearing
Details : In a paper published by Science Advances, Creighton scientists and students involved in the research found that dabrafenib can be repurposed to prevent cisplatin- and noise-induced hearing loss in mice.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 05, 2021
Details:
Tafinlar (dabrafenib) and Mekinist (trametinib) are approved in combination to treat people with a type of skin cancer called melanoma, non-small cell lung cancer and anaplastic thyroid cancer.
Lead Product(s): Dabrafenib Mesylate,Trametinib
Therapeutic Area: Oncology Brand Name: Tafinlar
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2020
Lead Product(s) : Dabrafenib Mesylate,Trametinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Tafinlar (dabrafenib) and Mekinist (trametinib) are approved in combination to treat people with a type of skin cancer called melanoma, non-small cell lung cancer and anaplastic thyroid cancer.
Brand Name : Tafinlar
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 29, 2020
Details:
PDR001 (spartalizumab) is an investigational monoclonal antibody directed against the human programmed death-1 (PD-1) receptor. Its development program continues, and investigating the immunotherapy across a range of tumor types.
Lead Product(s): Spartalizumab,Dabrafenib Mesylate,Trametinib
Therapeutic Area: Oncology Brand Name: PDR001
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2020
Lead Product(s) : Spartalizumab,Dabrafenib Mesylate,Trametinib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : PDR001 (spartalizumab) is an investigational monoclonal antibody directed against the human programmed death-1 (PD-1) receptor. Its development program continues, and investigating the immunotherapy across a range of tumor types.
Brand Name : PDR001
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 19, 2020
Details:
Phase III COMBI-i trial did not meet primary endpoint for patients with advanced BRAF V600-mutated melanoma.
Lead Product(s): Spartalizumab,Dabrafenib Mesylate,Trametinib
Therapeutic Area: Oncology Brand Name: PDR001
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 22, 2020
Lead Product(s) : Spartalizumab,Dabrafenib Mesylate,Trametinib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Phase III COMBI-i trial did not meet primary endpoint for patients with advanced BRAF V600-mutated melanoma.
Brand Name : PDR001
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 22, 2020
Details:
In a Phase II trial a combination targeted therapy achieved a 51% overall response rate in patients with cholangiocarcinoma and BRAF V600E mutations. This is the first prospective study for this group of patients.
Lead Product(s): Dabrafenib Mesylate,Trametinib
Therapeutic Area: Oncology Brand Name: MEDI4736
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2020
Lead Product(s) : Dabrafenib Mesylate,Trametinib
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : In a Phase II trial a combination targeted therapy achieved a 51% overall response rate in patients with cholangiocarcinoma and BRAF V600E mutations. This is the first prospective study for this group of patients.
Brand Name : MEDI4736
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 17, 2020
RLD : Yes
TE Code :
Brand Name : TAFINLAR
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 50MG BASE
Approval Date : 2013-05-29
Application Number : 202806
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : TAFINLAR
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 75MG BASE
Approval Date : 2013-05-29
Application Number : 202806
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : TAFINLAR
Dosage Form : TABLET, FOR SUSPENSION;ORAL
Dosage Strength : EQ 10MG BASE
Approval Date : 2023-03-16
Application Number : 217514
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD :
TE Code :
Brand Name : TAFINLAR
Dosage Form : CAPSULE;ORAL
Dosage Strength : 75MG
Approval Date :
Application Number : 217514
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : TAFINLAR
Dosage Form : TABLET; ORAL SUSPENSION
Dosage Strength : 10MG
Approval Date :
Application Number : 217514
RX/OTC/DISCN :
RLD :
TE Code :
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