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Also known as: 1195768-06-9, Dabrafenib (mesylate), Gsk 2118436b, Dabrafenib mesilate, Dabrafenib mesylate [usan], Unii-b6dc89i63e
Molecular Formula
C24H24F3N5O5S3
Molecular Weight
615.7  g/mol
InChI Key
YKGMKSIHIVVYKY-UHFFFAOYSA-N
FDA UNII
B6DC89I63E

Dabrafenib Mesylate
Dabrafenib Mesylate is the mesylate salt form of dabrafenib, an orally bioavailable inhibitor of B-raf (BRAF) protein with potential antineoplastic activity. Dabrafenib selectively binds to and inhibits the activity of B-raf, which may inhibit the proliferation of tumor cells which contain a mutated BRAF gene. B-raf belongs to the raf/mil family of serine/threonine protein kinases and plays a role in regulating the MAP kinase/ERKs signaling pathway, which may be constitutively activated due to BRAF gene mutations.
1 2D Structure

Dabrafenib Mesylate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-[3-[5-(2-aminopyrimidin-4-yl)-2-tert-butyl-1,3-thiazol-4-yl]-2-fluorophenyl]-2,6-difluorobenzenesulfonamide;methanesulfonic acid
2.1.2 InChI
InChI=1S/C23H20F3N5O2S2.CH4O3S/c1-23(2,3)21-30-18(19(34-21)16-10-11-28-22(27)29-16)12-6-4-9-15(17(12)26)31-35(32,33)20-13(24)7-5-8-14(20)25;1-5(2,3)4/h4-11,31H,1-3H3,(H2,27,28,29);1H3,(H,2,3,4)
2.1.3 InChI Key
YKGMKSIHIVVYKY-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC(C)(C)C1=NC(=C(S1)C2=NC(=NC=C2)N)C3=C(C(=CC=C3)NS(=O)(=O)C4=C(C=CC=C4F)F)F.CS(=O)(=O)O
2.2 Other Identifiers
2.2.1 UNII
B6DC89I63E
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

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

2.3.2 Other Synonyms

1. 1195765-45-7

2. Dabrafenib

2.4 Create Date
2009-12-22
3 Chemical and Physical Properties
Molecular Weight 615.7 g/mol
Molecular Formula C24H24F3N5O5S3
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count14
Rotatable Bond Count6
Exact Mass615.08916689 g/mol
Monoisotopic Mass615.08916689 g/mol
Topological Polar Surface Area210 Ų
Heavy Atom Count40
Formal Charge0
Complexity910
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

* 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)


5 Pharmacology and Biochemistry
5.1 ATC Code

L01EC02


API SUPPLIERS

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Pharma Manufacturing 2024
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Dabrafenib Mesylate IHS

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), ...

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DABRAFENIB MESYLATE

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

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DABRAFENIB MESYLATE

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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Fermion Oy

Finland
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Dabrafenib

About the Company : Fermion is fully owned subsidiary of Orion Corporation & headquartered in Espoo, Finland. Together with Orion we are a fully integrated CDMO & offer services covering both APIs & F...

Fermion is fully owned subsidiary of Orion Corporation & headquartered in Espoo, Finland. Together with Orion we are a fully integrated CDMO & offer services covering both APIs & Formulations. API portfolio consists of >30 generic APIs & >10 NCEs & 2 mfg. sites as well as R&D facilities are all located in Finland. Fermion has invested & expanded capabilities in the production of HPAPIs. Drug product CMO services include hormonal & non-hormonal semi-solids, cytotoxic oral solids & packaging. We have 3 mfg. sites & one packaging center for drug products at Orion.
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Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

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Dabrafenib

About the Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include c...

Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include customized R&D as well as the production of small molecule pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs) for both international and domestic pharmaceutical firms. Our capabilities span from laboratory-scale kilograms to commercial ton-scale production. Additionally, we are committed to independent research and development, as well as the production and sales of high-end pharmaceutical intermediates and API products.
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Virtual BoothSichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..

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Dabrafenib Mesylate

About the Company : Specializing in natural & oncology APIs, we establish R&D and production platforms for new salt, crystal form & synthetic biology research. We cooperate with clients for IND, NDA, ...

Specializing in natural & oncology APIs, we establish R&D and production platforms for new salt, crystal form & synthetic biology research. We cooperate with clients for IND, NDA, ANDA, 505b(2) and P-IV challenges. Exploring macromolecular APIs, we focus on Glycans & polypeptides. Expertise in XDC drugs drives innovative research & payload production. With a global registration platform & international cGMP system, we offer API CMO/CDMO services worldwide. Our strategy combines FDF and APIs. Our labs meet GMP standards with a stable R&D team, over 10 years of experience, we've delivered 20+ successful projects.
Sichuan Elixir Pharmaceuticals

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Dabrafenib Mesylate

About the Company : Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutica...

Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutical products, pharmaceutical substances and Intermediates.
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Dabrafenib Mesylate

About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...

Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine chemicals and fundamental chemical materials. It has an efficient research and development team. Beijing Mesochem provides its customers customized development, craft optimization, contract customization and outsourcing services. The company has a well-established industrial base in Weinan, Shanxi Province. The production base features a 20,000 ㎡ plant with a production capacity of over 8,000 MT per year.
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Dabrafenib Mesylate

About the Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceutical ingredients an...

Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceutical ingredients and intermediates. We are specialized in applying organic catalysts into the process development to lower cost, and to provide cost-effective product and service to customers. With our strong R&D capability and our proprietary organic catalysts, we provide low cost and high quality active pharmaceutical ingredients and intermediates to pharmaceutical companies. We also provide world standard process development, custom synthesis and manufacturing service.
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dabrafenib

About the Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and chemical products, cat...

Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and chemical products, catering to both export and import markets. The company consists of two primary business departments: the Professional Sourcing/Product Team and the Quality Team. Backed by experienced partners, Longshine has evolved into a trustworthy supplier of high-quality products and received ISO9001:2008 certification in 2017.
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Dabrafenib Mesylate

About the Company : Parsian Pharmaceutical is dedicated to improving health outcomes by offering high-quality, effective pharmaceutical products. With a strong commitment to research, innovation, and ...

Parsian Pharmaceutical is dedicated to improving health outcomes by offering high-quality, effective pharmaceutical products. With a strong commitment to research, innovation, and quality, Parsian Pharmaceutical develops and manufactures a broad range of medications designed to meet international standards and address diverse therapeutic needs. Serving both local and global markets, Parsian Pharmaceutical strives to be a trusted healthcare partner, providing reliable, accessible solutions that enhance patient care and contribute to a healthier society.
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Dabrafenib Mesylate

About the Company : Hope Chem is dedicated to manufacturing, marketing, and CMO service of Active Pharmaceutical Ingredients (APIs), Intermediates, and Specialty Chemicals since the year 2010. Current...

Hope Chem is dedicated to manufacturing, marketing, and CMO service of Active Pharmaceutical Ingredients (APIs), Intermediates, and Specialty Chemicals since the year 2010. Currently, they have exclusive partnerships with multiple, state-of-the-art and GMP-compliant manufacturers in China and abroad to service our esteemed partners for competitive, long-term & stable supplies. The main products are APIs and intermediates of antiviral drug substances and anti-inflammatory, analgesic, and non-steroidal pharmaceuticals.
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Dabrafenib Mesylate

About the Company : Haorui, established in 1997, is a manufacturer and supplier of APIs, intermediates, veterinary and food additives. Meanwhile, it is assisting global pharmaceutical companies to get...

Haorui, established in 1997, is a manufacturer and supplier of APIs, intermediates, veterinary and food additives. Meanwhile, it is assisting global pharmaceutical companies to get the domestic registration of their finished dosage for their international expansion. Our USFDA approved products Flumazenil, Granisetron HCl, Granisetron Base, Docetaxel Anhydrous, Irinotecan HCl, Dasatinib Monohydrate, Oxaliplatin and Temozolomide have been recognized by our customers globally. In addition, our Amisulpride API acquired CEP, UK GMP & USDMF.
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05-Dec-2023
15-Dec-2023
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Drugs in Development

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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

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01

Pharmtech & Ingredients
Not Confirmed
Pharmtech & Ingredients
Not Confirmed

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

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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

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02

JS InnoPharm

China
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Pharmtech & Ingredients
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JS InnoPharm

China
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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

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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

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Pharmtech & Ingredients
Not Confirmed
Pharmtech & Ingredients
Not Confirmed

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

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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

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04

Pharmtech & Ingredients
Not Confirmed
Pharmtech & Ingredients
Not Confirmed

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

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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

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05

Pharmtech & Ingredients
Not Confirmed
Pharmtech & Ingredients
Not Confirmed

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

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  • Development Update

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

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Creighton University School of Medicine

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Creighton University School of Medicine

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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

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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

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07

Pharmtech & Ingredients
Not Confirmed
Pharmtech & Ingredients
Not Confirmed

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

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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

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08

Pharmtech & Ingredients
Not Confirmed
Pharmtech & Ingredients
Not Confirmed

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

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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

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09

Pharmtech & Ingredients
Not Confirmed
Pharmtech & Ingredients
Not Confirmed

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

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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

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10

Pharmtech & Ingredients
Not Confirmed
Pharmtech & Ingredients
Not Confirmed

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

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FDA Orange Book

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01

NOVARTIS

Switzerland
Pharmtech & Ingredients
Not Confirmed
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NOVARTIS

Switzerland
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Pharmtech & Ingredients
Not Confirmed

DABRAFENIB MESYLATE

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 :

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02

NOVARTIS

Switzerland
Pharmtech & Ingredients
Not Confirmed
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NOVARTIS

Switzerland
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Pharmtech & Ingredients
Not Confirmed

DABRAFENIB MESYLATE

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 :

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03

NOVARTIS

Switzerland
Pharmtech & Ingredients
Not Confirmed
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NOVARTIS

Switzerland
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Pharmtech & Ingredients
Not Confirmed

DABRAFENIB MESYLATE

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 :

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04

NOVARTIS

Switzerland
Pharmtech & Ingredients
Not Confirmed
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NOVARTIS

Switzerland
arrow
Pharmtech & Ingredients
Not Confirmed

DABRAFENIB MESYLATE

Brand Name : TAFINLAR

Dosage Form : CAPSULE;ORAL

Dosage Strength : 75MG

Approval Date :

Application Number : 217514

RX/OTC/DISCN :

RLD :

TE Code :

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05

NOVARTIS

Switzerland
Pharmtech & Ingredients
Not Confirmed
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NOVARTIS

Switzerland
arrow
Pharmtech & Ingredients
Not Confirmed

DABRAFENIB MESYLATE

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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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CAPSULE;ORAL - EQ 50MG BASE

USFDA APPLICATION NUMBER - 202806

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DOSAGE - CAPSULE;ORAL - EQ 75MG BASE

USFDA APPLICATION NUMBER - 202806

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