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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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USDMF

US DMFs Filed

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CEP/COS

CEP/COS Certifications

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JDMF

JDMFs Filed

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EU WC

EU WC

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KDMF

KDMF

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NDC API

NDC API

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VMF

NDC API

API REF. PRICE (USD/KG)

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MARKET PLACE

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API

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FDF

FINISHED DOSAGE FORMULATIONS

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Europe

Europe

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Canada

Canada

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Australia

Australia

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South Africa

South Africa

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DRUG PRODUCT COMPOSITIONS

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EDQM

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USP

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JP

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Others

PATENTS & EXCLUSIVITIES

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Health Canada Patents

GLOBAL SALES INFORMATION

US Medicaid

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Annual Reports

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Finished Drug Prices

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0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 1096708-71-2, Mln2480, Biib-024, Tak-580, Mln 2480, Mln-2480
Molecular Formula
C17H12Cl2F3N7O2S
Molecular Weight
506.3  g/mol
InChI Key
VWMJHAFYPMOMGF-ZCFIWIBFSA-N
FDA UNII
ZN90E4027M

Tovorafenib
Tovorafenib is an orally available inhibitor of wild-type and certain mutant forms of A-Raf, B-Raf and C-Raf protein kinases, with potential antineoplastic activity. Upon administration, tovorafenib inhibits Raf-mediated signal transduction pathways, which may lead to an inhibition of tumor cell growth. Raf protein kinases play a key role in the RAF/MEK/ERK signaling pathway, which is often deregulated in human cancers and plays a key role in tumor cell proliferation and survival.
1 2D Structure

Tovorafenib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[(1R)-1-[(6-amino-5-chloropyrimidine-4-carbonyl)amino]ethyl]-N-[5-chloro-4-(trifluoromethyl)pyridin-2-yl]-1,3-thiazole-5-carboxamide
2.1.2 InChI
InChI=1S/C17H12Cl2F3N7O2S/c1-6(28-15(31)12-11(19)13(23)27-5-26-12)16-25-4-9(32-16)14(30)29-10-2-7(17(20,21)22)8(18)3-24-10/h2-6H,1H3,(H,28,31)(H2,23,26,27)(H,24,29,30)/t6-/m1/s1
2.1.3 InChI Key
VWMJHAFYPMOMGF-ZCFIWIBFSA-N
2.1.4 Canonical SMILES
CC(C1=NC=C(S1)C(=O)NC2=NC=C(C(=C2)C(F)(F)F)Cl)NC(=O)C3=C(C(=NC=N3)N)Cl
2.1.5 Isomeric SMILES
C[C@H](C1=NC=C(S1)C(=O)NC2=NC=C(C(=C2)C(F)(F)F)Cl)NC(=O)C3=C(C(=NC=N3)N)Cl
2.2 Other Identifiers
2.2.1 UNII
ZN90E4027M
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 2-((1r)-1-((6-amino-5-chloropyrimidine-4-carbonyl)amino)ethyl)-n-(5-chloro-4-(trifluoromethyl)pyridin-2-yl)-1,3-thiazole-5-carboxamide

2. Mln 2480

3. Mln2480

4. Tak-580

2.3.2 Depositor-Supplied Synonyms

1. 1096708-71-2

2. Mln2480

3. Biib-024

4. Tak-580

5. Mln 2480

6. Mln-2480

7. Biib024

8. Tovorafenib

9. Biib 024

10. Day101

11. Tovorafenib [usan]

12. Tak-580 (mln2480)

13. Tak 580

14. Amg 2112819

15. Tak580

16. Zn90e4027m

17. 2-[(1r)-1-[(6-amino-5-chloropyrimidine-4-carbonyl)amino]ethyl]-n-[5-chloro-4-(trifluoromethyl)pyridin-2-yl]-1,3-thiazole-5-carboxamide

18. 6-amino-5-chloro-n-((1r)-1-(5-(((5-chloro-4-(trifluoromethyl)-2-pyridinyl)amino)carbonyl)-2-thiazolyl)ethyl)-4-pyrimidinecarboxamide

19. 6-amino-5-chloro-n-[(1r)-1-(5-{[5-chloro-4-(trifluoromethyl)pyridin-2-yl]carbamoyl}-1,3-thiazol-2-yl)ethyl]pyrimidine-4-carboxamide

20. 4-pyrimidinecarboxamide, 6-amino-5-chloro-n-[(1r)-1-[5-[[[5-chloro-4-(trifluoromethyl)-2-pyridinyl]amino]carbonyl]-2-thiazolyl]ethyl]-

21. Unii-zn90e4027m

22. 4-pyrimidinecarboxamide, 6-amino-5-chloro-n-((1r)-1-(5-(((5-chloro-4-(trifluoromethyl)-2-pyridinyl)amino)carbonyl)-2-thiazolyl)ethyl]-

23. 6-amino-5-chloro-n-[(1r)-1-[5-[[[5-chloro-4-(trifluoromethyl)-2-pyridinyl]amino]carbonyl]-2-thiazolyl]ethyl]-4-pyrimidinecarboxamide

24. Qop

25. Tovorafenib [inn]

26. Gtpl9977

27. Schembl4206123

28. Chembl3348923

29. Tak 580 [who-dd]

30. Day-101

31. Dtxsid70149011

32. Ex-a940

33. Chebi:167672

34. 4-pyrimidinecarboxamide, 6-amino-5-chloro-n-((1r)-1-(5-(((5-chloro-4-(trifluoromethyl)-2-pyridinyl)amino)carbonyl)-2-thiazolyl)ethyl)-

35. Bcp13797

36. Mfcd22571730

37. Nsc766906

38. Nsc800798

39. S7121

40. Who 11985

41. Zinc43202464

42. Mln 2480(biib-024)

43. Akos027323782

44. Amg2112819

45. Ccg-269746

46. Cs-0751

47. Db15266

48. Nsc-766906

49. Nsc-800798

50. Amg-2112819

51. Ncgc00346458-01

52. Ncgc00346458-02

53. Example 10da [us20090036419]

54. Hy-15246

55. P13369

56. J-690031

57. Q27295775

58. (2z,3z)-bis{amino[(2-aminophenyl)sulfanyl]methylene}succinonitrile - Ethanol (1:1)

2.4 Create Date
2009-02-23
3 Chemical and Physical Properties
Molecular Weight 506.3 g/mol
Molecular Formula C17H12Cl2F3N7O2S
XLogP33
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count11
Rotatable Bond Count5
Exact Mass505.0102337 g/mol
Monoisotopic Mass505.0102337 g/mol
Topological Polar Surface Area164 Ų
Heavy Atom Count32
Formal Charge0
Complexity695
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

API SUPPLIERS

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01

Chongqing Sintaho Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Medlab Asia & Asia Health
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  • WHO-GMP

Virtual BoothChongqing Sintaho Pharma: A trusted partner globally for chemosynthetic APIs.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Chongqing Sintaho Pharmaceutical
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Listed Suppliers

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Virtual BoothChongqing Sintaho Pharma: A trusted partner globally for chemosynthetic APIs.

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Tovorafenib

About the Company : Sintaho Pharmaceutical Co., Ltd., located in Chongqing, China, contributes to being the most dependable partner for global pharmaceutical companies. Sintaho specializes in chemosyn...

Sintaho Pharmaceutical Co., Ltd., located in Chongqing, China, contributes to being the most dependable partner for global pharmaceutical companies. Sintaho specializes in chemosynthetic APIs (application contains oncology, nervous system, and metabolic diseases and etc.,) with a product portfolio ranging from small molecule APIs, ADC compounds (linkers and payloads) to polypeptides, also provides CDMO services of cytotoxic and OEB4/5 grade APIs.
Chongqing Sintaho Pharmaceutical
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Drugs in Development

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Details:

The private placement proceeds will fund the clinical development of the late-stage product Ojemda (tovorafenib) for treating RAF-mutated Pediatric Low-Grade Glioma.


Lead Product(s): Tovorafenib

Therapeutic Area: Oncology Brand Name: Ojemda

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Fairmount

Deal Size: $175.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement July 30, 2024

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01

Cosmoprof India
Not Confirmed
Cosmoprof India
Not Confirmed

Details : The private placement proceeds will fund the clinical development of the late-stage product Ojemda (tovorafenib) for treating RAF-mutated Pediatric Low-Grade Glioma.

Brand Name : Ojemda

Molecule Type : Small molecule

Upfront Cash : Undisclosed

July 30, 2024

blank

Details:

The agreement aims to commercialize Ojemda (tovorafenib), an oral, once-weekly, type II RAF inhibitor for pediatric low grade glioma, the most common form of childhood brain cancer outside the US.


Lead Product(s): Tovorafenib

Therapeutic Area: Oncology Brand Name: Ojemda

Study Phase: DiscoveryProduct Type: Small molecule

Sponsor: Ipsen

Deal Size: $461.0 million Upfront Cash: $111.0 million

Deal Type: Licensing Agreement July 25, 2024

blank

02

Cosmoprof India
Not Confirmed
Cosmoprof India
Not Confirmed

Details : The agreement aims to commercialize Ojemda (tovorafenib), an oral, once-weekly, type II RAF inhibitor for pediatric low grade glioma, the most common form of childhood brain cancer outside the US.

Brand Name : Ojemda

Molecule Type : Small molecule

Upfront Cash : $111.0 million

July 25, 2024

blank

Details:

XOMA acquired potential milestones associated with Ojemda (tovorafenib), approved for patients 6 months age and older with relapsed or refractory pediatric low-grade glioma with BRAF V600 mutation.


Lead Product(s): Tovorafenib

Therapeutic Area: Oncology Brand Name: Ojemda

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Viracta Therapeutics

Deal Size: $108.0 million Upfront Cash: Undisclosed

Deal Type: Agreement June 12, 2024

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03

XOMA

U.S.A
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Cosmoprof India
Not Confirmed

XOMA

U.S.A
arrow
Cosmoprof India
Not Confirmed

Details : XOMA acquired potential milestones associated with Ojemda (tovorafenib), approved for patients 6 months age and older with relapsed or refractory pediatric low-grade glioma with BRAF V600 mutation.

Brand Name : Ojemda

Molecule Type : Small molecule

Upfront Cash : Undisclosed

June 12, 2024

blank

Details:

Day One sold its rare pediatric disease PRV for FDA approved Ojemda (tovorafenib). It is indicated for the treatment of relapsed/refractory BRAF-mutated glioma.


Lead Product(s): Tovorafenib

Therapeutic Area: Oncology Brand Name: Ojemda

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Undisclosed

Deal Size: $108.0 million Upfront Cash: Undisclosed

Deal Type: Divestment May 30, 2024

blank

04

Cosmoprof India
Not Confirmed
Cosmoprof India
Not Confirmed

Details : Day One sold its rare pediatric disease PRV for FDA approved Ojemda (tovorafenib). It is indicated for the treatment of relapsed/refractory BRAF-mutated glioma.

Brand Name : Ojemda

Molecule Type : Small molecule

Upfront Cash : Undisclosed

May 30, 2024

blank

Details:

Onco360 is being selected as a pharmacy partner by Day One Biopharmaceuticals for Ojemda, a cutting-edge treatment for children diagnosed with certain central nervous system tumors.


Lead Product(s): Tovorafenib

Therapeutic Area: Oncology Brand Name: Ojemda

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Onco360

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership May 20, 2024

blank

05

Cosmoprof India
Not Confirmed
Cosmoprof India
Not Confirmed

Details : Onco360 is being selected as a pharmacy partner by Day One Biopharmaceuticals for Ojemda, a cutting-edge treatment for children diagnosed with certain central nervous system tumors.

Brand Name : Ojemda

Molecule Type : Small molecule

Upfront Cash : Undisclosed

May 20, 2024

blank

Details:

XOMA acquired mid-single digit royalties related to Ojemda (tovorafenib), approved for treating patients aged 6 months and older with r/r pediatric low-grade glioma harboring BRAF V600 mutation.


Lead Product(s): Tovorafenib

Therapeutic Area: Oncology Brand Name: Ojemda

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Day One Biopharmaceuticals

Deal Size: $54.0 million Upfront Cash: Undisclosed

Deal Type: Agreement April 25, 2024

blank

06

XOMA

U.S.A
arrow
Cosmoprof India
Not Confirmed

XOMA

U.S.A
arrow
Cosmoprof India
Not Confirmed

Details : XOMA acquired mid-single digit royalties related to Ojemda (tovorafenib), approved for treating patients aged 6 months and older with r/r pediatric low-grade glioma harboring BRAF V600 mutation.

Brand Name : Ojemda

Molecule Type : Small molecule

Upfront Cash : Undisclosed

April 25, 2024

blank

Details:

Ojemda (tovorafenib), a type II RAF inhibitor, is approved for relapsed or refractory braf-altered pediatric low-grade glioma (pLGG) in patients 6 months and older.


Lead Product(s): Tovorafenib

Therapeutic Area: Oncology Brand Name: Ojemda

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 23, 2024

blank

07

Cosmoprof India
Not Confirmed
Cosmoprof India
Not Confirmed

Details : Ojemda (tovorafenib), a type II RAF inhibitor, is approved for relapsed or refractory braf-altered pediatric low-grade glioma (pLGG) in patients 6 months and older.

Brand Name : Ojemda

Molecule Type : Small molecule

Upfront Cash : Not Applicable

April 23, 2024

blank

Details:

Under the agreement, XOMA acquired potential royalty economics related to DAY101 (tovorafenib), an investigational, oral, brain-penetrant, highly-selective type II RAF kinase inhibitor, being developed as a monotherapy for relapsed or progressive pediatric low-grade glioma.


Lead Product(s): Tovorafenib

Therapeutic Area: Oncology Brand Name: DAY101

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Day One Biopharmaceuticals

Deal Size: $59.0 million Upfront Cash: Undisclosed

Deal Type: Agreement October 31, 2023

blank

08

XOMA

U.S.A
arrow
Cosmoprof India
Not Confirmed

XOMA

U.S.A
arrow
Cosmoprof India
Not Confirmed

Details : Under the agreement, XOMA acquired potential royalty economics related to DAY101 (tovorafenib), an investigational, oral, brain-penetrant, highly-selective type II RAF kinase inhibitor, being developed as a monotherapy for relapsed or progressive pediatr...

Brand Name : DAY101

Molecule Type : Small molecule

Upfront Cash : Undisclosed

October 31, 2023

blank

Details:

DAY101 (tovorafenib) is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway, which is being investigated in relapsed or progressive pediatric low-grade glioma.


Lead Product(s): Tovorafenib

Therapeutic Area: Oncology Brand Name: DAY101

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 30, 2023

blank

09

Cosmoprof India
Not Confirmed
Cosmoprof India
Not Confirmed

Details : DAY101 (tovorafenib) is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway, which is being investigated in relapsed or progressive pediatric low-grade...

Brand Name : DAY101

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 30, 2023

blank

Details:

DAY101 (tovorafenib) is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway, which is being investigated in primary brain tumors or brain metastases of solid tumors.


Lead Product(s): Tovorafenib

Therapeutic Area: Oncology Brand Name: DAY101

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 11, 2023

blank

10

Cosmoprof India
Not Confirmed
Cosmoprof India
Not Confirmed

Details : DAY101 (tovorafenib) is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway, which is being investigated in primary brain tumors or brain metastases of...

Brand Name : DAY101

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 11, 2023

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Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

US Patents

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01

DAY ONE BIOPHARMS

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Cosmoprof India
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DAY ONE BIOPHARMS

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Cosmoprof India
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TOVORAFENIB

US Patent Number : 10426782

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 217700

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-06-23

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02

DAY ONE BIOPHARMS

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Cosmoprof India
Not Confirmed

DAY ONE BIOPHARMS

Country
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Cosmoprof India
Not Confirmed

TOVORAFENIB

US Patent Number : 8293752

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 218033

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-08-04

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03

DAY ONE BIOPHARMS

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Cosmoprof India
Not Confirmed

DAY ONE BIOPHARMS

Country
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Cosmoprof India
Not Confirmed

TOVORAFENIB

US Patent Number : 8293752

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 217700

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-08-04

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04

DAY ONE BIOPHARMS

arrow
Cosmoprof India
Not Confirmed

DAY ONE BIOPHARMS

Country
arrow
Cosmoprof India
Not Confirmed

TOVORAFENIB

US Patent Number : 10426782

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 218033

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-06-23

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