Synopsis
Synopsis
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API Suppliers
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USDMF
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CEP/COS
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JDMF
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EU WC
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KDMF
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NDC API
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VMF
0
Listed Suppliers
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EDQM
0
USP
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JP
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Others
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Europe
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Canada
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
US Medicaid
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Annual Reports
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Regulatory FDF Prices
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API
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FDF
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Weekly News Recap #Phispers
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
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)
Molecular Weight | 506.3 g/mol |
---|---|
Molecular Formula | C17H12Cl2F3N7O2S |
XLogP3 | 3 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 11 |
Rotatable Bond Count | 5 |
Exact Mass | 505.0102337 g/mol |
Monoisotopic Mass | 505.0102337 g/mol |
Topological Polar Surface Area | 164 Ų |
Heavy Atom Count | 32 |
Formal Charge | 0 |
Complexity | 695 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Details:
Ojemda (tovorafenib) is a a type II RAF inhibitor small molecule drug candidate. It is approved for the treatment of R/R pediatric low-grade glioma (pLGG) in patients 6 months of age and older.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Brand Name: Ojemda
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Foundation Medicine
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 17, 2025
Lead Product(s) : Tovorafenib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Foundation Medicine
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves FoundationOne®CDx as Companion Diagnostic for OJEMDA in Pediatric Brain Tumor
Details : Ojemda (tovorafenib) is a a type II RAF inhibitor small molecule drug candidate. It is approved for the treatment of R/R pediatric low-grade glioma (pLGG) in patients 6 months of age and older.
Product Name : Ojemda
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 17, 2025
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
Lead Product(s) : Tovorafenib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Fairmount
Deal Size : $175.0 million
Deal Type : Private Placement
Day One Announces Oversubscribed $175.0 Million Private Placement
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.
Product Name : Ojemda
Product Type : Small molecule
Upfront Cash : Undisclosed
July 30, 2024
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
Lead Product(s) : Tovorafenib
Therapeutic Area : Oncology
Highest Development Status : Discovery
Partner/Sponsor/Collaborator : Ipsen
Deal Size : $461.0 million
Deal Type : Licensing Agreement
Ipsen and Day One Announce Exclusive Ex-U.S. Licensing Agreement for Tovorafenib
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.
Product Name : Ojemda
Product Type : Small molecule
Upfront Cash : $111.0 million
July 25, 2024
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
Lead Product(s) : Tovorafenib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Viracta Therapeutics
Deal Size : $108.0 million
Deal Type : Agreement
XOMA Receives $8.1 Million Milestone for Day One Biopharmaceuticals’ Priority Voucher
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.
Product Name : Ojemda
Product Type : Small molecule
Upfront Cash : Undisclosed
June 12, 2024
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
Lead Product(s) : Tovorafenib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : $108.0 million
Deal Type : Divestment
Day One Announces Sale of Priority Review Voucher for $108 Million
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.
Product Name : Ojemda
Product Type : Small molecule
Upfront Cash : Undisclosed
May 30, 2024
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
Lead Product(s) : Tovorafenib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Onco360
Deal Size : Undisclosed
Deal Type : Partnership
BrightSpring Health Announces Onco360 was Selected as National Pharmacy Partner for OJEMDA
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.
Product Name : Ojemda
Product Type : Small molecule
Upfront Cash : Undisclosed
May 20, 2024
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
Lead Product(s) : Tovorafenib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Day One Biopharmaceuticals
Deal Size : $54.0 million
Deal Type : Agreement
XOMA Earns $9 Million Milestone As FDA Approves OJEMDATM for pLGG
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.
Product Name : Ojemda
Product Type : Small molecule
Upfront Cash : Undisclosed
April 25, 2024
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
Lead Product(s) : Tovorafenib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Day One’s OJEMDA Receives FDA Accelerated Approval for Pediatric Glioma
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.
Product Name : Ojemda
Product Type : Small molecule
Upfront Cash : Not Applicable
April 23, 2024
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
Lead Product(s) : Tovorafenib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Day One Biopharmaceuticals
Deal Size : $59.0 million
Deal Type : Agreement
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...
Product Name : DAY101
Product Type : Small molecule
Upfront Cash : Undisclosed
October 31, 2023
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
Lead Product(s) : Tovorafenib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Product Name : DAY101
Product Type : Small molecule
Upfront Cash : Not Applicable
October 30, 2023
CAS Number : 91-00-9
End Use API : Tovorafenib
About The Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pil...
5-acetylthiophene-2-carboxylic acid
CAS Number : 4066-41-5
End Use API : Tovorafenib
About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...
Brand Name : OJEMDA
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Approval Date : 2024-04-23
Application Number : 217700
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Portfolio PDF
Product Web Link
Virtual Booth
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Corporate PDF
Brand Name : OJEMDA
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 25MG/ML
Approval Date : 2024-04-23
Application Number : 218033
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Patents & EXCLUSIVITIES
Patent Expiration Date : 2035-06-23
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Patent Expiration Date : 2031-08-04
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Patent Expiration Date : 2031-08-04
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Patent Expiration Date : 2035-06-23
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Exclusivity Code : ODE-478
Exclusivity Expiration Date : 2031-04-23
Application Number : 217700
Product Number : 1
Exclusivity Details :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Exclusivity Code : NCE
Exclusivity Expiration Date : 2029-04-23
Application Number : 217700
Product Number : 1
Exclusivity Details :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Exclusivity Code : ODE-478
Exclusivity Expiration Date : 2031-04-23
Application Number : 218033
Product Number : 1
Exclusivity Details :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Exclusivity Code : NCE
Exclusivity Expiration Date : 2029-04-23
Application Number : 218033
Product Number : 1
Exclusivity Details :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ABOUT THIS PAGE
12
PharmaCompass offers a list of Tovorafenib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Tovorafenib manufacturer or Tovorafenib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tovorafenib manufacturer or Tovorafenib supplier.
PharmaCompass also assists you with knowing the Tovorafenib API Price utilized in the formulation of products. Tovorafenib API Price is not always fixed or binding as the Tovorafenib Price is obtained through a variety of data sources. The Tovorafenib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tovorafenib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tovorafenib, including repackagers and relabelers. The FDA regulates Tovorafenib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tovorafenib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Tovorafenib supplier is an individual or a company that provides Tovorafenib active pharmaceutical ingredient (API) or Tovorafenib finished formulations upon request. The Tovorafenib suppliers may include Tovorafenib API manufacturers, exporters, distributors and traders.
Tovorafenib Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Tovorafenib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Tovorafenib GMP manufacturer or Tovorafenib GMP API supplier for your needs.
A Tovorafenib CoA (Certificate of Analysis) is a formal document that attests to Tovorafenib's compliance with Tovorafenib specifications and serves as a tool for batch-level quality control.
Tovorafenib CoA mostly includes findings from lab analyses of a specific batch. For each Tovorafenib CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Tovorafenib may be tested according to a variety of international standards, such as European Pharmacopoeia (Tovorafenib EP), Tovorafenib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tovorafenib USP).