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Chemistry

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Also known as: 1616632-77-9, Onc 201, Onc-201, Onc201, Nsc-350625, 9u35a31jai
Molecular Formula
C24H26N4O
Molecular Weight
386.5  g/mol
InChI Key
VLULRUCCHYVXOH-UHFFFAOYSA-N
FDA UNII
9U35A31JAI

Dordaviprone
Akt/ERK Inhibitor ONC201 is a water soluble, orally bioavailable inhibitor of the serine/threonine protein kinase Akt (protein kinase B) and extracellular signal-regulated kinase (ERK), with potential antineoplastic activity. Upon administration, Akt/ERK inhibitor ONC201 binds to and inhibits the activity of Akt and ERK, which may result in inhibition of the phosphatidylinositol 3-kinase (PI3K)/Akt signal transduction pathway as well as the mitogen-activated protein kinase (MAPK)/ERK-mediated pathway. This may lead to the induction of tumor cell apoptosis mediated by tumor necrosis factor (TNF)-related apoptosis-inducing ligand (TRAIL)/TRAIL death receptor type 5 (DR5) signaling in AKT/ERK-overexpressing tumor cells. The PI3K/Akt signaling pathway and MAPK/ERK pathway are upregulated in a variety of tumor cell types and play a key role in tumor cell proliferation, differentiation and survival by inhibiting apoptosis. In addition, ONC201 is able to cross the blood-brain barrier.
1 2D Structure

Dordaviprone

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
11-benzyl-7-[(2-methylphenyl)methyl]-2,5,7,11-tetrazatricyclo[7.4.0.02,6]trideca-1(9),5-dien-8-one
2.1.2 InChI
InChI=1S/C24H26N4O/c1-18-7-5-6-10-20(18)16-28-23(29)21-17-26(15-19-8-3-2-4-9-19)13-11-22(21)27-14-12-25-24(27)28/h2-10H,11-17H2,1H3
2.1.3 InChI Key
VLULRUCCHYVXOH-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=CC=CC=C1CN2C(=O)C3=C(CCN(C3)CC4=CC=CC=C4)N5C2=NCC5
2.2 Other Identifiers
2.2.1 UNII
9U35A31JAI
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 7-benzyl-4-(2-methylbenzyl)-1,2,6,7,8,9-hexahydroimidazo(1,2-a)pyrido(3,4-e)pyrimidin-5(4h)-one

2. Onc201

3. Tic10 Compound

4. Trail-inducing Compound 10

2.3.2 Depositor-Supplied Synonyms

1. 1616632-77-9

2. Onc 201

3. Onc-201

4. Onc201

5. Nsc-350625

6. 9u35a31jai

7. Mfcd28118993

8. 11-benzyl-7-[(2-methylphenyl)methyl]-2,5,7,11-tetrazatricyclo[7.4.0.02,6]trideca-1(9),5-dien-8-one

9. 1342897-86-2

10. Active Isomer 2

11. Tic10 Compound

12. 7-benzyl-4-(2-methylbenzyl)-1,2,6,7,8,9-hexahydroimidazo(1,2-a)pyrido(3,4-e)pyrimidin-5(4h)-one

13. Angular Tic10

14. Tic10 Active Isomer

15. Unii-9u35a31jai

16. Gtpl9978

17. Tic10?

18. Chembl4297310

19. Onc 201 [who-dd]

20. Schembl16227974

21. Ex-a669

22. Hms3874g13

23. Bcp14991

24. Hy-15615a

25. Nsc784931

26. S7963

27. Zinc169620396

28. Ccg-264705

29. Cs-3564

30. Db14844

31. Nsc 350625

32. Nsc-784931

33. Sb17110

34. Ncgc00386747-03

35. Ncgc00386747-06

36. Ncgc00386747-09

37. Ncgc00386747-10

38. As-16735

39. Sy242153

40. Ft-0700231

41. A883070

42. J-690224

43. Q27895916

44. 2,4,6,7,8,9-hexahydro-4-((2-methylphenyl)methyl)-7-(phenylmethyl)imidazo(1,2-a)pyrido(3,4-e)pyrimidin-5(1h)-one

45. 2,4,6,7,8,9-hexahydro-4-((2-methylphenyl)methyl)-7-phenylmethyl)imidazo)(1,2-a)pyrido(3,4-e)pyrimidin-5(1h)-one

2.4 Create Date
2014-05-26
3 Chemical and Physical Properties
Molecular Weight 386.5 g/mol
Molecular Formula C24H26N4O
XLogP32.3
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count3
Rotatable Bond Count4
Exact Mass386.21066147 g/mol
Monoisotopic Mass386.21066147 g/mol
Topological Polar Surface Area39.2 Ų
Heavy Atom Count29
Formal Charge0
Complexity693
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Antineoplastic Agents

Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)


Drugs in Development

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Details:

Through the acquisition, Jazz will strengthen it's oncology pipeline, which includes ONC201 (dordaviprone). It is being evaluated in the late-stage for the treatment of H3 K27M-mutant diffuse glioma.


Lead Product(s): Dordaviprone,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Jazz Pharmaceuticals

Deal Size: $935.0 million Upfront Cash: $935.0 million

Deal Type: Acquisition April 21, 2025

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Chimerix

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Details : Through the acquisition, Jazz will strengthen it's oncology pipeline, which includes ONC201 (dordaviprone). It is being evaluated in the late-stage for the treatment of H3 K27M-mutant diffuse glioma.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : $935.0 million

April 21, 2025

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Details:

Through the acquisition, Jazz will strengthen it's oncology pipeline, which includes ONC201 (dordaviprone). It is being in the evaluated late-stage for the treatment of H3 K27M-mutant diffuse glioma.


Lead Product(s): Dordaviprone,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Jazz Pharmaceuticals

Deal Size: $935.0 million Upfront Cash: $935.0 million

Deal Type: Acquisition March 05, 2025

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Chimerix

U.S.A
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Chimerix

U.S.A
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Details : Through the acquisition, Jazz will strengthen it's oncology pipeline, which includes ONC201 (dordaviprone). It is being in the evaluated late-stage for the treatment of H3 K27M-mutant diffuse glioma.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : $935.0 million

March 05, 2025

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Details:

ONC201 (dordaviprone) is a novel first-in-class small molecule imipridone that selectively targets the mitochondrial protease ClpP and dopamine receptor D2 for recurrent H3 K27M-Mutant diffuse glioma.


Lead Product(s): Dordaviprone,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 18, 2025

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Chimerix

U.S.A
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Chimerix

U.S.A
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Details : ONC201 (dordaviprone) is a novel first-in-class small molecule imipridone that selectively targets the mitochondrial protease ClpP and dopamine receptor D2 for recurrent H3 K27M-Mutant diffuse glioma.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 18, 2025

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Details:

ONC201 (dordaviprone) is a novel first-in-class small molecule imipridone that selectively targets the mitochondrial protease ClpP and dopamine receptor D2 for recurrent H3 K27M-Mutant diffuse glioma.


Lead Product(s): Dordaviprone,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 30, 2024

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Chimerix

U.S.A
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Chimerix

U.S.A
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Details : ONC201 (dordaviprone) is a novel first-in-class small molecule imipridone that selectively targets the mitochondrial protease ClpP and dopamine receptor D2 for recurrent H3 K27M-Mutant diffuse glioma.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 30, 2024

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Details:

ONC201 (dordaviprone) targets the targets the mitochondrial protease ClpP and dopamine receptor D2. It is being evaluated for the treatment of recurrent H3 K27M-mutant diffuse glioma.


Lead Product(s): Dordaviprone,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 09, 2024

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Chimerix

U.S.A
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Chimerix

U.S.A
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Details : ONC201 (dordaviprone) targets the targets the mitochondrial protease ClpP and dopamine receptor D2. It is being evaluated for the treatment of recurrent H3 K27M-mutant diffuse glioma.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 09, 2024

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  • Development Update

Details:

ONC201 is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Meningioma.


Lead Product(s): Dordaviprone,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Chimerix

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 28, 2023

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University of Nebraska

Country
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University of Nebraska

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Details : ONC201 is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Meningioma.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 28, 2023

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Details:

ONC201 is a new drug candidate that kills cancer cells but not normal cells in laboratory studies and has been previously evaluated in a phase I clinical trial in advanced cancer patients.


Lead Product(s): Dordaviprone,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 08, 2022

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Chimerix

U.S.A
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Chimerix

U.S.A
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Details : ONC201 is a new drug candidate that kills cancer cells but not normal cells in laboratory studies and has been previously evaluated in a phase I clinical trial in advanced cancer patients.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 08, 2022

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Details:

Dordaviprone is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Glioma.


Lead Product(s): Dordaviprone,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 14, 2022

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Chimerix

U.S.A
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Chimerix

U.S.A
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Details : Dordaviprone is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Glioma.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 14, 2022

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  • Development Update

Details:

Atezolizumab is a Antibody drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Endometrial Neoplasms.


Lead Product(s): Atezolizumab,Dordaviprone

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Antibody, Unconjugated

Sponsor: Genentech | Oncoceutics Inc | National Cancer Institute

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 15, 2022

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UNC Lineberger Comprehensive Cancer Center

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UNC Lineberger Comprehensive Cancer Center

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Lead Product(s) : Atezolizumab,Dordaviprone

Therapeutic Area : Oncology

Highest Development Status : Phase I

Partner/Sponsor/Collaborator : Genentech | Oncoceutics Inc | National Cancer Institute

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Atezolizumab is a Antibody drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Endometrial Neoplasms.

Product Name : Undisclosed

Product Type : Antibody, Unconjugated

Upfront Cash : Inapplicable

September 15, 2022

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  • Development Update

Details:

ONC201 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Diffuse Intrinsic Pontine Glioma.


Lead Product(s): Dordaviprone,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Chimerix | Innovative Therapies for Children with Cancer Consortium | Ministry of Health, France

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 27, 2022

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Gustave Roussy

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Gustave Roussy

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Lead Product(s) : Dordaviprone,Inapplicable

Therapeutic Area : Oncology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Chimerix | Innovative Therapies for Children with Cancer Consortium | Ministry of Health, France

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : ONC201 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Diffuse Intrinsic Pontine Glioma.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

July 27, 2022

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FDF Dossiers

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Chimerix

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Chimerix

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DORDAVIPRONE HYDROCHLORIDE

Brand Name : MODEYSO

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 125MG BASE

Packaging :

Approval Date : 2025-08-06

Application Number : 219876

Regulatory Info : RX

Registration Country : USA

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Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

US Patents

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CHIMERIX

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DORDAVIPRONE HYDROCHLORIDE

US Patent Number : 12102639

Drug Substance Claim :

Drug Product Claim :

Application Number : 219876

Patent Use Code : U-4254

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-01-30

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CHIMERIX

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DORDAVIPRONE HYDROCHLORIDE

US Patent Number : 10369154

Drug Substance Claim :

Drug Product Claim :

Application Number : 219876

Patent Use Code : U-4254

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-01-30

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CHIMERIX

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DORDAVIPRONE HYDROCHLORIDE

US Patent Number : 10172862

Drug Substance Claim :

Drug Product Claim :

Application Number : 219876

Patent Use Code : U-4254

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-01-30

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CHIMERIX

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DORDAVIPRONE HYDROCHLORIDE

US Patent Number : 9629842

Drug Substance Claim :

Drug Product Claim :

Application Number : 219876

Patent Use Code : U-4254

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-04-30

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CHIMERIX

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DORDAVIPRONE HYDROCHLORIDE

US Patent Number : RE46290

Drug Substance Claim :

Drug Product Claim :

Application Number : 219876

Patent Use Code : U-4254

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-04-30

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CHIMERIX

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DORDAVIPRONE HYDROCHLORIDE

US Patent Number : 11976068

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 219876

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2036-03-01

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CHIMERIX

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DORDAVIPRONE HYDROCHLORIDE

US Patent Number : 9265765

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 219876

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-07-26

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ABOUT THIS PAGE

Looking for 1342897-86-2 / Dordaviprone API manufacturers, exporters & distributors?

Dordaviprone manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Dordaviprone 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 Dordaviprone manufacturer or Dordaviprone supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dordaviprone manufacturer or Dordaviprone supplier.

PharmaCompass also assists you with knowing the Dordaviprone API Price utilized in the formulation of products. Dordaviprone API Price is not always fixed or binding as the Dordaviprone Price is obtained through a variety of data sources. The Dordaviprone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Dordaviprone

Synonyms

1616632-77-9, Onc 201, Onc-201, Onc201, Nsc-350625, 9u35a31jai

Cas Number

1342897-86-2

Unique Ingredient Identifier (UNII)

9U35A31JAI

About Dordaviprone

Akt/ERK Inhibitor ONC201 is a water soluble, orally bioavailable inhibitor of the serine/threonine protein kinase Akt (protein kinase B) and extracellular signal-regulated kinase (ERK), with potential antineoplastic activity. Upon administration, Akt/ERK inhibitor ONC201 binds to and inhibits the activity of Akt and ERK, which may result in inhibition of the phosphatidylinositol 3-kinase (PI3K)/Akt signal transduction pathway as well as the mitogen-activated protein kinase (MAPK)/ERK-mediated pathway. This may lead to the induction of tumor cell apoptosis mediated by tumor necrosis factor (TNF)-related apoptosis-inducing ligand (TRAIL)/TRAIL death receptor type 5 (DR5) signaling in AKT/ERK-overexpressing tumor cells. The PI3K/Akt signaling pathway and MAPK/ERK pathway are upregulated in a variety of tumor cell types and play a key role in tumor cell proliferation, differentiation and survival by inhibiting apoptosis. In addition, ONC201 is able to cross the blood-brain barrier.

Dordaviprone Manufacturers

A Dordaviprone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dordaviprone, including repackagers and relabelers. The FDA regulates Dordaviprone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dordaviprone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Dordaviprone Suppliers

A Dordaviprone supplier is an individual or a company that provides Dordaviprone active pharmaceutical ingredient (API) or Dordaviprone finished formulations upon request. The Dordaviprone suppliers may include Dordaviprone API manufacturers, exporters, distributors and traders.

Dordaviprone GMP

Dordaviprone 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 Dordaviprone 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 Dordaviprone GMP manufacturer or Dordaviprone GMP API supplier for your needs.

Dordaviprone CoA

A Dordaviprone CoA (Certificate of Analysis) is a formal document that attests to Dordaviprone's compliance with Dordaviprone specifications and serves as a tool for batch-level quality control.

Dordaviprone CoA mostly includes findings from lab analyses of a specific batch. For each Dordaviprone 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.

Dordaviprone may be tested according to a variety of international standards, such as European Pharmacopoeia (Dordaviprone EP), Dordaviprone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dordaviprone USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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