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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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Chemistry

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Also known as: 923978-27-2, Gft505, Gft-505, 824932-88-9, Elafibranor [inn], Elafibranor [usan]
Molecular Formula
C22H24O4S
Molecular Weight
384.5  g/mol
InChI Key
AFLFKFHDSCQHOL-IZZDOVSWSA-N
FDA UNII
2J3H5C81A5

Elafibranor
Elafibranor (code name GFT505) is a multimodal and pluripotent medication for treatment of atherogenic dyslipidemia for an overweight patient with or without diabetes. It is an oral treatment that acts on the 3 sub-types of PPAR (PPARa, PPARg, PPARd) with a preferential action on PPARa. As of February 2016, elafibranor has completed 8 clinical trials and a phase III is in progress.
1 2D Structure

Elafibranor

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[2,6-dimethyl-4-[(E)-3-(4-methylsulfanylphenyl)-3-oxoprop-1-enyl]phenoxy]-2-methylpropanoic acid
2.1.2 InChI
InChI=1S/C22H24O4S/c1-14-12-16(13-15(2)20(14)26-22(3,4)21(24)25)6-11-19(23)17-7-9-18(27-5)10-8-17/h6-13H,1-5H3,(H,24,25)/b11-6+
2.1.3 InChI Key
AFLFKFHDSCQHOL-IZZDOVSWSA-N
2.1.4 Canonical SMILES
CC1=CC(=CC(=C1OC(C)(C)C(=O)O)C)C=CC(=O)C2=CC=C(C=C2)SC
2.1.5 Isomeric SMILES
CC1=CC(=CC(=C1OC(C)(C)C(=O)O)C)/C=C/C(=O)C2=CC=C(C=C2)SC
2.2 Other Identifiers
2.2.1 UNII
2J3H5C81A5
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxo-1-propenyl)phenoxyl)-2-methylpropanoic Acid

2. Gft505

2.3.2 Depositor-Supplied Synonyms

1. 923978-27-2

2. Gft505

3. Gft-505

4. 824932-88-9

5. Elafibranor [inn]

6. Elafibranor [usan]

7. Gft 505

8. Elafibranor(gft505)

9. 2-[2,6-dimethyl-4-[(e)-3-(4-methylsulfanylphenyl)-3-oxoprop-1-enyl]phenoxy]-2-methylpropanoic Acid

10. 2j3h5c81a5

11. Elafibranor (usan)

12. (e)-2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxoprop-1-en-1-yl)phenoxy)-2-methylpropanoic Acid

13. 2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxoprop-1-en-1-yl)phenoxy)-2-methylpropanoic Acid

14. 2-{2,6-dimethyl-4-[(1e)-3-[4-(methylsulfanyl)phenyl]-3-oxoprop-1-en-1-yl]phenoxy}-2-methylpropanoic Acid

15. Propanoic Acid, 2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxo-1-propen-1-yl)phenoxy)-2-methyl-

16. Unii-2j3h5c81a5

17. Gft-505;elafibranor

18. Surecn815512

19. Elafibranor [who-dd]

20. Schembl815512

21. Chembl3707395

22. Schembl16552997

23. Gtpl11135

24. Ex-a757

25. Dtxsid601045330

26. Bcp19067

27. Zhb93288

28. Bdbm50502541

29. Mfcd27987940

30. S3720

31. Zinc114643710

32. Ccg-268462

33. Cs-5522

34. Db05187

35. (e)-2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxoprop-1-enyl)phenoxy)-2-methylpropanoic Acid

36. Ac-31455

37. Ac-35189

38. As-57112

39. Be163306

40. Hy-16737

41. D11208

42. A856857

43. J-690356

44. Q15409440

45. 2-(2,6-dimethyl-4-(3-(4-(methylsulfanyl)phenyl)-3-oxoprop- 1-en-1-yl)phenoxy)-2-methylpropanoic Acid

46. 2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxoprop-1-en-1-yl)phenoxy)-2-methylpropanoicacid

47. 2-[2,6-dimethyl-4-[(1e)-3-[4-(methylthio)phenyl]-3-oxo-1-propen-1-yl]phenoxy]-2-methylpropanoic Acid

48. Propanoic Acid, 2-(2,6-dimethyl-4-((1e)-3-(4-(methylthio)phenyl)-3-oxo-1-propen-1-yl)phenoxy)-

49. Propanoic Acid, 2-[2,6-dimethyl-4-[(1e)-3-[4-(methylthio)phenyl]-3-oxo-1-propen-1-yl]phenoxy]-2-methyl-

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 384.5 g/mol
Molecular Formula C22H24O4S
XLogP35.1
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count5
Rotatable Bond Count7
Exact Mass384.13953042 g/mol
Monoisotopic Mass384.13953042 g/mol
Topological Polar Surface Area88.9 Ų
Heavy Atom Count27
Formal Charge0
Complexity537
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Investigated for use/treatment in atherosclerosis and diabetes mellitus type 2.


Treatment of primary biliary cholangitis


Treatment of non-alcoholic fatty liver disease (NAFLD) including non-alcoholic steatohepatitis (NASH)


5 Pharmacology and Biochemistry
5.1 Mechanism of Action

GFT505 is an oral treatment that acts on the 3 sub-types of PPAR (PPARa, PPARg, PPARd) with a preferential action on PPARa. It has a sophisticated mechanism of action. It is able to differentially recruit cofactors to the nuclear receptor, which subsequently lead to differential regulation of genes and biological effect. Therefore, the ability to identify and profile the activity of selective nuclear receptor modulator (SNuRMs) is a powerful approach to select innovative drug candidates with improved efficacy and diminished side effects. These pluripotent and multimodal molecules have significant positive effects on obesity, insulin-resistance and diabetes, atherosclerosis, inflammation, and the lipid triad (increasing of HDL cholesterol, lowering of triglycerides and LDL cholesterol).


API SUPPLIERS

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Biophore India Pharmaceuticals Pvt...

India

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Metrochem API Private Limited

India

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HRV Pharma

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Maithri Drugs

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Enaltec Labs

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ApiSyn

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Cdymax

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Cdymax

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Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Elafibranor

About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...

Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
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Elafibranor

About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
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HRV Pharma

India
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Elafibranor

About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...

HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing, manufacturing, and supply services to support partners entering new markets worldwide. HRV Pharma works closely with major pharma and food additive companies and represents over 30 Indian drugmakers, primarily serving Europe, the US, and the Middle East. Headquartered in India, it operates offices in the US, Switzerland, Dubai, Lithuania, and Turkey. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Elafibranor

About the Company : Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, ant...

Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, antibiotics, ARVs, CNS, and cardiovascular segments. The company operates facilities approved by US FDA, EDQM, Health Canada, and WHO-GMP, supported by multiple global DMFs and Ecovadis recognition. Backed by strong R&D, global patents, and customer-focused practices, Maithri delivers high-quality APIs with regulatory excellence. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Enaltec Labs

India
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Elafibranor

About the Company : Enaltec, founded in 2006, specializes in developing and manufacturing complex, small-volume, technology-driven APIs at competitive prices, leveraging the India advantage for global...

Enaltec, founded in 2006, specializes in developing and manufacturing complex, small-volume, technology-driven APIs at competitive prices, leveraging the India advantage for global generic formulators. The company operates USFDA-approved and WHO-GMP-approved facilities, a DSIR-approved R&D center, GLP-compliant labs, and cGMP-certified plants. Enaltec has developed over 90 products for regulated and semi-regulated markets in just 16 years, driving advanced synthesis and analytical research. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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ApiSyn

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Elafibranor

About the Company : ApiSyn Healthcare, established in 2017, is a vertically integrated manufacturer of APIs & intermediates serving the global pharmaceutical industry. As part of SynZeal Research, a p...

ApiSyn Healthcare, established in 2017, is a vertically integrated manufacturer of APIs & intermediates serving the global pharmaceutical industry. As part of SynZeal Research, a privately owned organization founded in 2011, ApiSyn is driven by innovation & strong R&D capabilities. Supported by an experienced workforce, the company offers end-to-end CDMO services including synthesis and development, early-phase studies, custom synthesis, and cGMP manufacturing, delivering high-quality and flexible chemistry solutions worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Cdymax

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Cdymax

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Elafibranor

About the Company : Cdymax (India) Pharma Private Limited was founded in 1994. The company's line of business includes the manufacturing, fabricating, or processing of drugs in pharmaceutical preparat...

Cdymax (India) Pharma Private Limited was founded in 1994. The company's line of business includes the manufacturing, fabricating, or processing of drugs in pharmaceutical preparations for human or veterinary use.CDYMAX ensures and adherence to HSE practices. System and procedures are in place to control and monitoring. All employees under go periodic health check-up once in a year and twice in a year for oncology employees. Effluent treatment plant meeting Government regulation.
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Drugs in Development

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Details:

Under the licensing agreement, Ipsen’s Iqirvo (elafibranor) has been granted pricing and reimbursement in Italy for Primary Biliary Cholangitis.


Lead Product(s): Elafibranor,Ursodeoxycholic Acid

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Iqirvo

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Ipsen

Deal Size: $542.8 million Upfront Cash: $135.7 million

Deal Type: Licensing Agreement May 20, 2025

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Genfit

France
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Arab Health
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Genfit

France
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Details : Under the licensing agreement, Ipsen’s Iqirvo (elafibranor) has been granted pricing and reimbursement in Italy for Primary Biliary Cholangitis.

Product Name : Iqirvo

Product Type : Miscellaneous

Upfront Cash : $135.7 million

May 20, 2025

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Details:

Elafibranor is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Liver Cirrhosis, Biliary.


Lead Product(s): Elafibranor,Inapplicable

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 12, 2024

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02

Ipsen

France
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Arab Health
Not Confirmed

Ipsen

France
arrow
Arab Health
Not Confirmed

Details : Elafibranor is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Liver Cirrhosis, Biliary.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 12, 2024

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Details:

Iqirvo (elafibranor) is an approved, novel, oral, PPAR alpha/delta agonist, as a treatment for patients with primary biliary cholangitis.


Lead Product(s): Elafibranor,Inapplicable

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Iqirvo

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 10, 2024

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03

Ipsen

France
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Arab Health
Not Confirmed

Ipsen

France
arrow
Arab Health
Not Confirmed

Details : Iqirvo (elafibranor) is an approved, novel, oral, PPAR alpha/delta agonist, as a treatment for patients with primary biliary cholangitis.

Product Name : Iqirvo

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 10, 2024

blank

Details:

Iqirvo (elafibranor) is an approved, novel, oral, PPAR alpha/delta agonist, as a treatment for patients with primary biliary cholangitis.


Lead Product(s): Elafibranor,Inapplicable

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Iqirvo

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 20, 2024

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04

Ipsen

France
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Arab Health
Not Confirmed

Ipsen

France
arrow
Arab Health
Not Confirmed

Details : Iqirvo (elafibranor) is an approved, novel, oral, PPAR alpha/delta agonist, as a treatment for patients with primary biliary cholangitis.

Product Name : Iqirvo

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 20, 2024

blank

Details:

Iqirvo (elafibranor) is a novel, oral, dual peroxisome activated receptor (PPAR) alpha/delta agonist, recommended for the treatment of patients with primary biliary cholangitis.


Lead Product(s): Elafibranor,Inapplicable

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Iqirvo

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 26, 2024

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05

Ipsen

France
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Arab Health
Not Confirmed

Ipsen

France
arrow
Arab Health
Not Confirmed

Details : Iqirvo (elafibranor) is a novel, oral, dual peroxisome activated receptor (PPAR) alpha/delta agonist, recommended for the treatment of patients with primary biliary cholangitis.

Product Name : Iqirvo

Product Type : Miscellaneous

Upfront Cash : Inapplicable

July 26, 2024

blank

Details:

Iqirvo (elafibranor) is a novel, oral, dual peroxisome activated receptor (PPAR) alpha/delta agonist, currently under investigation as a treatment for patients with primary biliary cholangitis.


Lead Product(s): Elafibranor,Inapplicable

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Iqirvo

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 10, 2024

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06

Ipsen

France
arrow
Arab Health
Not Confirmed

Ipsen

France
arrow
Arab Health
Not Confirmed

Details : Iqirvo (elafibranor) is a novel, oral, dual peroxisome activated receptor (PPAR) alpha/delta agonist, currently under investigation as a treatment for patients with primary biliary cholangitis.

Product Name : Iqirvo

Product Type : Miscellaneous

Upfront Cash : Inapplicable

June 10, 2024

blank

Details:

Elafibranor is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Liver Cirrhosis, Biliary.


Lead Product(s): Elafibranor,Inapplicable

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 25, 2024

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07

Ipsen

France
arrow
Arab Health
Not Confirmed

Ipsen

France
arrow
Arab Health
Not Confirmed

Details : Elafibranor is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Liver Cirrhosis, Biliary.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

April 25, 2024

blank

Details:

GFT505 (elafibranor) is a novel, oral, once-daily, dual peroxisome activated receptor (PPAR) alpha/delta agonist, currently under investigation as a treatment for patients with primary biliary cholangitis.


Lead Product(s): Elafibranor,Inapplicable

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Iqirvo

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 07, 2023

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08

Ipsen

France
arrow
Arab Health
Not Confirmed

Ipsen

France
arrow
Arab Health
Not Confirmed

Details : GFT505 (elafibranor) is a novel, oral, once-daily, dual peroxisome activated receptor (PPAR) alpha/delta agonist, currently under investigation as a treatment for patients with primary biliary cholangitis.

Product Name : Iqirvo

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 07, 2023

blank

Details:

Elafibranor is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Liver Cirrhosis, Biliary.


Lead Product(s): Elafibranor,Inapplicable

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 30, 2023

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09

Ipsen

France
arrow
World Health Expo
Not Confirmed

Ipsen

France
arrow
World Health Expo
Not Confirmed

Details : Elafibranor is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Liver Cirrhosis, Biliary.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 30, 2023

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Details:

GFT505 (elafibranor) is a novel, oral, once-daily, dual peroxisome activated receptor (PPAR) alpha/delta (α,δ) agonist, currently under investigation as a treatment for patients with PBC, a rare liver disease.


Lead Product(s): Elafibranor,Inapplicable

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Iqirvo

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Genfit

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 30, 2023

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10

Ipsen

France
arrow
Arab Health
Not Confirmed

Ipsen

France
arrow
Arab Health
Not Confirmed

Details : GFT505 (elafibranor) is a novel, oral, once-daily, dual peroxisome activated receptor (PPAR) alpha/delta (α,δ) agonist, currently under investigation as a treatment for patients with PBC, a rare liver disease.

Product Name : Iqirvo

Product Type : Miscellaneous

Upfront Cash : Inapplicable

June 30, 2023

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Patents & EXCLUSIVITIES

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US Patents

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01

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IPSEN

France
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ELAFIBRANOR

US Patent Number : 11857523

Drug Substance Claim :

Drug Product Claim :

Application Number : 218860

Patent Use Code : U-3955

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-03-30

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02

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Arab Health
Not Confirmed

IPSEN

France
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Arab Health
Not Confirmed

ELAFIBRANOR

US Patent Number : 11850223

Drug Substance Claim :

Drug Product Claim :

Application Number : 218860

Patent Use Code : U-1854

Delist Requested :

Patent Use Description : TREATMENT OF PRIMARY B...

Patent Expiration Date : 2037-03-30

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03

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ELAFIBRANOR

US Patent Number : 11331292

Drug Substance Claim :

Drug Product Claim :

Application Number : 218860

Patent Use Code : U-1854

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Patent Use Description : TREATMENT OF PRIMARY B...

Patent Expiration Date : 2037-03-30

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US Patent Number : 11185519

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Application Number : 218860

Patent Use Code : U-3955

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Patent Expiration Date : 2037-03-30

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US Patent Number : 12310935

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Application Number : 218860

Patent Use Code : U-1854

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Patent Expiration Date : 2037-03-30

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US Patent Number : 12295928

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Application Number : 218860

Patent Use Code : U-1854

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Patent Expiration Date : 2037-03-30

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US Patent Number : 12295927

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Application Number : 218860

Patent Use Code : U-1854

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Patent Expiration Date : 2037-03-30

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US Patent Number : 12233038

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Application Number : 218860

Patent Use Code : U-1854

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Patent Use Description : TREATMENT OF PRIMARY B...

Patent Expiration Date : 2037-03-30

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US Exclusivities

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Exclusivity Code : NCE

Exclusivity Expiration Date : 2029-06-10

Application Number : 218860

Product Number : 1

Exclusivity Details :

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Exclusivity Code : ODE-486

Exclusivity Expiration Date : 2031-06-10

Application Number : 218860

Product Number : 1

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ABOUT THIS PAGE

Looking for 824932-88-9 / Elafibranor API manufacturers, exporters & distributors?

Elafibranor manufacturers, exporters & distributors 1

41

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

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

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

API | Excipient name

Elafibranor

Synonyms

923978-27-2, Gft505, Gft-505, 824932-88-9, Elafibranor [inn], Elafibranor [usan]

Cas Number

824932-88-9

Unique Ingredient Identifier (UNII)

2J3H5C81A5

About Elafibranor

Elafibranor (code name GFT505) is a multimodal and pluripotent medication for treatment of atherogenic dyslipidemia for an overweight patient with or without diabetes. It is an oral treatment that acts on the 3 sub-types of PPAR (PPARa, PPARg, PPARd) with a preferential action on PPARa. As of February 2016, elafibranor has completed 8 clinical trials and a phase III is in progress.

Elafibranor Manufacturers

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

click here to find a list of Elafibranor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Elafibranor Suppliers

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

click here to find a list of Elafibranor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Elafibranor GMP

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

Elafibranor CoA

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

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

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