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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

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REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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Others

FINISHED DOSAGE FORMULATIONS

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Europe

Europe

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Australia

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PATENTS & EXCLUSIVITIES

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Health Canada Patents

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GLOBAL SALES INFORMATION

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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).


Listed Suppliers

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01

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  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

Flag India
Digital Content Digital Content

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
Metrochem

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

Flag India
Digital Content Digital Content

Elafibranor

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
HRV Global Life Sciences

03

Cdymax

India
Discovery Europe
Not Confirmed
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Cdymax

India
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Discovery Europe
Not Confirmed

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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04

Lee Pharma

India
Discovery Europe
Not Confirmed
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Lee Pharma

India
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Discovery Europe
Not Confirmed

Elafibranor

About the Company : Founded in 1997, Lee Pharma Limited has transformed from a small venture into a global leader in the pharmaceutical industry. Our journey began with a commitment to providing affor...

Founded in 1997, Lee Pharma Limited has transformed from a small venture into a global leader in the pharmaceutical industry. Our journey began with a commitment to providing affordable and high-quality healthcare solutions. Through advanced research, modern manufacturing, and a strong emphasis on quality, we are dedicated to producing medicines that enhance lives. Lee Pharma is a research-focused company that prioritizes the development, synthesis, and commercialization of high-quality Active Pharmaceutical Ingredients (APIs), intermediate chemicals, and finished formulations.
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Patents & EXCLUSIVITIES

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US Patents

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01

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The Aesthetic Show
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IPSEN

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ELAFIBRANOR

US Patent Number : 12233038

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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02

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The Aesthetic Show
Not Confirmed

IPSEN

France
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The Aesthetic Show
Not Confirmed

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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03

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The Aesthetic Show
Not Confirmed

IPSEN

France
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The Aesthetic Show
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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04

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The Aesthetic Show
Not Confirmed

IPSEN

France
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The Aesthetic Show
Not Confirmed

ELAFIBRANOR

US Patent Number : 11331292

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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05

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The Aesthetic Show
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IPSEN

France
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The Aesthetic Show
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ELAFIBRANOR

US Patent Number : 11185519

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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06

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The Aesthetic Show
Not Confirmed

IPSEN

France
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The Aesthetic Show
Not Confirmed

ELAFIBRANOR

US Patent Number : 12310935

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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07

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The Aesthetic Show
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IPSEN

France
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The Aesthetic Show
Not Confirmed

ELAFIBRANOR

US Patent Number : 12295928

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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08

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The Aesthetic Show
Not Confirmed

IPSEN

France
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The Aesthetic Show
Not Confirmed

ELAFIBRANOR

US Patent Number : 12295927

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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ABOUT THIS PAGE

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Elafibranor manufacturers, exporters & distributors 1

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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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