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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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NDC API

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Chemistry

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Also known as: 254740-64-2, Sparsentan (re-021), Re-021, Sparsentan [usan], Ps433540, Ps-433540
Molecular Formula
C32H40N4O5S
Molecular Weight
592.8  g/mol
InChI Key
WRFHGDPIDHPWIQ-UHFFFAOYSA-N
FDA UNII
9242RO5URM

Sparsentan
Sparsentan has been used in trials studying the treatment of Focal Segmental Glomerulosclerosis. Sparsentan is the first and only dual-acting angiotensin and endothelin receptor antagonist (DARA) in development.
1 2D Structure

Sparsentan

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[4-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-2-(ethoxymethyl)phenyl]-N-(4,5-dimethyl-1,2-oxazol-3-yl)benzenesulfonamide
2.1.2 InChI
InChI=1S/C32H40N4O5S/c1-5-7-14-29-33-32(17-10-11-18-32)31(37)36(29)20-24-15-16-26(25(19-24)21-40-6-2)27-12-8-9-13-28(27)42(38,39)35-30-22(3)23(4)41-34-30/h8-9,12-13,15-16,19H,5-7,10-11,14,17-18,20-21H2,1-4H3,(H,34,35)
2.1.3 InChI Key
WRFHGDPIDHPWIQ-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCCCC1=NC2(CCCC2)C(=O)N1CC3=CC(=C(C=C3)C4=CC=CC=C4S(=O)(=O)NC5=NOC(=C5C)C)COCC
2.2 Other Identifiers
2.2.1 UNII
9242RO5URM
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (1,1'-biphenyl)-2-sulfonamide, 4'-((2-butyl-4-oxo-1,3-diazaspiro(4.4)non-1-en-3-yl)methyl)-n-(4,5-dimethyl-3-isoxazolyl)-2'-(ethoxymethyl)-

2. 4'-((2-butyl-4-oxo-1,3-diazaspiro(4.4)non-1-en-3-yl)methyl)-n-(4,5-dimethyl-1,2-oxazol-3-yl)-2'-(ethoxymethyl)-2-biphenylsulfonamide

3. 4'-((2-butyl-4-oxo-1,3-diazaspiro(4.4)non-1-en-3-yl)methyl)-n-(4,5-dimethyl-1,2-oxazol-3-yl)-2'-(ethoxymethyl)biphenyl-2-sulfonamide

4. Re-021

2.3.2 Depositor-Supplied Synonyms

1. 254740-64-2

2. Sparsentan (re-021)

3. Re-021

4. Sparsentan [usan]

5. Ps433540

6. Ps-433540

7. 9242ro5urm

8. Chembl539423

9. 2-[4-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-2-(ethoxymethyl)phenyl]-n-(4,5-dimethyl-1,2-oxazol-3-yl)benzenesulfonamide

10. 4'-((2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl)-n-(4,5-dimethylisoxazol-3-yl)-2'-(ethoxymethyl)-[1,1'-biphenyl]-2-sulfonamide

11. Retrophin

12. (1,1'-biphenyl)-2-sulfonamide, 4'-((2-butyl-4-oxo-1,3-diazaspiro(4.4)non-1-en-3-yl)methyl)-n-(4,5-dimethyl-3-isoxazolyl)-2'-(ethoxymethyl)-

13. [1,1'-biphenyl]-2-sulfonamide, 4'-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-n-(4,5-dimethyl-3-isoxazolyl)-2'-(ethoxymethyl)-

14. Unii-9242ro5urm

15. Dara

16. Compound 7 [pmid 15634011]

17. Dara-a

18. Ps 33540

19. Sparsentan [inn]

20. Sparsentan (usan/inn)

21. Sparsentan(ps433540)

22. Sparsentan [who-dd]

23. Schembl535109

24. Gtpl8448

25. Amy38147

26. Bcp23969

27. Ex-a3048

28. Bdbm50175523

29. S6665

30. Cs-7947

31. Db12548

32. Sb16876

33. Dara-a (dual Acting Receptor Antagonist Of Angiotension And Endothelin Receptors)

34. Ps-433540;re-021;dara

35. Ac-35179

36. Hy-17621

37. Sparsentan (ps-433540,re-021,dara)

38. D11776

39. F77045

40. A858308

41. L023324

42. Q27088845

43. 4''''-(2-butyl-4-oxo-1,3-diaza-spiro[4.4]non-1-en-3-ylmethyl)-2''''-ethoxymethyl-biphenyl-2-sulfonic Acid (4,5-dimethyl-isoxazol-3-yl)-amide

44. 4''-(2-butyl-4-oxo-1,3-diaza-spiro[4.4]non-1-en-3-ylmethyl)-2''-ethoxymethyl-biphenyl-2-sulfonic Acid (4,5-dimethyl-isoxazol-3-yl)-amide

45. 4'-((2-butyl-4-oxo-1,3-diazaspiro(4.4)non-1-en-3-yl)methyi)-n-(4,5- Dimethylisoxazol-3-yl)-2'-(ethoxymethyl)biphenyl-2-sulfonamide

46. 4'-((2-butyl-4-oxo-1,3-diazaspiro(4.4)non-1-en-3-yl)methyl)-n-(4,5-dimethyl-1,2-oxazol-3-yl)-2'-(ethoxymethyl)-2-biphenylsulfonamide

47. 4'-((2-butyl-4-oxo-1,3-diazaspiro(4.4)non-1-en-3-yl)methyl)-n-(4,5-dimethyl-1,2-oxazol-3-yl)-2'-(ethoxymethyl)biphenyl-2-sulfonamide

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 592.8 g/mol
Molecular Formula C32H40N4O5S
XLogP35
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count8
Rotatable Bond Count12
Exact Mass592.27194156 g/mol
Monoisotopic Mass592.27194156 g/mol
Topological Polar Surface Area123 Ų
Heavy Atom Count42
Formal Charge0
Complexity1060
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Treatment of focal segmental glomerulosclerosis


Treatment of primary IgA nephropathy


5 Pharmacology and Biochemistry
5.1 Mechanism of Action

Sparsentan, which possesses two clinically validated mechanisms of action in a single molecule, works by selectively blocking the action of two potent vasoconstrictor and mitogenic agents, angiotensin II (AII) and endothelin 1 (ET1), at their respective receptors. Sparsentan is highly selective (10,000-fold) for the AII receptor sub-type 1 and the ET receptor sub-type A. As such, Sparsentan combines the properties of an angiotensin receptor blocker (ARB) and an endothelin receptor antagonist (ERA) in the same molecule.


Listed Suppliers

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Seqens

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Sparsentan

About the Company : Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling ...

Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling up and manufacturing drug substances from the pre-clinical phase to the commercial phase. It offers a large portfolio of APIs and proprietary products. Seqens also develops custom solutions and ingredients for the most demanding industries, such as healthcare, electronics and cosmetics. Its unique range of technologies enables it to manufacture complex molecules for small- and large-scale demands. It operates 24 industrial plants and 10 R&D centres across the globe.
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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Sparsentan

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 ...

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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03

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Sparsentan

About the Company : Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients a...

Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients and their intermediates, electronic chemical materials and intermediates, large-scale production, sales and services, and provide customized synthetic services according to customer requirements. Sjar-Tech locates in Beijing Economic and Technological Development Zone, has its own R&D and development laboratory. Sjar-Tech has set up a R&D team with rich experience and strong technical strength, most of the practitioners have more than ten years' experience.
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Sparsentan

About the Company : Conscientia Industrial is a pharmaceutical company, mainly developing, manufacturing, marketing APIs (Active Pharmaceutical Ingredients), intermediates, fine chemicals in China. We...

Conscientia Industrial is a pharmaceutical company, mainly developing, manufacturing, marketing APIs (Active Pharmaceutical Ingredients), intermediates, fine chemicals in China. We started business in early 2010, producing and providing products for both human and veterinary health at home and abroad. Conscientia Industrial makes regular productions and also provides custom synthesis, contract manufacturing services. We have series of products, such as Hormones, Prostaglandins, Peptides, Anti-cancer, Anti-tumor, Anti-virus, Anti-diabetic APIs and their related intermediates, impurities, chemicals.
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Sparsentan

About the Company : Founded by chemists with years of working experiences in famous CRO companies in China, Excenen Pharmatech experienced in organic chemistry expecially in medicinal chemistry resear...

Founded by chemists with years of working experiences in famous CRO companies in China, Excenen Pharmatech experienced in organic chemistry expecially in medicinal chemistry research/discovery fields. Excenen PharmaTech is dedicated to serve the pharmaceutical, scientific research and development industries for 10 years. During the past 10 years we supplied building blocks, small molecules, inhitbitors to world's leading companies like Janssen (Johnson&Johnson), Gilead, Abbvie..., Universities like Duke University, University of Chicago, University of Barcelona, University of Pécs etc.
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06

FandaChem

China
SupplySide West 2024
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FandaChem

China
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Sparsentan

About the Company : FandaChem, headquartered in Hangzhou, China, is a reputable supplier and exporter of chemicals with a focus on delivering high-quality products. Our expertise lies in exporting a w...

FandaChem, headquartered in Hangzhou, China, is a reputable supplier and exporter of chemicals with a focus on delivering high-quality products. Our expertise lies in exporting a wide range of superior chemicals, specializing in areas such as agrochemicals, flavors, fragrances, pharmaceuticals, intermediates, paints, resins, plastics, surfactants, polymers, cosmetics, and more. Dedicated to being your dependable partner in China, FandaChem is devoted to offering top-notch products, competitive prices, and excellent service to meet the needs of our customers.
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Sparsentan

About the Company : For more than 60 years, GYMA Laboratories has been the leading and trusted API supplier to the US pharmaceutical industry. We’re proud that many of the pharmaceutical manufacture...

For more than 60 years, GYMA Laboratories has been the leading and trusted API supplier to the US pharmaceutical industry. We’re proud that many of the pharmaceutical manufacturers who rely on our integrity, expertise, and follow-through have been with us for three, four, and even five decades.
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Sparsentan

About the Company : Hebi Xinhe Pharmaceutical Co., Ltd. is a subsidiary of Tianjin Zhennuo Pharmaceutical Group Co., Ltd., with a registered capital of CNY 100 million. Located in Jijiashan Industrial...

Hebi Xinhe Pharmaceutical Co., Ltd. is a subsidiary of Tianjin Zhennuo Pharmaceutical Group Co., Ltd., with a registered capital of CNY 100 million. Located in Jijiashan Industrial Park in Heshan District, Hebi City, the company spans 146,200 square meters, with a planned construction area of 80,300 square meters and a total investment of CNY 750 million. Our facilities include production plants, warehouses, office buildings, fire safety infrastructure, and waste treatment systems.
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Drugs in Development

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Details:

Filspari (sparsentan) is a once-daily approved oral medication, designed to selectively target two critical pathways in the disease progression of IgAN (endothelin-1 and angiotensin II).


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Brand Name: Filspari

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: CSL Vifor

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 17, 2024

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01

SupplySide West 2024
Not Confirmed
SupplySide West 2024
Not Confirmed

Details : Filspari (sparsentan) is a once-daily approved oral medication, designed to selectively target two critical pathways in the disease progression of IgAN (endothelin-1 and angiotensin II).

Brand Name : Filspari

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 17, 2024

blank

Details:

Filspari (sparsentan) is a once-daily approved oral medication, designed to selectively target two critical pathways in the disease progression of IgAN (endothelin-1 and angiotensin II).


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Brand Name: Filspari

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Ligand Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 06, 2024

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02

SupplySide West 2024
Not Confirmed
SupplySide West 2024
Not Confirmed

Details : Filspari (sparsentan) is a once-daily approved oral medication, designed to selectively target two critical pathways in the disease progression of IgAN (endothelin-1 and angiotensin II).

Brand Name : Filspari

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 06, 2024

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Details:

RE-021 (sparsentan) is an oral drug designed to selectively target two critical pathways - endothelin-1 and angiotensin II. It is approved for the treatment of IgA Nephropathy.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Brand Name: RE-021

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 18, 2024

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03

SupplySide West 2024
Not Confirmed
SupplySide West 2024
Not Confirmed

Details : RE-021 (sparsentan) is an oral drug designed to selectively target two critical pathways - endothelin-1 and angiotensin II. It is approved for the treatment of IgA Nephropathy.

Brand Name : RE-021

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 18, 2024

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Details:

The financing will enable Renalys Pharma to complete its Phase III clinical trial for RE-021 (sparsentan), a promising treatment for IgA nephropathy, in Japan.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Brand Name: RE-021

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Catalys Pacific

Deal Size: $38.8 million Upfront Cash: Undisclosed

Deal Type: Series A Financing July 17, 2024

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04

SupplySide West 2024
Not Confirmed
SupplySide West 2024
Not Confirmed

Details : The financing will enable Renalys Pharma to complete its Phase III clinical trial for RE-021 (sparsentan), a promising treatment for IgA nephropathy, in Japan.

Brand Name : RE-021

Molecule Type : Small molecule

Upfront Cash : Undisclosed

July 17, 2024

blank

Details:

Filspari (sparsentan) is an oral medication targeting critical pathways in IgAN progression, approved for treating IgA nephropathy.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Brand Name: Filspari

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: CSL Vifor

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 24, 2024

blank

05

SupplySide West 2024
Not Confirmed
SupplySide West 2024
Not Confirmed

Details : Filspari (sparsentan) is an oral medication targeting critical pathways in IgAN progression, approved for treating IgA nephropathy.

Brand Name : Filspari

Molecule Type : Small molecule

Upfront Cash : Not Applicable

April 24, 2024

blank

Details:

Filspari (sparsentan) is a once-daily oral medication targeting critical pathways in IgAN, approved for the treatment of IgA nephropathy.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Brand Name: Filspari

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 07, 2024

blank

06

SupplySide West 2024
Not Confirmed
SupplySide West 2024
Not Confirmed

Details : Filspari (sparsentan) is a once-daily oral medication targeting critical pathways in IgAN, approved for the treatment of IgA nephropathy.

Brand Name : Filspari

Molecule Type : Small molecule

Upfront Cash : Not Applicable

April 07, 2024

blank

Details:

Filspari (sparsentan) is an oral medication targeting endothelin-1 and angiotensin II pathways in IgAN, approved for treating IgA nephropathy.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Brand Name: Filspari

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 11, 2024

blank

07

SupplySide West 2024
Not Confirmed
SupplySide West 2024
Not Confirmed

Details : Filspari (sparsentan) is an oral medication targeting endothelin-1 and angiotensin II pathways in IgAN, approved for treating IgA nephropathy.

Brand Name : Filspari

Molecule Type : Small molecule

Upfront Cash : Not Applicable

March 11, 2024

blank

Details:

Filspari (sparsentan) is an oral medication targeting endothelin-1 and angiotensin II pathways in IgAN, approved for treating IgA nephropathy.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Brand Name: Filspari

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: CSL Vifor

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 23, 2024

blank

08

SupplySide West 2024
Not Confirmed
SupplySide West 2024
Not Confirmed

Details : Filspari (sparsentan) is an oral medication targeting endothelin-1 and angiotensin II pathways in IgAN, approved for treating IgA nephropathy.

Brand Name : Filspari

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 23, 2024

blank

Details:

Under the agreement, Renalys will bring Filspari (sparsentan), a dual endothelin angiotensin receptor antagonist for the treatment of IgA nephropathy, to patients in Japan and other countries in Asia.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Brand Name: Filspari

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Renalys Pharma

Deal Size: $120.0 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement January 25, 2024

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09

SupplySide West 2024
Not Confirmed
SupplySide West 2024
Not Confirmed

Details : Under the agreement, Renalys will bring Filspari (sparsentan), a dual endothelin angiotensin receptor antagonist for the treatment of IgA nephropathy, to patients in Japan and other countries in Asia.

Brand Name : Filspari

Molecule Type : Small molecule

Upfront Cash : Undisclosed

January 25, 2024

blank

Details:

Filspari (sparsentan) is an oral medication targeting key pathways in IgAN disease progression, approved for treating IgA nephropathy.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Brand Name: Filspari

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 25, 2024

blank

10

SupplySide West 2024
Not Confirmed
SupplySide West 2024
Not Confirmed

Details : Filspari (sparsentan) is an oral medication targeting key pathways in IgAN disease progression, approved for treating IgA nephropathy.

Brand Name : Filspari

Molecule Type : Small molecule

Upfront Cash : Not Applicable

January 25, 2024

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FDF Dossiers

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SPARSENTAN

Brand Name : FILSPARI

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Packaging :

Approval Date : 2023-02-17

Application Number : 216403

Regulatory Info : RX

Registration Country : USA

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SPARSENTAN

Brand Name : FILSPARI

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Packaging :

Approval Date : 2023-02-17

Application Number : 216403

Regulatory Info : RX

Registration Country : USA

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