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Chemistry

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Also known as: 1018899-04-1, Lx-4211, Lx4211, Lp-802034, (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2h-pyran-3,4,5-triol, 6b4zbs263y
Molecular Formula
C21H25ClO5S
Molecular Weight
424.9  g/mol
InChI Key
QKDRXGFQVGOQKS-CRSSMBPESA-N
FDA UNII
6B4ZBS263Y

Sotagliflozin
Sotagliflozin is an orally bioavailable inhibitor of the sodium-glucose co-transporter subtype 1 (SGLT1) and 2 (SGLT2), with potential antihyperglycemic activity. Upon oral administration, sotagliflozin binds to and blocks both SGLT1 in the gastrointestinal (GI) tract and SGLT2 in the kidneys, thereby suppressing the absorption of glucose from the GI tract and the reabsorption of glucose by the proximal tubule into the bloodstream, respectively. This decreases glucose uptake and enhances the urinary excretion of glucose, which lowers and/or normalizes blood glucose levels. SGLT1 is the primary transporter responsible for glucose absorption from the GI tract. SGLT2, a transport protein exclusively expressed in the proximal renal tubules, mediates approximately 90% of renal glucose reabsorption from tubular fluid.
1 2D Structure

Sotagliflozin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S,3R,4R,5S,6R)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-methylsulfanyloxane-3,4,5-triol
2.1.2 InChI
InChI=1S/C21H25ClO5S/c1-3-26-15-7-4-12(5-8-15)10-14-11-13(6-9-16(14)22)20-18(24)17(23)19(25)21(27-20)28-2/h4-9,11,17-21,23-25H,3,10H2,1-2H3/t17-,18-,19+,20+,21-/m1/s1
2.1.3 InChI Key
QKDRXGFQVGOQKS-CRSSMBPESA-N
2.1.4 Canonical SMILES
CCOC1=CC=C(C=C1)CC2=C(C=CC(=C2)C3C(C(C(C(O3)SC)O)O)O)Cl
2.1.5 Isomeric SMILES
CCOC1=CC=C(C=C1)CC2=C(C=CC(=C2)[C@H]3[C@@H]([C@H]([C@@H]([C@H](O3)SC)O)O)O)Cl
2.2 Other Identifiers
2.2.1 UNII
6B4ZBS263Y
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2h-pyran-3,4,5-triol

2. Lx-4211

3. Lx4211

2.3.2 Depositor-Supplied Synonyms

1. 1018899-04-1

2. Lx-4211

3. Lx4211

4. Lp-802034

5. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2h-pyran-3,4,5-triol

6. 6b4zbs263y

7. Sar439954

8. Sar-439954

9. (2s,3r,4r,5s,6r)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-methylsulfanyloxane-3,4,5-triol

10. Zynquista

11. Beta-l-xylopyranoside, Methyl 5-c-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)-1-thio-, (5s)-

12. Sotagliflozin [usan:inn]

13. Unii-6b4zbs263y

14. Beta-l-xylopyranoside, Methyl 5-c-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-1-thio-, (5s)-

15. Mfcd22493506

16. Lx 4211

17. Lp 802034

18. Sotagliflozin [mi]

19. Sotagliflozin (lx4211)

20. Sotagliflozin [inn]

21. Sotagliflozin (usan/inn)

22. Sotagliflozin [usan]

23. Sotagliflozin (lx-4211)

24. Sotagliflozin [who-dd]

25. Gtpl8312

26. Schembl1038287

27. Chembl3039507

28. Dtxsid20144314

29. Amy12393

30. Ex-a1167

31. Bdbm50235017

32. S8103

33. Zinc95641922

34. Akos025290846

35. Ccg-268940

36. Cs-1069

37. Db12713

38. Ac-29890

39. As-35202

40. Bl161424

41. Hy-15516

42. D10669

43. A852129

44. Q27088840

45. (2s,3r,4r,5s,6r)-2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-tetrahydro-6-(methylthio)-2h-pyran-3,4,5-triol;lx4211

46. (2s,3r,4r,5s,6r)-2-[4-chloro-3-(4-ethoxybenzyl)phenyl]-6-(methylsulfanyl)tetrahydro-2h-pyran-3,4,5-triol

47. .beta.-l-xylopyranoside, Methyl 5-c-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)-1-thio-, (5s)-

48. Methyl (5s)-5-c-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)-1-thio-.beta.-l-xylopyranoside

2.4 Create Date
2008-07-07
3 Chemical and Physical Properties
Molecular Weight 424.9 g/mol
Molecular Formula C21H25ClO5S
XLogP33.2
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count6
Rotatable Bond Count6
Exact Mass424.1111228 g/mol
Monoisotopic Mass424.1111228 g/mol
Topological Polar Surface Area104 Ų
Heavy Atom Count28
Formal Charge0
Complexity476
Isotope Atom Count0
Defined Atom Stereocenter Count5
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

Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy.


Treatment of type II diabetes mellitus


Treatment of type I diabetes mellitus


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Sodium-Glucose Transporter 2 Inhibitors

Compounds that inhibit SODIUM-GLUCOSE TRANSPORTER 2. They lower blood sugar by preventing the reabsorption of glucose by the kidney and are used in the treatment of TYPE 2 DIABETES MELLITUS. (See all compounds classified as Sodium-Glucose Transporter 2 Inhibitors.)


5.2 ATC Code

A10


A - Alimentary tract and metabolism

A10 - Drugs used in diabetes

A10B - Blood glucose lowering drugs, excl. insulins

A10BK - Sodium-glucose co-transporter 2 (sglt2) inhibitors

A10BK06 - Sotagliflozin


USDMF

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Lee Pharma Ltd

India

USDMF

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 41249

Submission : 2025-01-27

Status : Active

Type : II

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NDC API

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SOTAGLIFLOZIN

NDC Package Code : 48087-0150

Start Marketing Date : 2019-12-17

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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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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Digital Content Digital Content

Sotagliflozin

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

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Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.

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Sotagliflozin

About the Company : Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 ...

Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 years, MOEHS has considerable technical experience in the production of these substances. At Moehs Group we have a large tradition and experience in the area of manufacturing of active pharmaceutical and veterinary ingredients, agrochemicals, nutraceutical, cosmetic, as well as fine chemistry in general, with high levels of quality and safety standards-GMP´s, ICH, approved by the FDA and TGA.
Moehs Iberica

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

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Sotagliflozin

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

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Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Sotagliflozin

About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry with over 350 Products portfolio. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
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Honour Lab

India
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Honour Lab

India
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Sotagliflozin

About the Company : Honour is a leading global Contract Development and Manufacturing Organization (CDMO) as well as a manufacturer of specialty chemicals and ingredients, operating six facilities tha...

Honour is a leading global Contract Development and Manufacturing Organization (CDMO) as well as a manufacturer of specialty chemicals and ingredients, operating six facilities that adhere to international standards of safety and quality. Through our offerings, Honour Synthesis and Honour Specialty, we are committed to fostering partnerships and exploring new possibilities. Our team of over 2,000 professionals delivers exceptional service to our pharmaceutical and biotechnology partners by providing practical solutions.
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Lee Pharma

India
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Lee Pharma

India
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Sotagliflozin

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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Sotagliflozin

About the Company : Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide range of therapeutic cat...

Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide range of therapeutic categories specifically focusing on Anti-Fungal and Anti-Platelets. Our vision is to attain market leadership in development of innovator molecules for the domestic and export market.
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Viatris

U.S.A
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Viatris

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Sotagliflozin

About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (N...

In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.
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API Reference Price

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23-Apr-2024
14-Nov-2024
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Drugs in Development

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Details:

Zynquista (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.


Lead Product(s): Sotagliflozin

Therapeutic Area: Endocrinology Brand Name: Zynquista

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 20, 2024

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01

AACR Annual meeting
Not Confirmed
AACR Annual meeting
Not Confirmed

Details : Zynquista (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.

Product Name : Zynquista

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 20, 2024

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Details:

Inpefa (sotagliflozin), an SGLT2/SGLT1 inhibitor, is in phase III trials for treating type 1 diabetes and chronic kidney failure.


Lead Product(s): Sotagliflozin

Therapeutic Area: Endocrinology Brand Name: SAR439954

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 03, 2024

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02

AACR Annual meeting
Not Confirmed
AACR Annual meeting
Not Confirmed

Details : Inpefa (sotagliflozin), an SGLT2/SGLT1 inhibitor, is in phase III trials for treating type 1 diabetes and chronic kidney failure.

Product Name : SAR439954

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 03, 2024

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Details:

Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.


Lead Product(s): Sotagliflozin

Therapeutic Area: Endocrinology Brand Name: SAR439954

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Sanofi

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 03, 2024

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03

AACR Annual meeting
Not Confirmed
AACR Annual meeting
Not Confirmed

Details : Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.

Product Name : SAR439954

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 03, 2024

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Details:

Zynquista (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.


Lead Product(s): Sotagliflozin

Therapeutic Area: Endocrinology Brand Name: SAR439954

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 31, 2024

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04

AACR Annual meeting
Not Confirmed
AACR Annual meeting
Not Confirmed

Details : Zynquista (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.

Product Name : SAR439954

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 31, 2024

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Details:

Under the license agreement, Viatris will acquire the rights to Inpefa (sotagliflozin) from Lexicon for the treatment of heart failure and type 2 diabetes in all markets outside the U.S. and Europe.


Lead Product(s): Sotagliflozin

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: SAR439954

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Viatris

Deal Size: Undisclosed Upfront Cash: $25.0 million

Deal Type: Licensing Agreement October 16, 2024

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05

AACR Annual meeting
Not Confirmed
AACR Annual meeting
Not Confirmed

Details : Under the license agreement, Viatris will acquire the rights to Inpefa (sotagliflozin) from Lexicon for the treatment of heart failure and type 2 diabetes in all markets outside the U.S. and Europe.

Product Name : SAR439954

Product Type : Other Small Molecule

Upfront Cash : $25.0 million

October 16, 2024

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Details:

Zynquista (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.


Lead Product(s): Sotagliflozin

Therapeutic Area: Endocrinology Brand Name: SAR439954

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 21, 2024

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06

AACR Annual meeting
Not Confirmed
AACR Annual meeting
Not Confirmed

Details : Zynquista (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.

Product Name : SAR439954

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

August 21, 2024

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Details:

Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.


Lead Product(s): Sotagliflozin

Therapeutic Area: Endocrinology Brand Name: SAR439954

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 16, 2024

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07

AACR Annual meeting
Not Confirmed
AACR Annual meeting
Not Confirmed

Details : Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.

Product Name : SAR439954

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

July 16, 2024

blank

Details:

Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.


Lead Product(s): Sotagliflozin

Therapeutic Area: Endocrinology Brand Name: SAR439954

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 21, 2024

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08

AACR Annual meeting
Not Confirmed
AACR Annual meeting
Not Confirmed

Details : Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.

Product Name : SAR439954

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

June 21, 2024

blank

Details:

Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.


Lead Product(s): Sotagliflozin

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: SAR439954

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 14, 2024

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09

AACR Annual meeting
Not Confirmed
AACR Annual meeting
Not Confirmed

Details : Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.

Product Name : SAR439954

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 14, 2024

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Details:

Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is indicated for the treatment of heart failure in patients with type 1 diabetes.


Lead Product(s): Sotagliflozin

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: SAR439954

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 09, 2024

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10

AACR Annual meeting
Not Confirmed
AACR Annual meeting
Not Confirmed

Details : Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is indicated for the treatment of heart failure in patients with type 1 diabetes.

Product Name : SAR439954

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

March 09, 2024

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FDF Dossiers

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SOTAGLIFLOZIN

Brand Name : INPEFA

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Packaging :

Approval Date : 2023-05-26

Application Number : 216203

Regulatory Info : RX

Registration Country : USA

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SOTAGLIFLOZIN

Brand Name : INPEFA

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Packaging :

Approval Date : 2023-05-26

Application Number : 216203

Regulatory Info : RX

Registration Country : USA

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SOTAGLIFLOZIN

Brand Name : INPEFA

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 2023-05-26

Application Number : 216203

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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AACR Annual meeting
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SOTAGLIFLOZIN

Brand Name : INPEFA

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Approval Date : 2023-05-26

Application Number : 216203

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Patents & EXCLUSIVITIES

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US Patents

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SOTAGLIFLOZIN

US Patent Number : 7781577

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 216203

Patent Use Code : U-3628

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-05-04

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SOTAGLIFLOZIN

US Patent Number : 7781577

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 216203

Patent Use Code : U-3628

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-05-04

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SOTAGLIFLOZIN

US Patent Number : 8217156

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 216203

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-10-07

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SOTAGLIFLOZIN

US Patent Number : 8217156

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 216203

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-10-07

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SOTAGLIFLOZIN

US Patent Number : 8476413

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 216203

Patent Use Code : U-3628

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-05-29

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SOTAGLIFLOZIN

US Patent Number : 8476413

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 216203

Patent Use Code : U-3628

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-05-29

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ABOUT THIS PAGE

Looking for 1018899-04-1 / Sotagliflozin API manufacturers, exporters & distributors?

Sotagliflozin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Sotagliflozin

Synonyms

1018899-04-1, Lx-4211, Lx4211, Lp-802034, (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2h-pyran-3,4,5-triol, 6b4zbs263y

Cas Number

1018899-04-1

Unique Ingredient Identifier (UNII)

6B4ZBS263Y

About Sotagliflozin

Sotagliflozin is an orally bioavailable inhibitor of the sodium-glucose co-transporter subtype 1 (SGLT1) and 2 (SGLT2), with potential antihyperglycemic activity. Upon oral administration, sotagliflozin binds to and blocks both SGLT1 in the gastrointestinal (GI) tract and SGLT2 in the kidneys, thereby suppressing the absorption of glucose from the GI tract and the reabsorption of glucose by the proximal tubule into the bloodstream, respectively. This decreases glucose uptake and enhances the urinary excretion of glucose, which lowers and/or normalizes blood glucose levels. SGLT1 is the primary transporter responsible for glucose absorption from the GI tract. SGLT2, a transport protein exclusively expressed in the proximal renal tubules, mediates approximately 90% of renal glucose reabsorption from tubular fluid.

Sotagliflozin Manufacturers

A Sotagliflozin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sotagliflozin, including repackagers and relabelers. The FDA regulates Sotagliflozin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sotagliflozin 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 Sotagliflozin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Sotagliflozin Suppliers

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

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

Sotagliflozin USDMF

A Sotagliflozin DMF (Drug Master File) is a document detailing the whole manufacturing process of Sotagliflozin active pharmaceutical ingredient (API) in detail. Different forms of Sotagliflozin DMFs exist exist since differing nations have different regulations, such as Sotagliflozin USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Sotagliflozin DMF submitted to regulatory agencies in the US is known as a USDMF. Sotagliflozin USDMF includes data on Sotagliflozin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sotagliflozin USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Sotagliflozin suppliers with USDMF on PharmaCompass.

Sotagliflozin NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Sotagliflozin as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Sotagliflozin API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Sotagliflozin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Sotagliflozin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sotagliflozin NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Sotagliflozin suppliers with NDC on PharmaCompass.

Sotagliflozin GMP

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

Sotagliflozin CoA

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

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

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