Find Zuranolone manufacturers, exporters & distributors on PharmaCompass

PharmaCompass

Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

0

USDMF

US DMFs Filed

0

CEP/COS

CEP/COS Certifications

0

JDMF

JDMFs Filed

0

EU WC

EU WC

0

KDMF

KDMF

0

VMF

NDC API

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

FINISHED DOSAGE FORMULATIONS

0

Europe

Europe

0

Canada

Canada

0

Australia

Australia

0

South Africa

South Africa

0

Listed Dossiers

Listed Dossiers

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

PATENTS & EXCLUSIVITIES

0

Health Canada Patents

API REF. PRICE (USD/KG)

$
$ 0

GLOBAL SALES INFORMATION

US Medicaid

NA

Annual Reports

NA

Regulatory FDF Prices

NA

API/FDF Prices: Book a Demo to
explore the features and consider
upgrading later

MARKET PLACE

0

API

0

FDF

Chemistry

Click the arrow to open the dropdown
read-moreClick the button for full data set
Also known as: Sage-217, 1632051-40-1, Zuranolone [inn], Zuranolone [usan], Sge-797, Chembl4105630
Molecular Formula
C25H35N3O2
Molecular Weight
409.6  g/mol
InChI Key
HARRKNSQXBRBGZ-GVKWWOCJSA-N
FDA UNII
7ZW49N180B

Zuranolone
1 2D Structure

Zuranolone

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-[2-[(3R,5R,8R,9R,10S,13S,14S,17S)-3-hydroxy-3,13-dimethyl-2,4,5,6,7,8,9,10,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl]pyrazole-4-carbonitrile
2.1.2 InChI
InChI=1S/C25H35N3O2/c1-24(30)9-7-18-17(11-24)3-4-20-19(18)8-10-25(2)21(20)5-6-22(25)23(29)15-28-14-16(12-26)13-27-28/h13-14,17-22,30H,3-11,15H2,1-2H3/t17-,18+,19-,20-,21+,22-,24-,25+/m1/s1
2.1.3 InChI Key
HARRKNSQXBRBGZ-GVKWWOCJSA-N
2.1.4 Canonical SMILES
CC1(CCC2C(C1)CCC3C2CCC4(C3CCC4C(=O)CN5C=C(C=N5)C#N)C)O
2.1.5 Isomeric SMILES
C[C@]1(CC[C@H]2[C@@H](C1)CC[C@@H]3[C@@H]2CC[C@]4([C@H]3CC[C@@H]4C(=O)CN5C=C(C=N5)C#N)C)O
2.2 Other Identifiers
2.2.1 UNII
7ZW49N180B
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 1-(3.alpha.-hydroxy-3.beta.-methyl-20-oxo-19-nor-5.beta.-pregnan-21-yl)-1h-pyrazole-4-carbonitrile

2. 1h-pyrazole-4-carbonitrile, 1-((3.alpha.,5.beta.)-3-hydroxy-3-methyl-20-oxo-19-norpregnan-21-yl)-

3. 3alpha-hydroxy-3beta-methyl-21-(4-cyano-1h-pyrazol-1'-yl)-19-nor-5beta-pregnan-20-one

4. 3beta-methyl-21-(4-cyano-1h-pyrazol-1'-yl)-19-norpregnanolone

5. Sage-217

2.3.2 Depositor-Supplied Synonyms

1. Sage-217

2. 1632051-40-1

3. Zuranolone [inn]

4. Zuranolone [usan]

5. Sge-797

6. Chembl4105630

7. 7zw49n180b

8. S-812217

9. 1-[2-[(3r,5r,8r,9r,10s,13s,14s,17s)-3-hydroxy-3,13-dimethyl-2,4,5,6,7,8,9,10,11,12,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl]pyrazole-4-carbonitrile

10. Zuranolonesage-217

11. Zuranolone (usan/inn)

12. Unii-7zw49n180b

13. Schembl16189866

14. Dtxsid601128500

15. Glxc-15028

16. Amy27908

17. Ex-a1880

18. Bdbm50258216

19. Who 10896

20. Akos037648887

21. Db15490

22. Ac-35591

23. Bs-15950

24. Hy-103040

25. Cs-0023489

26. D11793

27. D80690

28. A905859

29. 3beta-methyl-21-(4-cyano-1h-pyrazol-1'-yl)-19-norpregnanolone

30. 3alpha-hydroxy-3beta-methyl-21-(4-cyano-1h-pyrazol-1'-yl)-19-nor-5beta-pregnan-20-one

31. 1-(2-((3r,5r,8r,9r,10s,13s,14s,17s)-3-hydroxy-3,13-dimethylhexadecahydro-1h-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl)-1h-pyrazole-4-carbonitrile

32. 1-(2-((3r,5r,8r,9r,10s,13s,14s,17s)-3-hydroxy-3,13-dimethylhexadecahydro-1h-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl)-1h-pyrazole-4-carbonitrile;1-[(3alpha,5beta)-3-hydroxy-3-methyl-20-oxo-19-norpregnan-21-yl]-1h-pyrazole-4-carbonitrile

33. 1-(3.alpha.-hydroxy-3.beta.-methyl-20-oxo-19-nor-5.beta.-pregnan-21-yl)-1h-pyrazole-4-carbonitrile

34. 1-(3alpha-hydroxy-3beta-methyl-20-oxo-19-nor-5beta-pregnan-21-yl)-1h-pyrazole-4-carbonitrile

35. 1h-pyrazole-4-carbonitrile, 1-((3.alpha.,5.beta.)-3-hydroxy-3-methyl-20-oxo-19-norpregnan-21-yl)-

36. 1h-pyrazole-4-carbonitrile, 1-((3alpha,5beta)-3-hydroxy-3-methyl-20-oxo-19-norpregnan-21-yl)-

2.4 Create Date
2014-12-29
3 Chemical and Physical Properties
Molecular Weight 409.6 g/mol
Molecular Formula C25H35N3O2
XLogP34.5
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count4
Rotatable Bond Count3
Exact Mass409.27292737 g/mol
Monoisotopic Mass409.27292737 g/mol
Topological Polar Surface Area78.9 Ų
Heavy Atom Count30
Formal Charge0
Complexity746
Isotope Atom Count0
Defined Atom Stereocenter Count8
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

API SUPPLIERS

read-more
read-more

01

Metrochem API Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • 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
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Metrochem

02

Shandong Loncom Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

Flag China
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Shandong Loncom Pharmaceutical company banner

03

TAPI Technology & API Services

Israel

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

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

Flag Israel
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
TAPI Company Banner

04

Henan Lihua Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Iran Expo
Not Confirmed
arrow

05

Beijing Sjar Technology Developmen...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Iran Expo
Not Confirmed
arrow

06

Curia

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Iran Expo
Not Confirmed
arrow

07

Ash Stevens

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Iran Expo
Not Confirmed
arrow

Ash Stevens

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

arrow
Iran Expo
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
blank

08

Catalent Pharma Solutions

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Iran Expo
Not Confirmed
arrow

Catalent Pharma Solutions

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

arrow
Iran Expo
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

NDC API

read-more
read-moreread-more

01

CST
Not Confirmed
arrow
arrow
CST
Not Confirmed

ZURANOLONE

NDC Package Code : 48957-0115

Start Marketing Date : 2023-10-31

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

blank

02

CST
Not Confirmed
arrow
arrow
CST
Not Confirmed

ZURANOLONE

NDC Package Code : 69988-0059

Start Marketing Date : 2023-08-01

End Marketing Date : 2026-12-31

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

Marketing Category : DRUG FOR FURTHER PROCESSING

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Listed Suppliers

read-more
read-more

01

  • fda
  • 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

Zuranolone

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 BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

Flag China
Digital Content Digital Content

Zuranolone

About the Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development...

Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development Zone, Shandong Province, Shandong Loncom has operational API pilot tests and production bases adhering to international standards. With 13 production lines dedicated to oral solid preparations, oral liquid preparations and API, it is actively expanding its preparation workshops for small-volume injections, soft capsules, eye drops, topical medicines and innovative drug R&D centres.
Shandong Loncom Pharmaceutical company banner

03

  • fda
  • EDQM
  • WHO-GMP

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

Flag Israel
Digital Content Digital Content

Zuranolone

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.
TAPI Company Banner

04

BioProcess International Europe
Not Confirmed
arrow
arrow
BioProcess International Europe
Not Confirmed

Zuranolone

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.
blank

05

Curia

U.S.A
BioProcess International Europe
Not Confirmed
arrow

Curia

U.S.A
arrow
BioProcess International Europe
Not Confirmed

Zuranolone

About the Company : Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners tur...

Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners turn their ideas into real-world impact. We partner closely with pharmaceutical and biotechnology companies to boost business performance and improve patients’ lives. From early discovery and development through manufacturing and commercialization, our suite of custom solutions allows us to tailor every engagement to your precise needs, whether that’s an independent project or an opportunity that cuts across the drug continuum.
blank

06

BioProcess International Europe
Not Confirmed
arrow
arrow
BioProcess International Europe
Not Confirmed

Zuranolone

About the Company : Henan Lihua Pharmaceutical Co., Ltd. is a manufacturer specializing in production of corticosteroids APIs and related intermediates. We are also classified as “Enterprises of Cl...

Henan Lihua Pharmaceutical Co., Ltd. is a manufacturer specializing in production of corticosteroids APIs and related intermediates. We are also classified as “Enterprises of Class AA in Custom Management” as well as “National Hi-Tech Enterprise.” Our main products are: Prednisolone, Prednisone, Hydrocortisone, Betamethasone and their derivatives. The company takes great pride in the core values of Innovation, High Efficiency, Quality is morality. All products are produced in compliance with ICHQ7, cGMP, OHSAS18001 and other quality systems.
blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Drugs in Development

read-more
read-more

Details:

Zurzuvae (zuranolone), the first and only oral, once-daily, 14-day treatment course, has shown to provide rapid improvements in depressive symptoms at Day 15 and as early as Day 3 for women with PPD.


Lead Product(s): Zuranolone

Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Sage Therapeutics

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 14, 2023

blank

01

Biogen

U.S.A
arrow
Excipient World
Not Confirmed

Biogen

U.S.A
arrow
Excipient World
Not Confirmed

Details : Zurzuvae (zuranolone), the first and only oral, once-daily, 14-day treatment course, has shown to provide rapid improvements in depressive symptoms at Day 15 and as early as Day 3 for women with PPD.

Product Name : SAGE-217

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 14, 2023

blank

Details:

Zurzuvae (zuranolone), a neuroactive steroid GABA-A receptor positive allosteric modulator, is the first and only oral, once-daily, 14-day treatment approved by FDA, that can provide rapid improvements in depressive symptoms for women with postpartum depression.


Lead Product(s): Zuranolone

Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Biogen

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 31, 2023

blank

02

Excipient World
Not Confirmed
Excipient World
Not Confirmed

Details : Zurzuvae (zuranolone), a neuroactive steroid GABA-A receptor positive allosteric modulator, is the first and only oral, once-daily, 14-day treatment approved by FDA, that can provide rapid improvements in depressive symptoms for women with postpartum dep...

Product Name : SAGE-217

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

August 31, 2023

blank

Details:

SAGE-217 (zuranolone) is an oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). Currently being developed for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).


Lead Product(s): Zuranolone

Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Sage Therapeutics

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 03, 2023

blank

03

Biogen

U.S.A
arrow
Excipient World
Not Confirmed

Biogen

U.S.A
arrow
Excipient World
Not Confirmed

Details : SAGE-217 (zuranolone) is an oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). Currently being developed for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).

Product Name : SAGE-217

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

August 03, 2023

blank

Details:

SAGE-217 (zuranolone) is an oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). Currently being developed for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).


Lead Product(s): Zuranolone

Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Biogen

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 02, 2023

blank

04

Excipient World
Not Confirmed
Excipient World
Not Confirmed

Details : SAGE-217 (zuranolone) is an oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). Currently being developed for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).

Product Name : SAGE-217

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

June 02, 2023

blank

Details:

Zurzuvae (zuranolone), a neuroactive steroid GABA-A receptor positive allosteric modulator, is the first and only oral, once-daily, 14-day treatment approved by FDA, that can provide rapid improvements in depressive symptoms for women with postpartum depression.


Lead Product(s): Zuranolone

Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Sage Therapeutics

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 08, 2023

blank

05

Biogen

U.S.A
arrow
IPEC-Americas
Not Confirmed

Biogen

U.S.A
arrow
IPEC-Americas
Not Confirmed

Details : Zurzuvae (zuranolone), a neuroactive steroid GABA-A receptor positive allosteric modulator, is the first and only oral, once-daily, 14-day treatment approved by FDA, that can provide rapid improvements in depressive symptoms for women with postpartum dep...

Product Name : SAGE-217

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

April 08, 2023

blank

Details:

Zuranolone 50 mg demonstrated a clinically meaningful and statistically significant improvement in depressive symptoms at Day 15, the primary endpoint, and at Days 3, 28, and 45, key secondary endpoints as previously reported.


Lead Product(s): Zuranolone

Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Sage Therapeutics

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 17, 2022

blank

06

Biogen

U.S.A
arrow
Excipient World
Not Confirmed

Biogen

U.S.A
arrow
Excipient World
Not Confirmed

Details : Zuranolone 50 mg demonstrated a clinically meaningful and statistically significant improvement in depressive symptoms at Day 15, the primary endpoint, and at Days 3, 28, and 45, key secondary endpoints as previously reported.

Product Name : SAGE-217

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 17, 2022

blank

Details:

Zuranolone (SAGE-217/BIIB125) is a once-daily, 14-day, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).


Lead Product(s): Zuranolone

Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Biogen

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 19, 2022

blank

07

Excipient World
Not Confirmed
Excipient World
Not Confirmed

Details : Zuranolone (SAGE-217/BIIB125) is a once-daily, 14-day, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).

Product Name : SAGE-217

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

September 19, 2022

blank

Details:

SAGE-217 (zuranolone) is a once-daily, 14-day, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM).


Lead Product(s): Zuranolone

Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Sage Therapeutics

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 12, 2022

blank

08

Biogen

U.S.A
arrow
Excipient World
Not Confirmed

Biogen

U.S.A
arrow
Excipient World
Not Confirmed

Details : SAGE-217 (zuranolone) is a once-daily, 14-day, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an oral neuroactive steroid (NAS) GABA-A receptor positive allosteric m...

Product Name : SAGE-217

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

June 12, 2022

blank

Details:

At the Day 3 primary endpoint, SAGE-217/BIIB125 (Zuranolone), investigational oral neuroactive steroid GABA-A receptor-positive allosteric modulator, 50 mg co-initiated with a standard of care antidepressant showed a statistically significant reduction in depressive symptoms.


Lead Product(s): Zuranolone,Escitalopram Oxalate

Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Biogen

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 16, 2022

blank

09

Excipient World
Not Confirmed
Excipient World
Not Confirmed

Details : At the Day 3 primary endpoint, SAGE-217/BIIB125 (Zuranolone), investigational oral neuroactive steroid GABA-A receptor-positive allosteric modulator, 50 mg co-initiated with a standard of care antidepressant showed a statistically significant reduction i...

Product Name : SAGE-217

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 16, 2022

blank

Details:

SAGE-217/BIIB125 (zuranolone) is a once-daily, two-week, investigational drug in development for treatment of major depressive disorder and postpartum depression. Zuranolone is an investigational oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator.


Lead Product(s): Zuranolone

Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Biogen

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 05, 2022

blank

10

Excipient World
Not Confirmed
Excipient World
Not Confirmed

Details : SAGE-217/BIIB125 (zuranolone) is a once-daily, two-week, investigational drug in development for treatment of major depressive disorder and postpartum depression. Zuranolone is an investigational oral neuroactive steroid (NAS) GABA-A receptor positive al...

Product Name : SAGE-217

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 05, 2022

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

INTERMEDIATE SUPPLIERS

read-more
read-more

01

LinkChem

China
CST
Not Confirmed
arrow

LinkChem

China
CST
Not Confirmed
arrow

CAS Number : 1430063-93-6

End Use API : Zuranolone

About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDF Dossiers

read-more
read-more

01

Biogen

U.S.A
BPI Europe
Not Confirmed
arrow

Biogen

U.S.A
arrow
BPI Europe
Not Confirmed

ZURANOLONE

Brand Name : ZURZUVAE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 20MG

Packaging :

Approval Date : 2023-10-31

Application Number : 217369

Regulatory Info : RX

Registration Country : USA

blank

02

Biogen

U.S.A
BPI Europe
Not Confirmed
arrow

Biogen

U.S.A
arrow
BPI Europe
Not Confirmed

ZURANOLONE

Brand Name : ZURZUVAE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2023-10-31

Application Number : 217369

Regulatory Info : RX

Registration Country : USA

blank

03

Biogen

U.S.A
BPI Europe
Not Confirmed
arrow

Biogen

U.S.A
arrow
BPI Europe
Not Confirmed

ZURANOLONE

Brand Name : ZURZUVAE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 30MG

Packaging :

Approval Date : 2023-10-31

Application Number : 217369

Regulatory Info : RX

Registration Country : USA

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDA Orange Book

read-more
read-more

01

BIOGEN INC

U.S.A
Bioequity Europe
Not Confirmed
arrow

BIOGEN INC

U.S.A
arrow
Bioequity Europe
Not Confirmed

ZURANOLONE

Brand Name : ZURZUVAE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 20MG

Approval Date : 2023-10-31

Application Number : 217369

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

02

BIOGEN INC

U.S.A
Bioequity Europe
Not Confirmed
arrow

BIOGEN INC

U.S.A
arrow
Bioequity Europe
Not Confirmed

ZURANOLONE

Brand Name : ZURZUVAE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 25MG

Approval Date : 2023-10-31

Application Number : 217369

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

03

BIOGEN INC

U.S.A
Bioequity Europe
Not Confirmed
arrow

BIOGEN INC

U.S.A
arrow
Bioequity Europe
Not Confirmed

ZURANOLONE

Brand Name : ZURZUVAE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 30MG

Approval Date : 2023-10-31

Application Number : 217369

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Digital Content read-more

Create Content with PharmaCompass, ask us

DATA COMPILATION #PharmaFlow

read-more
read-more

STOCK RECAP #PipelineProspector

read-more
read-more
Pipeline Prospector July 2024: Indices continue to climb; Lilly buys Morphic for US$ 3.2 bn, Kisunla bags FDA nod
The biotechnology sector ended in the green for the third month in a row in July, significantly outperforming the broader market. The Nasdaq Biotechnology Index (NBI) climbed by a robust 6.6 percent, closing at 4,843.6, up from a close of 4,545.28 in June. Similarly, the SPDR S&P Biotech ETF (XBI) index surged by 6.8 percent, reaching 99.06, up from June’s closing of 92.71. The S&P Biotechnology Select Industry Index (SPSIBI) followed suit, jumping 6.8 percent to 7,716.95 compared to a 4.25 percent rise in June, when it closed at 7,225.07.The month saw a few significant deals. Eli Lilly announced the acquisition of Massachusetts-based Morphic Holding for approximately US$ 3.2 billion in cash, bolstering its presence in the US$ 26.65 billion inflammatory bowel disease (IBD) market. Lilly also signed a strategic deal with radiopharmaceutical company Radionetics Oncology for US$ 140 million, with an option to purchase the entire company for US$ 1 billion. As the month drew to a close, Boehringer Ingelheim said it is acquiring Nerio Therapeutics for up to US$ 1.3 billion, in order to expand its immuno-oncology portfolio. Access the Pipeline Prospector Dashboard for July 2024 Newsmakers (Free Excel)Lilly’s donanemab finally gets approved; Dupixent okayed as add-on therapy for COPDWith the Alzheimer's Association International Conference (AAIC) taking place in Philadelphia (in the US), the spotlight was firmly on Alzheimer’s disease. In the last week of July, the US Food and Drug Administration (FDA) approved Alpha Cognition’s Zunveyl (benzgalantamine) to treat mild-to-moderate Alzheimer’s disease. In early July, and weeks prior to the conference, the FDA had granted a long-awaited approval to Eli Lilly’s donanemab, to be marketed as Kisunla, for the treatment of early symptomatic Alzheimer’s disease.In other approvals, European regulators became the first in the world to approve Sanofi and Regeneron’s Dupixent as an add-on therapy for chronic obstructive pulmonary disease (COPD) patients with high levels of certain white blood cells.In May, FDA had extended its target action date of its priority review of Dupixent as an add-on maintenance treatment for COPD by three months. The revised target action date is now September 27, 2024. Access the Pipeline Prospector Dashboard for July 2024 Newsmakers (Free Excel)Merck’s RSV jab shows efficacy in infants; GSK’s Dovato measures up to Gilead’s BiktarvyMerck said its monoclonal antibody jab to protect infants against RSV-related infections has met the main goals of a mid-to-late-stage trial. Clesrovimab reduced medically attended lower respiratory infections caused by RSV through day 150. Merck plans to submit the data to global regulators. Currently, Sanofi and Astra’s Beyfortus is approved by the FDA to prevent RSV in children up to 24 months.In the largest study of its kind, GSK’s HIV drug Dovato was found to be non-inferior to Gilead Sciences’ Biktarvy, which is seen as the benchmark for HIV treatment. Significantly, Dovato did so with lesser weight gain in a 48-week head-to-head study of virologically suppressed HIV-1 patients. Both Dovato and Biktarvy are single pill treatments for HIV given once a day. Biktarvy raked in US$ 11.9 billion in 2023.Pfizer’s gene therapy for hemophilia A, giroctocogene fitelparvovec, showed promising results in a late-stage trial by significantly reducing the number of annual bleeding episodes. This brings Pfizer closer to securing FDA approval, competing with BioMarin’s Roctavian. Pfizer also said it is moving ahead to mid-stage trials with a once-daily version of its glucagon-like peptide 1 (GLP-1) drug danuglipron for weight loss. In December, Pfizer had discontinued a twice-daily version of danuglipron on account of side effects. Pfizer’s stock also benefited from its healthy second quarter (Q2) results.Swiss drugmaker Roche is reintroducing Susvimo in the US after voluntarily recalling it in October 2022. The implant used to treat patients with neovascular age-related macular degeneration (wet AMD) requires a one-time surgery to be inserted into the eye.Roche also revealed that a second drug candidate from its up to US$ 3.1 billion buyout of Carmot Therapeutics — an obesity drug —  has delivered promising results in an early-stage trial. This once-daily weight-loss pill CT-996 reduced on average 6.1 percent of participants’ starting weight after four weeks. CT-996 works in a similar manner as other blockbuster weight loss drugs, such as Wegovy and Zepbound. Access the Pipeline Prospector Dashboard for July 2024 Newsmakers (Free Excel)Biogen-Sage’s essential tremor drug rejected; Novo’s weekly insulin hit with FDA’s CRL Several drugmakers faced setbacks last month. Novo Nordisk received a complete response letter (CRL) from the FDA, declining approval for its weekly insulin Awiqli. The agency requested additional information related to the manufacturing process, as well as on the type 1 diabetes indication. In May, an FDA panel had voted seven to four against the benefits of Awiqli outweighing its risks. Sage and Biogen’s partnership experienced another setback after the failure of their drug SAGE-324 in a phase 2 trial for essential tremor, a disorder that causes uncontrollable shaking of hands, arms and other parts of the body. This follows the previous failure of Zurzuvae to secure an FDA approval for clinical depression.Meanwhile, Eisai and Biogen’s Alzheimer’s drug Leqembi, faced a setback in Europe when the EU drugs regulator rejected its approval. The European Medicines Agency said the drug’s meager benefit on slowing cognitive decline in early Alzheimer’s did not outweigh the risk it brings of serious brain swelling. Leqembi is approved in the US market, where it has a new competitor — Lilly’s Kisunla.Also, BMS walked away from its rights to the ADC farletuzumab ecteribulin after having paid Japanese drugmaker Eisai US$ 650 million. As part of its portfolio reprioritization, BMS decided to end the co-development agreement. Access the Pipeline Prospector Dashboard for July 2024 Newsmakers (Free Excel) Our viewAs July drew to a close, several pharma majors announced their second quarter (Q2) earnings, including Pfizer, Merck, AbbVie and, AstraZeneca. Most of these drugmakers ended up beating Wall Street expectations. For instance, Pfizer saw revenue growth in Q2 after shrinking for five quarters. It posted revenues of US$ 13.3 billion in the second quarter of 2024, compared to US$ 13 billion in the corresponding quarter last year. It has subsequently raised its 2024 guidance by US$ 1 billion. This means it’s not just the indices and share prices, but even the brass tacks — the top line and the bottomline of drugmakers — are looking up. And that may bring more cheer to the markets in August. Access the Pipeline Prospector Dashboard for July 2024 Newsmakers (Free Excel) 

Impressions: 2463

https://www.pharmacompass.com/pipeline-prospector-blog/indices-continue-to-climb-lilly-buys-morphic-for-us-3-2-bn-its-alzheimer-s-drug-finally-bags-fda-nod

#PharmaFlow by PHARMACOMPASS
01 Aug 2024

NEWS #PharmaBuzz

read-more
read-more

https://www.businesswire.com/news/home/20250428466645/en/Sage-Therapeutics-Announces-First-Quarter-2025-Financial-Results-and-Highlights-Pipeline-and-Business-Updates

BUSINESSWIRE
29 Apr 2025

https://www.fiercepharma.com/pharma/sage-discontinues-zulresso-drops-pair-pipeline-prospects

FIERCE PHARMA
30 Oct 2024

https://www.businesswire.com/news/home/20241029531414/en

BUSINESSWIRE
29 Oct 2024

https://www.expresspharma.in/zuranolone-to-face-challenges-in-japans-mdd-market-despite-demonstrating-rapid-onset-of-action-globaldata/

EXPRESSPHARMA
21 Oct 2024

https://www.businesswire.com/news/home/20240925189899/en

BUSINESSWIRE
26 Sep 2024

https://www.businesswire.com/news/home/20240731771837/en

BUSINESSWIRE
31 Jul 2024

Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

US Patents

read-more
read-more

01

arrow
BPI Europe
Not Confirmed

BIOGEN INC

U.S.A
arrow
BPI Europe
Not Confirmed

ZURANOLONE

US Patent Number : 10342810

Drug Substance Claim :

Drug Product Claim :

Application Number : 217369

Patent Use Code : U-2552

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-04-17

blank

02

arrow
BPI Europe
Not Confirmed

BIOGEN INC

U.S.A
arrow
BPI Europe
Not Confirmed

ZURANOLONE

US Patent Number : 11236121

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 217369

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-08-23

blank

03

arrow
BPI Europe
Not Confirmed

BIOGEN INC

U.S.A
arrow
BPI Europe
Not Confirmed

ZURANOLONE

US Patent Number : 11236121

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 217369

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-08-23

blank

04

arrow
BPI Europe
Not Confirmed

BIOGEN INC

U.S.A
arrow
BPI Europe
Not Confirmed

ZURANOLONE

US Patent Number : 10342810

Drug Substance Claim :

Drug Product Claim :

Application Number : 217369

Patent Use Code : U-2552

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-04-17

blank

05

arrow
BPI Europe
Not Confirmed

BIOGEN INC

U.S.A
arrow
BPI Europe
Not Confirmed

ZURANOLONE

US Patent Number : 9512165

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 217369

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-04-17

blank

06

arrow
BPI Europe
Not Confirmed

BIOGEN INC

U.S.A
arrow
BPI Europe
Not Confirmed

ZURANOLONE

US Patent Number : 10172871

Drug Substance Claim :

Drug Product Claim :

Application Number : 217369

Patent Use Code : U-2552

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-04-17

blank

07

arrow
BPI Europe
Not Confirmed

BIOGEN INC

U.S.A
arrow
BPI Europe
Not Confirmed

ZURANOLONE

US Patent Number : 10172871

Drug Substance Claim :

Drug Product Claim :

Application Number : 217369

Patent Use Code : U-2552

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-04-17

blank

08

arrow
BPI Europe
Not Confirmed

BIOGEN INC

U.S.A
arrow
BPI Europe
Not Confirmed

ZURANOLONE

US Patent Number : 11884696

Drug Substance Claim :

Drug Product Claim :

Application Number : 217369

Patent Use Code : U-2552

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-08-23

blank

09

arrow
BPI Europe
Not Confirmed

BIOGEN INC

U.S.A
arrow
BPI Europe
Not Confirmed

ZURANOLONE

US Patent Number : 10172871

Drug Substance Claim :

Drug Product Claim :

Application Number : 217369

Patent Use Code : U-2552

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-04-17

blank

10

arrow
BPI Europe
Not Confirmed

BIOGEN INC

U.S.A
arrow
BPI Europe
Not Confirmed

ZURANOLONE

US Patent Number : 11884696

Drug Substance Claim :

Drug Product Claim :

Application Number : 217369

Patent Use Code : U-2552

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-08-23

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

US Exclusivities

read-more
read-more

01

arrow
CST
Not Confirmed

BIOGEN INC

U.S.A
arrow
CST
Not Confirmed

ZURANOLONE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2028-10-31

Application Number : 217369

Product Number : 1

Exclusivity Details :

blank

02

arrow
CST
Not Confirmed

BIOGEN INC

U.S.A
arrow
CST
Not Confirmed

ZURANOLONE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2028-10-31

Application Number : 217369

Product Number : 2

Exclusivity Details :

blank

03

arrow
CST
Not Confirmed

BIOGEN INC

U.S.A
arrow
CST
Not Confirmed

ZURANOLONE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2028-10-31

Application Number : 217369

Product Number : 3

Exclusivity Details :

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

ABOUT THIS PAGE

Looking for 1632051-40-1 / Zuranolone API manufacturers, exporters & distributors?

Zuranolone manufacturers, exporters & distributors 1

62

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

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

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

API | Excipient name

Zuranolone

Synonyms

Sage-217, 1632051-40-1, Zuranolone [inn], Zuranolone [usan], Sge-797, Chembl4105630

Cas Number

1632051-40-1

Unique Ingredient Identifier (UNII)

7ZW49N180B

Zuranolone Manufacturers

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

Zuranolone Suppliers

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

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

Zuranolone 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 Zuranolone as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Zuranolone 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 Zuranolone 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 Zuranolone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zuranolone NDC to their finished compounded human drug products, they may choose to do so.

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

Zuranolone GMP

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

Zuranolone CoA

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

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

Zuranolone may be tested according to a variety of international standards, such as European Pharmacopoeia (Zuranolone EP), Zuranolone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zuranolone 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.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty