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Chemistry

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Also known as: 1315449-72-9, Lci699-aza, Unii-y6581yaw9v, Osilodrostat phosphate [usan], Y6581yaw9v, Isturisa
Molecular Formula
C13H13FN3O4P
Molecular Weight
325.23  g/mol
InChI Key
FMCPYRDGUZBOJZ-BTQNPOSSSA-N
FDA UNII
Y6581YAW9V

Osilodrostat Phosphate
1 2D Structure

Osilodrostat Phosphate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-[(5R)-6,7-dihydro-5H-pyrrolo[1,2-c]imidazol-5-yl]-3-fluorobenzonitrile;phosphoric acid
2.1.2 InChI
InChI=1S/C13H10FN3.H3O4P/c14-12-5-9(6-15)1-3-11(12)13-4-2-10-7-16-8-17(10)13;1-5(2,3)4/h1,3,5,7-8,13H,2,4H2;(H3,1,2,3,4)/t13-;/m1./s1
2.1.3 InChI Key
FMCPYRDGUZBOJZ-BTQNPOSSSA-N
2.1.4 Canonical SMILES
C1CC2=CN=CN2C1C3=C(C=C(C=C3)C#N)F.OP(=O)(O)O
2.1.5 Isomeric SMILES
C1CC2=CN=CN2[C@H]1C3=C(C=C(C=C3)C#N)F.OP(=O)(O)O
2.2 Other Identifiers
2.2.1 UNII
Y6581YAW9V
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (+)-osilodrostat

2. 4-((5r)-6,7-dihydro-5h-pyrrolo(1,2-c)imidazol-5-yl)-3-fluoro-benzonitrile

3. Benzonitrile, 4-((5r)-6,7-dihydro-5h-pyrrolo(1,2-c)imidazol-5-yl)-3-fluoro-

4. Isturisa

5. Lci699

6. Osilodrostat

2.3.2 Depositor-Supplied Synonyms

1. 1315449-72-9

2. Lci699-aza

3. Unii-y6581yaw9v

4. Osilodrostat Phosphate [usan]

5. Y6581yaw9v

6. Isturisa

7. Osilodrostat(lci699) Phosphate

8. Osilodrostat (phosphate)

9. 4-((5r)-6,7-dihydro-5h-pyrrolo(1,2-c)imidazol-5-yl)-3-fluorobenzonitrile Dihydrogen Phosphate

10. 4-[(5r)-6,7-dihydro-5h-pyrrolo[1,2-c]imidazol-5-yl]-3-fluorobenzonitrile;phosphoric Acid

11. Benzonitrile, 4-((5r)-6,7-dihydro-5h-pyrrolo(1,2-c)imidazol-5-yl)-3-fluoro-, Phosphate (1:1)

12. Isturisa (tn)

13. 4-[(5r)-6,7-dihydro-5h-pyrrolo[1,2-c]imidazol-5-yl]-3-fluorobenzonitrile Dihydrogen Phosphate

14. Chembl3707393

15. Schembl13837602

16. Dtxsid401027857

17. Osilodrostat Phosphate [mi]

18. Osilodrostat Phosphate (jan/usan)

19. Osilodrostat Phosphate [jan]

20. Hy-16276a

21. Akos040749099

22. Osilodrostat Phosphate [who-dd]

23. Da-76469

24. Osilodrostat Phosphate [orange Book]

25. Cs-0068058

26. D11062

27. Q27294304

28. 4-((5r)-6,7-dihydro-5h-pyrrolo(1,2-c)imidazol-5-yl)-3-fluorobenzonitrile Monophosphate

2.3.3 Other Synonyms

1. Lci699

2. Osilodrostat

3. Osilodrostat (lci699)

4. Osilodrostat Free Base

2.4 Create Date
2013-03-21
3 Chemical and Physical Properties
Molecular Weight 325.23 g/mol
Molecular Formula C13H13FN3O4P
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count7
Rotatable Bond Count1
Exact Mass g/mol
Monoisotopic Mass g/mol
Topological Polar Surface Area119
Heavy Atom Count22
Formal Charge0
Complexity387
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

Isturisa is indicated for the treatment of endogenous Cushing's syndrome in adults.


5 Pharmacology and Biochemistry
5.1 ATC Code

H02CA02


API SUPPLIERS

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01

Alven Laboratories

Czech Republic

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

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Biophore India Pharmaceuticals Pvt...

India

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

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Metrochem API Private Limited

India

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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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Maithri Drugs

India

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

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Virtual BoothMaithri Drugs: Dedicated to your API needs.

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Recordati

Italy

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euroPLX 90 Lisbon
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Recordati

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Biosynth AG

Switzerland

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Biosynth AG

Switzerland

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BOC Sciences

U.S.A

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euroPLX 90 Lisbon
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BOC Sciences

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Amadis Chemical

China

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euroPLX 90 Lisbon
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Amadis Chemical

China

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AstaTech

U.S.A

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euroPLX 90 Lisbon
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AstaTech

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Venkatasai Life Sciences

India

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euroPLX 90 Lisbon
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Venkatasai Life Sciences

India

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Listed Suppliers

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Alven Laboratories

Czech Republic
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Virtual BoothTrusted Partner for Innovative, Sustainable, and High-Quality API Development and Production.

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Osilodrostat Phosphate

About the Company : Alven Laboratories is a pharmaceutical company focused on the development, scale-up, and production of original and generic Active Pharmaceutical Ingredients (APIs). With expertise...

Alven Laboratories is a pharmaceutical company focused on the development, scale-up, and production of original and generic Active Pharmaceutical Ingredients (APIs). With expertise in complex molecule chemistry and organic synthesis, the company delivers cost-efficient and technologically advanced solutions. Its cGMP-compliant facility supports efficient manufacturing with an emphasis on environmental sustainability, offering reliable and flexible services from early development through commercial production. Note:Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
AlvenLab

02

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

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Osilodrostat Phosphate

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

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

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Osilodrostat

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

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

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Osilodrostat Phosphate

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

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

U.S.A
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Osilodrostat

About the Company : BOC Sciences is a brand of BOCSCI Inc. We leverage our wide spectrum of business in the fields of development, manufacturing, marketing, and distribution to help you make best-info...

BOC Sciences is a brand of BOCSCI Inc. We leverage our wide spectrum of business in the fields of development, manufacturing, marketing, and distribution to help you make best-informed decisions tailored to your evolving needs for premium chemicals. Our complete suite of CRO services spans the entire molecule development pipeline including contract research for target identification, building blocks, compound synthesis, biochemical and cellular analysis, preclinical animal tests, and clinical studies.
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DC Chemicals

China
euroPLX 90 Lisbon
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DC Chemicals

China
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Osilodrostat

About the Company : DC Chemicals is a fine organics manufacturing facility based in Shanghai, P.R. China. The company offers a wide range of research chemicals and biochemicals, including novel life-s...

DC Chemicals is a fine organics manufacturing facility based in Shanghai, P.R. China. The company offers a wide range of research chemicals and biochemicals, including novel life-science reagents, reference compounds, APIs, and natural compounds for laboratory and scientific use.
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Osilodrostat

About the Company : Glixx Laboratories Inc (Glixx) is a global leading company specializing in biological research chemicals, providing services to meet the needs of biomedical research markets. With ...

Glixx Laboratories Inc (Glixx) is a global leading company specializing in biological research chemicals, providing services to meet the needs of biomedical research markets. With its fast and efficient synthesis, the Glixx R&D team focuses on commercializing newly discovered research chemicals and bringing them to the life sciences R&D communities. Our company goal is to help our community by lowering the cost of the essential chemicals for research needs, to better progress on to new discoveries in drug development, medical screening, and all facets of scientific innovations.
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Osilodrostat

About the Company : Hefei Home Sunshine Pharmaceutical Technology Co., Ltd.is a high-tech enterprise, which is an integration of R & D, producing and custom synthesis. The products quality is assured ...

Hefei Home Sunshine Pharmaceutical Technology Co., Ltd.is a high-tech enterprise, which is an integration of R & D, producing and custom synthesis. The products quality is assured because of our continuously-optimizing management and technology innovation, complete QA system, advanced testing methods and equipments. We have won the trust of a wide range of customers/partners in the industry. Our Products include active pharmaceutical ingredients (API), pharmaceutical and agrochemical intermediates and chiral compounds.
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Osilodrostat

About the Company : Sapphire Biotech, Inc. is dedicated to improving lives around the world through advancing global cancer care with innovative research and discovery methods. Our mission is to impro...

Sapphire Biotech, Inc. is dedicated to improving lives around the world through advancing global cancer care with innovative research and discovery methods. Our mission is to improve global cancer care through the development of novel Therapeutics for inhibiting metastatic cancer growth, Diagnostic for early cancer detection, response to treatment, and recurrence monitoring.
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Osilodrostat

About the Company : Shanghai Yifei Biotechnology Co., Ltd., located in Shanghai, China's high-tech and educational hub, is a comprehensive biotechnology company specializing in product research and de...

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Drugs in Development

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Details:

Osilodrostat Phosphate is a small molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Hypertension-associated with Hypercortisolaemia.


Lead Product(s): Osilodrostat Phosphate,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 25, 2025

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01

Recordati

Italy
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BIO CEO & Investor
Not Confirmed

Recordati

Italy
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BIO CEO & Investor
Not Confirmed

Details : Osilodrostat Phosphate is a small molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Hypertension-associated with Hypercortisolaemia.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

November 25, 2025

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Details:

Osilodrostat is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of unspecified medical condition.


Lead Product(s): Osilodrostat Phosphate,Inapplicable

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Recordati Rare Diseases

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 05, 2025

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02

Mayo Clinic

U.S.A
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BIO CEO & Investor
Not Confirmed

Mayo Clinic

U.S.A
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BIO CEO & Investor
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Details : Osilodrostat is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of unspecified medical condition.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 05, 2025

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Details:

Isturisa (osilodrostat phosphate) is approved for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome.


Lead Product(s): Osilodrostat Phosphate,Inapplicable

Therapeutic Area: Endocrinology Brand Name: Isturisa

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 16, 2025

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03

Recordati

Italy
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BIO CEO & Investor
Not Confirmed

Recordati

Italy
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BIO CEO & Investor
Not Confirmed

Details : Isturisa (osilodrostat phosphate) is approved for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome.

Product Name : Isturisa

Product Type : Miscellaneous

Upfront Cash : Inapplicable

April 16, 2025

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Details:

Isturisa (osilodrostat phosphate) is an oral inhibitor of CYP11B1, which catalyses the final step of cortisol synthesis in the adrenal glands. It is being evaluated for endogenous Cushing’s syndrome .


Lead Product(s): Osilodrostat Phosphate,Inapplicable

Therapeutic Area: Endocrinology Brand Name: Isturisa

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 16, 2024

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04

BIO CEO & Investor
Not Confirmed
BIO CEO & Investor
Not Confirmed

Details : Isturisa (osilodrostat phosphate) is an oral inhibitor of CYP11B1, which catalyses the final step of cortisol synthesis in the adrenal glands. It is being evaluated for endogenous Cushing’s syndrome .

Product Name : Isturisa

Product Type : Miscellaneous

Upfront Cash : Inapplicable

May 16, 2024

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Details:

Isturisa (osilodrostat phosphate) is an oral inhibitor of 11β-hydroxylase (CYP11B1), which catalyses the final step of cortisol synthesis in the adrenal glands. Isturisa® is available as 1 mg, 5 mg and 10 mg film-coated tablets.


Lead Product(s): Osilodrostat Phosphate,Inapplicable

Therapeutic Area: Endocrinology Brand Name: Isturisa

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 31, 2022

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05

Recordati

Italy
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BIO CEO & Investor
Not Confirmed

Recordati

Italy
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BIO CEO & Investor
Not Confirmed

Details : Isturisa (osilodrostat phosphate) is an oral inhibitor of 11β-hydroxylase (CYP11B1), which catalyses the final step of cortisol synthesis in the adrenal glands. Isturisa® is available as 1 mg, 5 mg and 10 mg film-coated tablets.

Product Name : Isturisa

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 31, 2022

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Details:

ISTURISA® (osilodrostat), a cortisol synthesis inhibitor that works by inhibiting 11-beta-hydroxylase maintained normal mean urinary free cortisol (mUFC) long-term in patients with Cushing’s disease.


Lead Product(s): Osilodrostat Phosphate,Inapplicable

Therapeutic Area: Endocrinology Brand Name: Isturisa

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 15, 2022

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06

BIO CEO & Investor
Not Confirmed
BIO CEO & Investor
Not Confirmed

Details : ISTURISA® (osilodrostat), a cortisol synthesis inhibitor that works by inhibiting 11-beta-hydroxylase maintained normal mean urinary free cortisol (mUFC) long-term in patients with Cushing’s disease.

Product Name : Isturisa

Product Type : Miscellaneous

Upfront Cash : Inapplicable

June 15, 2022

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Details:

ISTURISA (osilodrostat), is a cortisol synthesis inhibitor indicated for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.


Lead Product(s): Osilodrostat Phosphate,Inapplicable

Therapeutic Area: Endocrinology Brand Name: Isturisa

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 08, 2022

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07

Recordati

Italy
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BIO CEO & Investor
Not Confirmed

Recordati

Italy
arrow
BIO CEO & Investor
Not Confirmed

Details : ISTURISA (osilodrostat), is a cortisol synthesis inhibitor indicated for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.

Product Name : Isturisa

Product Type : Miscellaneous

Upfront Cash : Inapplicable

June 08, 2022

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Details:

LINC 3 study demonstrated that Isturisa (osilodrostat) therapy provided long-term mean urinary free cortisol control and clinical improvements, with decreases inpatient weight and the severity of physical features, including hirsutism, that were maintained through to week 72.


Lead Product(s): Osilodrostat Phosphate,Inapplicable

Therapeutic Area: Endocrinology Brand Name: Isturisa

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 13, 2022

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08

BIO CEO & Investor
Not Confirmed
BIO CEO & Investor
Not Confirmed

Details : LINC 3 study demonstrated that Isturisa (osilodrostat) therapy provided long-term mean urinary free cortisol control and clinical improvements, with decreases inpatient weight and the severity of physical features, including hirsutism, that were maintain...

Product Name : Isturisa

Product Type : Miscellaneous

Upfront Cash : Inapplicable

May 13, 2022

blank

Details:

Isturisa (osilodrostat) is a cortisol synthesis inhibitor indicated for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.


Lead Product(s): Osilodrostat Phosphate,Inapplicable

Therapeutic Area: Endocrinology Brand Name: Isturisa

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 10, 2022

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09

BIO CEO & Investor
Not Confirmed
BIO CEO & Investor
Not Confirmed

Details : Isturisa (osilodrostat) is a cortisol synthesis inhibitor indicated for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.

Product Name : Isturisa

Product Type : Miscellaneous

Upfront Cash : Inapplicable

May 10, 2022

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Details:

The LINC 4 study demonstrated superiority of ISTURISA® (osilodrostat) over placebo in achieving cortisol control during the 12-week, double-blind, randomized phase (77% vs 8%, P<0.0001).


Lead Product(s): Osilodrostat Phosphate,Inapplicable

Therapeutic Area: Endocrinology Brand Name: Isturisa

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 29, 2022

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10

BIO CEO & Investor
Not Confirmed
BIO CEO & Investor
Not Confirmed

Details : The LINC 4 study demonstrated superiority of ISTURISA® (osilodrostat) over placebo in achieving cortisol control during the 12-week, double-blind, randomized phase (77% vs 8%, P<0.0001).

Product Name : Isturisa

Product Type : Miscellaneous

Upfront Cash : Inapplicable

March 29, 2022

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Osilodrostat Phosphate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Osilodrostat Phosphate

Synonyms

1315449-72-9, Lci699-aza, Unii-y6581yaw9v, Osilodrostat phosphate [usan], Y6581yaw9v, Isturisa

Cas Number

1315449-72-9

Unique Ingredient Identifier (UNII)

Y6581YAW9V

Osilodrostat Manufacturers

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

Osilodrostat Suppliers

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

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

Osilodrostat USDMF

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

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

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

Osilodrostat GMP

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

Osilodrostat CoA

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

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

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