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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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Alven Laboratories

Czech Republic

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Metrochem API Private Limited

India

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Recordati

Italy

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Biosynth AG

Switzerland

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BOC Sciences

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Amadis Chemical

China

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Amadis Chemical

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AstaTech

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Chemicea

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Evitachem

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Sichuan Taienkang Pharmaceutical

China

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Listed Suppliers

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Alven Laboratories

Czech Republic
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Osilodrostat Phosphate

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

Alven Laboratories is a pharmaceutical company specializing in the development, scale-up, and production of original and generic Active Pharmaceutical Ingredients (APIs). With expertise in complex molecule chemistry and organic synthesis, we offer cost-efficient, technologically advanced solutions. Our cGMP-compliant facility ensures high production efficiency with a focus on environmental sustainability. From early-stage development to market approvals and commercial production, we provide reliable, flexible, and high-quality services, making us a trusted partner in the pharmaceutical industry.
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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
Metrochem

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Osilodrostat

About the Company : Amadis Chemical Company Limited has become a professional innovative chemical product manufacturer and a technical service provider. We're specialists in sales, manufacture, and ...

Amadis Chemical Company Limited has become a professional innovative chemical product manufacturer and a technical service provider. We're specialists in sales, manufacture, and service covering building block, key intermediate and API especially for the service of process development, pilot scale and manufacture. And the core products are Carbohydrates, Nucleosides, Nucleotides, Phosphonamidites, APIS and Pharmaceutical intermediates.
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Evitachem

U.S.A
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Evitachem

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Osilodrostat

About the Company : EvitaChem, headquartered in California, USA, stands as a premier global manufacturer and provider of high-quality specialty chemicals. Our diverse range includes building blocks, i...

EvitaChem, headquartered in California, USA, stands as a premier global manufacturer and provider of high-quality specialty chemicals. Our diverse range includes building blocks, innovative life-science reagents, reference compounds, APIs, and natural compounds tailored for laboratory and scientific applications. Expanding our reach, we've established representatives and branch offices across the East Coast of the US, Europe, and Asia. Our clientele comprises academic, industrial, and government research and development labs, alongside commercial enterprises in the pharmaceutical and chemical sectors.
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FandaChem

China
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FandaChem

China
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Osilodrostat

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

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

U.S.A
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GLP Bio

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Osilodrostat

About the Company : Glpbio Technology Inc is a leading supplier specializing in small molecule inhibitors, activators, compound libraries, peptides, and laboratory reagents. With a vast inventory of o...

Glpbio Technology Inc is a leading supplier specializing in small molecule inhibitors, activators, compound libraries, peptides, and laboratory reagents. With a vast inventory of over 30,000 products spanning more than 20 research fields including cancer, immunology, neurosciences, apoptosis, and epigenetics, Glpbio offers a comprehensive range of solutions for scientific research. Our commitment to quality and innovation ensures that researchers worldwide have access to high-quality tools and compounds essential for advancing discoveries in biomedicine and beyond.
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Osilodrostat

About the Company : Hanhong Scientific, founded in 2003, focuses on researching, developing, manufacturing, and exporting unnatural amino acids, nucleosides, nucleotides, chiral chemicals, APIs, and o...

Hanhong Scientific, founded in 2003, focuses on researching, developing, manufacturing, and exporting unnatural amino acids, nucleosides, nucleotides, chiral chemicals, APIs, and other fine chemicals for drug discovery and production in China. Its core business includes advanced chemical reagents (mainly building blocks), APIs and intermediates, and custom synthesis. The company employs senior researchers, including doctors, professors, and organic chemistry experts, and has built an R&D center in universities. Hanhong Scientific operates a plant with over 120 reactors ranging from 10L to 5000L.
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Leapchem

China
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Leapchem

China
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Osilodrostat

About the Company : LEAPChem is a specialized fine chemical supplier for research, development and production. LEAPChem provides nearly 200,000 rare and innovative chemical products to support the evo...

LEAPChem is a specialized fine chemical supplier for research, development and production. LEAPChem provides nearly 200,000 rare and innovative chemical products to support the evolving needs of our customers in research & bulk manufacturing activities. As a highly customer-oriented enterprise, we are committed to providing high-quality customer services and products to our global customers in a cost-effective and efficient manner. Our client list includes many major pharmaceutical and science companies, universities, research institutions and chemical catalogue companies.
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Osilodrostat

About the Company : Sun-shine chemical has over 1,500m² of operation premises. The R&D laboratory is more than 1,000m² and is equipped with a variety of R&D laboratory equipment. The quality control...

Sun-shine chemical has over 1,500m² of operation premises. The R&D laboratory is more than 1,000m² and is equipped with a variety of R&D laboratory equipment. The quality control management laboratory is over 200m², equipped with high-efficient liquid chromatograph, digital melting point apparatus, digital polarimeter, UV spectrophotometer, etc. We have set up one kilogram-level intermediate laboratories, which may ensure growing customer demand and smooth commercial production. Sun-shine chemical is a reliable world supplier in fine chemicals and custom manufacturing.
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Osilodrostat

About the Company : LS (United Life Science) aims to be a leading global supplier of innovative, high-quality life science products, including inhibitors, agonists, API impurity standards, natural pro...

LS (United Life Science) aims to be a leading global supplier of innovative, high-quality life science products, including inhibitors, agonists, API impurity standards, natural products, and peptide compounds. Specializing in small molecule inhibitors and agonists, ULS boasts years of development experience and a seasoned team of chemists and biologists. Our comprehensive quality management system, from product preparation and analysis to biological activity data, ensures we deliver superior products efficiently.
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Drugs in Development

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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: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 16, 2025

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01

Recordati

Italy
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Pharmaconex
Not Confirmed

Recordati

Italy
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Pharmaconex
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 : Other Small Molecule

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: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 16, 2024

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02

Pharmaconex
Not Confirmed
Pharmaconex
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 : Other Small Molecule

Upfront Cash : Inapplicable

May 16, 2024

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: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 05, 2022

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03

Pharmaconex
Not Confirmed
Pharmaconex
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 : Other Small Molecule

Upfront Cash : Inapplicable

October 05, 2022

blank

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: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 31, 2022

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04

Recordati

Italy
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Pharmaconex
Not Confirmed

Recordati

Italy
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Pharmaconex
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 : Other Small Molecule

Upfront Cash : Inapplicable

August 31, 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: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 06, 2022

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05

Recordati

Italy
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Pharmaconex
Not Confirmed

Recordati

Italy
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Pharmaconex
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 : Other Small Molecule

Upfront Cash : Inapplicable

August 06, 2022

blank

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: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 15, 2022

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06

Pharmaconex
Not Confirmed
Pharmaconex
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 : Other Small Molecule

Upfront Cash : Inapplicable

June 15, 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: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 13, 2022

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07

Pharmaconex
Not Confirmed
Pharmaconex
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 : Other Small Molecule

Upfront Cash : Inapplicable

May 13, 2022

blank

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: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 29, 2022

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08

Pharmaconex
Not Confirmed
Pharmaconex
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 : Other Small Molecule

Upfront Cash : Inapplicable

March 29, 2022

blank

Details:

Isturisa (osilodrostat phosphate) is an oral inhibitor of 11β-hydroxylase (CYP11B1), which catalyses the final step of cortisol synthesis in the adrenal glands. It is approved for Cushing Syndrome.


Lead Product(s): Osilodrostat Phosphate,Inapplicable

Therapeutic Area: Endocrinology Brand Name: Isturisa

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 03, 2020

blank

09

Pharmaconex
Not Confirmed
Pharmaconex
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. It is approved for Cushing Syndrome.

Product Name : Isturisa

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

September 03, 2020

blank

Details:

Data from the Phase III LINC-3 study, published in Lancet Diabetes & Endocrinology, demonstrate that Isturisa® (osilodrostat) rapidly decreases mean urinary free cortisol (mUFC) in patients with Cushing’s disease.


Lead Product(s): Osilodrostat Phosphate,Inapplicable

Therapeutic Area: Endocrinology Brand Name: Isturisa

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 28, 2020

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10

Recordati

Italy
arrow
Pharmaconex
Not Confirmed

Recordati

Italy
arrow
Pharmaconex
Not Confirmed

Details : Data from the Phase III LINC-3 study, published in Lancet Diabetes & Endocrinology, demonstrate that Isturisa® (osilodrostat) rapidly decreases mean urinary free cortisol (mUFC) in patients with Cushing’s disease.

Product Name : Isturisa

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

July 28, 2020

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FDF Dossiers

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01

CPHI Shenzhen
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Osilodrostat

Brand Name : Isturisa

Dosage Form : Tablet

Dosage Strength : 1MG

Packaging :

Approval Date :

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Regulatory Info :

Registration Country :

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Osilodrostat

Brand Name : Isturisa

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging :

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Regulatory Info :

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Recordati

Italy
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OSILODROSTAT PHOSPHATE

Brand Name : ISTURISA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Packaging :

Approval Date : 2020-03-06

Application Number : 212801

Regulatory Info : RX

Registration Country : USA

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OSILODROSTAT PHOSPHATE

Brand Name : ISTURISA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Packaging :

Approval Date : 2020-03-06

Application Number : 212801

Regulatory Info : RX

Registration Country : USA

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Italy
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OSILODROSTAT PHOSPHATE

Brand Name : ISTURISA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Packaging :

Approval Date : 2020-03-06

Application Number : 212801

Regulatory Info : DISCN

Registration Country : USA

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Italy
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Recordati

Italy
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Osilodrostatum

Brand Name : Isturisa

Dosage Form : Filmtabl

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Recordati

Italy
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Italy
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Osilodrostatum

Brand Name : Isturisa

Dosage Form : Filmtabl

Dosage Strength : 1mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Recordati

Italy
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Recordati

Italy
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Osilodrostatum

Brand Name : Isturisa

Dosage Form : Filmtabl

Dosage Strength : 5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Osilodrostat

Brand Name : Isturisa

Dosage Form :

Dosage Strength :

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Osilodrostat

Brand Name : Isturisa

Dosage Form :

Dosage Strength :

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Company : Recordati Rare

Osilodrostat Phosphate

Drug Cost (USD) : 34,621,980

Year : 2023

Prescribers : 202

Prescriptions : 1480

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Company : Recordati Rare

Osilodrostat Phosphate

Drug Cost (USD) : 17,110,721

Year : 2022

Prescribers : 148

Prescriptions : 960

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Company : Recordati Rare

Osilodrostat Phosphate

Drug Cost (USD) : 9,457,234

Year : 2021

Prescribers : 100

Prescriptions : 511

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Company : Recordati Rare

Osilodrostat Phosphate

Drug Cost (USD) : 2,176,243

Year : 2020

Prescribers : 36

Prescriptions : 115

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Regulatory FDF Prices

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Brand Name : Isturisa

Italy
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Brand Name : Isturisa

Italy
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Osilodrostat Phosphate

Dosage Form : Filmtabl

Dosage Strength : 10mg

Price Per Pack (Euro) : 6067.01

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

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Brand Name : Isturisa

Italy
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Brand Name : Isturisa

Italy
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Osilodrostat Phosphate

Dosage Form : Filmtabl

Dosage Strength : 1mg

Price Per Pack (Euro) : 1441.36

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

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Brand Name : Isturisa

Italy
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Brand Name : Isturisa

Italy
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Osilodrostat Phosphate

Dosage Form : Filmtabl

Dosage Strength : 5mg

Price Per Pack (Euro) : 5766.51

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

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Patents & EXCLUSIVITIES

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US Patents

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OSILODROSTAT PHOSPHATE

US Patent Number : 8609862

Drug Substance Claim :

Drug Product Claim :

Application Number : 212801

Patent Use Code : U-4177

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-01-13

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OSILODROSTAT PHOSPHATE

US Patent Number : 8314097

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 212801

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-03-27

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OSILODROSTAT PHOSPHATE

US Patent Number : 10709691

Drug Substance Claim :

Drug Product Claim :

Application Number : 212801

Patent Use Code : U-2770

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-10-12

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OSILODROSTAT PHOSPHATE

US Patent Number : 8835646

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 212801

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2026-08-23

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OSILODROSTAT PHOSPHATE

US Patent Number : 10709691

Drug Substance Claim :

Drug Product Claim :

Application Number : 212801

Patent Use Code : U-2770

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-10-12

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OSILODROSTAT PHOSPHATE

US Patent Number : 9434754

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 212801

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-01-13

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OSILODROSTAT PHOSPHATE

US Patent Number : 8609862

Drug Substance Claim :

Drug Product Claim :

Application Number : 212801

Patent Use Code : U-2770

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-01-13

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OSILODROSTAT PHOSPHATE

US Patent Number : 10709691

Drug Substance Claim :

Drug Product Claim :

Application Number : 212801

Patent Use Code : U-2770

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-10-12

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Coatings Trends
Not Confirmed
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OSILODROSTAT PHOSPHATE

US Patent Number : 8314097

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 212801

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-03-27

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10

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Coatings Trends
Not Confirmed
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OSILODROSTAT PHOSPHATE

US Patent Number : 8314097

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 212801

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-03-27

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ABOUT THIS PAGE

Looking for 1315449-72-9 / Osilodrostat Phosphate API manufacturers, exporters & distributors?

Osilodrostat Phosphate manufacturers, exporters & distributors 1

71

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 Phosphate Manufacturers

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

Osilodrostat Phosphate Suppliers

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

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

Osilodrostat Phosphate USDMF

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

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

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

Osilodrostat Phosphate GMP

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

Osilodrostat Phosphate CoA

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

Osilodrostat Phosphate CoA mostly includes findings from lab analyses of a specific batch. For each Osilodrostat Phosphate 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 Phosphate may be tested according to a variety of international standards, such as European Pharmacopoeia (Osilodrostat Phosphate EP), Osilodrostat Phosphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Osilodrostat Phosphate 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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