Synopsis
Synopsis
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JP
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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
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
1. Lci699
2. Osilodrostat
3. Osilodrostat (lci699)
4. Osilodrostat Free Base
Molecular Weight | 325.23 g/mol |
---|---|
Molecular Formula | C13H13FN3O4P |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 1 |
Exact Mass | g/mol |
Monoisotopic Mass | g/mol |
Topological Polar Surface Area | 119 |
Heavy Atom Count | 22 |
Formal Charge | 0 |
Complexity | 387 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
Isturisa is indicated for the treatment of endogenous Cushing's syndrome in adults.
H02CA02
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
Lead Product(s) : Osilodrostat Phosphate,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Grants Isturisa (osilodrostat) Expanded Indication for Endogenous Hypercortisolemia
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
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
Lead Product(s) : Osilodrostat Phosphate,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Recordati Rare Diseases to Present Data in Cushing’s Disease at ENDO 2024
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
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
Lead Product(s) : Osilodrostat Phosphate,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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
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
Lead Product(s) : Osilodrostat Phosphate,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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
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
Lead Product(s) : Osilodrostat Phosphate,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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
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
Lead Product(s) : Osilodrostat Phosphate,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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
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
Lead Product(s) : Osilodrostat Phosphate,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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
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
Lead Product(s) : Osilodrostat Phosphate,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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
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
Lead Product(s) : Osilodrostat Phosphate,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Recordati: Isturisa® (Osilodrostat) Approved In The U.S.
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
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
Lead Product(s) : Osilodrostat Phosphate,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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
Regulatory Info :
Registration Country :
Brand Name : Isturisa
Dosage Form : Tablet
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country :
Regulatory Info :
Registration Country :
Brand Name : Isturisa
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country :
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info :
Registration Country : Switzerland
Brand Name : Isturisa
Dosage Form : Filmtabl
Dosage Strength : 10mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Isturisa
Dosage Form : Filmtabl
Dosage Strength : 1mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Isturisa
Dosage Form : Filmtabl
Dosage Strength : 5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Australia
Brand Name : Isturisa
Dosage Form :
Dosage Strength :
Packaging : 60
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Isturisa
Dosage Form :
Dosage Strength :
Packaging : 60
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Global Sales Information
Market Place
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Patents & EXCLUSIVITIES
ABOUT THIS PAGE
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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.
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.
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.
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 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.
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).