API Suppliers
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
Annual Reports
0
0
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
Therapeutic Area: Endocrinology Product Name: Isturisa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 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
Therapeutic Area: Endocrinology Product Name: Isturisa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 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
Therapeutic Area: Endocrinology Product Name: Isturisa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 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
Therapeutic Area: Endocrinology Product Name: Isturisa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 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
Therapeutic Area: Endocrinology Product Name: Isturisa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 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
Therapeutic Area: Endocrinology Product Name: Isturisa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2022
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
Therapeutic Area: Endocrinology Product Name: Isturisa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2020
Details:
ISTURISA® (osilodrostat) demonstrates significant and sustained benefit over placebo at normalizing mean urinary free cortisol (mUFC) levels in patients with Cushing’s disease.
Lead Product(s): Osilodrostat
Therapeutic Area: Endocrinology Product Name: Isturisa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2020
Details:
Isturisa® (osilodrostat), a novel treatment for Cushing’s Syndrome, is now commercially available in France, and will be across select other European Union markets over 2020.
Lead Product(s): Osilodrostat
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2020
Details:
In the Phase 3 LINC?3 study, a significantly higher proportion of patients treated with Isturisa® (osilodrostat) maintained normal mean urinary free cortisol (mUFC) at the end of the 8?week.
Lead Product(s): Osilodrostat
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 26, 2020