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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:
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:
U.S. FDA has approved a new indication for CARBAGLU® (carglumic acid) tablets 200mg as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA) in pediatric and adult patients.
Lead Product(s): Carglumic Acid
Therapeutic Area: Hematology Product Name: Carbaglu
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 26, 2021
Details:
CYSTADROPS demonstrated a significant reduction in cystine crystal deposits in the cornea of the eye and is the first and only FDA-approved cysteamine drop formulation with four times a day dosing.
Lead Product(s): Cysteamine Hydrochloride
Therapeutic Area: Genetic Disease Product Name: Cystadrops
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 25, 2020
Details:
Cystadrops (cysteamine) ophthalmic solution, acts as a cystine-depleting agent by converting cystine to cysteine and is indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.
Lead Product(s): Cysteamine Bitartrate
Therapeutic Area: Genetic Disease Product Name: Cystadrops
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 25, 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
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