Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Osilodrostat Phosphate
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 .
Brand Name : Isturisa
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 16, 2024
Lead Product(s) : Osilodrostat Phosphate
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Osilodrostat Phosphate
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Isturisa
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 15, 2022
Lead Product(s) : Osilodrostat Phosphate
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Osilodrostat Phosphate
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Brand Name : Isturisa
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 13, 2022
Lead Product(s) : Osilodrostat Phosphate
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Osilodrostat Phosphate
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Isturisa
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 10, 2022
Lead Product(s) : Osilodrostat Phosphate
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Osilodrostat Phosphate
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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).
Brand Name : Isturisa
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 29, 2022
Lead Product(s) : Osilodrostat Phosphate
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Carglumic Acid
Therapeutic Area : Hematology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Recordati Rare Diseases: Carbaglu® Tablets 200mg Gets Approval for A New Indication
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...
Brand Name : Carbaglu
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 26, 2021
Lead Product(s) : Carglumic Acid
Therapeutic Area : Hematology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Cysteamine Hydrochloride
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Cystadrops
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 25, 2020
Lead Product(s) : Cysteamine Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Cysteamine Bitartrate
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Cystadrops
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 25, 2020
Lead Product(s) : Cysteamine Bitartrate
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Osilodrostat Phosphate
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : ISTURISA® (osilodrostat) demonstrates significant and sustained benefit over placebo at normalizing mean urinary free cortisol (mUFC) levels in patients with Cushing’s disease.
Brand Name : Isturisa
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 17, 2020
Lead Product(s) : Osilodrostat Phosphate
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Osilodrostat Phosphate
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Recordati Rare Diseases Announces First European Launch of Isturisa® (osilodrostat)
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.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 02, 2020
Lead Product(s) : Osilodrostat Phosphate
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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