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CPhI North America CPhI North America
Industry Trade Show
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20-22 May, 2025
AACR Annual meetingAACR Annual meeting
Industry Trade Show
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25-30 April, 2025
AOCS Annual MeetingAOCS Annual Meeting
Industry Trade Show
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27-30 April, 2025
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27 Oct 2022
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31 Aug 2022
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13 May 2022
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25 Aug 2021
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23 Mar 2021
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https://www.businesswire.com/news/home/20210323005021/en/Recordati-Rare-Diseases-Positive-Results-From-the-Phase-III-LINC-4-Study-Presented-Today-at-the-Endocrine-Society%E2%80%99s-Annual-Meeting-Reinforce-the-Efficacy-and-Safety-of-Isturisa%C2%AE-osilodrostat-in-Cushing%E2%80%99s-Disease
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
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
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
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
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), 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
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
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
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
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
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
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:
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 Brand Name: Carbaglu
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 26, 2021
Lead Product(s) : Carglumic Acid
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Carbaglu
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 26, 2021
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
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
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:
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 Hydrochloride
Therapeutic Area: Genetic Disease Brand Name: Cystadrops
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 25, 2020
Lead Product(s) : Cysteamine Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Cystadrops
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 25, 2020
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 Brand Name: Cystadrops
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 25, 2020
Lead Product(s) : Cysteamine Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Cystadrops
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
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 Phosphate
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 17, 2020
Lead Product(s) : Osilodrostat Phosphate
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ISTURISA® (osilodrostat) demonstrates significant and sustained benefit over placebo at normalizing mean urinary free cortisol (mUFC) levels in patients with Cushing’s disease.
Product Name : Isturisa
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 17, 2020
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