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Catalyst Info & Data Links
TITLE: RECORLEV (levoketoconazole) in Endogenous Cushing's syndrome
ClinicalTrial.gov (NCT03277690): A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.
ClinicalTrial.gov (NCT03621280): Open-label Treatment in Cushing's Syndrome (OPTICS)
ClinicalTrial.gov (NCT01838551): Treatment for Endogenous Cushing's Syndrome
WHAT IS THE NEXT CATALYST EVENT?
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
2019: Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing's syndrome (SONICS): a phase 3, multicentre, open-label, single-arm trial. The Lancet Diabetes & Endocrinology, 7(11), 855-865.
MECHANISM OF ACTION / RATIONALE
RECORLEV (levoketoconazole), or COR-003, is an investigational cortisol synthesis inhibitor. It has received orphan drug designation from the FDA and the European Medicines Agency for the treatment of endogenous Cushing's syndrome.
RECORLEV (levoketoconazole) is the pure 2S,4R enantiomer of ketoconazole, a steroidogenesis inhibitor used to treat endogenous Cushing’s syndrome. Ketoconazole is recommended for use in treating Cushing's syndrome, but is not approved for that use in the US. We believe that RECORLEV (levoketoconazole) may have favorable efficacy, safety, and tolerability for patients with endogenous Cushing’s syndrome (Learn more HERE).
Updated by HC
#SBBP, #RECORLEV, #levoketoconazole, #Endogenous Cushing's syndrome, #Cushing's syndrome, #adrenal, #glucocorticoid, #cortisol
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