SBBP

RECORLEV (levoketoconazole)

Endogenous Cushing's syndrome

NDA Submission

Exp Date

Q1 2021

Amp Volatility Score

N/A

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?

  • NDA Submission


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?


PRIOR DATA

PRESS RELEASES

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

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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