RECORLEVTM (levoketoconazole): Cortisol Synthesis Inhibitor for Endogenous Cushing’s Syndrome

RECORLEV (levoketoconazole), or COR-003, is an investigational cortisol synthesis inhibitor. It has received orphan designation in the US and EU for treatment of endogenous Cushing’s syndrome.

RECORLEV (levoketoconazole): A Pure Enantiomer of Ketoconazole

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,1 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.

SONICS: A Global Phase 3 Trial in Endogenous Cushing’s Syndrome

RECORLEV (levoketoconazole) is currently being evaluated in a phase 3 trial for patients with endogenous Cushing’s syndrome.

3.1_sonics_trialdesign_chart_desktop

SONICS Trial Design2

  • Single-arm, open-label study
  • Orally administered study drug
  • Enrollment goal: 90 patients
  • Up to 90 sites globally
  • 76 activated sites
  • Titrate to therapeutic dose (weeks 2–21)
  • 6-month maintenance phase on therapeutic dose
  • 6-month extended evaluation

The safety and efficacy of RECORLEV (levoketoconazole) for treatment of endogenous Cushing’s syndrome have not been established.

Additional Information on SONICS Trial

* Cortendo AB (Cortendo), a subsidiary of Strongbridge Biopharma plc, is the sponsor of the SONICS trial.

References

  1. Nieman LK, Biller BMK, Findling MHM, et al. Treatment of Cushing’s syndrome: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015;100:2807-2831.
  2. Salvatori R, DelConte A, Geer EB, et al. An open-label study to assess the safety and efficacy of levoketoconazole (COR-003) in the treatment of endogenous Cushing’s syndrome. Presented at: The Endocrine Society’s 97th Annual Meeting & Expo; March 6, 2015; San Diego, CA. https://endo.confex.com/endo/2015endo/webprogram/Paper20580.html. Accessed December 1, 2015.

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