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# Strongbridge NDA for Cushing’s Syndrome
- URL: https://www.fdaweb.com/strongbridge-nda-for-cushings-syndrome/
- Published: 2021-05-13T12:00:00.000Z
- Updated: 2026-09-14T16:58:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149320

FDA has accepted for review a Strongbridge Biopharma NDA for Recorlev (levoketoconazole) for treating endogenous Cushing's syndrome. The agency has set a user fee review action target date of 1/1/2022.

  
The submission is based on data from the Phase 3 SONICS and LOGICS studies, which the company says demonstrated that Recorlev significantly suppresses serum cortisol. Endogenous Cushing’s syndrome is a rare, serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure, which is often the result of a benign tumor on the pituitary gland. This benign tumor tells the body to overproduce high levels of cortisol for a sustained period of time, and this often results in undesirable physical changes, the company says.

  
Recorlev is described as an investigational adrenal steroidogenesis inhibitor.