> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Approves Xeris Biopharma’s Recorlev
- URL: https://www.fdaweb.com/fda-approves-xeris-biopharmas-recorlev/
- Published: 2022-01-03T12:00:00.000Z
- Updated: 2026-09-14T17:26:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150844

FDA has approved Xeris Biopharma’s Recorlev (levoketoconazole) to treat endogenous hypercortisolemia in adults with Cushing’s syndrome who aren’t eligible for surgery or haven’t responded to surgery. *Fierce Pharma* [reports](https://www.fiercepharma.com/pharma/xeris-biopharma-scores-fda-approval-for-endogenous-cushing-s-syndrome-drug-recorlev?ref=fdaweb.com) the company obtained the drug in 2021 through its acquisition of rare disease company Stonebridge Biopharma.

The approval was based on results from Phase 3 SONICS and LOGICS studies.

The company says the SONICS trial showed Recorlev significantly cut and normalized mean urinary free cortisol concentrations without a dose increase, while the LOGICS trial confirmed its efficacy and safety.