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Recorlev FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 6, 2022.

FDA Approved: Yes (First approved December 30, 2021)
Brand name: Recorlev
Generic name: levoketoconazole
Dosage form: Capsules
Company: Xeris Biopharma Holdings
Treatment for: Cushing's Syndrome

Recorlev (levoketoconazole) is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome.

  • Endogenous Cushing’s syndrome is caused by chronic elevated cortisol exposure, often the result of a benign tumor of the pituitary gland. Recorlev works by inhibiting key steps in the synthesis of cortisol.
  • Recorlev is the pure 2S,4R enantiomer of the approved steroidogenesis inhibitor ketoconazole.
  • Recorlev capsules are taken orally twice daily, with or without food.
  • Recorlev may cause serious adverse reactions including hypocortisolism, hypersensitivity reactions, and decreased testosterone levels.
  • Common adverse reactions include nausea/vomiting, hypokalemia, hemorrhage/contusion, systemic hypertension, headache, hepatic injury, abnormal uterine bleeding, erythema, fatigue, abdominal pain/dyspepsia, arthritis, upper respiratory infection, myalgia, arrhythmia, back pain, insomnia/sleep disturbances, and peripheral edema.

Development timeline for Recorlev

Dec 30, 2021Approval FDA Approves Recorlev (levoketoconazole) for the Treatment of Endogenous Hypercortisolemia in Adult Patients With Cushing’s Syndrome
May 13, 2021Strongbridge Biopharma plc Announces U.S. Food & Drug Administration (FDA) Filing Acceptance of New Drug Application (NDA) for Recorlev (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome
Mar  2, 2021Strongbridge Biopharma plc Announces Submission of New Drug Application for Recorlev (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome to the FDA

Further information

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