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
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