Last reviewed 2026-04-20 · How we verify

Recorlev (LEVOKETOCONAZOLE)

Recorlev (levoketoconazole) is a cortisol synthesis inhibitor, a small molecule drug developed by Strongbridge, which is still owned by the company. It was approved by the FDA in 2021 for the treatment of Cushing's syndrome and endogenous hypercortisolemia. Recorlev works by inhibiting the production of cortisol in the body, a hormone that can be overproduced in these conditions. The drug has a relatively short half-life of 3 to 4.5 hours and is not yet available as a generic. It is a patented medication with no generic manufacturers.

At a glance

Approved indications

• Cushing's syndrome
• endogenous hypercortisolemia

Boxed warnings

• WARNING: HEPATOTOXICITY AND QT PROLONGATION Hepatotoxicity • Cases of hepatotoxicity with a fatal outcome or requiring liver transplantation have been reported with use of oral ketoconazole. Some patients had no obvious risk factors for liver disease. Serious hepatotoxicity has been reported in patients receiving RECORLEV [see Warnings and Precautions ( 5.1 )]. • RECORLEV is contraindicated in patients with cirrhosis, acute liver disease or poorly controlled chronic liver disease, recurrent symptomatic cholelithiasis, a prior history of drug induced liver injury due to ketoconazole or any azole antifungal therapy that required discontinuation of treatment, or extensive metastatic liver disease [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. • Evaluate liver enzymes prior to and during treatment. Interrupt RECORLEV treatment immediately if signs of hepatotoxicity occur [see Dosage and Administration ( 2.1 , 2.3 , 2.4 ), Warnings and Precautions ( 5.1 )]. QT Prolongation • RECORLEV is associated with dose-related QT interval prolongation. QT interval prolongation may lead to life-threatening ventricular dysrhythmias such as torsades de pointes [see Warnings and Precautions ( 5.2 )]. • Coadministration of RECORLEV with other drugs that prolong the QT interval associated with ventricular arrhythmias, including torsades de pointes, and use in patients with a prolonged QTcF interval of greater than 470 msec at baseline, history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or long QT syndrome (including first-degree family history) are contraindicated [see Contraindications ( 4 ), Drug Interactions ( 7.1 , 7.2 )]. • Perform an ECG and correct hypokalemia and hypomagnesemia prior to and during treatment. Temporarily discontinue RECORLEV if QTcF interval exceeds 500 msec [Dosage and Administration ( 2.1 , 2.3 , 2.4 )]. WARNING: HEPATOTOXICITY AND QT PROLONGATION See full prescribing information for complete boxed warning. Cases of hepatotoxicity with fatal outcome or requiring liver transplantation have been reported with oral ketoconazole. Some patients had no obvious risk factors for liver disease. RECORLEV is associated with serious hepatotoxicity. Evaluate liver enzymes prior to and during treatment ( 5.1 ) RECORLEV is associated with dose-related QT interval prolongation. QT interval prolongation may result in life-threatening ventricular dysrhythmias such as torsades de pointes. Perform ECG prior to and during treatment ( 5.2 )

Common side effects

• Nausea/Vomiting
• Hypokalemia
• Systemic hypertension
• Hemorrhage/Contusion
• Headache
• Abnormal uterine bleeding
• Arrhythmia
• Fatigue
• Upper respiratory infection
• Abdominal pain/Dyspepsia
• Dizziness
• Diarrhea

Drug interactions

• Atorvastatin
• Metformin
• Bosutinib
• Cisapride
• Clarithromycin
• Cobimetinib
• Crizotinib
• Disopyramide
• Dofetilide
• Dronedarone
• Eliglustat
• Ivabradine

Key clinical trials

• Open-label Treatment in Cushing's Syndrome (PHASE3)
• A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome. (PHASE3)
• Treatment for Endogenous Cushing's Syndrome (PHASE3)
• Bioavailability of Levoketoconazole and Ketoconazole Tablets (PHASE1)
• Drug Interaction Study of Levoketoconazole and Metformin (PHASE1)
• Levoketoconazole Food Effect Study in Healthy Subjects (PHASE1)

Patents

Primary sources

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