FDA Approves Cortisol Synthesis Inhibitor for Treatment of Severe Endocrine Diseases

Recently, Xeris Biopharma announced that the US FDA has approved the cortisol synthesis inhibitor Recorlev (generic name of the drug: levoketoconazole) for the treatment of endogenous hypercortisolemia in adult patients with Cushing's syndrome.

Cushing syndrome is a rare and potentially fatal serious endocrine disease

Recorlev is the pure 2S, 4R enantiomer of the steroid production inhibitor ketoconazole

This approval is based on the positive safety and efficacy data obtained from two phase 3 clinical trials, enrolling a total of 166 patients with Cushing syndrome

The second phase 3 trial of randomized drug withdrawal also reached its primary and key secondary endpoints, demonstrating the efficacy and safety of Recorlev in normalizing patient indicators and maintaining treatment response compared with placebo

Reference materials:

[1] Xeris Biopharma Announces US FDA Approval of Recorlev® (levoketoconazole) for the Treatment of Endogenous Hypercortisolemia in Adult Patients With Cushing's Syndrome.

[2] Strongbridge Biopharma plc Announces Positive Top-Line Results from the Pivotal Phase 3 SONICS Study of RECORLEV™ (levoketoconazole) for the Treatment of Endogenous Cushing's Syndrome.

[3] Strongbridge Biopharma plc Announces Positive and Statistically Significant Top-Line Results from the Pivotal Phase 3 LOGICS Study of RECORLEV® (levoketoconazole) for the Treatment of Endogenous Cushing's Syndrome.

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