Recorlev

(Levoketoconazole)

Small molecule

SSports Surgery Clinic, Santry, Dublin

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Endogenous Cushing's Syndrome2 trials

A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.

Completed·CCortendo AB·Phase 3·NCT03277690·84 enrolled

Treatment for Endogenous Cushing's Syndrome

Completed·CCortendo AB·Phase 3·NCT01838551·94 enrolled

Interaction1 trial

Drug Interaction Study of Levoketoconazole and Metformin

Completed·CCortendo AB·Phase 1·NCT03880825·32 enrolled

Cushing's Syndrome1 trial

Open-label Treatment in Cushing's Syndrome

Completed·CCortendo AB·Phase 3·NCT03621280·51 enrolled

Unspecified2 trials

Levoketoconazole Food Effect Study in Healthy Subjects

Completed·CCortendo AB·Phase 1·NCT03768388·22 enrolled

Bioavailability of Levoketoconazole and Ketoconazole Tablets

Completed·CCortendo AB·Phase 1·NCT04212000·34 enrolled

Regulatory

FDA Approval Timeline[3]

Dec 30, 2021

RECORLEV

NDA NDA214133

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Levoketoconazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Levoketoconazole compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA214133). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Recorlev. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Sports Surgery Clinic, Santry, Dublin company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: SSports Surgery Clinic, Santry, Dublin

Patent Landscape[4]

Patent Cliff

May 3, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10098877Jan 10, 2026

11478471Jan 10, 2026

10835530Jan 10, 2026

10517868Jan 10, 2026

9918984May 3, 2028

4 more patents

11020393Mar 2, 2040

11278547Mar 2, 2040

11903940Mar 2, 2040

12377096Mar 2, 2040