Levoketoconazole

Generic Name
Levoketoconazole
Brand Names
Recorlev
Drug Type
Small Molecule
Chemical Formula
C26H28Cl2N4O4
CAS Number
142128-57-2
Unique Ingredient Identifier
2DJ8R0NT7K
Background

Cushing's syndrome (CS) is underpinned by chronic hypercortisolism leading to multisystem morbidity, including effects on the cardiovascular and endocrine systems, metabolic syndrome with accompanying changes in body composition, neuropsychiatric effects, changes in blood pressure and chemistry, and opportunistic infections. Ketoconazole has been used both o...

Indication

Levoketoconazole is indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. Levoketoconazole is not indicated for the treatment of fungal infections.

Associated Conditions
Endogenous Cushing's Syndrome
Associated Therapies
-
Clinical Trials
Related News

Bioavailability of Levoketoconazole and Ketoconazole Tablets

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Levoketoconazole
Drug: Ketoconazole
First Posted Date
2019-12-26
Last Posted Date
2020-01-31
Lead Sponsor
Cortendo AB
Target Recruit Count
34
Registration Number
NCT04212000
Locations
🇺🇸

Pharmaceutical Research Associates, Inc., Salt Lake City, Utah, United States

Levoketoconazole Food Effect Study in Healthy Subjects

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
Drug: levoketoconazole
First Posted Date
2018-12-07
Last Posted Date
2019-02-04
Lead Sponsor
Cortendo AB
Target Recruit Count
22
Registration Number
NCT03768388
Locations
🇺🇸

Clinical Pharmacology of Miami, LLC, Miami, Florida, United States

Open-label Treatment in Cushing's Syndrome

Phase 3
Completed
Conditions
Cushing Syndrome
Cushing Disease
Interventions
Drug: Levoketoconazole
First Posted Date
2018-08-08
Last Posted Date
2023-05-10
Lead Sponsor
Cortendo AB
Target Recruit Count
51
Registration Number
NCT03621280
Locations
🇺🇸

Columbia University Medical Center, New York, New York, United States

🇫🇷

APHM Hôpital de la Conception, Marseille, France

🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 27 locations

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

First Posted Date
2017-09-11
Last Posted Date
2022-11-08
Lead Sponsor
Cortendo AB
Target Recruit Count
84
Registration Number
NCT03277690
Locations
🇺🇸

University of Michigan, Comprehensive Endocrine Research, Internal Medicine - MEND, Ann Arbor, Michigan, United States

🇵🇱

Wojskowy Instytut Medyczny, Klinika Gastroenterologii, Endokrynologii I Chorob Wewnetrznych, Warsaw, Poland

🇬🇷

Evangelismos Athens General Hospital, Department of Endocrinology, Athens, Greece

and more 42 locations

Treatment for Endogenous Cushing's Syndrome

Phase 3
Completed
Conditions
Endogenous Cushing's Syndrome
Interventions
Drug: Levoketoconazole
First Posted Date
2013-04-24
Last Posted Date
2021-04-19
Lead Sponsor
Cortendo AB
Target Recruit Count
94
Registration Number
NCT01838551
Locations
🇵🇱

Szpital Kliniczny im. Heliodora Swiecickiego, Poznań, Poland

🇺🇸

UCLA School of Medicine, Los Angeles, California, United States

🇺🇸

University of New Mexico HSC, Albuquerque, New Mexico, United States

and more 39 locations
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