Levoketoconazole - Strongbridge Biopharma
Alternative Names: (2S,4R)-ketoconazole; 2S-4R-ketoconazole; COR-003; DIO 902; Levdexketoconazole - StrongBridge Biopharma; NormoCort; RECORLEVLatest Information Update: 09 Jun 2024
At a glance
- Originator Cortendo
- Developer Strongbridge Biopharma
- Class Antihyperglycaemics; Chlorobenzenes; Dioxolanes; Imidazoles; Piperazines; Small molecules
- Mechanism of Action 14-alpha demethylase inhibitors; Mixed function oxygenase inhibitors; Steroid 11-beta-hydroxylase inhibitors; Steroid 17-alpha-hydroxylase inhibitors; Steroid 21 hydroxylase inhibitors
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Marketed Cushing syndrome
- Discontinued Type 2 diabetes mellitus
Most Recent Events
- 09 Jun 2024 Levoketoconazol has boxed warning of hepatotoxicity and QT prolongation
- 30 Jan 2023 The US FDA grants Orphan Drug Exclusivity (ODE) for levoketoconazole for Cushing’s syndrome
- 01 Nov 2022 Efficacy and safety data from the phase III SONICS trial in Cushing syndrome released by Xeris Biopharma Holdings