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Levoketoconazole - Strongbridge Biopharma

Drug Profile

Levoketoconazole - Strongbridge Biopharma

Alternative Names: (2S,4R)-ketoconazole; 2S-4R-ketoconazole; COR-003; DIO 902; Levdexketoconazole - StrongBridge Biopharma; NormoCort; RECORLEV

Latest Information Update: 05 Nov 2023

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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
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Cushing syndrome
  • New Molecular Entity No

Highest Development Phases

  • Marketed Cushing syndrome
  • Discontinued Type 2 diabetes mellitus

Most Recent Events

  • 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
  • 31 Jan 2022 Launched for Cushing syndrome (In adults) in USA (PO)
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