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Levoketoconazole - Strongbridge Biopharma

Drug Profile

Levoketoconazole - Strongbridge Biopharma

Alternative Names: 2S-4R-ketoconazole; COR-003; NormoCort; RECORLEV

Latest Information Update: 08 Jan 2020

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At a glance

  • Originator Cortendo
  • Developer Strongbridge Biopharma
  • Class Chlorobenzenes; Dioxolanes; Imidazoles; Piperazines; Small molecules
  • Mechanism of Action 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

  • Phase III Cushing syndrome

Most Recent Events

  • 16 Dec 2019 Strongbridge Biopharma plans a phase I bioavailability trial (In volunteers, In adults) in USA (PO, Tablet) (NCT04212000)
  • 05 Nov 2019 Strongebridge Biopharma plans to file New Drug Application for Cushing's syndrome after third quarter of 2020
  • 03 May 2019 Cortendo AB completes a phase I drug-drug interaction trial of levoketoconazole and metformin (In volunteers) in USA (PO) (NCT03880825)
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