Hydrocortisone - Diurnal

Drug Profile

Hydrocortisone - Diurnal

Alternative Names: Alkindi; Chronocort; Hydrocortisone extended release - Diurnal; Infacort

Latest Information Update: 08 Nov 2018

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At a glance

  • Originator Diurnal
  • Class Anti-inflammatories; Antiallergics; Glucocorticoids; Pregnenediones; Small molecules
  • Mechanism of Action Glucocorticoid receptor agonists
  • Orphan Drug Status

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

    Yes - Congenital adrenal hyperplasia; Adrenal insufficiency
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Adrenal insufficiency
  • Phase III Congenital adrenal hyperplasia

Most Recent Events

  • 25 Oct 2018 Diurnal suspends the phase III RESTORE trial in Congenital adrenal hyperplasia in USA due to inconclusive phase III results in the EU and consideration of protocol re-design (NCT03532022)
  • 17 Oct 2018 Diurnal announces intention to submit NDA to the US FDA for Alkindi® for Paediatric adrenal insufficiency (PAI) in the Q3 of 2019
  • 17 Oct 2018 Diurnal expects the commercial availability of Alkindi® in the UK, Germany, Austria and the Nordic region by early 2019
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