A Phase III study of efficacy, safety and tolerability of Chronocort compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia
Latest Information Update: 09 Feb 2023
At a glance
- Drugs Hydrocortisone (Primary) ; Dexamethasone; Prednisolone
- Indications Congenital adrenal hyperplasia
- Focus Registrational; Therapeutic Use
- Sponsors Diurnal
- 02 Feb 2021 Results assessing effect of modified-release hydrocortisone on improving disease control from Phase III trial and its extension (NCT02716818 & NCT03062280) published in the Journal of Clinical Endocrinology and Metabolism
- 16 Dec 2019 According to an Diurnal media release, a Marketing Authorisation Application (MAA) has been submitted to the European Medicines Agency (EMA) for Chronocort(modified release hydrocortisone) as a treatment for adult and adolescent patients with the rare condition congenital adrenal hyperplasia (CAH) in Europe. The MAA in Europe is anticipated in Q1 2021.
- 09 May 2019 According to a Diurnal media release, an Intent to Submit letter to the European Medicines Agency (EMA) for a Market Authorisation Application (MAA) for Chronocort has been tendered. This follows a positive meeting with the EMA in March 2019 and written formal Scientific Advice from the EMA in April 2019 confirming the current clinical and regulatory path for Chronocort. This scientific advice was based on this study and the open-label safety extension study.