Drugs / Chronocort

Trials 3

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT03343327 Feb → Apr 2018 adrenocortical insufficiency Neurocrine UK Limited Completed No outcome recorded
Phase 1 NCT03019614 Mar → Apr 2010 congenital adrenal hyperplasia Neurocrine UK Limited Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT00519818 Aug 2007 → May 2009 classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency Neurocrine UK Limited Completed No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2026-05-08 Immedica Pharma AB Regulatory Efmody® (modified-release hydrocortisone) receives MHRA approval for adrenal insufficiency in the UK immedica.com ↗
2026-04-07 Immedica Pharma AB Regulatory Efmody® (modified-release hydrocortisone) granted extension of indication for adrenal insufficiency immedica.com ↗
Immedica Pharma AB is pleased to announce that the European Commission (EC) has granted extension of indication for Efmody® (modified-release hydrocortisone) to include treatment of adrenal insufficiency (AI) in adolescents aged 12 years and over and adults.
2023-06-15 Neurocrine Biosciences Results Diurnal Ltd., a Neurocrine Biosciences Company, Presents Phase 3 Extension Study Data for Modified-Release Hydrocortisone in Patients with Congenital Adrenal Hyperplasia at ENDO 2023 gcs-web.com ↗
The number of patients achieving lower androgen levels while receiving ≤25 mg of hydrocortisone per day increased significantly, with 48 percent of the subjects achieving 17-OHP levels <36 nmol/L compared with 31 percent at baseline.

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 3 sources stand behind the page.

FieldValueCited text
Known as Chronocort ClinicalTrials.gov intervention name — accepted as the source's own label NCT03019614 ↗
2

NCT03343327 ↗

NCT00519818 ↗

Known as hydrocortisone “This study will test a new, extended release form of hydrocortisone called Chronocort in patients with congenital adrenal hyperplasia (CAH).” NCT00519818 ↗
Known as Hydrocortisone modified release tablet treatment “Hydrocortisone modified release tablet treatment” NCT00519818 ↗
Action Restore “This new medical strategy, physiologic cortisol replacement, offers the prospect of an improved outcome of treatment.” NCT00519818 ↗
Route Oral “Chronocort® 5mg given at night (\~ 23:00h) as one 5mg capsule” NCT03019614 ↗