Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Hydrocortisone Modified Release Capsules
Hydrocortisone Modified Release · 1 trial · 3 indications
The maximum plasma concentration (Cmax) of chronocort
Area under the curve (AUC) from 0 to 24 hours (sampling occurs at the following timepoints: 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)
Time to maximum plasma concentration (tmax)
| Arm | Type | Description |
|---|---|---|
| Hydrocortisone Modified Release Capsules | EXPERIMENTAL | Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response |
| Name | Type | Description |
|---|---|---|
| Hydrocortisone Modified Release Capsules | DRUG | Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment |
Inclusion Criteria: 1. Known CAH due to 21-hydroxylase deficiency (classic CAH) based on hormonal and genetic testing currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone on a stable dosage for a minimum of 3 months. 2. Male or female patients aged 18 and above. 3. Provi...
Hydrocortisone modified release is an investigational oral small molecule developed by Neurocrine Biosciences, Inc. (ticker NBIX). It is being studied in endocrine disease, specifically for adrenal insufficiency and congenital adrenal hyperplasia. The formulation is designed to release hydrocortisone in a modified manner, and it is also referred to as hydrocortisone modified release capsules.
Hydrocortisone modified release is being studied for endocrine disease, including adrenal insufficiency and congenital adrenal hyperplasia. It is an investigational therapy and has not been established as a treatment for these conditions. The clinical program has focused on adults with congenital adrenal hyperplasia, a condition in which the adrenal glands do not produce sufficient cortisol.
Hydrocortisone modified release targets NR3C1, the glucocorticoid receptor, and acts as an agonist at that receptor. By binding and activating NR3C1, the drug is intended to provide glucocorticoid replacement. NR3C1 agonism is the mechanism underlying hydrocortisone's physiologic effects in endocrine replacement therapy.
Hydrocortisone modified release is being developed by Neurocrine Biosciences, Inc., which trades under the ticker NBIX. The company is the sponsor of the clinical program evaluating this modified release hydrocortisone formulation in endocrine disease.
Hydrocortisone modified release is in Phase 2 development. It is an investigational product and is not approved by the FDA. The Phase 2 program has completed one trial, and no active trials are currently listed for this asset.
Hydrocortisone modified release has been evaluated in one completed Phase 2 trial, NCT01735617, titled a pilot study to characterize and examine the pharmacokinetics and efficacy of Chronocort in adults with CAH. The trial enrolled 16 participants in the United States, included adults 18 years and older, and was uncontrolled, non-randomized, and not double blinded.
Yes. Hydrocortisone modified release capsules is an alternative name for hydrocortisone modified release, the investigational oral formulation developed by Neurocrine Biosciences, Inc. (NBIX). Searches using either name refer to the same Phase 2 endocrine asset being studied in adrenal insufficiency and congenital adrenal hyperplasia.