Chronocort® is a cortisol replacement product for the life-long treatment of congenital adrenal insufficiency and adrenal insufficiency.

The body's inability to produce the important metabolic hormone cortisol comes in two forms: adrenal insufficiency (acquired) and congenital adrenal hyperplasia (genetic). There are over 250,000 patients worldwide who are unable to produce the healthy required amounts of cortisol.

Cortisol has a distinctive daily rhythm. Current therapies are considered to be sub-optimal in mapping hydrocortisone release against this daily rhythm and could be superseded with more effective physiological hormonal replacement products. Chronocort® is specifically designed to replicate physiological cortisol replacement, as closely as possible, over the whole day. In clinical trials Chronocort® is being administered at bedtime and on waking with the aim to provide overnight coverage of cortisol as well as sustained replacement during the day.

Diurnal has successfully completed human volunteer studies of Chronocort® and completed a Phase 3 trial. It is expected that submission of a marketing authorisation application for Chronocort® will occur by the end of 2019.

CAH patient studies using twice daily dosing have shown that modified release hydrocortisone can mimic the physiological rhythm of cortisol (ref: Mallappa et al 2015)