Last reviewed 2026-04-23 · How we verify

Infacort®

Infacort is a modified-release hydrocortisone formulation designed to mimic the natural circadian rhythm of cortisol secretion in patients with adrenal insufficiency.

Infacort is a modified-release hydrocortisone formulation designed to mimic the natural circadian rhythm of cortisol secretion in patients with adrenal insufficiency. Used for Adrenal insufficiency (primary, secondary, and tertiary).

At a glance

Mechanism of action

Infacort delivers hydrocortisone in a biphasic release pattern that approximates the body's natural cortisol curve, with higher levels in the early morning and lower levels in the evening. This circadian-aligned dosing aims to reduce glucocorticoid-related adverse effects while maintaining adequate cortisol replacement throughout the day. The modified-release formulation allows for once-daily dosing compared to multiple daily doses of conventional hydrocortisone.

Approved indications

• Adrenal insufficiency (primary, secondary, and tertiary)

Common side effects

• Headache
• Nausea
• Abdominal pain
• Fatigue

Key clinical trials

• Treatment of Adrenal Insufficiency in Children (PHASE3)
• An Investigational Study of Hydrocortisone (PHASE1)
• Extension Study for Patients Entered Into Study Infacort 003 (PHASE3)
• A Study of Infacort® Versus Cortef® in Healthy Adult Male and Female Subjects (PHASE1)
• Comparison of Pharmacokinetics of Infacort® Versus Immediate-release Hydrocortisone (PHASE1)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Infacort® CI brief — competitive landscape report
• Infacort® updates RSS · CI watch RSS
• Neurocrine UK Limited portfolio CI