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Modified release hydrocortisone
Modified release hydrocortisone provides sustained glucocorticoid replacement by delivering hydrocortisone in a controlled manner to mimic the body's natural cortisol rhythm.
Modified release hydrocortisone provides sustained glucocorticoid replacement by delivering hydrocortisone in a controlled manner to mimic the body's natural cortisol rhythm. Used for Adrenal insufficiency (primary and secondary), Congenital adrenal hyperplasia.
At a glance
| Generic name | Modified release hydrocortisone |
|---|---|
| Also known as | Plenadren |
| Sponsor | The Adelaide and Meath Hospital, incorporating The National Children's Hospital |
| Drug class | Glucocorticoid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | FDA-approved |
Mechanism of action
Hydrocortisone is a glucocorticoid that binds to glucocorticoid receptors in the cytoplasm and nucleus, modulating gene expression to produce anti-inflammatory and immunosuppressive effects. The modified release formulation extends drug delivery over time, allowing for more physiologic cortisol replacement patterns compared to immediate-release formulations, particularly beneficial in adrenal insufficiency where maintaining appropriate circulating cortisol levels throughout the day is critical.
Approved indications
- Adrenal insufficiency (primary and secondary)
- Congenital adrenal hyperplasia
Common side effects
- Hypertension
- Hypokalemia
- Hyperglycemia
- Osteoporosis
- Insomnia
- Mood changes
Key clinical trials
- Platform of Randomized Adaptive Clinical Trials in Critical Illness (NA)
- Long-term Safety Study of Chronocort in the Treatment of Participants With Congenital Adrenal Hyperplasia (PHASE3)
- Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial (PHASE2)
- Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia (PHASE3)
- A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAH (PHASE3)
- A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)
- Amphotericin Versus Posaconazole for Pulmonary Mucormycosis (PHASE2)
- Post Extraction Changes Following Ridge Preservation Using Partially Demineralized Dentin Block Versus L- PRF Block (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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