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Fixed-duration higher dose Hydrocortisone
Fixed-duration higher dose Hydrocortisone is a Glucocorticoid Small molecule drug developed by UMC Utrecht. It is currently in Phase 3 development for Acute critical illness or sepsis (phase 3 investigational use), Severe inflammatory conditions requiring short-term high-dose corticosteroid therapy.
Hydrocortisone is a glucocorticoid that suppresses immune and inflammatory responses by binding to glucocorticoid receptors and modulating cytokine production.
Hydrocortisone is a small molecule glucocorticoid receptor agonist, classified as an agonist. It has been studied in various clinical trials, including those for conditions such as respiratory insufficiency and acute lymphoblastic leukemia, often in combination with other interventions like ultra-protective ventilation facilitated by extracorporeal support.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Fixed-duration higher dose Hydrocortisone |
|---|---|
| Sponsor | UMC Utrecht |
| Drug class | Glucocorticoid |
| Target | Glucocorticoid receptor (GR) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Critical Care / Inflammation |
| Phase | Phase 3 |
Mechanism of action
Hydrocortisone (cortisol) is an endogenous glucocorticoid that acts as an immunosuppressant and anti-inflammatory agent. It binds to intracellular glucocorticoid receptors, translocates to the nucleus, and alters gene expression to reduce production of pro-inflammatory cytokines and chemokines. The fixed-duration higher-dose formulation is designed to deliver elevated corticosteroid levels over a defined treatment period for acute inflammatory or critical conditions.
Approved indications
- Acute critical illness or sepsis (phase 3 investigational use)
- Severe inflammatory conditions requiring short-term high-dose corticosteroid therapy
Common side effects
- Hyperglycemia
- Hypertension
- Immunosuppression / increased infection risk
- Insomnia
- Mood disturbances
- Hypokalemia
Key clinical trials
- Platform of Randomized Adaptive Clinical Trials in Critical Illness (NA)
- Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents (PHASE3)
- Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (PHASE3)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fixed-duration higher dose Hydrocortisone CI brief — competitive landscape report
- Fixed-duration higher dose Hydrocortisone updates RSS · CI watch RSS
- UMC Utrecht portfolio CI
Frequently asked questions about Fixed-duration higher dose Hydrocortisone
What is Fixed-duration higher dose Hydrocortisone?
How does Fixed-duration higher dose Hydrocortisone work?
What is Fixed-duration higher dose Hydrocortisone used for?
Who makes Fixed-duration higher dose Hydrocortisone?
What drug class is Fixed-duration higher dose Hydrocortisone in?
What development phase is Fixed-duration higher dose Hydrocortisone in?
What are the side effects of Fixed-duration higher dose Hydrocortisone?
What does Fixed-duration higher dose Hydrocortisone target?
Related
- Drug class: All Glucocorticoid drugs
- Target: All drugs targeting Glucocorticoid receptor (GR)
- Manufacturer: UMC Utrecht — full pipeline
- Therapeutic area: All drugs in Immunology / Critical Care / Inflammation
- Indication: Drugs for Acute critical illness or sepsis (phase 3 investigational use)
- Indication: Drugs for Severe inflammatory conditions requiring short-term high-dose corticosteroid therapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing