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Low-dose corticosteroids: Dexamethasone
Low-dose corticosteroids: Dexamethasone is a Corticosteroid Small molecule drug developed by University of Oxford. It is currently in Phase 3 development for COVID-19 (hospitalized patients requiring oxygen support), Severe inflammatory conditions.
Dexamethasone is a synthetic corticosteroid that suppresses the immune system and reduces inflammation by binding to glucocorticoid receptors and inhibiting pro-inflammatory cytokine production.
Dexamethasone is a synthetic corticosteroid that suppresses the immune system and reduces inflammation by binding to glucocorticoid receptors and inhibiting pro-inflammatory cytokine production. Used for COVID-19 (hospitalized patients requiring oxygen support), Severe inflammatory conditions.
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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 | Low-dose corticosteroids: Dexamethasone |
|---|---|
| Sponsor | University of Oxford |
| Drug class | Corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Dexamethasone acts as a glucocorticoid receptor agonist, translocating to the nucleus to modulate gene expression and suppress inflammatory pathways. At low doses, it reduces excessive immune activation and inflammatory responses without causing severe immunosuppression. This mechanism makes it useful in conditions characterized by harmful inflammation, such as severe COVID-19 and other inflammatory diseases.
Approved indications
- COVID-19 (hospitalized patients requiring oxygen support)
- Severe inflammatory conditions
Common side effects
- Hyperglycemia
- Insomnia
- Mood changes
- Infection risk (immunosuppression)
- Hypertension
Key clinical trials
- Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients (PHASE2)
- Platform of Randomized Adaptive Clinical Trials in Critical Illness (NA)
- Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents (PHASE3)
- Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease (PHASE2)
- Prospective Observational Study on the Incidence of Opportunistic Fungal Infections
- Study of the Safety, Tolerability and Efficacy of KPT-8602 in Participants With Relapsed/Refractory Cancer Indications (PHASE1, PHASE2)
- Glucocorticoid Therapy for Acute Respiratory Distress Syndrome (PHASE2)
- 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:
- Low-dose corticosteroids: Dexamethasone CI brief — competitive landscape report
- Low-dose corticosteroids: Dexamethasone updates RSS · CI watch RSS
- University of Oxford portfolio CI
Frequently asked questions about Low-dose corticosteroids: Dexamethasone
What is Low-dose corticosteroids: Dexamethasone?
How does Low-dose corticosteroids: Dexamethasone work?
What is Low-dose corticosteroids: Dexamethasone used for?
Who makes Low-dose corticosteroids: Dexamethasone?
What drug class is Low-dose corticosteroids: Dexamethasone in?
What development phase is Low-dose corticosteroids: Dexamethasone in?
What are the side effects of Low-dose corticosteroids: Dexamethasone?
What does Low-dose corticosteroids: Dexamethasone target?
Related
- Drug class: All Corticosteroid drugs
- Target: All drugs targeting Glucocorticoid receptor
- Manufacturer: University of Oxford — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for COVID-19 (hospitalized patients requiring oxygen support)
- Indication: Drugs for Severe inflammatory conditions
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing