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Glucocorticoids [Reduced Dose]
Glucocorticoids [Reduced Dose] is a Glucocorticoid Small molecule drug developed by University of Pennsylvania. It is currently in Phase 3 development for Inflammatory and autoimmune conditions (specific indication under investigation in phase 3 trial).
Reduced-dose glucocorticoids suppress immune and inflammatory responses by binding to glucocorticoid receptors and modulating gene expression.
Reduced-dose glucocorticoids suppress immune and inflammatory responses by binding to glucocorticoid receptors and modulating gene expression. Used for Inflammatory and autoimmune conditions (specific indication under investigation in phase 3 trial).
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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 | Glucocorticoids [Reduced Dose] |
|---|---|
| Sponsor | University of Pennsylvania |
| Drug class | Glucocorticoid |
| Target | Glucocorticoid receptor (GR) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Glucocorticoids are corticosteroids that work by entering cells and binding to intracellular glucocorticoid receptors, which then translocate to the nucleus and regulate transcription of anti-inflammatory and immunosuppressive genes. The reduced-dose formulation aims to maintain therapeutic efficacy while minimizing systemic adverse effects associated with standard glucocorticoid dosing. This approach is being investigated to improve the risk-benefit profile in chronic inflammatory and autoimmune conditions.
Approved indications
- Inflammatory and autoimmune conditions (specific indication under investigation in phase 3 trial)
Common side effects
- Hyperglycemia
- Hypertension
- Osteoporosis
- Immunosuppression/increased infection risk
- Adrenal suppression
- Mood changes
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Glucocorticoids [Reduced Dose] CI brief — competitive landscape report
- Glucocorticoids [Reduced Dose] updates RSS · CI watch RSS
- University of Pennsylvania portfolio CI
Frequently asked questions about Glucocorticoids [Reduced Dose]
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Related
- Drug class: All Glucocorticoid drugs
- Target: All drugs targeting Glucocorticoid receptor (GR)
- Manufacturer: University of Pennsylvania — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Inflammatory and autoimmune conditions (specific indication under investigation in phase 3 trial)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing