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Glucocorticoids [Reduced Dose]

University of Pennsylvania · Phase 3 active Small molecule

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).

Likelihood of approval
59.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • 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.
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameGlucocorticoids [Reduced Dose]
SponsorUniversity of Pennsylvania
Drug classGlucocorticoid
TargetGlucocorticoid receptor (GR)
ModalitySmall molecule
Therapeutic areaImmunology
PhasePhase 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

Common side effects

Competitive intelligence

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

Frequently asked questions about Glucocorticoids [Reduced Dose]

What is Glucocorticoids [Reduced Dose]?

Glucocorticoids [Reduced Dose] is a Glucocorticoid drug developed by University of Pennsylvania, indicated for Inflammatory and autoimmune conditions (specific indication under investigation in phase 3 trial).

How does Glucocorticoids [Reduced Dose] work?

Reduced-dose glucocorticoids suppress immune and inflammatory responses by binding to glucocorticoid receptors and modulating gene expression.

What is Glucocorticoids [Reduced Dose] used for?

Glucocorticoids [Reduced Dose] is indicated for Inflammatory and autoimmune conditions (specific indication under investigation in phase 3 trial).

Who makes Glucocorticoids [Reduced Dose]?

Glucocorticoids [Reduced Dose] is developed by University of Pennsylvania (see full University of Pennsylvania pipeline at /company/university-of-pennsylvania).

What drug class is Glucocorticoids [Reduced Dose] in?

Glucocorticoids [Reduced Dose] belongs to the Glucocorticoid class. See all Glucocorticoid drugs at /class/glucocorticoid.

What development phase is Glucocorticoids [Reduced Dose] in?

Glucocorticoids [Reduced Dose] is in Phase 3.

What are the side effects of Glucocorticoids [Reduced Dose]?

Common side effects of Glucocorticoids [Reduced Dose] include Hyperglycemia, Hypertension, Osteoporosis, Immunosuppression/increased infection risk, Adrenal suppression, Mood changes.

What does Glucocorticoids [Reduced Dose] target?

Glucocorticoids [Reduced Dose] targets Glucocorticoid receptor (GR) and is a Glucocorticoid.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing