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Glucocorticoids [Standard Dose]

University of Pennsylvania · Phase 3 active Small molecule

Glucocorticoids [Standard Dose] is a Glucocorticoid Small molecule drug developed by University of Pennsylvania. It is currently in Phase 3 development for Inflammatory and autoimmune disorders (specific indication in phase 3 trial unknown), Immunosuppression in transplantation or severe inflammatory conditions.

Glucocorticoids suppress immune and inflammatory responses by binding to glucocorticoid receptors and inhibiting pro-inflammatory cytokine production.

Glucocorticoids suppress immune and inflammatory responses by binding to glucocorticoid receptors and inhibiting pro-inflammatory cytokine production. Used for Inflammatory and autoimmune disorders (specific indication in phase 3 trial unknown), Immunosuppression in transplantation or severe inflammatory conditions.

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 [Standard Dose]
SponsorUniversity of Pennsylvania
Drug classGlucocorticoid
TargetGlucocorticoid receptor (GR)
ModalitySmall molecule
Therapeutic areaImmunology
PhasePhase 3

Mechanism of action

Glucocorticoids are steroid hormones that bind intracellular glucocorticoid receptors, translocate to the nucleus, and modulate gene transcription to reduce production of inflammatory mediators (TNF-α, IL-1, IL-6) and suppress T-cell activation. They also promote apoptosis of lymphocytes and reduce vascular permeability, making them broad-spectrum anti-inflammatory and immunosuppressive agents.

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 [Standard Dose]

What is Glucocorticoids [Standard Dose]?

Glucocorticoids [Standard Dose] is a Glucocorticoid drug developed by University of Pennsylvania, indicated for Inflammatory and autoimmune disorders (specific indication in phase 3 trial unknown), Immunosuppression in transplantation or severe inflammatory conditions.

How does Glucocorticoids [Standard Dose] work?

Glucocorticoids suppress immune and inflammatory responses by binding to glucocorticoid receptors and inhibiting pro-inflammatory cytokine production.

What is Glucocorticoids [Standard Dose] used for?

Glucocorticoids [Standard Dose] is indicated for Inflammatory and autoimmune disorders (specific indication in phase 3 trial unknown), Immunosuppression in transplantation or severe inflammatory conditions.

Who makes Glucocorticoids [Standard Dose]?

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

What drug class is Glucocorticoids [Standard Dose] in?

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

What development phase is Glucocorticoids [Standard Dose] in?

Glucocorticoids [Standard Dose] is in Phase 3.

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

Common side effects of Glucocorticoids [Standard Dose] include Hyperglycemia, Hypertension, Osteoporosis, Infection (opportunistic), Insomnia, Mood changes.

What does Glucocorticoids [Standard Dose] target?

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

Related

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