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Corticosteroid (prednisolone)
Corticosteroid (prednisolone) is a Corticosteroid (glucocorticoid) Small molecule drug developed by Assistance Publique - Hôpitaux de Paris. It is currently in Phase 3 development for Inflammatory and autoimmune disorders (e.g., rheumatoid arthritis, systemic lupus erythematosus), Allergic reactions and asthma, Adrenal insufficiency. Also known as: Both groups.
Prednisolone suppresses the immune system and reduces inflammation by binding to glucocorticoid receptors and inhibiting pro-inflammatory cytokine production.
Prednisolone is a small molecule glucocorticoid receptor agonist used to treat various conditions, including Rheumatoid Arthritis, Alcoholic Hepatitis, Alcoholic Liver Disease, Systemic Sclerosis, and Scleral Buckling. It is classified as an AGONIST drug class, acting on the glucocorticoid receptor to exert its effects.
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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 | Corticosteroid (prednisolone) |
|---|---|
| Also known as | Both groups |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Drug class | Corticosteroid (glucocorticoid) |
| Target | Glucocorticoid receptor (GR) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Prednisolone is a synthetic glucocorticoid that enters cells and binds to intracellular glucocorticoid receptors, translocating to the nucleus to modulate gene expression. This leads to decreased production of inflammatory mediators (cytokines, chemokines, adhesion molecules) and suppression of T-cell and B-cell function. The result is broad anti-inflammatory and immunosuppressive effects across multiple organ systems.
Approved indications
- Inflammatory and autoimmune disorders (e.g., rheumatoid arthritis, systemic lupus erythematosus)
- Allergic reactions and asthma
- Adrenal insufficiency
- Certain hematologic malignancies and lymphomas
Common side effects
- Hyperglycemia / glucose intolerance
- Hypertension
- Osteoporosis (with chronic use)
- Immunosuppression / increased infection risk
- Insomnia and mood changes
- Cushingoid features (with chronic use)
- Gastrointestinal upset
Key clinical trials
- A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001) (PHASE3)
- Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
- Loteprednol Etabonate Versus Prednisolone Acetate for Anterior Chamber Granulomas (PHASE4)
- OMT for Adhesive Capsulitis (PHASE4)
- Corticosteroid Tapering in Sarcoidosis (NA)
- A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression (PHASE2)
- Gene Replacement Therapy for Treatment of Paediatric Patients With CTNNB1 Neurodevelopmental Syndrome (PHASE1, PHASE2)
- Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids (PHASE1, PHASE2)
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:
- Corticosteroid (prednisolone) CI brief — competitive landscape report
- Corticosteroid (prednisolone) updates RSS · CI watch RSS
- Assistance Publique - Hôpitaux de Paris portfolio CI
Frequently asked questions about Corticosteroid (prednisolone)
What is Corticosteroid (prednisolone)?
How does Corticosteroid (prednisolone) work?
What is Corticosteroid (prednisolone) used for?
Who makes Corticosteroid (prednisolone)?
Is Corticosteroid (prednisolone) also known as anything else?
What drug class is Corticosteroid (prednisolone) in?
What development phase is Corticosteroid (prednisolone) in?
What are the side effects of Corticosteroid (prednisolone)?
What does Corticosteroid (prednisolone) target?
Related
- Drug class: All Corticosteroid (glucocorticoid) drugs
- Target: All drugs targeting Glucocorticoid receptor (GR)
- Manufacturer: Assistance Publique - Hôpitaux de Paris — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Inflammatory and autoimmune disorders (e.g., rheumatoid arthritis, systemic lupus erythematosus)
- Indication: Drugs for Allergic reactions and asthma
- Indication: Drugs for Adrenal insufficiency
- Also known as: Both groups
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing