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Corticosteroid: Prednisone
Corticosteroid: Prednisone is a Corticosteroid Small molecule drug developed by Bristol-Myers Squibb. It is currently in Phase 2 development for Rheumatoid arthritis, Asthma, Multiple sclerosis.
Glucocorticoid receptor agonist
Prednisone is a small molecule glucocorticosteroid used to treat various conditions, including chronic sinusitis, rhinosinusitis, nasal polyps, autoimmune diseases, and hemangioma. It is administered as an intervention in clinical trials, often in combination with other medications such as iguratimod or leflunomide.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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. -
Big-pharma sponsor
+3.0pp
Bristol-Myers Squibb is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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: Prednisone |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | Corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 2 |
Mechanism of action
Prednisone acts as a synthetic glucocorticoid receptor agonist, which leads to anti-inflammatory and immunosuppressive effects.
Approved indications
- Rheumatoid arthritis
- Asthma
- Multiple sclerosis
Common side effects
- Weight gain
- Insomnia
- Hypertension
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)
- Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement (NA)
- A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) (PHASE3)
- Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids (PHASE1, PHASE2)
- A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma (PHASE3)
- Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder (EARLY_PHASE1)
- A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease (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: Prednisone CI brief — competitive landscape report
- Corticosteroid: Prednisone updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI
Frequently asked questions about Corticosteroid: Prednisone
What is Corticosteroid: Prednisone?
How does Corticosteroid: Prednisone work?
What is Corticosteroid: Prednisone used for?
Who makes Corticosteroid: Prednisone?
What drug class is Corticosteroid: Prednisone in?
What development phase is Corticosteroid: Prednisone in?
What are the side effects of Corticosteroid: Prednisone?
What does Corticosteroid: Prednisone target?
Related
- Drug class: All Corticosteroid drugs
- Target: All drugs targeting Glucocorticoid receptor
- Manufacturer: Bristol-Myers Squibb — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Asthma
- Indication: Drugs for Multiple sclerosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing