Last reviewed · How we verify
Predinsone/Prednisolone
Predinsone/Prednisolone is a Corticosteroid (glucocorticoid) Small molecule drug developed by Celgene. It is currently in Phase 3 development for Inflammatory and autoimmune disorders (rheumatoid arthritis, lupus, vasculitis), Hematologic malignancies (as adjunctive therapy in lymphomas and leukemias), Allergic and respiratory conditions (asthma, COPD exacerbations).
Prednisone/prednisolone is a corticosteroid that suppresses the immune system and reduces inflammation by binding to glucocorticoid receptors and inhibiting pro-inflammatory cytokine production.
Prednisone/Prednisolone is a small molecule glucocorticoid receptor agonist, classified as an AGONIST. It is used to treat various conditions, including metastatic castration-resistant prostate cancer, as per clinical trials registered on ClinicalTrials.gov.
-
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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 | Predinsone/Prednisolone |
|---|---|
| Sponsor | Celgene |
| Drug class | Corticosteroid (glucocorticoid) |
| Target | Glucocorticoid receptor (GR) |
| Modality | Small molecule |
| Therapeutic area | Immunology, Rheumatology, Oncology (supportive care), Endocrinology |
| Phase | Phase 3 |
Mechanism of action
These synthetic glucocorticoids mimic cortisol and bind to intracellular glucocorticoid receptors, translocating to the nucleus to modulate gene expression. This results in broad immunosuppression, reduced production of inflammatory mediators (cytokines, chemokines, adhesion molecules), and decreased immune cell proliferation and migration. They are used across multiple therapeutic areas for their potent anti-inflammatory and immunosuppressive effects.
Approved indications
- Inflammatory and autoimmune disorders (rheumatoid arthritis, lupus, vasculitis)
- Hematologic malignancies (as adjunctive therapy in lymphomas and leukemias)
- Allergic and respiratory conditions (asthma, COPD exacerbations)
- Adrenal insufficiency and other endocrine disorders
Common side effects
- Hyperglycemia / glucose intolerance
- Hypertension
- Osteoporosis / bone loss
- Infections (opportunistic)
- Insomnia / mood changes
- Gastrointestinal upset
- Cushingoid features (with chronic use)
- Immunosuppression
Key clinical trials
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:
- Predinsone/Prednisolone CI brief — competitive landscape report
- Predinsone/Prednisolone updates RSS · CI watch RSS
- Celgene portfolio CI
Frequently asked questions about Predinsone/Prednisolone
What is Predinsone/Prednisolone?
How does Predinsone/Prednisolone work?
What is Predinsone/Prednisolone used for?
Who makes Predinsone/Prednisolone?
What drug class is Predinsone/Prednisolone in?
What development phase is Predinsone/Prednisolone in?
What are the side effects of Predinsone/Prednisolone?
What does Predinsone/Prednisolone target?
Related
- Drug class: All Corticosteroid (glucocorticoid) drugs
- Target: All drugs targeting Glucocorticoid receptor (GR)
- Manufacturer: Celgene — full pipeline
- Therapeutic area: All drugs in Immunology, Rheumatology, Oncology (supportive care), Endocrinology
- Indication: Drugs for Inflammatory and autoimmune disorders (rheumatoid arthritis, lupus, vasculitis)
- Indication: Drugs for Hematologic malignancies (as adjunctive therapy in lymphomas and leukemias)
- Indication: Drugs for Allergic and respiratory conditions (asthma, COPD exacerbations)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing