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prednisone discontinuation
prednisone discontinuation is a Corticosteroid Small molecule drug developed by Groupe Hospitalier Pitie-Salpetriere. It is currently in Phase 3 development for Rheumatoid arthritis, Multiple sclerosis, Asthma. Also known as: prednisone maintenance.
Prednisone is a corticosteroid that suppresses the immune system by inhibiting the production of inflammatory cytokines.
Prednisone is a corticosteroid that suppresses the immune system by inhibiting the production of inflammatory cytokines. Used for Rheumatoid arthritis, Multiple sclerosis, Asthma.
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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 | prednisone discontinuation |
|---|---|
| Also known as | prednisone maintenance |
| Sponsor | Groupe Hospitalier Pitie-Salpetriere |
| Drug class | Corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Prednisone works by binding to the glucocorticoid receptor, which then translocates to the nucleus and regulates the expression of genes involved in inflammation. This leads to a decrease in the production of pro-inflammatory cytokines, such as IL-1 and TNF-alpha, and an increase in the production of anti-inflammatory cytokines, such as IL-10.
Approved indications
- Rheumatoid arthritis
- Multiple sclerosis
- Asthma
- Allergic reactions
- Urticaria
Common side effects
- Weight gain
- Insomnia
- Mood changes
- Increased blood pressure
- Osteoporosis
Key clinical trials
- Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A) (PHASE1, PHASE2)
- Influence of Methotrexate Discontinuation on Immunogenicity After PCV-20 Vaccine in Patients ARDs (PHASE4)
- Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease (PHASE3)
- Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer (PHASE2)
- Orelabrutinib in the Treatment of Relapsed/Refractory AIHA (PHASE2)
- Tocilizumab Discontinuation Versus Dose Reduction for Patients With Well-Controlled Giant Cell Arteritis (PHASE2)
- Study in Human iPSCs-derived RPE Cells Transplantation for Late-Stage AMD (PHASE1, PHASE2)
- An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC (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:
- prednisone discontinuation CI brief — competitive landscape report
- prednisone discontinuation updates RSS · CI watch RSS
- Groupe Hospitalier Pitie-Salpetriere portfolio CI
Frequently asked questions about prednisone discontinuation
What is prednisone discontinuation?
How does prednisone discontinuation work?
What is prednisone discontinuation used for?
Who makes prednisone discontinuation?
Is prednisone discontinuation also known as anything else?
What drug class is prednisone discontinuation in?
What development phase is prednisone discontinuation in?
What are the side effects of prednisone discontinuation?
What does prednisone discontinuation target?
Related
- Drug class: All Corticosteroid drugs
- Target: All drugs targeting Glucocorticoid receptor
- Manufacturer: Groupe Hospitalier Pitie-Salpetriere — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Multiple sclerosis
- Indication: Drugs for Asthma
- Also known as: prednisone maintenance
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing