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Steroid + rituximab
Steroid + rituximab is a Monoclonal antibody + corticosteroid combination Small molecule drug developed by University Hospital, Rouen. It is currently in Phase 3 development for Autoimmune or inflammatory conditions responsive to B cell depletion (specific indication not publicly detailed for this University Hospital, Rouen phase 3 trial).
Rituximab depletes B cells while steroids suppress broader immune inflammation, together reducing autoimmune-mediated disease activity.
Rituximab is an antibody that binds to the B-lymphocyte antigen CD20, used in the treatment of various lymphomas including Follicular Lymphoma, Marginal Zone Lymphoma, and Mantle-Cell Lymphoma. It is often combined with other medications such as Cyclophosphamide in clinical trials for these conditions.
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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 | Steroid + rituximab |
|---|---|
| Sponsor | University Hospital, Rouen |
| Drug class | Monoclonal antibody + corticosteroid combination |
| Target | CD20 (rituximab component); glucocorticoid receptor (steroid component) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Rituximab is a chimeric monoclonal antibody targeting CD20 on B cell surfaces, leading to B cell depletion and reduced autoantibody production. Corticosteroids provide rapid anti-inflammatory and immunosuppressive effects across multiple immune pathways. The combination leverages both targeted B cell reduction and broad immunosuppression to control severe autoimmune or inflammatory conditions.
Approved indications
- Autoimmune or inflammatory conditions responsive to B cell depletion (specific indication not publicly detailed for this University Hospital, Rouen phase 3 trial)
Common side effects
- Infusion reactions
- Infections (due to immunosuppression)
- Steroid-related adverse effects (hyperglycemia, osteoporosis, mood changes)
- Cytopenias
Key clinical trials
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma (PHASE2)
- Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity (PHASE2)
- Bortezomib, Combination Chemotherapy, and Rituximab as First-Line Therapy in Treating Patients With Stage III or Stage IV Follicular Non-Hodgkin's Lymphoma (PHASE2)
- Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas (PHASE2, PHASE3)
- Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma (PHASE2)
- A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010) (PHASE3)
- Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma (PHASE1)
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:
- Steroid + rituximab CI brief — competitive landscape report
- Steroid + rituximab updates RSS · CI watch RSS
- University Hospital, Rouen portfolio CI
Frequently asked questions about Steroid + rituximab
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Related
- Drug class: All Monoclonal antibody + corticosteroid combination drugs
- Target: All drugs targeting CD20 (rituximab component); glucocorticoid receptor (steroid component)
- Manufacturer: University Hospital, Rouen — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Autoimmune or inflammatory conditions responsive to B cell depletion (specific indication not publicly detailed for this University Hospital, Rouen phase 3 trial)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing