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rituximab maintenance
rituximab maintenance is a Monoclonal antibody (anti-CD20) Small molecule drug developed by Ludwig-Maximilians - University of Munich. It is currently in Phase 3 development for Rheumatoid arthritis (maintenance therapy), Granulomatosis with polyangiitis (GPA), Microscopic polyangiitis (MPA).
Rituximab is a monoclonal antibody that binds to CD20 on B cells, leading to their depletion and reduction of autoimmune activity.
Rituximab is used to treat various types of non-Hodgkin's B-cell lymphomas, including follicular lymphoma and marginal zone lymphoma, as indicated by ClinicalTrials.gov. It works by binding to the B-lymphocyte antigen CD20, as verified by ChEMBL, which is a mechanism of action for a binding agent antibody.
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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 | rituximab maintenance |
|---|---|
| Sponsor | Ludwig-Maximilians - University of Munich |
| Drug class | Monoclonal antibody (anti-CD20) |
| Target | CD20 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Rituximab targets the CD20 antigen expressed on the surface of B lymphocytes, triggering antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), which results in B cell destruction. Maintenance therapy involves periodic dosing to sustain B cell depletion and prevent disease relapse in conditions driven by pathogenic B cells.
Approved indications
- Rheumatoid arthritis (maintenance therapy)
- Granulomatosis with polyangiitis (GPA)
- Microscopic polyangiitis (MPA)
- Certain B-cell lymphomas
Common side effects
- Infusion reactions
- Infections (including serious infections)
- Cytopenias (neutropenia, thrombocytopenia)
- Fatigue
- Headache
- Progressive multifocal leukoencephalopathy (PML)
Key clinical trials
- Testing the Addition of an Immunotherapy Agent, Atezolizumab, When Given With the Usual Chemo-Immunotherapy Drug Combination (Rituximab Plus Gemcitabine and Oxaliplatin) for Relapsed/Refractory (That Has Come Back or Not Responded to Treatment) Transformed Diffuse Large B-Cell Lymphoma (PHASE1)
- 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)
- Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma (PHASE1)
- Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL (PHASE2)
- Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma (PHASE2)
- Rituximab With or Without Stem Cell Transplant in Treating Patients With Minimal Residual Disease-Negative Mantle Cell Lymphoma in First Complete Remission (PHASE3)
- Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease (PHASE3)
- A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients (PHASE3)
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:
- rituximab maintenance CI brief — competitive landscape report
- rituximab maintenance updates RSS · CI watch RSS
- Ludwig-Maximilians - University of Munich portfolio CI
Frequently asked questions about rituximab maintenance
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Related
- Drug class: All Monoclonal antibody (anti-CD20) drugs
- Target: All drugs targeting CD20
- Manufacturer: Ludwig-Maximilians - University of Munich — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis (maintenance therapy)
- Indication: Drugs for Granulomatosis with polyangiitis (GPA)
- Indication: Drugs for Microscopic polyangiitis (MPA)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing