FDA · United States
rituximab — FDA regulatory status
rituximab (RIXIMYO) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- RIXIMYO
- Originator
- Pfizer Australia Pty Ltd
- Mechanism
- B-lymphocyte antigen CD20 binding agent
- Target
- B-lymphocyte antigen CD20
- Structured fields
- 8
Sponsor / originator context: Pfizer Australia Pty Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: B-lymphocyte antigen CD20 binding agent. Target: B-lymphocyte antigen CD20. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 119 published clinical programs and 5 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 20190360 | Phase 3 | Amgen | 2023-503640-14-00 |
| ACE-CL-311 (AMPLIFY) | Phase 3 | Anaxis Pharma | 2023-509349-11-00 |
| ACE-LY-308 | Phase 3 | Anaxis Pharma | 2023-509354-58-00 |
| APG2575CC301 | Phase 3 | Anaxis Pharma | 2024-514084-26-00 |
| APHP200026 | Phase 3 | PARItec | 2024-516687-28-00 |
| APHP211057 | Phase 3 | PARItec | 2024-516243-81-00 |
| APHP240909 | Phase 3 | PARItec | 2025-521331-36-00 |
| BGB-11417-303CLL-RR1 | Phase 3 | BEONE MEDICINES AUS | 2024-517131-52-00 |
| BGB-16673-302 | Phase 3 | BEONE MEDICINES AUS | 2024-518893-15-00 |
| BGB-3111-304 | Phase 3 | BEONE MEDICINES AUS | 2023-509976-40-00 |
| BGB-3111-306 | Phase 3 | BEONE MEDICINES AUS | 2023-509908-15-00 |
| CA073-1003 | Phase 3 | Celgene | 2024-519152-82-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 11896617 | Polynucleotides encoding rituximab-resistant chimeric antigen receptors | US |
| 11352426 | CD3 binding polypeptides | US |
| 10307481 | CD37 immunotherapeutics and uses thereof | US |
| 10202452 | CD3 binding polypeptides | US |
| 10143748 | B-cell reduction using CD37-specific and CD20-specific binding molecules | US |
Related hubs
FAQ
What is the FDA approval status of rituximab?
rituximab currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get rituximab regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to rituximab?
This spoke lists 119 published programs associated with rituximab in our pipeline index.