FDA · United States
atezolizumab — FDA regulatory status
atezolizumab (TECENTRIQ) 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
- TECENTRIQ
- Originator
- Hoffmann-La Roche
- Mechanism
- Programmed cell death 1 ligand 1 inhibitor
- Target
- Programmed cell death 1 ligand 1
- Structured fields
- 8
Sponsor / originator context: Hoffmann-La Roche. 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: Programmed cell death 1 ligand 1 inhibitor. Target: Programmed cell death 1 ligand 1. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 105 published clinical programs and 12 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 |
|---|---|---|---|
| 1438-0012 | Phase 3 | Boehringer Ingelheim | 2025-520565-51-00 |
| 1479-0032 | Phase 3 | Boehringer Ingelheim | 2025-521284-12-00 |
| A021502 | Phase 3 | George Institute for | 2024-517269-18-00 |
| ABC-HCC | Phase 3 | George Institute for | 2024-512953-26-00 |
| Atezolizumab | Phase 3 | HOFFMANN-LA ROCHE | NCT04102098 |
| Atezolizumab | Phase 3 | HOFFMANN-LA ROCHE | NCT02807636, NCT03869190 |
| Atezolizumab | Phase 3 | HOFFMANN-LA ROCHE | NCT02908672 |
| Atezolizumab | Phase 3 | Jazz Pharmaceuticals Ireland | NCT05091567 |
| Atezolizumab | Phase 3 | HOFFMANN-LA ROCHE | NCT03726879 |
| BEATcc | Phase 3 | Ningbo Cancer Hospital | 2024-514179-17-00 |
| BNT327-03 | Phase 3 | BioNTech SE | 2024-515765-34-00 |
| BO40729 | Phase 3 | HOFFMANN-LA ROCHE | 2023-506184-34-00 |
Related patents
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|---|---|---|
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Related hubs
FAQ
What is the FDA approval status of atezolizumab?
atezolizumab 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 atezolizumab 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 atezolizumab?
This spoke lists 105 published programs associated with atezolizumab in our pipeline index.