FDA · United States
durvalumab — FDA regulatory status
durvalumab (IMFINZI) 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
- IMFINZI
- Originator
- AstraZeneca
- Mechanism
- Programmed cell death 1 ligand 1 inhibitor
- Target
- Programmed cell death 1 ligand 1
- Structured fields
- 8
Sponsor / originator context: AstraZeneca. 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: 127 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 |
|---|---|---|---|
| 1479-0032 | Phase 3 | Boehringer Ingelheim | 2025-521284-12-00 |
| 20200041 | Phase 3 | Amgen | 2023-505989-29-00 |
| 20240178 | Phase 3 | Amgen | 2024-520050-38-00 |
| BO42777 | Phase 3 | HOFFMANN-LA ROCHE | 2023-503920-14-00 |
| C16-40 | Phase 3 | George Institute for | 2024-514873-22-00 |
| CA2660001 | Phase 3 | Bristol-Myers Squibb Australia | 2025-523576-23-00 |
| CSET N° 2023/3729 | Phase 3 | George Institute for | 2023-503326-39-00 |
| D4191C00140 | Phase 3 | AstraZeneca | 2022-502043-35-01 |
| D419CC00002 | Phase 3 | AstraZeneca | 2024-512212-21-00 |
| D419JC00001(POTOMAC) | Phase 3 | AstraZeneca | 2023-505341-23-00 |
| D5086C00001 | Phase 3 | AstraZeneca | 2022-503105-38-00 |
| D533BC00001 | Phase 3 | AstraZeneca | 2023-509429-37-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12357705 | Negatively charged peg-lipid conjugates | US |
| 12350383 | Cationic lipids containing silicon | US |
| 12083118 | Substituted 1,1′-biphenyl compounds, analogues thereof, and methods using same | US |
| 12042541 | Lipids and compositions for the delivery of therapeutics | US |
| 12023383 | Lipid compositions | US |
| 11712476 | Lipids and compositions for the delivery of therapeutics | US |
| 11702427 | Substituted 2-pyridone tricyclic compounds, analogues thereof, and methods using same | US |
| 11566002 | Substituted tetrahydrocyclopenta[C]pyrroles, substituted dihydropyrrolizines, analogues thereof, and methods using same | US |
| 11505551 | Methods for preparing substituted pyridinone-containing tricyclic compounds | US |
| 11395854 | Trialkyl cationic lipids and methods of use thereof | US |
| 11191849 | Compositions and methods for delivering messenger RNA | US |
| 11130740 | Substituted 2,3-dihydro-1H-indene analogs and methods using same | US |
Related hubs
FAQ
What is the FDA approval status of durvalumab?
durvalumab 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 durvalumab 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 durvalumab?
This spoke lists 127 published programs associated with durvalumab in our pipeline index.