FDA · United States
aflibercept — FDA regulatory status
aflibercept (AFQLIR) 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
- AFQLIR
- Originator
- Bayer Australia Ltd
- Mechanism
- Placenta growth factor inhibitor
- Target
- Placenta growth factor
- Structured fields
- 8
Sponsor / originator context: Bayer Australia 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: Placenta growth factor inhibitor. Target: Placenta growth factor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 85 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 |
|---|---|---|---|
| 13406 | Phase 3 | Regeneron UK | NCT01482910 |
| 14130 | Phase 3 | Regeneron UK | NCT01012973 |
| 15161 | Phase 3 | Bayer HealthCare Animal | NCT01783886 |
| 15161 | Phase 3 | Regeneron UK | NCT01783886 |
| 2-mg Intravitreous Aflibercept Injection | Phase 3 | Regeneron UK | NCT02858076 |
| 2.0 mg intravitreal aflibercept | Phase 3 | Regeneron UK | NCT01627249 |
| 22153 | Phase 3 | Regeneron UK | NCT05850520 |
| 4D-150-C004 | Phase 3 | 4D Molecular Therapeutics | 2025-521349-25-00 |
| 8 mg aflibercept (BAY 86-5321) (High Dose) | Phase 3 | Regeneron UK | NCT06422507 |
| Aflibercept | Phase 3 | Regeneron UK | NCT01661270, NCT01670721 |
| Aflibercept | Phase 3 | Regeneron UK | NCT00519285 |
| Aflibercept | Phase 3 | HOFFMANN-LA ROCHE | NCT03622593 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2025146482 | FINÉRÉNONE DESTINÉE À ÊTRE UTILISÉE DANS UN PROCÉDÉ DE PRÉVENTION OU DE TRAITEMENT D'UNE INSUFFISANCE CARDIAQUE CHEZ UN PATIENT RECEVANT UN INHIBITEUR DE CYP3A4 OU UN INDUCTEUR DE CYP3A4 | WO |
| 4567716 | ERZEUGUNG SYNTHETISCHER DARSTELLUNGEN | EP |
| 4567715 | ERZEUGUNG SYNTHETISCHER DARSTELLUNGEN | EP |
| 12280093 | Use of a VEGF receptor-based fusion protein antagonist to treat nonproliferative diabetic retinopathy | US |
| 12268730 | Use of a VEGF antagonist to treat angiogenic eye disorders | US |
| 12202883 | Anti-VEGF protein compositions and methods for producing the same | US |
| 12168036 | Methods for treating angiogenic eye disorders with high doses of VEGF receptor fusion proteins | US |
| 12116622 | Methods of associating genetic variants with a clinical outcome in patients suffering from age-related macular degeneration treated with anti-VEGF | US |
| 12077570 | Anti-VEGF protein compositions and methods for producing the same | US |
| 12054533 | Anti-VEGF protein compositions and methods for producing the same | US |
| 11986511 | Use of a VEGF antagonist to treat angiogenic eye disorders | US |
| 11975045 | Use of a VEGF antagonist to treat angiogenic eye disorders | US |
Related hubs
FAQ
What is the FDA approval status of aflibercept?
aflibercept 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 aflibercept 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 aflibercept?
This spoke lists 85 published programs associated with aflibercept in our pipeline index.