Drugs / CT-P42
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | Eydenzelt | — | — | “Eydenzelt® was also filed for regulatory approval with the U.S.” celltrion.com ↗ “Eydenzelt was filed for regulatory approval with the U.S.” celltrion.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04739306 | Jul 2021 → Oct 2022 | diabetic macular edema | Celltrion | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-02-19 | Celltrion | Regulatory Celltrion Expands Biosimilar Portfolio in the European Union Following European Commission Approval of Two Biosimilars celltrion.com ↗
Celltrion gains simultaneous regulatory approval of two monoclonal antibody biosimilars across three treatments – Eydenzelt® (aflibercept), Stoboclo® and Osenvelt® (denosumab) in the EU market |
| 2024-12-16 | Celltrion | Regulatory Celltrion Receives Positive CHMP Opinion for Three Biosimilars in the European Union celltrion.com ↗ |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-02-19 | Celltrion | Celltrion Expands Biosimilar Portfolio in the European Union Following European Commission Approval of Two Biosimilars celltrion.com ↗ |
| 2024-12-16 | Celltrion | Celltrion Receives Positive CHMP Opinion for Three Biosimilars in the European Union celltrion.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CT-P42 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04739306 ↗ |
| Route | Intravitreal | “2mg/0.05 mL by Intravitreal injection” NCT04739306 ↗ |