Drugs / regdanvimab
regdanvimab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Regkirona | — | 2025-04-14 | europa.eu ↗ |
| Approved | EU (EMA) | Regkirona | — | 2021-11-12 | europa.eu ↗ |
Trials 3 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04593641 | Sep → Oct 2020 | COVID-19 | Celltrion | Completed | No outcome recorded |
| Phase 1 | NCT04525079 | Jul → Aug 2020 | COVID-19 | Celltrion | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04602000 | Oct 2020 → May 2021 | COVID-19 | Celltrion | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT05982704 Comparator | Aug → Sep 2022 | COVID-19 | City Clinical Hospital No.52 of Moscow Healthcare Department | Unknown | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | regdanvimab | “CT-P59 (regdanvimab), a SARS-CoV-2 neutralizing monoclonal antibody, was examined in 2 randomized, double-blind, placebo-controlled, single ascending dose, Phase I studies.” PMID 34551869 ↗ Aug 2021 |
| Known as | CT-P59 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04525079 ↗ |
| Known as | Regkirona | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650462 ↗ |
| Modality | Monoclonal antibody | “CT-P59 (regdanvimab), a SARS-CoV-2 neutralizing monoclonal antibody” PMID 34551869 ↗ Aug 2021 |
| Route | Intravenous | “CT-P59 (40 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)” NCT04602000 ↗ |