Drugs / Inmazeb
Inmazeb
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | INMAZEB | — | 2020-10-14 | fda.gov ↗ |
Trials 5 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02777151 | May 2016 → Apr 2017 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05202288 | Jan → Aug 2027 expected | Ebola hemorrhagic fever | ANRS, Emerging Infectious Diseases | Not yet recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03719586 | Nov 2018 → Sep 2019 | Ebola hemorrhagic fever | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06841614 | Sep 2026 → Aug 2027 expected | Ebola hemorrhagic fever | ANRS, Emerging Infectious Diseases | Not yet recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03576690 | — | Ebola hemorrhagic fever | Regeneron Pharmaceuticals | Available | No outcome recorded |
Press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-10-28 | Regeneron Pharmaceuticals | Inmazeb® (atoltivimab, maftivimab, and odesivimab-ebgn) Wins Prestigious 2022 Prix Galien USA Best Biotechnology Product Award regeneron.com ↗ |
| 2020-10-14 | Regeneron Pharmaceuticals | Regeneron's Antibody Cocktail REGN-EB3 (Inmazeb®) is First FDA-Approved Treatment for Ebola (Zaire Ebolavirus) regeneron.com ↗ |
| 2020-07-29 | Regeneron Pharmaceuticals | BARDA Procures Regeneron's REGN-EB3 Investigational Ebola Treatment for National Preparedness regeneron.com ↗ |
| 2020-04-16 | Regeneron Pharmaceuticals | FDA Accepts for Priority Review Biologics License Application for REGN-EB3 to Treat Ebola regeneron.com ↗ |
| 2019-11-27 | Regeneron Pharmaceuticals | New England Journal of Medicine Publishes Results of Ebola Clinical Trial Confirming Superiority of Regeneron's REGN-EB3 to ZMapp in Preventing Ebola Deaths regeneron.com ↗ |
| 2019-08-12 | Regeneron Pharmaceuticals | PALM Ebola Clinical Trial Stopped Early as Regeneron's REGN-EB3 Therapy Shows Superiority to ZMapp in Preventing Ebola Deaths regeneron.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Inmazeb | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06841614 ↗ |
| Known as | REGN-EB3 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03719586 ↗ |
| Known as | REGN3470-3471-3479 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02777151 ↗ |
| Action | Inhibit | “Inmazeb inhibits viral entry into the target cell (12).” NCT06841614 ↗ |
| Modality | Monoclonal antibody | “co-formulated cocktail of three human monoclonal antibodies” PMID 29929783 ↗ Jun 2018 |
| Route | Intravenous | “receive a single intravenous dose of REGN3470-3471-3479 or placebo on day 1 (baseline)” PMID 29929783 ↗ Jun 2018 |