Drugs / 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 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT05202288 | Jan → Aug 2027 expected | Ebola hemorrhagic fever | ANRS, Emerging Infectious Diseases | Not yet recruiting | 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 |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-05-28 | Regeneron Pharmaceuticals | Regulatory Regeneron’s Ebola Antibody Recommended by World Health Organization for Investigational Use in Response to Current Bundibugyo Ebolavirus Outbreak regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that maftivimab, the most potent neutralizing antibody included in Inmazeb® (maftivimab, atoltivimab and odesivimab-ebgn), has been recommended by the World Health Organization’s (WHO) Therapeutics Advisory Group to be prioritized for evaluation in clinical trials of investigational treatments for Bundibugyo ebolavirus. |
| 2020-10-14 | Regeneron Pharmaceuticals | Regulatory Regeneron's Antibody Cocktail REGN-EB3 (Inmazeb®) is First FDA-Approved Treatment for Ebola (Zaire Ebolavirus) regeneron.com ↗
We are incredibly proud that the FDA has approved Inmazeb, which is also known as REGN-EB3. |
| 2020-04-16 | Regeneron Pharmaceuticals | Regulatory FDA Accepts for Priority Review Biologics License Application for REGN-EB3 to Treat Ebola regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a new Biologics License Application (BLA) for REGN-EB3, an investigational triple antibody cocktail treatment for Ebola virus infection. |
| 2019-11-27 | Regeneron Pharmaceuticals | Results 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 ↗
The trial was stopped in August 2019 when preliminary results showed that REGN-EB3 crossed the pre-specified superiority threshold for preventing death compared to ZMapp. |
| 2019-08-12 | Regeneron Pharmaceuticals | Results PALM Ebola Clinical Trial Stopped Early as Regeneron's REGN-EB3 Therapy Shows Superiority to ZMapp in Preventing Ebola Deaths regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Company was informed by study investigators that a randomized, controlled trial evaluating four investigational therapies for Ebola virus infection was stopped early because REGN-EB3 was superior to ZMapp in preventing death. |
All press releases naming this drug 6 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Inmazeb | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06841614 ↗ |
| Action | Inhibit | “Inmazeb inhibits viral entry into the target cell (12).” NCT06841614 ↗ |
| Modality | Monoclonal antibody | “two monoclonal antibodies (Mabs) have demonstrated their efficacy in reducing mortality in patients with EVD: REGN-E3B (Inmazeb).” NCT05202288 ↗ |
| Route | Intravenous | “Inmazeb IV (150 mg/kg) D0” NCT06841614 ↗ |