INMAZEB is a combination of three human monoclonal antibodies indicated for the treatment of infection caused by Orthoebolavirus zairense. The treatment is approved for use in adult and pediatric patients, including neonates born to mothers who are RT-PCR positive for the virus. Its therapeutic role is specific to this species, as efficacy has not been established for other members of the Orthoebolavirus or Orthomarburgvirus genera. Clinical use should take into account available information on drug susceptibility patterns, as viral evolution or resistance may diminish the drug's effectiveness.
How INMAZEB Works
INMAZEB is an antiviral combination composed of three recombinant human IgG1κ monoclonal antibodies: atoltivimab, maftivimab, and odesivimab. These antibodies are directed against the Orthoebolavirus zairense glycoprotein. By targeting this specific viral component, the monoclonal antibody combination works to inhibit the Orthoebolavirus zairense pathogen.
Details
- Status
- Prescription
- First Approved
- 2020-10-14
- Patent Cliff
- 2027
- Routes
- INJECTION
- Dosage Forms
- SOLUTION
INMAZEB Approval History
What INMAZEB Treats
1 indicationsINMAZEB is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Orthoebolavirus zairense Infection
Regeneron's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06841614 EBO-PEP | ANRS 0515s EBO-PEP | Ph 3 | not yet recruiting | EBOla Post-Exposure Prophylaxis |
| NCT05202288 | ANRS 0064S IMOVA | Ph 2 | not yet recruiting | Impact of Delay Between Administration of Inmazeb Administration and Vaccination by Ervebo on Vaccine Immune Response on Healthy Volunteers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
INMAZEB FDA Label Details
Indications & Usage
FDA Label (PDF)INMAZEB is indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration , and Clinical Studies ] . INMAZEB is a combination of Orthoebolavirus zairense glycoprotein-directed human monoclonal antibodies (atoltivimab, maftivimab, and odesivimab), indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoe...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.