atoltivimab
Trade name: Inmazeb
mAbapprovedOrphan Drug FDABreakthrough Therapy FDA
Approved
Oct 14, 2020
Clinical trial activity
2 trials · 2 clinical orgs · 2 marketing orgs
Phase 1
1
Phase 2
0
Phase 3
0
Phase 4
0
Earliest trial started May 1, 2016 (NCT02777151)
Timeline
2020s
- Oct 14, 2020
Regeneron — Earliest FDA Approval
- Oct 14, 2020
Regeneron — Marketing Organization
- Oct 14, 2020
Jazz Pharmaceuticals — Marketing Organization
- Oct 14, 2020
Regeneron — NDA Secondary Org
- Oct 14, 2020
Regeneron — NDA Organization
Indications
Approved for
Studied for
Mechanism of action
- MarburgvirusANTAGONIST
Marburgvirus antagonist
- EbolavirusANTAGONIST
Ebolavirus antagonist
- Envelope glycoproteinINHIBITOR
Envelope glycoprotein inhibitor
Binds to and inactivates the viral glycoprotein which mediates virus attachment to host cells. The viral glycoprotein is also expressed on the surface of virus-infected cells.
Combination products
inmazeb
with maftivimab, odesivimab
Also known as atoltivimab, maftivimab, and odesivimab-ebgn
Approval history
- approvedPriority reviewBreakthroughOct 14, 2020
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- ChEMBLCHEMBL4298183 ↗
Also known as
- regn3470
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02777151 | Phase 1 | May 1, 2016 | Department of Health and Human Services, Regeneron |
| NCT03576690 | N/A | — | Regeneron |
Showing 2 of 2 trials
Page 1 / 1
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Regeneron | For profit | 2 | 2 | 2 | 2016 |
| Department of Health and Human Services | Government | 1 | 0 | 1 | 2016 |
2 organizations
Page 1 / 1
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Jazz Pharmaceuticals | For profit | MKTG | Oct 14, 2020 |
| Regeneron | For profit | MKTG | Oct 14, 2020 |
| Regeneron | For profit | NDA2 | Oct 14, 2020 |
| Regeneron | For profit | NDA | Oct 14, 2020 |