ANSUVIMAB
Trade name: Ebanga
mAbapprovedMulti-specificOrphan Drug FDABreakthrough Therapy FDA
Approved
Dec 21, 2020
Clinical trial activity
2 trials · 3 clinical orgs · 2 marketing orgs
Phase 1
0
Phase 2
1
Phase 3
0
Phase 4
0
Earliest trial started Oct 17, 2021 (NCT04822376)
Timeline
2010s
- May 8, 2019
Orphan Drug Designation
2020s
- Dec 21, 2020
Emergent BioSolutions — Earliest FDA Approval
- Dec 21, 2020
Ridgeback Biotherapeutics, LP — Marketing Organization
- Dec 21, 2020
Emergent BioSolutions — NDA Secondary Org
- Dec 21, 2020
Emergent BioSolutions — NDA Organization
- Jan 1, 2021
Earliest Phase 2 Sponsor(trial)
Indications
Studied for
Mechanism of action
- EbolavirusANTAGONIST
Ebolavirus antagonist
- Envelope glycoproteinBINDING AGENT
Envelope glycoprotein binding agent
Binds the viral glycoprotein and prevents interaction with the host receptor.
ERBB2 inhibitor
FCGR3A inhibitor
Approval history
- approvedPriority reviewBreakthroughDec 21, 2020
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- Yes
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL4594388 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04822376 | Phase 2 | Oct 17, 2021 | Government of France |
| NCT05067166 | N/A | — | Government of Congo, Ridgeback Biotherapeutics, LP |
Showing 2 of 2 trials
Page 1 / 1
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Government of Congo | Government | 1 | 0 | 1 | — |
| Government of France | Government | 1 | 1 | 1 | 2021 |
| Ridgeback Biotherapeutics, LP | For profit | 1 | 1 | 1 | — |
3 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Emergent BioSolutions | For profit | NDA2 | Dec 21, 2020 |
| Emergent BioSolutions | For profit | NDA | Dec 21, 2020 |
| Ridgeback Biotherapeutics, LP | For profit | MKTG | Dec 21, 2020 |