avacincaptad pegol
Trade name: Izervay
PeptideapprovedFast Track FDABreakthrough Therapy FDA
Approved
Aug 4, 2023
Clinical trial activity
12 trials · 5 clinical orgs · 3 marketing orgs
Phase 1
1
Phase 2
9
Phase 3
3
Phase 4
1
Earliest trial started Mar 1, 2015 (NCT02397954)
Timeline
2010s
- Jan 1, 2015
Iveric Bio — Earliest Phase 2 Sponsor(trial)
2020s
- Jan 1, 2020
Iveric Bio — Earliest Phase 3 Sponsor(trial)
- Aug 4, 2023
Leo Pharma — Earliest FDA Approval
- Aug 4, 2023
Astellas — Marketing Organization
- Aug 4, 2023
Iveric Bio — Marketing Organization
- Aug 4, 2023
Iveric Bio — NDA Secondary Org
- Aug 4, 2023
Leo Pharma — NDA Organization
- Jan 1, 2025
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Complement C5INHIBITOR
C5 inhibitor
Approval history
- approvedPriority reviewFast trackBreakthroughAug 4, 2023
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL6068573 ↗
- ChEMBLCHEMBL4297889 ↗
Also known as
- zimura
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06961370 | Phase 1 | Jul 16, 2025 | Roche |
| NCT06970665 | Phase 4 | Jul 8, 2025 | Astellas |
| NCT06659445 | Phase 2 | Mar 31, 2025 | ONL Therapeutics |
| NCT05839041 | Phase 2 | May 2, 2023 | Aviceda Therapeutics |
| NCT05536297 | Phase 3 | Sep 26, 2022 | Iveric Bio |
| NCT04435366 | Phase 3 | Jun 30, 2020 | Iveric Bio |
| NCT03374670 | Phase 2 | Nov 30, 2018 | Iveric Bio |
| NCT03364153 | Phase 2 | Jan 12, 2018 | Iveric Bio |
| NCT03362190 | Phase 2 | Oct 11, 2017 | Iveric Bio |
| NCT05571267 | Phase 2 | Oct 20, 2016 | Iveric Bio |
| NCT02686658 | Phase 2/Phase 3 (Phase 3) | Jan 1, 2016 | Iveric Bio |
| NCT02397954 | Phase 2 | Mar 1, 2015 | Iveric Bio |
Showing 12 of 12 trials
Page 1 / 1
Organizations
Research & Development (5)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Iveric Bio | For profit | 8 | 8 | 2 | 2015 |
| Astellas | For profit | 1 | 1 | 1 | 2025 |
| Aviceda Therapeutics | For profit | 1 | 1 | 1 | 2023 |
| ONL Therapeutics | For profit | 1 | 1 | 1 | 2025 |
| Roche | For profit | 1 | 1 | 1 | 2025 |
5 organizations
Page 1 / 1
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Astellas | For profit | MKTG | Aug 4, 2023 |
| Iveric Bio | For profit | MKTG | Aug 4, 2023 |
| Iveric Bio | For profit | NDA2 | Aug 4, 2023 |
| Leo Pharma | For profit | NDA | Aug 4, 2023 |