avacopan
Trade name: Tavneos
Small moleculeapprovedOrphan Drug FDA
Approved
Oct 7, 2021
Clinical trial activity
21 trials · 10 clinical orgs · 1 marketing orgs
Phase 1
9
Phase 2
9
Phase 3
3
Phase 4
2
Earliest trial started Dec 21, 2009 (NCT05984251)
Timeline
2000s
- Jan 1, 2009
Earliest Phase 1 Sponsor(trial)
2010s
- Jan 1, 2011
ChemoCentryx — Earliest Phase 2 Sponsor(trial)
- Jun 2, 2014
Orphan Drug Designation
- Jan 1, 2016
ChemoCentryx — Earliest Phase 3 Sponsor(trial)
2020s
- Oct 7, 2021
ChemoCentryx — Earliest FDA Approval
- Oct 7, 2021
ChemoCentryx — Marketing Organization
- Oct 7, 2021
ChemoCentryx — NDA Secondary Org
- Oct 7, 2021
ChemoCentryx — NDA Organization
Indications
Approved for
Studied for
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis · Phase 3
- Atypical Hemolytic Uremic Syndrome · Phase 2
- Electrocardiography · Phase 1
- Glomerulonephritis, IGA · Phase 2
- Granulomatosis with Polyangiitis · Phase 2/Phase 3
- Healthy Volunteers · Phase 1
- Hidradenitis Suppurativa · Phase 2
- Kidney Diseases · Phase 2
- Kidney Failure, Chronic · Phase 1
- Liver Diseases · Phase 1
- Lupus Erythematosus, Systemic · Phase 1
- Vasculitis · Phase 4
Mechanism of action
- C5a anaphylatoxin chemotactic receptorANTAGONIST
C5AR1 antagonist
Approval history
- approvedOct 7, 2021
Chemistry & pharmacology
Loading structure…
SMILES
Cc1ccc(NC(=O)[C@H]2CCCN(C(=O)c3c(C)cccc3F)[C@H]2c2ccc(NC3CCCC3)cc2)cc1C(F)(F)F- Mol. weight
- 581.65 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
First in class
Sources
- ChEMBLCHEMBL3989871 ↗
- ChEMBLCHEMBL3545099 ↗
Also known as
- ccx168
- ccx168
- ccx168
- ccx-168
- ccx-168
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07176546 | Phase 2/Phase 3 (Phase 3) | Jul 31, 2026 | Amgen, Rockefeller University |
| NCT06676579 | Phase 2 | Dec 2, 2024 | Mayo Clinic |
| NCT06611696 | Phase 4 | Nov 15, 2024 | Chiba University, International University of Health and Welfare, Kissei Pharmaceuticals |
| NCT06321601 | Phase 3 | Nov 15, 2024 | Amgen |
| NCT06468826 | Phase 1 | Jul 11, 2024 | Amgen |
| NCT06072482 | Phase 4 | Dec 12, 2023 | Amgen |
| NCT06207682 | Phase 1 | Jun 28, 2022 | Amgen |
| NCT05988034 | Phase 1 | Nov 8, 2019 | Amgen |
| NCT03852472 | Phase 2 | Dec 28, 2018 | ChemoCentryx |
| NCT06004934 | Phase 1 | Apr 17, 2018 | Amgen |
| NCT05988008 | Phase 1 | Oct 23, 2017 | Amgen |
| NCT03301467 | Phase 2 | Sep 29, 2017 | ChemoCentryx |
| NCT02994927 | Phase 3 | Dec 1, 2016 | ChemoCentryx |
| NCT06004947 | Phase 1 | Jan 14, 2016 | Amgen |
| NCT05988021 | Phase 1 | Dec 3, 2015 | Amgen |
| NCT02464891 | Phase 2 | Jun 4, 2015 | ChemoCentryx, Mario Negri Institute, Vita-Salute University of Milano. Italy |
| NCT02384317 | Phase 2 | Feb 1, 2015 | ChemoCentryx |
| NCT06004960 | Phase 1 | Oct 20, 2014 | Amgen |
| NCT02222155 | Phase 2 | Sep 1, 2014 | ChemoCentryx, University of North Carolina at Chapel Hill |
| NCT01363388 | Phase 2 | Aug 1, 2011 | ChemoCentryx |
Showing 20 of 21 trials
Page 1 / 2
Organizations
Research & Development (10)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Amgen | For profit | 12 | 11 | 3 | 2009 |
| ChemoCentryx | For profit | 7 | 6 | 2 | 2011 |
| Chiba University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| International University of Health and Welfare | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Kissei Pharmaceuticals | For profit | 1 | 0 | 1 | 2024 |
| Mario Negri Institute | Academic/Hospital | 1 | 1 | 1 | 2015 |
| Mayo Clinic | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Rockefeller University | Academic/Hospital | 1 | 1 | 1 | 2026 |
| University of North Carolina at Chapel Hill | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Vita-Salute University of Milano. Italy | Academic/Hospital | 1 | 0 | 1 | 2015 |
10 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ChemoCentryx | For profit | MKTG | Oct 7, 2021 |
| ChemoCentryx | For profit | NDA2 | Oct 7, 2021 |
| ChemoCentryx | For profit | NDA | Oct 7, 2021 |