Drugs / Avacopan
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Tavneos | — | 2022-01-11 | europa.eu ↗ |
| Approved | US (FDA) | TAVNEOS | — | 2021-10-07 | fda.gov ↗ |
Trials 20 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT07556484 | May 2026 → Mar 2028 expected | anti-neutrophil cytoplasmic antibody-associated vasculitis, diffuse alveolar hemorrhage | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 1 | NCT06468826 | Jun → Oct 2024 | end stage renal failure | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT06207682 | Jun → Aug 2022 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05988034 | Nov 2019 → Jan 2020 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT06004934 | Apr → Sep 2018 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05988008 | Oct 2017 → Jan 2018 | anti-neutrophil cytoplasmic antibody-associated vasculitis | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT06004947 | Jan → Mar 2016 | anti-neutrophil cytoplasmic antibody-associated vasculitis | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05988021 | Dec 2015 → Feb 2016 | anti-neutrophil cytoplasmic antibody-associated vasculitis | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT06004960 | Oct → Dec 2014 | anti-neutrophil cytoplasmic antibody-associated vasculitis | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05984251 | Dec 2009 → Sep 2010 | systemic lupus erythematosus, vasculitis | Amgen | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT03852472 | Dec 2018 → Jan 2021 | hidradenitis suppurativa | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT03301467 | Sep 2017 → Mar 2021 | complement 3 glomerulopathy | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT02464891 | Jun 2015 → Jul 2017 | atypical hemolytic-uremic syndrome | Mario Negri Institute for Pharmacological Research | Terminated | No outcome recorded |
| Phase 2 | NCT02384317 | Mar → Sep 2015 | IgA glomerulonephritis | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT01363388 | Sep 2011 → Oct 2015 | vasculitis | Amgen | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07373262 | Mar 2026 → Mar 2030 expected | anti-neutrophil cytoplasmic antibody-associated vasculitis | University Hospital, Toulouse | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06321601 | Oct 2024 → Jul 2027 expected | vasculitis | Amgen | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02994927 | Mar 2017 → Sep 2019 | anti-neutrophil cytoplasmic antibody-associated vasculitis | Amgen | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06611696 | Nov 2024 → Mar 2027 expected | anti-neutrophil cytoplasmic antibody-associated vasculitis | Chiba University | Recruiting | No outcome recorded |
| Phase 4 | NCT06072482 | Feb 2024 → Dec 2036 expected | anti-neutrophil cytoplasmic antibody-associated vasculitis | Amgen | Recruiting | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT06676579 Comparator | Jun 2025 → Mar 2028 expected | IgA glomerulonephritis | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT02222155 Comparator | Feb 2015 → Apr 2016 | anti-neutrophil cytoplasmic antibody-associated vasculitis | Amgen | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07176546 Comparator | Jul 2026 → Jul 2030 expected | granulomatosis with polyangiitis | Robert Spiera, MD | Not yet recruiting | No outcome recorded |
Press releases naming this drug 10 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-08-06 | CSL Behring | European Commission (EC) adopts decision to revoke marketing authorisation for TAVNEOS® (avacopan) in the European Union and European Economic Area countries csl.com ↗ |
| 2026-08-06 | CSL Behring | A further update on TAVNEOS® (avacopan) in the European Union csl.com ↗ |
| 2026-06-26 | CSL Behring | CHMP recommends revoking marketing authorisation for TAVNEOS® (avacopan) in the European Union csl.com ↗ |
| 2026-06-26 | CSL Behring | An Update on TAVNEOS® (avacopan) in the European Union: Our commitment to continued support for the ANCA Associated Vasculitis Community csl.com ↗ |
| 2022-08-18 | CSL Behring | Tavneos® (avacopan) recommended by England’s NICE for the treatment of AAV (GPA/MPA) csl.com ↗ |
| 2022-01-19 | CSL Behring | VFMCRP receives EU approval for Tavneos® for the treatment of ANCA-associated vasculitis csl.com ↗ |
| 2021-11-12 | CSL Behring | VFMCRP receives positive CHMP opinion for Tavneos® for the treatment of ANCA-associated vasculitis csl.com ↗ |
| 2021-09-27 | CSL Behring | VFMCRP announces approval for TAVNEOS® (avacopan) for the treatment of ANCA-associated vasculitis in Japan csl.com ↗ |
| 2020-11-03 | CSL Behring | VFMCRP and Chemocentryx Announce European Medicines Agency Has Accepted to Review the Marketing Authorization Application for Avacopan csl.com ↗ |
| 2019-11-26 | CSL Behring | VFMCRP Press Release Phase-iii Advocate Trial of Avacopan csl.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Avacopan | “CCX168 (Avacopan)” NCT02384317 ↗ |
| Known as | AVACOPAN (CCX168) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989871 ↗ |
| Known as | CCX168 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06004947 ↗ |
| Known as | TAVNEOS | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989871 ↗ |
| Action | Inhibit | “C5a anaphylatoxin chemotactic receptor antagonist” CHEMBL3989871 ↗1“C5aR inhibitor” NCT02222155 ↗ |
| Modality | Small molecule | “Avacopan, a Small-Molecule Complement C5a Receptor Antagonist” PMID 38993026 ↗ Jul 2024 |
| Route | Oral | “orally administered C5a receptor inhibitor” PMID 33128347 ↗ Oct 2020 |
| Target | C5AR1 | “C5a anaphylatoxin chemotactic receptor antagonist” CHEMBL3989871 ↗ |