Drugs / Avacopan
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed anti-neutrophil antibody associated vasculitis 2 milestones | |||||
| Filed | Japan (PMDA) | — | anti-neutrophil antibody associated vasculitis | 2021-03-01 | “「アバコパン（一般名、開発番号：CCX168）」の日本国内における製造販売承認申請を行いました” kissei.co.jp ↗ |
| Filed | EU (EMA) | — | anti-neutrophil antibody associated vasculitis | 2020-11-03 | “EMA accepted to review the Marketing Authorization Application (MAA) for avacopan for the treatment of patients with ANCA-associated vasculitis” csl.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Tavneos | — | 2022-01-11 | europa.eu ↗ |
| Approved | US (FDA) | TAVNEOS | — | 2021-10-07 | fda.gov ↗ |
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials · 1 met primary | ||||||
| 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 | Met primary |
| 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 · 3 missed | ||||||
| Phase 2 | NCT03852472 | Dec 2018 → Jan 2021 | hidradenitis suppurativa | Amgen | Completed | Missed primary |
| Phase 2 | NCT03301467 | Sep 2017 → Mar 2021 | complement 3 glomerulopathy | Amgen | Completed | Missed primary |
| Phase 2 | NCT02464891 | Jun 2015 → Jul 2017 | atypical hemolytic-uremic syndrome | Mario Negri Institute for Pharmacological Research | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02384317 | Mar → Sep 2015 | IgA glomerulonephritis | Amgen | Completed | Missed primary |
| Phase 2 | NCT01363388 | Sep 2011 → Oct 2015 | vasculitis | Amgen | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| 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 | Met primary |
| 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 |
| Comparator or background therapy3 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 2/3 | NCT07176546 Comparator | May 2026 → Jul 2030 expected | granulomatosis with polyangiitis | Robert Spiera, MD | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-06-03 | Amgen | Results AMGEN TO PRESENT NEW DATA ACROSS RARE AUTOIMMUNE AND INFLAMMATORY DISEASES AT EULAR 2026 amgen.com ↗
Additionally, new real-world evidence on TAVNEOS ® (avacopan) further support its established efficacy and safety profile with reduced steroid use in people living with anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis. |
| 2021-09-27 | Kissei Pharmaceutical Co., Ltd. | Regulatory 選択的C5a受容体拮抗薬「タブネオス®カプセル10mg」国内における製造販売承認取得のお知らせ kissei.co.jp ↗
本日、選択的C5a受容体拮抗薬「タブネオス ® カプセル10mg」（一般名：アバコパン）につきまして、厚生労働省より国内における製造販売承認を取得しましたので、お知らせいたします。 |
| 2021-03-01 | Kissei Pharmaceutical Co., Ltd. | Regulatory 補体C5a受容体阻害剤「アバコパン（CCX168）」の国内製造販売承認申請のお知らせ kissei.co.jp ↗
キッセイ薬品工業株式会社（本社：長野県松本市、代表取締役会長兼最高経営責任者：神澤陸雄、以下「キッセイ薬品」）は、このたび、抗好中球細胞質抗体（ANCA）関連血管炎に分類される顕微鏡的多発血管炎及び多発血管炎性肉芽腫症の治療薬として、補体C5a受容体阻害剤「アバコパン（一般名、開発番号：CCX168）」の日本国内における製造販売承認申請を行いましたので、お知らせいたします。 |
| 2020-11-03 | CSL Behring | Regulatory VFMCRP and Chemocentryx Announce European Medicines Agency Has Accepted to Review the Marketing Authorization Application for Avacopan csl.com ↗ |
| 2019-11-26 | Kissei Pharmaceutical Co., Ltd. | Results 補体C5a受容体阻害剤「アバコパン（CCX168）」の国際共同第Ⅲ相臨床試験（ADVOCATE試験）の結果について kissei.co.jp ↗
本試験の結果、アバコパン治療群は、標準治療群に対し、26週における非劣性及び52週における統計的に有意な優越性を示しました。 |
| 2019-11-26 | CSL Behring | Results VFMCRP Press Release Phase-iii Advocate Trial of Avacopan csl.com ↗
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and ChemoCentryx, Inc., (NASDAQ: CCXI) today announced positive topline data from the pivotal phase-III ADVOCATE trial of avacopan, an orally administered selective complement 5a receptor inhibitor, for the treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis). |
| 2019-01-24 | CSL Behring | Regulatory Vifor Pharma Press Release Chemocentryx Cma Withdrawal Aav csl.com ↗
Since pivotal topline data will be available from our global Phase III ADVOCATE trial later this year, we have decided not to proceed with our limited Phase II-based CMA in Europe, |
All press releases naming this drug 16 releases
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 ↗ |