Avacopan clinical trials
Avacopan is named as an intervention in 4 current clinical trials in our USA, France, Poland, Czechia, Spain, Belgium, Turkey, Canada, Denmark and Japan registers. 2 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Amgen (2). The most-studied condition is Vasculitis.
Where Avacopan is approved
All regulators →Of the three regulators tracked here, the first to approve Avacopan was the US, on 7 Oct 2021. It is approved in 2 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of C3 glomerulopathy (20 Jun 2017, positive)
- 1 EU safety letter (DHPC), latest: referral - article 20 procedure for Tavneos, 16 Jul 2026
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Avacopan patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Avacopan, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 4 listed patents; the last listed expires 27 Nov 2039 (US 11603356).
- Latest patent on the drug substance itself: 27 Nov 2039 (US 11603356).
- Exclusivity ODE-377: Orphan drug exclusivity: as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (anca)-as…, until 7 Oct 2028.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Avacopan
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Avacopan works
All drug targets →- C5a anaphylatoxin chemotactic receptor antagonist AntagonistTarget: C5AR1 complement C5a receptor 1✓ In ChEMBL and the Guide to Pharmacology
- Rapidly progressive glomerulonephritisPhase 3
- C3 glomerulonephritisPhase 2
- IgA glomerulonephritisPhase 2
- Atypical hemolytic-uremic syndromePhase 2
- Dense deposit diseasePhase 2
- Eosinophilic granulomatosis with polyangiitisPhase 2
- Hidradenitis suppurativaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3989871, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 9450, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Avacopan
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Avacopan. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Avacopan for treating severe active granulomatosis with polyangiitis or microscopic polyangiitis NICE TA825 | Recommended | 21 Sep 2022 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Avacopan
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Avacopan
- ChEMBL
- CHEMBL3989871
- DrugBank
- DB15011
- PubChem CID
- 49841217
- CAS number
- 1346623-17-3
- FDA UNII
- O880NM097T
- Wikidata
- Q27285470
- Wikipedia
- Avacopan
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Avacopan
4 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
NCT06072482 · Antineutrophil Cytoplasmic Antibody-associated Vasculitis
|
Phase 4 | Recruiting | Amgen | USA, Denmark, Poland, Czechia |
|
Special Drug Use-results Survey for Long-term Use（Avacopan）
NCT06758271 · ClinicalTrials.gov ↗ · Microscopic Polyangiitis (MPA), Granulomatosis With Polyangiitis (GPA)
|
Observational | Recruiting | Kissei Pharmaceutical Co., Ltd | Japan |
|
Avacopan Added to Standard-of-care Therapy in ANCA-associated Vasculitis With Severe Kidney Involvement
NCT07373262 · ClinicalTrials.gov ↗ · ANCA-Associated Vasculitis (AAV)
|
Phase 3 | Not yet open | University Hospital, Toulouse | France |
|
Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Years to < 18 Years of Age With AAV.
NCT06321601 · Vasculitis
|
Phase 3 | Active, closed | Amgen | USA, France, Spain, Belgium, Poland, Czechia, Turkey, Canada |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Avacopan across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Avacopan on the HPRA medicines list.
- TAVNEOS 10 mg Capsule, hardVifor Fresenius Medical Care Renal Pharma France · EU/1/21/1605/001-002
Supply shortages
No entry for Avacopan in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Avacopan
5 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Amgen | 2 |
| University Hospital, Toulouse | 1 |
| Kissei Pharmaceutical Co., Ltd | 1 |
By country register
A trial with sites in more than one country appears in each of those registers.
Questions about Avacopan trials
How many clinical trials are testing Avacopan?
4 current trials in our USA, France, Poland, Czechia, Spain, Belgium, Turkey, Canada, Denmark and Japan registers name Avacopan (also registered as AMG 569) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Avacopan trials recruiting patients?
Yes. 2 of the 4 trials are recruiting: 1 with sites in USA, 1 with sites in Poland, 1 with sites in Czechia, 1 with sites in Denmark and 1 with sites in Japan. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Avacopan clinical trials?
Amgen (2), University Hospital, Toulouse (1) and Kissei Pharmaceutical Co., Ltd (1). The number in brackets is how many trials each organisation leads.
Is Avacopan licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Avacopan, for example TAVNEOS 10 mg Capsule, hard (Vifor Fresenius Medical Care Renal Pharma France). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Avacopan shortage?
Not in the lists we track: Avacopan has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Avacopan works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Avacopan works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Avacopan (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.