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Drug

Avacopan

Withdrawn from market
ClassC5a anaphylatoxin chemotactic receptor antagonist

Also known as Tavneos.

RxNorm2572100ChEMBLCHEMBL3989871ATCL04AJ05UNIIO880NM097T
6
Active clinical trials
C5AR1
Primary target
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Kidney Disease: Improving Global Outcomes (KDIGO) responds to the retraction of the ADVOCATE trial of avacopan for the treatment of ANCA-associated vasculitis

Clinical trial2026-09-08Trial news · Kidney International

Avacopan in Vasculitis: Uncommon but Severe Liver Risks

Industry2026-09-04Medscape Medical News

UK regulator halts sales of Tavneos; UniQure seeks approval for Huntington's gene therapy

Regulatory2026-09-02Regulatory news · Endpoints News

MHRA concludes review of Avacopan Vifor following reassessment of benefit-risk balance

Regulatory2026-09-01Regulatory news · MHRA (gov.uk)

Pharmacokinetics Of Emulsified Avacopan In ANCA-associated Vasculitis With Severe Diffuse Alveolar Hemorrhage

Clinical trial2026-08-06Results expected Q1 2028 · ClinicalTrials.gov

Market withdrawal: Tavneos (EMA)

Regulatory2026-08-04EMA

Jasper finds new purpose in merger with Kira, while offloading Tavneos rival to Mirador

Industry2026-07-17Acquisition · Fierce Biotech

Regulatory tracker: Another Tavneos domino falls as UK rescinds authorization

Regulatory2026-07-01Regulatory news · Fierce Pharma

A Phase 3, Open-label, Uncontrolled Single-arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Avacopan in Combination With a Rituximab or a Cyclophosphamide-containing Regimen in Children From 6 Years to < 18 Years of Age With Active ANCA-associated Vasculitis (AAV)

Clinical trial2026-06-18Results expected Q3 2028 · ClinicalTrials.gov

A Randomized, Double-blind, Placebo-controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Participants With Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

Clinical trial2026-06-18Results expected Q4 2036 · ClinicalTrials.gov

TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis

Clinical trial2026-06-17Results expected Q3 2030 · ClinicalTrials.gov

Approval: Tavneos (EMA)

Regulatory2022-01-11EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Avacopan
Aliases & brands
Tavneos
RxNorm CUI
2572100
ChEMBL ID
CHEMBL3989871
ATC codes
L04AJ05
UNII
O880NM097T
Primary mechanism
C5a anaphylatoxin chemotactic receptor antagonist
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

C5a anaphylatoxin chemotactic receptor 1
C5AR1 · P21730
ANTAGONISTC5a anaphylatoxin chemotactic receptor antagonist

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2022-01-11
Latest approval
2022-01-11
Authorities
EMA
Total events
2
emaEuropean Medicines Agency· 2 events
2026-08-04Market withdrawalMarket
Market withdrawal: Tavneos (EMA)
Indication: Tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA)… Show full indication

Tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).

Evidence ↗
2022-01-11Approval
Approval: Tavneos (EMA)
Indication: Tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA)… Show full indication

Tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

13 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
13
registered trials across all phases
LATEST COMPLETION 2024
6
Active studies
6
Recruiting
5
Late-stage (III+)
7
Completed
PHASE DISTRIBUTIONn = 13
Phase 15Phase 23Phase 2 / 31Phase 33Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Randomized, Double-blind, Placebo-controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Participants With Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

RecruitingPH IVAmgenn=3002036

TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis

Not yet recruitingPH II/IIIRobert Spiera, MDn=302030

Avacopan Added to Standard-of-care Therapy in ANCA-associated Vasculitis With Severe Kidney Involvement: a Randomized, Placebo-controlled, Double-blinded Multicenter Superiority Study

Not yet recruitingPH IIIUniversity Hospital, Toulousen=1302030

A Phase 3, Open-label, Uncontrolled Single-arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Avacopan in Combination With a Rituximab or a Cyclophosphamide-containing Regimen in Children From 6 Years to < 18 Years of Age With Active ANCA-associated Vasculitis (AAV)

RecruitingPH IIIAmgenn=202028

A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine

CompletedPH IIIAmgenn=3312019

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Avacopan in Subjects With Normal Renal Function and Subjects With End-Stage Renal Disease (ESRD) Requiring Hemodialysis

CompletedPH IAmgenn=132024

An Open-Label, Phase 1 Study to Evaluate the Effect of Repeated Oral Doses of Avacopan on the Pharmacokinetics of a Single Dose of Simvastatin in Healthy Volunteers

CompletedPH IAmgenn=322022

A Randomized, Double Blind, Placebo Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients With C3 Glomerulopathy

CompletedPH IIAmgenn=572021

A Randomized , Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa

CompletedPH IIAmgenn=4352021

A Multiple-dose, Randomized, Double-blind, Placebo-controlled, Active-Comparator, Parallel Study to Investigate the Effect of Avacopan at Therapeutic and Supratherapeutic Doses on the QT/QTc Interval in Healthy Subjects

CompletedPH IAmgenn=582020

A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine

CompletedPH IIIAmgenn=3312019
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.