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Granulomatosis With Polyangiitis

2
Pipeline Programs
5
Companies
14
Clinical Trials
2 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
1
0
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
3100%
+ 4 programs with unclassified modality

On Market (1)

Approved therapies currently available

TAVNEOSApproved
avacopan
Unknown Company
Complement 5a Receptor Antagonist [EPC]oral2021
34M Part D

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Amgen
AmgenTHOUSAND OAKS, CA
1 program
1
avacopanPhase 2/35 trials
Active Trials
NCT07176546Not Yet Recruiting30Est. Oct 2030
NCT06321601Recruiting20Est. Sep 2028
NCT06468826Completed13Est. Oct 2024
+2 more trials
Airway Therapeutics
Airway TherapeuticsGA - Marietta
2 programs
Airway assessmentN/A1 trial
Granulomatosis With Polyangiitis Natural History StudyN/A
Active Trials
NCT03182049Withdrawn0Est. May 2023
Genentech
GenentechCA - Oceanside
2 programs
RituximabN/AMonoclonal Antibody1 trial
ObinutuzumabPHASE_2Monoclonal Antibody1 trial
Active Trials
NCT01613599Completed100Est. Apr 2017
NCT05376319Terminated6Est. May 2024
Chia Tai TianQing Pharmaceutical Group
1 program
Meperizumab injectionPHASE_11 trial
Active Trials
NCT05353179Unknown88Est. Oct 2022
Roche
RocheSTAVANGER NORWAY, Norway
1 program
RituximabPHASE_2Monoclonal Antibody

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Amgenavacopan
Amgenavacopan
Amgenavacopan
Amgenavacopan
GenentechObinutuzumab
Amgenavacopan
Amgenavacopan
Amgenavacopan
Amgenavacopan
Chia Tai TianQing Pharmaceutical GroupMeperizumab injection
Amgenavacopan
Amgenavacopan
Airway TherapeuticsAirway assessment
GenentechRituximab

Clinical Trials (14)

Total enrollment: 1,494 patients across 14 trials

A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis

Start: Feb 2024Est. completion: Dec 2036300 patients
Phase 4Recruiting

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.

Start: Oct 2024Est. completion: Sep 202820 patients
Phase 3Recruiting

A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis

Start: Mar 2017Est. completion: Nov 2019331 patients
Phase 3Completed

TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis

Start: Jul 2026Est. completion: Oct 203030 patients
Phase 2/3Not Yet Recruiting

PR3-AAV Resilient Remission or PRRR

Start: Jun 2023Est. completion: May 20246 patients
Phase 2Terminated

Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA)

Start: Dec 2018Est. completion: Mar 2021435 patients
Phase 2Completed

Controlled Trial Evaluating Avacopan in C3 Glomerulopathy

Start: Sep 2017Est. completion: Oct 202157 patients
Phase 2Completed

A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD)

Start: Jun 2024Est. completion: Oct 202413 patients
Phase 1Completed

Effect of Repeated Oral Doses of Avacopan on the Pharmacokinetics (PK) of a Single Dose of Simvastatin

Start: Jun 2022Est. completion: Aug 202232 patients
Phase 1Completed

Study on Pharmacokinetics of Meperizumab Injection and NUCALA® in Healthy Male Volunteers

Start: Jun 2022Est. completion: Oct 202288 patients
Phase 1Unknown

A Study to Assess the Effect of Avacopan at Therapeutic and Supratherapeutic Doses on the QT/QTc Interval in Healthy Participants

Start: Nov 2019Est. completion: Mar 202058 patients
Phase 1Completed

A Study to Evaluate the Pharmacokinetics of Avacopan (CCX168) in Participants With Mild or Moderate Hepatic Impairment

Start: Apr 2018Est. completion: Sep 201824 patients
Phase 1Completed

Natural History of Granulomatosis With Polyangiitis: Clinical and Genetic Biomarkers of Airway Disease NoAAC PR-03 Study

Start: Dec 2020Est. completion: May 20230
N/AWithdrawn

An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis

Start: Jun 2012Est. completion: Apr 2017100 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

2 actively recruiting trials targeting 1,494 patients
5 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.