Avacopan
- Generic Name
- Avacopan
- Brand Names
- Tavneos
- Drug Type
- Small Molecule
- Chemical Formula
- C33H35F4N3O2
- CAS Number
- 1346623-17-3
- Unique Ingredient Identifier
- O880NM097T
- Background
Anti-neutrophil cytoplasmic (auto)antibody (ANCA)-associated vasculitis (AAV) is a rare (estimated incidence of 3 cases per 100,000 per year) form of "pauci-immune" systemic small-vessel vasculitis typified by the presence of ANCAs in the serum. The full spectrum of AAV includes granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), eosinoph...
- Indication
Avacopan is indicated for the adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis; GPA/MPA) in combination with standard therapy including glucocorticoids. Avacopan does not eliminate the need for glucocorticoids.
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- Associated Conditions
- Severe, active Granulomatosis With Polyangiitis, Severe, active Microscopic Polyangiitis (MPA), Microscopic Polyangiitis (MPA), Severe Anti-neutrophil cytoplasmic antibody positive vasculitis, Granulomatosis With Polyangiitis
- Associated Therapies
- -
Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)
- Conditions
- Interventions
- First Posted Date
- 2024-11-06
- Last Posted Date
- 2024-11-06
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 16
- Registration Number
- NCT06676579
- Locations
- 🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸Mayo Clinic in Rochester, Rochester, Minnesota, United States
A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD)
- First Posted Date
- 2024-06-21
- Last Posted Date
- 2024-10-15
- Lead Sponsor
- Amgen
- Target Recruit Count
- 13
- Registration Number
- NCT06468826
- Locations
- 🇺🇸
Floridian Clinical Research, LLC, Miami Lakes, Florida, United States
🇺🇸Orlando Clinical Research Center, Orlando, Florida, United States
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.
- First Posted Date
- 2024-03-20
- Last Posted Date
- 2024-11-18
- Lead Sponsor
- Amgen
- Target Recruit Count
- 20
- Registration Number
- NCT06321601
- Locations
- 🇺🇸
Texas Childrens Hospital, Houston, Texas, United States
🇺🇸Riley Hospital for Children, Indianapolis, Indiana, United States
🇺🇸University of North Carolina, Chapel Hill, North Carolina, United States
Effect of Repeated Oral Doses of Avacopan on the Pharmacokinetics (PK) of a Single Dose of Simvastatin
- First Posted Date
- 2024-01-17
- Last Posted Date
- 2024-01-17
- Lead Sponsor
- Amgen
- Target Recruit Count
- 32
- Registration Number
- NCT06207682
- Locations
- 🇺🇸
Celerion, Tempe, Arizona, United States
A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
- Conditions
- Interventions
- First Posted Date
- 2023-10-10
- Last Posted Date
- 2024-12-13
- Lead Sponsor
- Amgen
- Target Recruit Count
- 300
- Registration Number
- NCT06072482
- Locations
- 🇺🇸
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
🇺🇸University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
🇺🇸University of Kentucky, Lexington, Kentucky, United States
A Study to Evaluate the Pharmacokinetics of Avacopan (CCX168) in Participants With Mild or Moderate Hepatic Impairment
- First Posted Date
- 2023-08-22
- Last Posted Date
- 2023-08-22
- Lead Sponsor
- Amgen
- Target Recruit Count
- 24
- Registration Number
- NCT06004934
- Locations
- 🇺🇸
Clinical Pharmacology of Miami, Inc., Hialeah, Florida, United States
A Study to Assess the Effect of Avacopan at Therapeutic and Supratherapeutic Doses on the QT/QTc Interval in Healthy Participants
- Conditions
- Interventions
- First Posted Date
- 2023-08-14
- Last Posted Date
- 2023-08-14
- Lead Sponsor
- Amgen
- Target Recruit Count
- 58
- Registration Number
- NCT05988034
- Locations
- 🇺🇸
Celerion, Tempe, Arizona, United States
Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA)
- Conditions
- Interventions
- First Posted Date
- 2019-02-25
- Last Posted Date
- 2024-03-15
- Lead Sponsor
- ChemoCentryx
- Target Recruit Count
- 435
- Registration Number
- NCT03852472
- Locations
- 🇺🇸
Clinical Site, Morgantown, West Virginia, United States
Controlled Trial Evaluating Avacopan in C3 Glomerulopathy
- Conditions
- Interventions
- First Posted Date
- 2017-10-04
- Last Posted Date
- 2024-05-03
- Lead Sponsor
- ChemoCentryx
- Target Recruit Count
- 57
- Registration Number
- NCT03301467
- Locations
- 🇬🇧
Clinical Site, Newcastle Upon Tyne, United Kingdom
🇺🇸University of Utah, Salt Lake City, Utah, United States
🇺🇸Clinical Trial Site, East Providence, Rhode Island, United States
A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis
- Conditions
- Interventions
- First Posted Date
- 2016-12-16
- Last Posted Date
- 2024-01-29
- Lead Sponsor
- ChemoCentryx
- Target Recruit Count
- 331
- Registration Number
- NCT02994927
- Locations
- 🇬🇧
Clinical Trial Site, Westcliff-on-Sea, United Kingdom
Drug Development Updates
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