Product Description
TAVNEOS (avacopan), approved by the FDA as an adjunctive treatment of ANCA-associated vasculitis, is a first-in-class, orally-administered small molecule that employs a novel, highly targeted mode of action in complement-driven autoimmune and inflammatory diseases. While the precise mechanism in ANCA vasculitis has not been definitively established, TAVNEOS, by blocking the complement 5a receptor (C5aR) for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells such as blood neutrophils, is presumed to arrest the ability of those cells to do damage in response to C5a activation, which is known to be the driver of ANCA vasculitis. TAVNEOS’s selective inhibition of only the C5aR leaves the beneficial C5a pathway through the C5L2 receptor functioning normally. (Sourced from: https://ir.chemocentryx.com/news-releases/news-release-details/chemocentryx-announces-fda-approval-tavneostm-avacopan-anca)
Mechanisms of Action: C5 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | Germany | Greece | Hungary | Iceland | Ireland | Italy | Japan | Latvia | Lithuania | Luxembourg | Netherlands | Norway | Poland | Portugal | Slovakia | Spain | Sweden | Switzerland | United Arab Emirates | United Kingdom | United States
Approved Indications: Granuloma | ANCA Vasculitis | Granulomatosis with Polyangiitis | Vasculitis | Microscopic Polyangiitis
Known Adverse Events: Hypertension | Abdominal Pain | Dizziness | Headache | Pain Unspecified | Paresthesia | Diarrhea
Company: Amgen
Company Location: THOUSAND OAKS CA 91320
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 4
Highest Development Phases
Phase 3: Vasculitis
Phase 1: ANCA Vasculitis|Healthy Volunteers|Kidney Failure, Chronic
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| NCT06321601 | P3 |
Recruiting |
Vasculitis |
2030-07-20 |
|
| NCT06468826 | P1 |
Completed |
Kidney Failure, Chronic |
2024-10-05 |
|
| Bioavailability and Food Effect Study for Pediatric Formulation | P1 |
Active, not recruiting |
ANCA Vasculitis |
2023-04-17 |
|
| CL020_168 | P1 |
Completed |
Healthy Volunteers |
2022-08-11 |
28% |
| CL020_168 | P1 |
Completed |
Healthy Volunteers |
2022-08-11 |
28% |