TAVNEOS (avacopan)
Tavneos helps adult patients with severe active forms of ANCA-associated vasculitis, specifically granulomatosis with polyangiitis and microscopic polyangiitis. It is used as an additional therapy alongside standard treatments, including glucocorticoids. While it provides extra support in managing these conditions, it does not completely replace the need for glucocorticoid use.
How TAVNEOS Works
This drug works by blocking the complement 5a receptor, which prevents it from interacting with a protein called C5a. By inhibiting this interaction, the medication stops the activation and movement of neutrophils. This process is intended to help manage the symptoms of vasculitis, though the exact way it produces its therapeutic effect is not fully established.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-10-07
- Patent Cliff
- 2039
- Revenue
- $152M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- CAPSULE
TAVNEOS Approval History
What TAVNEOS Treats
3 indicationsTAVNEOS is approved for 3 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anti-Neutrophil Cytoplasmic Autoantibody-Associated Vasculitis
- Granulomatosis with Polyangiitis
- Microscopic Polyangiitis
TAVNEOS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to TAVNEOS
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Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06321601 | 20230070 | Ph 3 | recruiting | 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. |
| NCT07556484 | 24-009571 | Ph 1 | recruiting | Pharmacokinetics Of Emulsified Avacopan Applied By NG Tube |
| NCT06072482 | 20220159 EU CT Number | Ph 4 | recruiting | A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis |
| NCT06468826 results posted | 20230265 | Ph 1 | completed | A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD) |
| NCT07373262 REVERSE | RC31/24/0321 2024-519620-24-01 | Ph 3 | not yet recruiting | Avacopan Added to Standard-of-care Therapy in ANCA-associated Vasculitis With Severe Kidney Involvement |
| NCT06676579 | 24-005668 | Ph 2 | recruiting | Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN) |
| NCT07176546 | 2023-1580 | Ph 2, Ph 3 | not yet recruiting | TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis |
| NCT02994927 ADVOCATE results posted | CL010_168 ADVOCATE | Ph 3 | completed | A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis |
| NCT03852472 results posted | CL016_168 | Ph 2 | completed | Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA) |
| NCT03301467 ACCOLADE results posted | CL011_168 1R01FD006342-01 | Ph 2 | completed | Controlled Trial Evaluating Avacopan in C3 Glomerulopathy |
| NCT06207682 | CL020_168 | Ph 1 | completed | Effect of Repeated Oral Doses of Avacopan on the Pharmacokinetics (PK) of a Single Dose of Simvastatin |
| NCT06004934 | CL013_168 | Ph 1 | completed | A Study to Evaluate the Pharmacokinetics of Avacopan (CCX168) in Participants With Mild or Moderate Hepatic Impairment |
| NCT05988034 | CL014_168 | Ph 1 | completed | A Study to Assess the Effect of Avacopan at Therapeutic and Supratherapeutic Doses on the QT/QTc Interval in Healthy Participants |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TAVNEOS FDA Label Details
Indications & Usage
FDA Label (PDF)TAVNEOS is indicated for the treatment of Anti-Neutrophil Cytoplasmic Autoantibody-Associated Vasculitis; Granulomatosis with Polyangiitis; Microscopic Polyangiitis.
TAVNEOS Patents & Exclusivity
Patents (4 active)
Exclusivity
Pro Intelligence Preview
Deep insights for TAVNEOS
Revenue Insights
- • Q4-2025: $152M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 4 active patents
Trial Analysis
- • 13 total trials
- • Stage: Stable
Competitive Landscape
- • 3 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment