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Tavneos

(Avacopan)

ApprovedSmall molecule

Avacopan is used to treat rare autoimmune diseases where the body's immune system attacks blood vessels, potentially damaging organs like the heart and lungs. It works by blocking a specific part of the immune system that causes this blood vessel damage.[2] Tavneos is currently approved and in use across 4 indications[4].[1]

Tavneos is one of 18 small molecule programs targeting ANCA-Associated Vasculitis. It is currently in Approved.

4

Indications

14

Total Trials

7

Active Trials

17

Competitors

3

FDA Applications

NDA/BLA/ANDA regulatory filings

4

Patents

Pipeline

Status by Indication[4][1]

Indication

ANCA-Associated VasculitisNot yet recruiting

VasculitisActive, not recruiting

Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisRecruiting

Diffuse Alveolar HemorrhageRecruiting

ANCA-Associated VasculitisApproved

Not yet recruiting

VasculitisPhase 3

Active, not recruiting

Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisApproved

Recruiting

Diffuse Alveolar HemorrhagePhase 1

Recruiting

Competition

Competitive Landscape

15 competitors in Vasculitis

#DrugCompanyPhaseTrials

Rituxan

Plaquenil

Jazz Pharmaceuticals

Imuran

LLegacy Health System

Campath

GGenzyme, a Sanofi Company

Tavneos

Fabhalta

Gazyva

NM8074

NNovelMed Therapeutics

Arava

CAR-T Therapy

UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 3Active, not recruiting

Vasculitis

NCT06321601

Q1 2028

Phase 1Recruiting

Diffuse Alveolar Hemorrhage

NCT07556484

Q2 2028

Drug

NCT06758271

Q1 2029

Phase 2Recruiting

Nephropathy

NCT06676579

Clinical

Trials by Indication[1]

ANCA-Associated Vasculitis2 trials

Avacopan Added to Standard-of-care Therapy in ANCA-associated Vasculitis With Severe Kidney Involvement

Not yet recruiting·UUniversity Hospital, Toulouse·Phase 3·NCT07373262·130 enrolled

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

Completed· Amgen logo

Amgen·Phase 3·NCT02994927·331 enrolled

ART1 trial

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

Completed· Amgen logo

Amgen·Phase 1·NCT05988034·58 enrolled

Moderate Hepatic Impairment1 trial

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

Completed· Amgen logo

Amgen·Phase 1·NCT06004934·24 enrolled

Hidradenitis Suppurativa1 trial

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

Completed· Amgen logo

Amgen·Phase 2·NCT03852472·435 enrolled

Nephropathy1 trial

Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)

Recruiting·MMayo Clinic·Phase 2·NCT06676579·16 enrolled

8 more indications

Drug1 trial

Special Drug Use-results Survey for Long-term Use（Avacopan）

Recruiting·KKissei Pharmaceutical Co., Ltd.··NCT06758271·250 enrolled

Single Dose1 trial

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

Completed· Amgen logo

Amgen·Phase 1·NCT06207682·32 enrolled

C3 Glomerulopathy1 trial

Controlled Trial Evaluating Avacopan in C3 Glomerulopathy

Completed· Amgen logo

Amgen·Phase 2·NCT03301467·57 enrolled

End Stage Renal Disease (ESRD)1 trial

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

Completed· Amgen logo

Amgen·Phase 1·NCT06468826·13 enrolled

Granulomatosis with Polyangiitis1 trial

TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis

Recruiting·RRobert Spiera, MD·Preclinical·NCT07176546·30 enrolled

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis1 trial

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

Recruiting· Amgen logo

Amgen·Approved·NCT06072482·300 enrolled

Diffuse Alveolar Hemorrhage1 trial

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

Recruiting·MMayo Clinic·Phase 1·NCT07556484·6 enrolled

Vasculitis1 trial

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)

Active, not recruiting· Amgen logo

Amgen·Phase 3·NCT06321601·19 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 7, 2021

TAVNEOS

NDA NDA214487

Oct 7, 2021

TAVNEOS

NDA NDA214487

Jun 3, 2024

TAVNEOS

NDA NDA214487

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Avacopan. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tavneos drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Avacopan compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Avacopan. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA214487). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Tavneos. U.S. Food & Drug Administration.
[7]
PubMed — 1 publication indexed for Avacopan. U.S. National Library of Medicine.
[8]
SEC EDGAR — Amgen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: C5a Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Amgen

Patent Landscape[6]

Patent Cliff

Feb 3, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8445515Feb 3, 2031

8906938Jan 6, 2034

11603356Nov 27, 2039

11951214Nov 27, 2039

Key Publications[7]

Avacopan for ANCA-Associated Vasculitis: ADVOCATE Extended Follow-Up

N Engl J MedJan 26, 2023DOI: 10.1056/NEJMoa2213206

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