This is a single center double-blind placebo-controlled study. Patients with GPA and active ears, nose, and throat (ENT) disease in at least two ENT domains, as defined after endoscopic visualization of the upper airway and audiometric evaluation, if applicable, by a single otolaryngologist using a validated GPA ENT disease activity score, will be eligible for inclusion. Patients will be treated with standard of care (SOC) treatment as determined by their treating rheumatologist. In addition to SOC, patients will be randomized to receive TAVNEOS 30mg BID or placebo. Patients will be followed for 52 weeks with standardized ENT assessment along with rheumatologic evaluation of overall disease activity with BVAS.

Start Date01 Jul 2026

Sponsor / Collaborator

Hospital for Special Surgery

[+1]

NCT07373262

/ Not yet recruitingPhase 3IIT

Avacopan Added to Standard-of-care Therapy in ANCA-associated Vasculitis With Severe Kidney Involvement: a Randomized, Placebo-controlled, Double-blinded Multicenter Superiority Study

ANCA-associated vasculitis (AAV) is a rare auto-immune disease, with high mortality in the absence of treatment. There is still an unmet need to define new treatment strategies to reduce drug side effects, as well as to reverse rare cases of refractory AAV and improve the kidney response to improve the long-term outcomes.
Severe forms of AAV-related necrotizing and crescentic rapidly progressive glomerulonephritis (RPGN) (i.e. estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m²) are associated with higher mortality, higher incidence of infections, and long-term consequences including chronic kidney disease (CKD) with subsequent complications (end-stage kidney disease (ESKD) requiring dialysis, cardiovascular diseases) and a burden of financial costs.
In patients with AAV and RPGN, recent guidelines recommend using a standard-of-care (SOC) immunosuppressive regimen including an induction regimen (rituximab or cyclophosphamide), plus glucocorticoids (GCs) (starting at 60 mg/day and tapering over 6-12 months) (+ or - plasma exchanges).
Since GCs also participate to the long-term control of AAV, new molecular pathophysiology-driven therapeutic approaches rapidly blocking and/or reversing AAV lesions are needed to go beyond the progressive control of AAV using GCs alone. Thus, an add-on approach including GCs-based immunosuppressive regimen plus a new targeted therapy may lead to both AAV control (systemic disease) and improvement of the kidney outcome (organ involvement).
Avacopan a selective inhibitor of the C5a receptor, recently emerged as a new therapeutic option in AAV. In a phase 3 comparative study (that included a small subset of patients with eGFR 15-29 mL/min/1.7m2), avacopan was superior to glucocorticoids taper with respect to sustained remission at week 52. In the avacopan arm, the cumulative dose of GCs was dramatically reduced and avacopan was thus proposed as an alternative to GCs rather to a synergic treatment. In the subgroup of patients with eGFR <30 mL/min/1.73m², avacopan was associated with a better eGFR gain at week 52 compared to prednisone, but data in this population at-risk of worse kidney outcomes are scarce, and did not include patients with eGFR < 15 mL/min/1.73m², those patients being excluded from the study.
In the REVERSE study, investigators put forward the hypothesis that avacopan added on GCs regimen may significantly improve the kidney outcome of severe AAV (synergic approach), and thus improve short- and long-term global outcomes (survival, cardiovascular status). REVERSE will thus compare GCs-based SOC + placebo to GCs-based SOC + avacopan.

Start Date01 Mar 2026

Sponsor / Collaborator

Toulouse University Hospital

NCT06676579

/ RecruitingPhase 2IIT

A Multi-Center, Phase II, Open Label, Randomized Trial Evaluating the Efficacy and Safety of Complement 5a Receptor Antagonist Avacopan in Crescentic IgA Nephropathy

The purpose of this study is to evaluate the efficacy and safety of Avacopan together with low-dose glucocorticoid in the treatment of patients with crescentic Imunoglobulin A Nephropathy (IgAN) and high risk of progression.

Start Date09 Jun 2025

Sponsor / Collaborator

Mayo Clinic

100 Clinical Results associated with Avacopan

100 Translational Medicine associated with Avacopan

100 Patents (Medical) associated with Avacopan

242

Literatures (Medical) associated with Avacopan

01 Apr 2026·Kidney International Reports

Systematic Review of Efficacy and Safety of Avacopan in Real-World Clinical Practice

Article

Author: Oh, Sarah Soyeon ; Untersulzner, Clemens ; Kronbichler, Andreas ; Berke, Ilay ; Park, Peong Gang ; Shin, Jae Il ; Callemeyn, Jasper ; Keller, Felix

Introduction:

Avacopan, a complement 5a receptor (C5aR) antagonist, is a therapeutic option for patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), and is used as a steroid-sparing agent. The efficacy and safety of avacopan were established in the pivotal phase III ADVOCATE trial. However, there remains a paucity of real-world evidence to confirm these findings across diverse clinical settings and populations.

Methods:

We conducted a systematic review of 16 real-world studies evaluating the clinical outcomes of avacopan in patients with AAV. Using a meta-analytic approach, we compared efficacy and safety outcomes reported in these studies with those of the main trial. Key end points included clinical remission and incidence of adverse events.

Results:

The aggregated real-world data demonstrated that the time from diagnosis of AAV or relapse and initiation of avacopan was 24 days (range: 6-54 days). The clinical remission rates at 6 months as assessed in 215 patients were 89% (95% confidence interval [CI]: 0.84-0.93), whereas the rates of serious infection were 14% (95% CI: 0.10-0.18). We observed a heterogeneity between populations when hepatotoxicity was assessed in real-world cohorts, with this signal being particularly pronounced in Japanese populations.

Conclusion:

Avacopan has been found to demonstrate both safety and high efficacy in the treatment of AAV in real-world settings, with remission rates exceeding and serious infection rates comparable to those observed in clinical trial data. However, the higher incidence of hepatotoxicity in certain populations underscores the need for careful monitoring and pharmacovigilance studies to clarify risk factors and guide patient selection.

01 Mar 2026·CURRENT OPINION IN NEPHROLOGY AND HYPERTENSION

Update on antineutrophil cytoplasmic antibody vasculitis

Review

Author: Reddy, Uttam ; Mandel, Dan A. ; Hanna, Ramy ; Shekhar, Nishitha

Purpose of review:

The purpose of this review is to discuss antineutrophil cytoplasmic antibody (ANCA) vasculitis (microscopic polyangiitis and granulomatosis with polyangiitis) and how we have arrived at our current guidelines and treatment methods. The goal is to offer a greater understanding of major clinical trials in the field, and how they have enabled treatment options which have led to reduced morbidity and improved survival for patients.

Recent findings:

Our understanding and treatment of ANCA vasculitis has changed tremendously over the past 40 years, from a condition with a high mortality without significant treatment options, to a treatable condition. We have moved from the use of more toxic therapies such as Cyclophosphamide towards more common use of rituximab for both induction and maintenance regimens. More recently, the focus has been on attempting to reduce steroid burden and toxicity. The approval of avacopan (a C5a inhibitor) enables a more rapid steroid taper regimen along with usual induction therapy with rituximab or cyclophosphamide. Readers will have the chance to learn about new targets being evaluated for the treatment of ANCA vasculitis.

Summary:

ANCA Vasculitis is complex with varying presentations. Through collaboration among multiple specialists, including nephrologists, rheumatologists, pulmonologists, ENT specialists, and neurologists, we are able to achieve a diagnosis and offer organ and life-saving treatments for our patients.

01 Feb 2026·Immunity Inflammation and Disease

The Complement System in ANCA‐Associated Vasculitis: Mechanistic Insights, Therapeutic Horizons, and Unmet Clinical Needs

Review

Author: Sunmboye, Kehinde ; Millan, Pauline

ABSTRACT:

Background:

ANCA‐associated vasculitides (AAV) are autoimmune small‐vessel vasculitides characterized by necrotizing inflammation with few immune deposits (“pauci‐immune” lesions). Historically, complement was thought to play a minor role in AAV due to scant complement deposition on biopsy. However, growing evidence from animal models and patient studies indicate that complement activation, particularly the alternative pathway, is a critical amplifier of inflammation in AAV.

Methods:

We searched PubMed, Embase, and Web of Science (January 2000–October 2024) for peer‐reviewed studies on complement in AAV prioritizing preclinical, clinical, and therapeutic research.

Findings:

Complement activation bridges innate and adaptive immunity in AAV: ANCA‐activated neutrophils release factors that trigger the alternative complement pathway, generating C5a, which further recruits and primes neutrophils, creating a self‐amplifying loop of inflammation. Complement components (C3a, C5a, C5b‐9) are detectable in active AAV patients' plasma/urine and in affected tissues, correlating with disease activity and severity. Therapeutically, the C5a‐receptor antagonist, avacopan has demonstrated clinical efficacy, achieving remission with reduced corticosteroid exposure.

Conclusion:

Complement dysregulation is a pivotal mechanism in AAV pathogenesis, opening a new era of complement‐targeted therapies. Avacopan's success illustrates the potential to improve outcomes and safety by modulating complement. Yet, major unmet clinical needs remain. Up to 50% of patients relapse within 5 years. There are no validated biomarkers to predict relapse. Long‐term steroid dependence and cumulative toxicity from rituximab and cyclophosphamide compromise patient safety. Better tools are needed to detect early disease, stratify relapse risk, and personalize therapy. Future directions must prioritize biomarker development, novel complement inhibitors, and deliver durable remission with fewer side effects.

119

News (Medical) associated with Avacopan

01 Apr 2026

·www.biospace.com

FDA Ties Amgen’s Rare Inflammatory Disease Drug to Eight Deaths, Dozens of Liver Injuries

iStock, Shutter2U The FDA in January asked Amgen to pull Tavneos from the market, citing liver toxicity issues that affected the drug’s overall risk-benefit profile. The pharma refused. The FDA has flagged eight deaths and 76 cases of liver injury in patients treated with Amgen’s rare disease therapy Tavneos—a drug that was recently the subject of a standoff between the regulator and the pharma. Drawing on postmarketing data from Amgen and incidents reported in the FDA’s own surveillance system, the agency flagged cases of drug-induced liver injury (DILI) “with reasonable evidence of a causal association” with Tavneos, according to a safety alert issued Tuesday . Seven of the 76 cases involved biopsy-confirmed vanishing bile duct syndrome, a complication of DILI that had a reasonable causal link to Tavneos. All seven of these patients required hospitalization, and three died. All told, 74 of the 76 patients with DILI had serious outcomes necessitating hospital care, the FDA said on Tuesday. Amgen had previously informed the FDA of the vanishing bile duct syndrome risk associated with Tavneos, a company spokesperson said in a statement to Endpoints News . The pharma in 2024 asked the regulator to update the drug’s label to reflect this safety signal, but the spokesperson noted that this request is still pending. The FDA in its communique on Tuesday acknowledged that “hepatotoxicity is a serious adverse reaction” that has been “identified in premarket clinical trials and described in product labelling” for Tavneos. Still, DILI and vanishing bile duct syndrome, especially those with fatal outcomes, “represent new safety concerns,” the agency asserted. Healthcare providers should monitor their patients’ liver function through panel testing every two weeks during the first month of treatment, before spreading out to monthly for the next five months and then as needed thereafter, the regulator recommended. Tavneos treatment should be stopped if abnormal elevations in liver enzyme levels occur. Tavneos came to Amgen in 2022, when the pharma dropped $3.7 billion to acquire ChemoCentryx . The drug was approved in 2021 for severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. ANCA vasculitis refers to a group of rare autoimmune inflammatory disorders affecting the blood vessels. When left unchecked, the disease can damage organs, including the kidneys, lungs and brain. Tavneos earned $423 million in 2025. In January, the FDA asked Amgen to pull Tavneos from the market, raising concerns with how ChemoCentryx re-adjudicated the primary outcome for nine of more than 330 patients in the pivotal study that led to the drug’s approval. The regulator also raised incidences of liver toxicities in the context of the drug’s benefit-risk profile. Amgen turned down this request. “Amgen is not aware of any issues with the underlying patient data and after review of the relevant clinical data and years of real-world evidence, Amgen is confident that Tavneos demonstrates effectiveness and a favorable benefit-risk profile,” the pharma said in a statement at the time. The FDA’s safety notice on Tuesday did not provide updates on its discussions with Amgen regarding the withdrawal of Tavneos.

Drug ApprovalClinical ResultAccelerated Approval

31 Mar 2026

·www.fiercepharma.com

FDA flags serious liver injury cases, 8 deaths with ‘reasonable’ link to Amgen's Tavneos

The drug has been under a regulatory microscope since its original approval in 2021, with the FDA recently requesting Amgen pull it from the market. Amgen’s rare disease drug Tavneos is under mounting regulatory scrutiny, with the FDA warning of serious liver injuries, including some fatalities, among patients who received the drug. From the drug’s approval in 2021 through October 2024, 76 cases of drug-induced liver injury with “reasonable evidence” of a causal association to Tavneos were reported to the FDA Adverse Event Reporting System (FAERS), according to a Tuesday safety communication.The medicine is available as an adjunct treatment for severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. But the FDA is looking to change that with a request for Amgen to withdraw the product, which the company has so far resisted.Nearly all of the cases in FAERS resulted in a serious outcome, including hospitalization in 54 patients and death in 8, the FDA said in the communication.Based on 73 reports that specified the time from Tavneos initiation to liver injury onset, the agency flagged a median time to onset of 46 days. The vast majority of the cases (66) were reported in Japan, with five in the U.S., four in Europe and one in Canada. Importantly, reports in FAERS alone do not establish causality. But the FDA reviewed the available evidence to identify “reasonable evidence” of new safety concerns.Vanishing bile duct syndrome (VBDS) occurred as a complication of liver injury in seven of the reported cases and has also been determined to have a causal association with Tavneos use, the FDA said. VBDS is a rare liver condition that causes the progressive destruction and loss of bile ducts and is signaled by jaundice, itchiness and tiredness. VBDS and drug-induced liver injury (DILI) are two “new safety concerns” for Tavneos, the FDA said, and join the known adverse reaction of hepatotoxicity. Amgen has been aware of VBDS cases in patients outside of the U.S. since 2021 and proactively submitted a proposed label update in 2024 to add the safety concern, a company spokesperson told Fierce Pharma in an emailed statement. The request is “still pending,” and Amgen continues to monitor the situation through its post-marketing and observational studies, the spokesperson added. “Patient safety always comes first, and we are in regular communication with the FDA about the safety of our medicines,” the spokesperson said, noting that the drug's label already warns of serious liver toxicity (hepatotoxicity). “We remain confident that Tavneos is an important and effective medicine for severe ANCA-associated vasculitis based on robust clinical data and real-world evidence demonstrating the effectiveness and favorable benefit–risk profile.”The FDA is also continuing to scour post-marketing safety data and advises patients to keep an eye on potential liver injury symptoms. Providers should conduct regular liver panel testing for patients on the drug and discontinue treatment if potential symptoms are spotted, the FDA said. Tavneos has been under increased global regulatory pressure this year, with the FDA in January asking Amgen to voluntarily withdraw the drug from the market and the European Medicines Agency (EMA) initiating a re-review of the med based on data integrity concerns. In February, Amgen said it had informed the FDA that it intended to keep the medicine on the market and that it was evaluating next steps to “determine a path forward.” The FDA and the EMA’s concerns stemmed from the pivotal trial behind Tavneos, which was run by ChemoCentryx. Amgen picked up ChemoCentryx for $3.7 billion in 2022, inheriting Tavneos and with it the regulatory scrutiny that had surrounded the trial since a 2021 adversary committee meeting, during which the FDA flagged several efficacy and safety issues.The FDA’s request for Amgen to pull its drug came as the agency reviewed its risk-benefit profile and took a closer look at the trial, specifically at its re-adjudicated primary endpoint results for some patients. “Amgen is not aware of any issue with the underlying patient data from the ChemoCentryx clinical trial,” the company wrote in its fourth-quarter earnings release. "And after review of the relevant clinical data and years of real-world evidence, Amgen is confident that Tavneos demonstrates effectiveness and a favorable benefit-risk profile.”The company still does not intend to withdraw Tavneos from the market, it reiterated in its emailed statement Tuesday.

AcquisitionDrug Approval

31 Mar 2026

·endpoints.news

FDA identifies eight deaths tied to Amgen’s rare disease drug Tavneos

The FDA on Tuesday flagged more than 70 cases of severe liver injury and eight deaths associated with Amgen’s autoimmune treatment Tavneos, but the company said it previously notified the agency about the risk of one of the most severe cases. The safety data from the FDA come as the agency and Amgen spar over Tavneos’ future. The FDA asked Amgen to pull the drug from the market in January, which it has declined to do . The FDA said in a new drug safety communication that it recorded 76 cases of drug-induced liver injury through October 9, 2024, including eight deaths. Of the 76 cases, seven were biopsy-confirmed cases of vanishing bile duct syndrome, all of which resulted in hospitalization and three of which led to death. Almost all of the liver injury cases were reported from Japan, with 10 cases coming from the US, Canada and Europe. “Although hepatotoxicity is a serious adverse reaction for Tavneos identified in premarket clinical trials and described in product labeling, [vanishing bile duct syndrome] and [drug-induced liver injury] cases with fatal outcomes represent new safety concerns,” the FDA said in its communication. The agency described the cases as giving “reasonable evidence of a causal association with avacopan use.” A spokesperson for Amgen told Endpoints News that it had previously flagged cases of vanishing bile duct syndrome to regulators and asked them in 2024 to update the label, a request that’s still pending. Amgen has said it’s working to continue compiling data, including a Phase 4 post-marketing study that began in 2024. The primary completion of that long-term safety study is expected to come at the end of 2036 , more than 10 years from now. Tavneos has not been a major growth driver for Amgen. It brought in $459 million in revenue last year, after joining the pipeline in 2022 as part of the $4 billion acquisition of ChemoCentryx. The drug was approved in 2021 to treat anti-neutrophil cytoplasmic autoantibody-associated vasculitis, a rare autoimmune condition where small to medium blood vessels get inflamed. “We remain confident that Tavneos is an important and effective medicine for severe active ANCA-associated vasculitis based on robust clinical data and real-world evidence demonstrating the effectiveness and favorable benefit-risk profile,” a company spokesperson said.

Drug ApprovalAcquisitionPhase 2Clinical Result

100 Deals associated with Avacopan

External Link

KEGG	Wiki	ATC	Drug Bank
D11093	Avacopan	-	DB15011

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Vasculitis	Canada	Vifor Fresenius Medical Care Renal Pharma Ltd.	14 Apr 2022
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis	United States	ChemoCentryx, Inc.	07 Oct 2021
Granulomatosis With Polyangiitis	Japan	Kissei Pharmaceutical Co., Ltd.	27 Sep 2021
Microscopic Polyangiitis	Japan	Kissei Pharmaceutical Co., Ltd.	27 Sep 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hidradenitis Suppurativa	Phase 2	United States	Amgen, Inc.	21 Dec 2018
C3 glomerulopathy	Phase 2	United States	Amgen, Inc.	29 Sep 2017
C3 glomerulopathy	Phase 2	Belgium	Amgen, Inc.	29 Sep 2017
C3 glomerulopathy	Phase 2	Canada	Amgen, Inc.	29 Sep 2017
C3 glomerulopathy	Phase 2	Denmark	Amgen, Inc.	29 Sep 2017
C3 glomerulopathy	Phase 2	France	Amgen, Inc.	29 Sep 2017
C3 glomerulopathy	Phase 2	Germany	Amgen, Inc.	29 Sep 2017
C3 glomerulopathy	Phase 2	Ireland	Amgen, Inc.	29 Sep 2017
C3 glomerulopathy	Phase 2	Italy	Amgen, Inc.	29 Sep 2017
C3 glomerulopathy	Phase 2	Netherlands	Amgen, Inc.	29 Sep 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06468826 (CTgov)	Phase 1	Kidney Failure, Chronic	13	Avacopan	werbrfitip(tusijerxze) = liffidyfvg rqjpwjclro (xoqfxsvnrn, 22.8) View more	-	25 Mar 2026
ACR2025	Not Applicable	Granulomatosis With Polyangiitis \| Microscopic Polyangiitis	119	Avacopan (GPA/MPA)	dayrahglxm(asvweabbrd) = 57 (60%) discontinued therapy before 12 months mostly due to completion of the provider’s planned treatment course (33/57, 58%) or adverse events (14/57, 25%). dqldrpviai (hpluwsynvg )	Positive	24 Oct 2025
ACR2025	Not Applicable	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis ANCA-associated vasculitis	3,658	Avacopan	jzhayagovo(ukkruhwojt) = wrehbnxkjh mopdtpizuq (cbirvjpduj )	Negative	24 Oct 2025
NCT02994927 (ADVOCATE, Pubmed \| RMD Open)	Phase 3	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis	116	Avacopan	jcxhioemyi(dqwyuanwzn) = ywfpvitdrz grcoryhfwu (clvxwcqyny ) View more	Positive	01 Oct 2025
				Prednisone taper	jcxhioemyi(dqwyuanwzn) = mszsokclar grcoryhfwu (clvxwcqyny ) View more
J-CANVAS (EULAR2025)	Not Applicable	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis	792	Avacopan	cksmzfflng(zvkhjrabff) = liver dysfunction being the most common (8 cases) dvelkzffmv (wwedoizjit ) View more	Positive	11 Jun 2025
				Non-Avacopan
ADVOCATE (ACR2024)	Phase 3	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis	62	Avacopan	wbizquwjzj(uozvppxqpk) = byazjbuont vkkrbrwhbm (akaelifsys ) View more	Positive	10 Nov 2024
				Prednisone taper	wbizquwjzj(uozvppxqpk) = fxgpfobfkx vkkrbrwhbm (akaelifsys ) View more
ADVOCATE (ACR2024)	Phase 3	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis	144	Avacopan	pninwalhtl(mvslugsvpm) = ovpafypoip wbcahogusf (sqoqsoscxu ) View more	Positive	10 Nov 2024
				Prednisone taper	cjbspanpss(zzlklaaqaf) = dkepvjfmbd grurdhwnzs (iqmrypcmzu ) View more
ACR2024	Not Applicable	Granulomatosis With Polyangiitis \| Microscopic Polyangiitis	80	Avacopan	etnrhfallw(uxliqqkogx) = defertptap kqzehjjzyy (ysrlqnafef ) View more	Positive	10 Nov 2024
				Avacopan (kidney involvement)	etnrhfallw(uxliqqkogx) = tojusoduqg kqzehjjzyy (ysrlqnafef ) View more
ACR2024	Not Applicable	Granulomatosis With Polyangiitis \| Microscopic Polyangiitis glomerulonephritis	701	Avacopan	znbdredijj(txuybikent) = utsjymijwb keyzloxauy (chtkxssgvq ) View more	Positive	10 Nov 2024
ASN2024	Not Applicable	Granulomatosis With Polyangiitis \| Microscopic Polyangiitis	80	Avacopan	lqlqxfiwqo(hqdilwjizv) = otuwfkxwkq bxqmxnllef (mobgfotmqa ) View more	Positive	26 Oct 2024

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