{"id":"ccx168","rwe":[{"pmid":"38051796","year":"2006","title":"Avacopan.","finding":"","journal":"","studyType":"Clinical Study"},{"pmid":"41044172","year":"2025","title":"Inhibition of C5a-C5aR1 axis suppresses tumour progression by enhancing antitumour immunity and chemotherapeutic effect in pancreatic ductal adenocarcinoma.","finding":"","journal":"British journal of cancer","studyType":"Clinical Study"},{"pmid":"40721660","year":"2025","title":"PABPN1-C5 axis promotes hepatocellular carcinoma progression via NF-κB activation.","finding":"","journal":"Oncogene","studyType":"Clinical Study"},{"pmid":"38993035","year":"2024","title":"Food Effect and Pharmacokinetic Bridging of Avacopan in Caucasian and Japanese Healthy Participants.","finding":"","journal":"Clinical pharmacology in drug development","studyType":"Clinical Study"},{"pmid":"37306717","year":"2023","title":"Successful treatment with avacopan (CCX168) in a pediatric patient with C3 glomerulonephritis.","finding":"","journal":"Pediatric nephrology (Berlin, Germany)","studyType":"Clinical Study"}],"tags":[{"label":"Complement 5a Receptor Antagonist","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"C5a anaphylatoxin chemotactic receptor 1","category":"target"},{"label":"C5AR1","category":"gene"},{"label":"L04AA59","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Active","category":"status"},{"label":"Anti-Neutrophil Cytoplasmic Autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis)","category":"indication"},{"label":"Granulomatosis with polyangiitis","category":"indication"},{"label":"Microscopic polyangiitis","category":"indication"},{"label":"Chemocentryx","category":"company"},{"label":"Approved 2020s","category":"decade"}],"phase":"discontinued","safety":{"safetySignals":[{"llr":100.561,"date":"","count":30,"signal":"Hepatic function abnormal","source":"DrugCentral FAERS","actionTaken":"Reported 30 times (LLR=101)"},{"llr":65.406,"date":"","count":25,"signal":"Hospitalisation","source":"DrugCentral FAERS","actionTaken":"Reported 25 times (LLR=65)"},{"llr":63.573,"date":"","count":21,"signal":"No adverse event","source":"DrugCentral FAERS","actionTaken":"Reported 21 times (LLR=64)"}],"commonSideEffects":[{"effect":"Nausea","drugRate":"23.5%","severity":"common"},{"effect":"Headache","drugRate":"20.5%","severity":"common"},{"effect":"Hypertension","drugRate":"18.1%","severity":"common"},{"effect":"Diarrhea","drugRate":"15.1%","severity":"common"},{"effect":"Vomiting","drugRate":"15.1%","severity":"common"},{"effect":"Rash","drugRate":"11.4%","severity":"common"},{"effect":"Fatigue","drugRate":"10.2%","severity":"common"},{"effect":"Upper abdominal pain","drugRate":"6.6%","severity":"mild"},{"effect":"Dizziness","drugRate":"6.6%","severity":"mild"},{"effect":"Blood creatinine increased","drugRate":"6.0%","severity":"mild"},{"effect":"Paresthesia","drugRate":"5.4%","severity":"mild"},{"effect":"Hepatotoxicity","drugRate":"5.4%","severity":"mild"},{"effect":"Elevated Liver Function Tests","drugRate":"5.4%","severity":"mild"},{"effect":"Angioedema","drugRate":"1.2%","severity":"mild"},{"effect":"Urinary tract infection","drugRate":"1.2%","severity":"mild"},{"effect":"Acute kidney injury","drugRate":"1.8%","severity":"mild"},{"effect":"Pneumonia","drugRate":"4.8%","severity":"mild"},{"effect":"Hepatic function abnormal","drugRate":"1.8%","severity":"mild"},{"effect":"Elevated Creatine Phosphokinase","drugRate":"3.6%","severity":"mild"},{"effect":"Hepatobiliary adverse reactions","drugRate":"13.3%","severity":"common"},{"effect":"Liver enzyme abnormalities","drugRate":"13.3%","severity":"common"}],"specialPopulations":{"Pregnancy":"There are no adequate and well-controlled studies with TAVNEOS in pregnant women to inform drug-associated risk. In animal reproduction studies, oral administration of avacopan to pregnant hamsters and rabbits during the period of organogenesis produced no evidence of fetal harm with exposures up to approximately and 0.6 times, respectively, the exposure at the maximum recommended human dose (MRHD) of 30 mg twice daily (on an area under the curve [AUC] basis). Avacopan caused an increase in the number of abortions in rabbits at an exposure 0.6 times the MRHD (see Animal Data).The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. DataAnimal DataIn an embryo-fetal development study with pregnant hamsters dosed by the oral route during the period of organogenesis from gestation days to 12, avacopan produced an increase in the incidence of skeletal variation, described as supernumerary ribs, at an exposure that was times the MRHD (on an AUC basis with maternal oral dose of 1000 mg/kg/day). No structural abnormalities were noted with exposures up to times the MRHD (on an AUC basis with maternal oral doses up to 1000 mg/kg/day).In an embryo-fetal development study with pregnant rabbits dosed by the oral route ","Geriatric use":"Of the 86 geriatric patients who received TAVNEOS in the phase randomized clinical trial for ANCA-associated vasculitis [see Clinical Studies (14)], 62 patients were between 65-74 years and 24 were 75 years or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients.","Paediatric use":"The safety and effectiveness of TAVNEOS in pediatric patients have not been established."}},"trials":[],"aliases":["Avacopan"],"company":"Chemocentryx","patents":[{"source":"FDA Orange Book via DrugCentral","expires":"2041-05-29","territory":"US","patentNumber":"11603356"},{"source":"FDA Orange Book via DrugCentral","expires":"2031-02-03","territory":"US","patentNumber":"8445515"},{"source":"FDA Orange Book via DrugCentral","expires":"2029-12-21","territory":"US","patentNumber":"8906938"}],"pricing":[],"allNames":"tavneos","offLabel":[],"synonyms":["avacopan","tavneos","CCX168"],"timeline":[{"date":"2021-09-27","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Kissei Pharmaceutical Co., Ltd.)"},{"date":"2021-10-07","type":"positive","source":"DrugCentral","milestone":"FDA approval (Chemocentryx)"},{"date":"2022-01-11","type":"positive","source":"DrugCentral","milestone":"EMA approval (Vifor Fresenius Medical Care Renal Pharma France)"}],"brandName":"Tavneos","ecosystem":[{"indication":"Anti-Neutrophil Cytoplasmic Autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis)","otherDrugs":[],"globalPrevalence":120000},{"indication":"Granulomatosis with polyangiitis","otherDrugs":[{"name":"rituximab","slug":"rituximab","company":"Genentech"}],"globalPrevalence":120000},{"indication":"Microscopic polyangiitis","otherDrugs":[{"name":"rituximab","slug":"rituximab","company":"Genentech"}],"globalPrevalence":342744}],"mechanism":{"target":"C5a anaphylatoxin chemotactic receptor 1","novelty":"Follow-on","targets":[{"gene":"C5AR1","source":"DrugCentral","target":"C5a anaphylatoxin chemotactic receptor 1","protein":"C5a anaphylatoxin chemotactic receptor 1"}],"moaClass":"Complement 5a Receptor Antagonists","modality":"Small Molecule","drugClass":"Complement 5a Receptor Antagonist","explanation":"Avacopan is complement 5a receptor (C5aR) antagonist that inhibits the interaction between C5aR and the anaphylatoxin C5a. Avacopan blocks C5a-mediated neutrophil activation and migration. The precise mechanism by which avacopan exerts therapeutic effect in patients with ANCA-associated vasculitis has not been definitively established.","oneSentence":"Tavneos blocks the action of a chemical called C5a, which is involved in inflammation and damage to blood vessels.","technicalDetail":"Tavneos (CCX168) is a small molecule antagonist of the C5a receptor 1 (C5aR1), a G-protein coupled receptor involved in the inflammatory response. By binding to C5aR1, Tavneos inhibits the action of C5a, a potent anaphylatoxin that recruits neutrophils and other inflammatory cells to sites of inflammation."},"commercial":{"launchDate":"2021","_launchSource":"DrugCentral (FDA 2021-10-07, CHEMOCENTRYX)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5494","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=CCX168","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CCX168","fields":["publications"],"source":"PubMed/NCBI"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T02:43:22.373487","biosimilars":[],"competitors":[{"drugName":"muromonab-CD3","drugSlug":"muromonab-cd3","fdaApproval":"1992-09-14","relationship":"same-class"},{"drugName":"mycophenolic 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protected","relationship":"same-class"},{"drugName":"teriflunomide","drugSlug":"teriflunomide","fdaApproval":"2012-09-12","patentExpiry":"Sep 14, 2030","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"apremilast","drugSlug":"apremilast","fdaApproval":"2014-03-21","patentExpiry":"Nov 29, 2034","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"vedolizumab","drugSlug":"vedolizumab","fdaApproval":"2014-05-20","relationship":"same-class"},{"drugName":"alemtuzumab","drugSlug":"alemtuzumab","fdaApproval":"2001-05-07","relationship":"same-class"},{"drugName":"ocrelizumab","drugSlug":"ocrelizumab","fdaApproval":"2017-03-28","relationship":"same-class"},{"drugName":"baricitinib","drugSlug":"baricitinib","fdaApproval":"2018-05-31","patentExpiry":"Nov 30, 2032","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"ccx168","indications":{"approved":[{"name":"Anti-Neutrophil Cytoplasmic Autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis)","source":"DrugCentral","snomedId":722191003,"regulator":"FDA","usPrevalence":null,"globalPrevalence":120000,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (18771432[PMID]_9805179[PMID]_17553910[PMID]_14872461[PMID])"},{"name":"Granulomatosis with polyangiitis","source":"DrugCentral","snomedId":195353004,"regulator":"FDA","eligibility":"adult patients with severe active disease","usPrevalence":null,"globalPrevalence":120000,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (18771432[PMID]_9805179[PMID]_17553910[PMID]_14872461[PMID])"},{"name":"Microscopic polyangiitis","source":"DrugCentral","snomedId":1144805008,"regulator":"FDA","eligibility":"adult patients with severe active disease","usPrevalence":null,"globalPrevalence":342744,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (25805746[PMID]_ORPHANET)"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"muromonab-cd3","brandName":"muromonab-CD3","genericName":"muromonab-CD3","approvalYear":"1992","relationship":"same-class"},{"drugId":"mycophenolic-acid","brandName":"mycophenolic acid","genericName":"mycophenolic 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Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD)","status":"COMPLETED","sponsor":"Amgen","startDate":"2024-06-18","conditions":["End-Stage Renal Disease (ESRD)"],"enrollment":13,"completionDate":"2024-10-05"},{"nctId":"NCT06321601","phase":"PHASE3","title":"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.","status":"RECRUITING","sponsor":"Amgen","startDate":"2024-10-22","conditions":["Vasculitis"],"enrollment":20,"completionDate":"2028-09-26"},{"nctId":"NCT06072482","phase":"PHASE4","title":"A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis","status":"RECRUITING","sponsor":"Amgen","startDate":"2024-02-07","conditions":["Antineutrophil Cytoplasmic Antibody-associated Vasculitis"],"enrollment":300,"completionDate":"2036-12-31"},{"nctId":"NCT07373262","phase":"PHASE3","title":"Avacopan Added to Standard-of-care Therapy in ANCA-associated Vasculitis With Severe Kidney Involvement","status":"NOT_YET_RECRUITING","sponsor":"University Hospital, Toulouse","startDate":"2026-03-01","conditions":["ANCA-Associated Vasculitis (AAV)"],"enrollment":130,"completionDate":"2030-07-01"},{"nctId":"NCT06676579","phase":"PHASE2","title":"Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)","status":"RECRUITING","sponsor":"Mayo Clinic","startDate":"2025-06-09","conditions":["IgA Nephropathy (IgAN)"],"enrollment":16,"completionDate":"2029-03-02"},{"nctId":"NCT07176546","phase":"PHASE2,PHASE3","title":"TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis","status":"NOT_YET_RECRUITING","sponsor":"Robert Spiera, MD","startDate":"2026-07","conditions":["Granulomatosis With Polyangiitis","Wegener&#39;s","GPA"],"enrollment":30,"completionDate":"2030-10"},{"nctId":"NCT06611696","phase":"PHASE4","title":"Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis","status":"RECRUITING","sponsor":"Chiba University","startDate":"2024-11-15","conditions":["ANCA Associated Vasculitis (AAV)"],"enrollment":160,"completionDate":"2028-09-30"},{"nctId":"NCT02994927","phase":"PHASE3","title":"A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis","status":"COMPLETED","sponsor":"Amgen","isPivotal":true,"startDate":"2017-03-15","conditions":["ANCA-Associated Vasculitis"],"enrollment":331,"completionDate":"2019-11-01"},{"nctId":"NCT03852472","phase":"PHASE2","title":"Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA)","status":"COMPLETED","sponsor":"Amgen","startDate":"2018-12-21","conditions":["Hidradenitis Suppurativa","Acne Inversa"],"enrollment":435,"completionDate":"2021-03-09"},{"nctId":"NCT01363388","phase":"PHASE2","title":"A Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With ANCA-Associated Vasculitis","status":"COMPLETED","sponsor":"Amgen","startDate":"2011-09","conditions":["Vasculitis"],"enrollment":67,"completionDate":"2016-01"},{"nctId":"NCT03301467","phase":"PHASE2","title":"Controlled Trial Evaluating Avacopan in C3 Glomerulopathy","status":"COMPLETED","sponsor":"Amgen","startDate":"2017-09-29","conditions":["C3 Glomerulopathy (C3G)"],"enrollment":57,"completionDate":"2021-10-27"},{"nctId":"NCT02384317","phase":"PHASE2","title":"Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade","status":"COMPLETED","sponsor":"Amgen","startDate":"2015-03-27","conditions":["Immunoglobulin A Nephropathy"],"enrollment":7,"completionDate":"2018-06-01"},{"nctId":"NCT02222155","phase":"PHASE2","title":"Clinical Trial to Evaluate Safety and Efficacy of CCX168 in ANCA-Associated Vasculitis","status":"COMPLETED","sponsor":"Amgen","startDate":"2015-02-04","conditions":["ANCA-associated Vasculitis"],"enrollment":42,"completionDate":"2016-07-19"},{"nctId":"NCT05897684","phase":"","title":"Avacostar - (PASS)","status":"RECRUITING","sponsor":"Vifor Fresenius Medical Care Renal Pharma","startDate":"2023-09-11","conditions":["ANCA-associated Vasculitis"],"enrollment":500,"completionDate":"2030-12-01"},{"nctId":"NCT06794827","phase":"","title":"Early-access Avacopan in Real-world ANCA-associated Vasculitis","status":"RECRUITING","sponsor":"Leiden University Medical Center","startDate":"2023-11-01","conditions":["ANCA Associated Vasculitis"],"enrollment":100,"completionDate":"2026-12-31"},{"nctId":"NCT06758271","phase":"","title":"Special Drug Use-results Survey for Long-term Use（Avacopan）","status":"RECRUITING","sponsor":"Kissei Pharmaceutical Co., Ltd.","startDate":"2022-07-29","conditions":["Microscopic Polyangiitis (MPA)","Granulomatosis With Polyangiitis (GPA)"],"enrollment":250,"completionDate":"2028-05-31"},{"nctId":"NCT06207682","phase":"PHASE1","title":"Effect of Repeated Oral Doses of Avacopan on the Pharmacokinetics (PK) of a Single Dose of Simvastatin","status":"COMPLETED","sponsor":"Amgen","startDate":"2022-06-28","conditions":["Healthy Volunteers"],"enrollment":32,"completionDate":"2022-08-11"},{"nctId":"NCT06004960","phase":"PHASE1","title":"A Study to Assess the Mass Balance Recovery (Absorption, Distribution, Metabolism and Excretion) of [14C]CCX168 in Healthy Participants","status":"COMPLETED","sponsor":"Amgen","startDate":"2014-10-20","conditions":["Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis"],"enrollment":6,"completionDate":"2014-12-05"},{"nctId":"NCT06004947","phase":"PHASE1","title":"A Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 With Concomitant Medications","status":"COMPLETED","sponsor":"Amgen","startDate":"2016-01-14","conditions":["Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis"],"enrollment":32,"completionDate":"2016-06-10"},{"nctId":"NCT06004934","phase":"PHASE1","title":"A Study to Evaluate the Pharmacokinetics of Avacopan (CCX168) in Participants With Mild or Moderate Hepatic Impairment","status":"COMPLETED","sponsor":"Amgen","startDate":"2018-04-17","conditions":["Hepatic Impairment"],"enrollment":24,"completionDate":"2018-09-18"},{"nctId":"NCT05988034","phase":"PHASE1","title":"A Study to Assess the Effect of Avacopan at Therapeutic and Supratherapeutic Doses on the QT/QTc Interval in Healthy Participants","status":"COMPLETED","sponsor":"Amgen","startDate":"2019-11-08","conditions":["Electrocardiography"],"enrollment":58,"completionDate":"2020-03-31"},{"nctId":"NCT05988008","phase":"PHASE1","title":"A Study of CCX168 in Japanese and Caucasian Healthy Adult Males","status":"COMPLETED","sponsor":"Amgen","startDate":"2017-10-23","conditions":["Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis"],"enrollment":80,"completionDate":"2018-09-20"},{"nctId":"NCT05988021","phase":"PHASE1","title":"A Study in Healthy Volunteers to Evaluate the Pharmacokinetic Food Effect and Cardiac Safety of CCX168","status":"COMPLETED","sponsor":"Amgen","startDate":"2015-12-03","conditions":["Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis"],"enrollment":16,"completionDate":"2016-05-25"},{"nctId":"NCT05984251","phase":"PHASE1","title":"A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Participants","status":"COMPLETED","sponsor":"Amgen","startDate":"2009-12-21","conditions":["Vasculitis","Systemic Lupus Erythematosus (SLE)"],"enrollment":48,"completionDate":"2011-04-11"},{"nctId":"NCT02464891","phase":"PHASE2","title":"Complement Inhibition in aHUS Dialysis Patients","status":"TERMINATED","sponsor":"Mario Negri Institute for Pharmacological Research","startDate":"2015-06-04","conditions":["Atypical Hemolytic Uremic Syndrome"],"enrollment":6,"completionDate":"2017-07-13"}],"_emaApprovals":[{"date":"2022-01-11","status":"Authorised","company":"Vifor Fresenius Medical Care Renal Pharma France"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"pivotalTrials":["NCT02994927"],"administration":{"route":"Oral","formulation":"Capsule","formulations":[{"form":"CAPSULE","route":"ORAL","productName":"TAVNEOS"}]},"_patentsChecked":true,"crossReferences":{"MMSL":"351739","NDDF":"018869","UNII":"O880NM097T","VANDF":"4040886","INN_ID":"10211","RXNORM":"2572100","UMLSCUI":"C4507514","ChEMBL_ID":"CHEMBL3989871","KEGG_DRUG":"D11093","DRUGBANK_ID":"DB15011","PDB_CHEM_ID":" EFD","PUBCHEM_CID":"49841217","SNOMEDCT_US":"1264265006","IUPHAR_LIGAND_ID":"9450","MESH_SUPPLEMENTAL_RECORD_UI":"C000620232"},"formularyStatus":[],"originalProduct":{"form":"CAPSULE","route":"ORAL","company":"ChemoCentryx, Inc.","brandName":"TAVNEOS","isOriginal":true,"marketingStatus":"NDA"},"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"2021-","companyName":"Chemocentryx","relationship":"Original Developer"},{"period":"2021","companyName":"Kissei Pharmaceutical Co., Ltd.","relationship":"PMDA Licensee"},{"period":"2022","companyName":"Vifor Fresenius Medical Care Renal Pharma France","relationship":"EMA Licensee"}],"publicationCount":20,"therapeuticAreas":["Rare Disease"],"atcClassification":{"source":"DrugCentral","atcCode":"L04AA59","allCodes":["L04AA59"]},"biosimilarFilings":[],"originalDeveloper":"Chemocentryx","recentPublications":[{"date":"2006","pmid":"38051796","title":"Avacopan.","journal":""},{"date":"2025 Dec","pmid":"41044172","title":"Inhibition of C5a-C5aR1 axis suppresses tumour progression by enhancing antitumour immunity and chemotherapeutic effect in pancreatic ductal adenocarcinoma.","journal":"British journal of cancer"},{"date":"2025 Sep","pmid":"40721660","title":"PABPN1-C5 axis promotes hepatocellular carcinoma progression via NF-κB activation.","journal":"Oncogene"},{"date":"2024 Sep","pmid":"38993035","title":"Food Effect and Pharmacokinetic Bridging of Avacopan in Caucasian and Japanese Healthy Participants.","journal":"Clinical pharmacology in drug development"},{"date":"2023 Dec","pmid":"37306717","title":"Successful treatment with avacopan (CCX168) in a pediatric patient with C3 glomerulonephritis.","journal":"Pediatric nephrology (Berlin, Germany)"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"discontinued","companyName":"Chemocentryx","companyId":"chemocentryx","modality":"Small molecule","firstApprovalDate":"2021","aiSummary":"Tavneos (CCX168) is a small molecule complement 5a receptor antagonist developed by Chemocentryx. It targets the C5a anaphylatoxin chemotactic receptor 1 to treat Anti-Neutrophil Cytoplasmic Autoantibody (ANCA)-associated vasculitis, including granulomatosis with polyangiitis and microscopic polyangiitis. Tavneos was FDA-approved in 2021 and is currently owned by Chemocentryx. It is a patented medication with unknown half-life and bioavailability. Key safety considerations include the need for further research on long-term effects.","enrichmentLevel":3,"visitCount":0,"patentsNormalised":[{"patent_number":"8906938","territory":"US","patent_type":null,"expiry_date":"2029-12-21T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"8445515","territory":"US","patent_type":null,"expiry_date":"2031-02-03T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"11603356","territory":"US","patent_type":null,"expiry_date":"2041-05-29T00:00:00.000Z","status":"active","paragraph_iv_filed":false}],"trialStats":{"total":7,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}