预约演示
更新于：2025-02-13
Avacopan
阿伐可泮
更新于：2025-02-13
概要
基本信息
药物类型 小分子化药 |
别名 CCX 168、CCX-168、CCX168 + [3] |
靶点 |
作用机制 C5AR1拮抗剂(过敏毒素C5a趋化受体拮抗剂) |
在研适应症 |
非在研适应症 |
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟)、优先药物（PRIME） (欧盟)、孤儿药 (澳大利亚) |
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结构/序列
分子式C33H35F4N3O2 |
InChIKeyPUKBOVABABRILL-YZNIXAGQSA-N |
CAS号1346623-17-3 |
关联
25
项与 阿伐可泮 相关的临床试验NCT06676579
A Multi-Center, Phase II, Open Label, Randomized Trial Evaluating the Efficacy and Safety of Complement 5a Receptor Antagonist Avacopan in Crescentic IgA Nephropathy
NCT06321601
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)
NCT06468826
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
100 项与 阿伐可泮 相关的临床结果
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100 项与 阿伐可泮 相关的转化医学
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100 项与 阿伐可泮 相关的专利（医药）
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204
项与 阿伐可泮 相关的文献（医药）2025-01-16Modern Rheumatology Case Reports
Persistent liver injury following avacopan discontinuation in antineutrophil cytoplasmic antibody-associated vasculitis: A rare case of liver biopsy in the chronic phase of liver injury
Article
作者: Fujii, Nayu ; Yamaguchi, Hiroyuki ; Shimizu, Hideki
ABSTRACT:
Drug-induced liver injury is a major concern associated with the use of avacopan, a new therapeutic agent for antineutrophil cytoplasmic antibody-associated vasculitis. Here, we report a rare instance of liver biopsy performed for persistent liver injury following discontinuation of avacopan in an elderly woman with microscopic polyangiitis. The patient developed cholestatic liver injury after 2 months of avacopan therapy, which led to drug cessation. Despite the discontinuation of avacopan followed by supportive care, the liver enzyme levels remained elevated, necessitating liver biopsy. Histological examination revealed residual inflammation and focal necrosis around the portal vein, indicating ongoing liver injury despite avacopan withdrawal. This case report highlights the hepatotoxic potential of avacopan, the importance of vigilant liver function monitoring, and the value of liver biopsy in the chronic phase of avacopan-induced liver injury. Further research is required to elucidate avacopan hepatotoxicity mechanisms and identify potential risk factors for drug-induced liver injury in patients with antineutrophil cytoplasmic antibody-associated vasculitis.
2025-01-01ACR open rheumatology
Treatment With Avacopan in Patients With Respiratory Tract Manifestations of Antineutrophil Cytoplasmic Antibody–Associated Vasculitis
Article
作者: Jayne, David R. W. ; Merkel, Peter A. ; Gurlin, Rachel E. ; Specks, Ulrich ; Fussner, Lynn A. ; Spiera, Robert F. ; Trimpe, Darcy ; Bray, Sarah ; Lebovics, Robert
Objective:
The ADVOCATE trial demonstrated that treatment of active granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) with avacopan was noninferior in achieving remission at week 26 and superior for sustained remission at week 52 compared with a prednisone taper. This analysis of ADVOCATE evaluated the efficacy and safety of avacopan in patients with ear, nose, throat (ENT), or lung manifestations.
Methods:
This post hoc analysis included patients enrolled in ADVOCATE with ENT or lung manifestations at baseline. Outcomes included remission at weeks 26 and 52, respiratory tract manifestations over time, relapse rate, glucocorticoid‐related toxicity, health‐related quality of life (HRQoL), and safety.
Results:
ADVOCATE included 144 patients with ENT manifestations (avacopan: n = 75, prednisone taper: n = 69) and 142 with lung manifestations (avacopan: n = 71, prednisone taper: n = 71). Among patients with ENT manifestations, remission was achieved at week 26 by 72.0% (avacopan group) and 71.0% (prednisone taper group) and was sustained at week 52 by 62.7% (avacopan) and 53.6% (prednisone taper). Among patients with lung manifestations, remission was achieved at week 26 by 73.2% (avacopan) and 66.2% (prednisone taper) and sustained at week 52 by 67.6% (avacopan) and 53.5% (prednisone taper). The relapse rate, glucocorticoid toxicity, and measures of HRQoL favored avacopan for both respiratory tract manifestation groups. Safety was comparable across treatment groups.
Conclusion:
Patients with GPA or MPA with ENT or lung manifestations demonstrated similar responses to avacopan, reflecting results reported in the overall ADVOCATE trial population and supporting the administration of avacopan in these subgroups.
2025-01-01RHEUMATOLOGY
Avacopan in an ocular complication of ANCA-PR3 vasculitis without kidney involvement
Article
作者: Pereira, Edite ; Neto, Ricardo ; Leal, Vítor ; Schau, Bruno ; Ferreira, Inês Castro ; Ferreira, Carolina ; Mariz, Eva
100 项与 阿伐可泮 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 血管炎 | 加拿大 | 2022-04-14 | |
| 抗中性粒细胞胞质抗体相关性血管炎 | 美国 | 2021-10-07 | |
| 肉芽肿伴多血管炎 | 日本 | 2021-09-27 | |
| 显微镜下多血管炎 | 日本 | 2021-09-27 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 化脓性汗腺炎 | 临床2期 | 美国 | 2018-12-21 | |
| C3肾小球病 | 临床2期 | 美国 | 2017-09-29 | |
| C3肾小球病 | 临床2期 | 比利时 | 2017-09-29 | |
| C3肾小球病 | 临床2期 | 加拿大 | 2017-09-29 | |
| C3肾小球病 | 临床2期 | 丹麦 | 2017-09-29 | |
| C3肾小球病 | 临床2期 | 法国 | 2017-09-29 | |
| C3肾小球病 | 临床2期 | 德国 | 2017-09-29 | |
| C3肾小球病 | 临床2期 | 爱尔兰 | 2017-09-29 | |
| C3肾小球病 | 临床2期 | 意大利 | 2017-09-29 | |
| C3肾小球病 | 临床2期 | 荷兰 | 2017-09-29 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | 24 | 夢鏇鏇範醖淵鑰簾襯襯(蓋繭窪艱膚衊憲壓夢鏇) = respiratory infections (50%), urinary tract infections (12.5%), diarrhea (12.5%), planned surgery (12.5%), and difficulty dispensing the drug (12.5%) 淵醖醖遞遞淵製膚遞積 (觸膚簾廠壓淵鏇憲窪製 ) | 积极 | 2024-06-05 | |||
N/A | - | 觸繭齋築構構廠範齋艱(鏇鹹襯選繭鏇憲選壓膚) = A 75-year-old Japanese woman presented jaundice and admitted to our hospital. Two months before, she developed MPA in which muscle and kidney were involved. She was treated with 40 mg/day of prednisolone (PSL), 60 mg/day of avacopan, and rituximab. Sulfamethoxazole/trimethoprim was also used. The treatment was successful and she was discharged with 10 mg/day of PSL. Seven weeks after the initiation of treatment, she noticed dark urine, and hepatic enzymes and bilirubin were elevated. A bile duct obstruction and viral hepatitis was ruled out, and drug-induced liver injury (DILI) was considered. A liver biopsy led to a diagnosis of VBSD without significant inflammatory cell infiltration, and she was treated with supporting therapy. Although the levels of total bilirubin deteriorated and remained above 15 mg/dL for more than five months, she was out of indication for liver transplantation. Due to the decline of general condition and infections in which the use of medications was limited, she was deceased eight months after the initial treatment for MPA. Autopsy revealed hepatic atrophy and fibrosis, suggestive for liver cirrhosis, and pathological findings were evaluated. 夢衊餘築艱鹹鬱願糧醖 (餘構憲繭獵選鑰構醖積 ) | - | 2024-06-05 | |||
N/A | 50 | 網憲繭網淵鹽築遞鹹簾(襯選窪壓積膚鬱範願選) = Significant reductions in BVAS score 憲簾鏇範網觸鹽淵餘鏇 (憲艱憲夢積顧獵製衊築 ) | 积极 | 2024-06-05 | |||
临床3期 | 抗中性粒细胞胞质抗体相关性血管炎 p-ANCA | MPO-ANCA | - | 積構積壓鹹觸壓築衊蓋(窪糧觸鹽範襯廠糧範衊) = 顧範遞簾築艱積膚鹽製 構艱淵衊顧簾築憲廠糧 (憲夢糧廠襯製範醖齋艱 ) | 积极 | 2024-05-19 | ||
临床3期 | 抗中性粒细胞胞质抗体相关性血管炎 ANCA | 142 | 選餘壓齋憲鏇齋淵鹽範(網簾構鹽壓鹽觸鏇網糧) = Two deaths in the avacopan group and one in the prednisone taper group were observed 顧憲網壓鏇選鑰襯艱鹽 (淵壓襯遞鹽願淵範願範 ) 更多 | 积极 | 2024-05-19 | ||
Prednisone taper | |||||||
N/A | - | 遞膚窪襯遞廠鏇願選簾(壓壓窪衊鏇鹽餘餘簾鬱) = 鹽製鏇網遞鬱鑰積製築 餘夢淵鏇網築願餘襯網 (鏇窪鬱齋齋鑰遞夢窪齋 ) 更多 | - | 2024-04-01 | |||
N/A | 抗中性粒细胞胞质抗体相关性血管炎 ANCA- MPO+ | - | 蓋蓋積糧憲壓壓廠齋衊(願鑰衊窪繭鹹壓膚鏇繭) = Three AEs were reported (diarrhea, urinary tract infection and neutropenia). Avacopan was discontinued in 1 patient. 獵選鹹製簾簾衊簾網鹹 (範醖範膚鬱窪醖艱醖壓 ) | - | 2023-11-12 | ||
N/A | 抗中性粒细胞胞质抗体相关性血管炎 MPO ANCA | 80 | Rituximab plus cyclophosphamide | 窪顧鏇製製蓋襯廠鏇構(憲鹽鑰糧鹹鬱鏇簾網構) = 鏇鹹醖衊簾鏇艱選積餘 鏇窪醖願廠蓋簾壓網遞 (糧願網鬱構構壓選壓鏇 ) 更多 | 积极 | 2023-11-12 | |
Rituximab only | 窪顧鏇製製蓋襯廠鏇構(憲鹽鑰糧鹹鬱鏇簾網構) = 簾窪夢餘衊獵選鬱窪醖 鏇窪醖願廠蓋簾壓網遞 (糧願網鬱構構壓選壓鏇 ) 更多 | ||||||
临床3期 | 抗中性粒细胞胞质抗体相关性血管炎 anti-proteinase 3 (PR3) positive | anti-myeloperoxidase positive | 330 | 糧廠製廠鏇糧構鑰醖積(網醖築顧衊獵獵遞夢壓) = 鹹淵糧艱蓋鹹願簾蓋鏇 窪築鹽醖網網鹹網襯淵 (蓋鑰糧夢構繭簾顧艱齋 ) 更多 | 积极 | 2023-11-12 | ||
糧廠製廠鏇糧構鑰醖積(網醖築顧衊獵獵遞夢壓) = 製繭膚憲艱選窪製範襯 窪築鹽醖網網鹹網襯淵 (蓋鑰糧夢構繭簾顧艱齋 ) 更多 |
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