An Open-label Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Odalasvir and AL-335 Alone and in Combination With Simeprevir in Subjects With Moderately Impaired Hepatic Function

The purpose of this study is to evaluate the pharmacokinetics (PK) of AL-335, odalasvir (ODV) and its metabolites ALS-022399 and ALS-022227, after a single oral dose of ODV and AL-335 respectively, in participants with moderately impaired hepatic function compared to participants with normal hepatic function. Also to evaluate the steady-state PK of AL-335 and its metabolites ALS-022399 and ALS-022227, ODV and simeprevir (SMV) after multiple oral doses of the combination of AL-335+ODV+SMV, in participants with moderately impaired hepatic function compared to participants with normal hepatic function.

开始日期2017-09-11

申办/合作机构

Janssen Research & Development LLC

NCT03155893

/ Completed临床1期

A Randomized, Double-blind, Double-dummy, Placebo- and Positive-controlled Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Subjects

The main purpose of this study is to assess the effect of a single supratherapeutic dose of AL-335 administered on top of multiple doses of odalasvir (ODV) and simeprevir (SMV) versus placebo on QT/QT interval corrected for heart rate (QTc) interval changes, using intersection-union test (IUT) analysis (Panel 1); to assess the effect of ODV on QT/QTc and PR interval changes after multiple supratherapeutic doses of ODV using an exposure-response (ER) approach (Panel 2); and to assess the effect of multiple supratherapeutic doses of ODV on echocardiographic left ventricular ejection fraction (LVEF) (Panel 2) in healthy participants.

开始日期2017-05-12

申办/合作机构

Janssen Research & Development LLC

NCT03099135

/ Terminated临床3期

A Prospective 3-Year Follow-up Study in Subjects Treated in a Preceding Phase 2 or 3 Study With a Regimen Containing Odalasvir and AL-335 With or Without Simeprevir for the Treatment of Hepatitis C Virus (HCV) Infection

The main purpose of this study is to evaluate the durability of Sustained virologic response (SVR) in participants who achieved SVR at last post-therapy visit of parent studies (LPVPS) with NCT Numbers NCT02569710 and NCT02765490.

开始日期2017-04-10

申办/合作机构

Janssen Research & Development LLC

100 项与 Odalasvir 相关的临床结果

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100 项与 Odalasvir 相关的转化医学

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100 项与 Odalasvir 相关的专利（医药）

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104

项与 Odalasvir 相关的文献（医药）

2026-09-01·CANADIAN JOURNAL OF PSYCHIATRY-REVUE CANADIENNE DE PSYCHIATRIE

Association Between Venlafaxine Exposure And Treatment Outcomes In Older Adults With Depression: Association entre l’exposition à la venlafaxine et les résultats du traitement chez les personnes âgées atteintes de dépression

Article

作者: Men, Xiaoyu ; Stefan, Cristiana ; Taylor, Zachary L ; Kennedy, James L ; Reynolds, Charles F ; Blumberger, Daniel M ; Ramsey, Laura B ; Marshe, Victoria S ; Lenze, Eric J ; Karp, Jordan F ; Müller, Daniel J ; Mulsant, Benoit H

Background:

Venlafaxine is commonly prescribed for older adults with depression, yet the relationship between venlafaxine-related exposure and treatment outcomes remains unclear. We aimed to assess the association of exposure to venlafaxine, its active metabolite O-desmethylvenlafaxine (ODV) and its active moiety (i.e., venlafaxine + ODV) with treatment response and adverse effects in late-life depression.

Method:

We analyzed data from 325 participants from the Incomplete Response in Late-Life Depression: Getting to Remission (IRL-GRey) study. Participants were ≥ 60 years old, treated openly with venlafaxine (up to 300 mg/day) for 12 weeks. Treatment response was assessed with the Montgomery–Asberg Depression Rating Scale and adverse effects were evaluated with the Udvalg for Kliniske Undersøgelser (UKU) rating scale. Venlafaxine-related exposures were derived from a published population pharmacokinetic model based on the IRL-GRey study, and their associations with treatment outcomes were assessed using regression analyses.

Result:

At week 4, the primary endpoint, higher venlafaxine-related exposures were not associated with greater symptom improvement. While at the end of treatment (week 12), we did not observe additional antidepressant benefit with increased venlafaxine-related exposures, higher ODV and active moiety exposures were associated with the occurrence of at least one adverse effect (odds ratio [OR] = 1.6 [1.1, 2.3], p = 0.02 and 1.8 [1.2, 2.6], p = 0.003, respectively). Also, higher venlafaxine and active moiety exposures were associated with nausea/vomiting (OR = 1.1 [1.0, 1.2], p = 0.02 and 2.3 [1.3, 4.0], p = 0.006); while higher active moiety exposure was associated with orthostatic dizziness (OR = 1.9 [1.1, 3.2], p = 0.02).

Conclusion:

Our findings suggest a potential threshold effect, where venlafaxine-related exposure past a certain level did not enhance antidepressant response but increased adverse-effect burden. These results support incorporating exposure measures from therapeutic drug monitoring in antidepressant studies to address the heterogeneity of safety and tolerability outcomes.

2026-08-05·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Article

作者: Lad, Latesh ; Sun, Kai-hui ; Xu, Yili ; Ma, Bin ; Babusis, Darius ; Liclican, Albert ; Lai, Yurong ; Belzile, Jean-Philippe ; Zhao, Xiaofeng ; Marchand, Bruno ; Bilello, John P. ; Menon, Saurabh ; Feng, Joy Y. ; Mackman, Richard L. ; Ramirez, Ricardo ; Chen, Chen ; Soulette, Cameron ; Chuang, Hsiu-Chun ; Wang, Liya ; Li, Li ; Wang, Ting ; Cihlar, Tomas ; Zhang, Jingyu ; Chaudhuri, Subhra ; Ortega, Joseph T. ; Nayak, Arabinda

ABSTRACT:

Obeldesivir (GS-5245, ODV), an orally administered 5′-isobutyryl ester prodrug of GS-441524, has demonstrated anti-SARS-CoV-2 activity in preclinical and clinical settings. ODV is hydrolyzed in plasma to provide high systemic exposures of GS-441524, enabling the efficient intracellular formation of the bioactive 5′-triphosphate GS-443902, an ATP analog inhibiting the SARS-CoV-2 RNA-dependent RNA polymerases. Remdesivir (RDV), the first US FDA-approved antiviral treatment for COVID-19, is also activated to GS-443902. In this paper, we systematically profiled the human enzymes potentially involved in ODV and RDV activation using multiple approaches: (i) biochemical studies on the catalytic efficiency ( kcat / Km ); (ii) analysis of activation in single-gene knockout cells; and (iii) the antiviral activity assessment in single-gene knockout cells. Our results demonstrated that ODV hydrolysis to GS-441524 is catalyzed by carboxylesterase 1 and 2 with high efficiency. For the enzymes involved in the consecutive formation of 5′-mono-, di-, and tri-phosphates (MP, DP, and TP), adenosine kinase (ADK) likely plays a minor role in forming GS-441524-MP, suggesting the involvement of other phosphotransferases. This was further supported by cell-based single-gene ADK-knockout studies. In contrast, both biochemical and cell-based assay data strongly support adenylate kinase 2 as the key enzyme for the phosphorylation of GS-441524-MP, while nucleoside diphosphate kinase NM23-H2, phosphoglycerate kinase, and pyruvate kinase likely all contribute to the formation of GS-441524-TP. This work leads to a deeper understanding of ODV and RDV metabolism, and suggests further studies are needed to identify the enzyme responsible for the activation of GS-441524 to its 5′-monophosphate.

2026-04-01·INTERNATIONAL IMMUNOPHARMACOLOGY

Article

作者: Liu, Ziyuan ; Zhuang, Tao ; Liu, Shuxian ; Song, Yangyang ; Zhang, Guisen ; Wang, Shiwen ; Zhang, Jiyang ; Chen, Haoyun ; Song, Jie

Depression and anxiety disorders are highly comorbid, yet their complex pathogenesis often limits the efficacy of monotherapy. Growing evidence implicates neuroinflammation in their pathogenesis. Co-drugs that linked two active molecules into a single compound and released the drugs after administration, which offering improved efficacy and tolerability than individual drug mixtures or monotherapy. In this work, five new co-drugs ODV-NSAIDs were synthesized from O-desmethylvenlafaxine (ODV) with non-steroidal anti-inflammatory drugs (NSAIDs) to achieve synergistic antidepression and anxiolytic effects. In vitro stability studies exhibited that these co-drugs can be metabolized into two single drugs within 60 min in simulated intestinal fluid. In both acute and chronic LPS-induced models, co-drug ODV-NAP significantly ameliorated depressive-like behaviors, evidenced by increased sucrose preference, reduced immobility in the tail suspension test (TST) and forced swim test (FST), and enhanced locomotion in the open field test (OFT). Furthermore, ODV-NAP decreased brain levels of pro-inflammatory cytokines (TNF-α, IL-1β, IL-6) and malondialdehyde (MDA), while elevating serotonin (5-HT), norepinephrine (NE), and superoxide dismutase (SOD) activity. Nissl staining confirmed ODV-NAP significantly attenuated hippocampal neuronal damage. Moreover, western blotting revealed ODV-NAP inhibited the TLR4/NF-κB signaling pathway and upregulated BDNF and p-TrkB protein expression. ODV-NAP also inhibited LPS-induced p65 nuclear translocation in BV-2 microglia in vitro, and caused no toxicity in histology. Thus, co-drug ODV-NAP represented a promising novel candidate for treating depression and anxiety.

项与 Odalasvir 相关的新闻（医药）

2026-06-14

·信狐药迅

五个1类新药获批上市：威凯尔安瑞替尼、麓鹏洛布替尼、征祥玛硒洛沙韦、天广实重组人源化单抗MIL62和贝捷泰STSP-0601| 新获批(6.8-6.14）

每周药品注册获批数据，分门别类呈现，一目了然。(6.8-6.14）新药上市申请药品名称企业注册分类受理号安瑞替尼胶囊江苏威凯尔医药科技股份有限公司 1 CXHS2500070 洛布替尼片广州麓鹏制药有限公司 1 CXHS2500057 洛布替尼片广州麓鹏制药有限公司 1 CXHS2500056 玛硒洛沙韦片南京征祥医药有限公司 1 CXHS2500029 重组人源化单抗MIL62注射液北京天广实生物技术股份有限公司 1 CXSS2500102 注射用STSP-0601 江苏贝捷泰生物科技有限公司 1 CXSS2500057 泰它西普注射液荣昌生物制药(烟台)股份有限公司 2.1;2.2 CXSS2500112 斯鲁利单抗注射液上海复宏瑞霖生物技术有限公司 2.2 CXSS2500141 注射用泰它西普荣昌生物制药(烟台)股份有限公司 2.2 CXSS2500090 新药临床申请药品名称企业注册分类受理号 HRS-8829注射用浓溶液北京盛迪医药有限公司 1 CXHL2600423 HSK46256片沈阳海思科制药有限公司 1 CXHL2600419 HSK46256片沈阳海思科制药有限公司 1 CXHL2600418 PC-0120片江苏长泰药业股份有限公司 1 CXHL2600420 VVD-133214 片拜耳医药保健有限公司 1 CXHL2600415 VVD-133214 片拜耳医药保健有限公司 1 CXHL2600412 VVD-133214 片拜耳医药保健有限公司 1 CXHL2600411 VVD-133214 片拜耳医药保健有限公司 1 CXHL2600410 VVD-133214 片拜耳医药保健有限公司 1 CXHL2600417 VVD-133214 片拜耳医药保健有限公司 1 CXHL2600416 ANS02胶囊北京鞍石生物科技股份有限公司 1 CXHL2600414 ANS02胶囊北京鞍石生物科技股份有限公司 1 CXHL2600413 LT-010391片领泰生物医药(绍兴)有限公司 1 CXHL2600408 LT-010391片领泰生物医药(绍兴)有限公司 1 CXHL2600407 VC005凝胶江苏威凯尔医药科技股份有限公司 1 CXHL2600405 CB03-154片上海挚盟医药科技有限公司 1 CXHL2600403 ARD-489AD片科辉智药(深圳)新药研究中心有限公司 1 CXHL2600402 ARD-489AD片科辉智药(深圳)新药研究中心有限公司 1 CXHL2600401 HRS9531注射液福建盛迪医药有限公司 1 CXHL2600400 HRS9531注射液福建盛迪医药有限公司 1 CXHL2600399 HRS9531注射液福建盛迪医药有限公司 1 CXHL2600398 注射用WP1302 百明信康生物技术(浙江)股份有限公司 1 CXHL2600395 INV-6452片广东省创新药转化医学研究院有限公司 1 CXHL2600382 INV-6452片广东省创新药转化医学研究院有限公司 1 CXHL2600381 APH03571片广州一品红制药有限公司 1 CXHL2600374 APH03571片广州一品红制药有限公司 1 CXHL2600373 TUL321胶囊珠海联邦制药股份有限公司 1 CXHL2600376 TUL321胶囊珠海联邦制药股份有限公司 1 CXHL2600377 TUL321胶囊珠海联邦制药股份有限公司 1 CXHL2600375 ODV混悬滴眼液深圳若见辉瞳生物科技有限公司 1 CXHL2600366 ODV混悬滴眼液深圳若见辉瞳生物科技有限公司 1 CXHL2600365 ODV混悬滴眼液深圳若见辉瞳生物科技有限公司 1 CXHL2600364 优替德隆胶囊成都华昊中天药业有限公司 2.2 CXHL2600404 DMET25001缓释片武汉龙升医药科技有限责任公司 2.2;2.4 CXHL2600397 DMET25001缓释片武汉龙升医药科技有限责任公司 2.2;2.4 CXHL2600396 流感病毒裂解疫苗(CpG佐剂) 华普石家庄医药有限公司 1.3 CXSL2600337 注射用IMD1828 上海英脉德医疗科技有限公司 1 CXSL2600517 注射用AX-023(冻干) 北京安信怀德生物技术有限公司 1 CXSL2600488 SYS6041 石药集团巨石生物制药有限公司 1 CXSL2600381 注射用DXC018 杭州多禧生物科技有限公司 1 CXSL2600375 注射用SIM0689 上海先纬医药科技有限公司 1 CXSL2600374 注射用GenSci136 长春金赛药业有限责任公司 1 CXSL2600371 注射用Efimosfermin alfa 葛兰素史克(中国)投资有限公司 1 CXSL2600372 LNF2401注射液(皮下注射) 山东新时代药业有限公司 1 CXSL2600370 LNF2401注射液(静脉滴注) 山东新时代药业有限公司 1 CXSL2600369 CMG2349注射液成都恩沐生物科技有限公司 1 CXSL2600368 BBT001注射液杉竹曜(北京)生物医药科技有限公司 1 CXSL2600364 IBI354 信达生物医药科技(杭州)有限公司 1 CXSL2600360 注射用QLF4113 齐鲁制药有限公司 1 CXSL2600363 注射用BL-M14D1 成都百利多特生物药业有限责任公司 1 CXSL2600361 ATG-201注射液德琪(杭州)生物有限公司 1 CXSL2600349 IBR854细胞注射液英百瑞(杭州)生物医药有限公司 1 CXSL2600346 IBR854细胞注射液英百瑞(杭州)生物医药有限公司 1 CXSL2600345 特瑞普利单抗注射液上海君实生物医药科技股份有限公司 2.2 CXSL2600367 特瑞普利单抗注射液上海君实生物医药科技股份有限公司 2.2 CXSL2600366 特瑞普利单抗注射液上海君实生物医药科技股份有限公司 2.2 CXSL2600357 特瑞普利单抗注射液上海君实生物医药科技股份有限公司 2.2 CXSL2600356 仿制药申请药品名称企业注册分类受理号琥珀酸多西拉敏片南京济群医药科技股份有限公司 3 CYHS2500515 琥珀酸多西拉敏片南京济群医药科技股份有限公司 3 CYHS2500514 马来酸曲美布汀片浙江诺得药业有限公司 3 CYHS2404381 唑来膦酸注射液浙江康吉尔药业有限公司 3 CYHS2404256 盐酸丙卡特罗颗粒浙江恒研医药科技有限公司 3 CYHS2404186 盐酸丙卡特罗颗粒浙江恒研医药科技有限公司 3 CYHS2404183 注射用硫酸多黏菌素B 山东序列生物科技有限公司 3 CYHS2404145 重酒石酸卡巴拉汀口服液广州大光制药有限公司 3 CYHS2404008 盐酸多巴胺注射液开封康诺药业有限公司 3 CYHS2404003 腺苷钴胺胶囊安徽省先锋制药有限公司 3 CYHS2403991 多索茶碱颗粒浙江赛默制药有限公司 3 CYHS2403960 依帕司他片广东九明制药有限公司 3 CYHS2403950 盐酸甲氧氯普胺注射液重庆天致药业股份有限公司 3 CYHS2403936 己酮可可碱注射液上海现代哈森(商丘)药业有限公司 3 CYHS2403851 碳酸氢钠注射液海南如康生物科技有限公司 3 CYHS2403788 碳酸氢钠林格注射液(I) 海南爱科制药有限公司 3 CYHS2403539 聚乙二醇3350散浙江远力健药业有限责任公司 3 CYHS2403528 碳酸氢钠注射液黑龙江省知润药业有限公司 3 CYHS2403453 呋塞米片上海理想制药有限公司 3 CYHS2403447 盐酸普罗帕酮注射液成都峻禾医药科技开发有限公司 3 CYHS2403329 盐酸伐地那非口腔崩解片江西施美药业股份有限公司 3 CYHS2403265 盐酸舍曲林口服浓缩液海南斯达制药有限公司 3 CYHS2403263 复方匹可硫酸钠口服溶液浙江同伍生物医药有限公司 3 CYHS2403122 碳酸氢钠林格注射液(I) 浙江康吉尔药业有限公司 3 CYHS2403111 注射用左亚叶酸钙安徽省先锋制药有限公司 3 CYHS2403091 米诺地尔搽剂曼秀雷敦(中国)药业有限公司 3 CYHS2403080 米诺地尔搽剂曼秀雷敦(中国)药业有限公司 3 CYHS2403079 普瑞巴林口崩片江苏和晨药业有限公司 3 CYHS2403056 普瑞巴林口崩片江苏和晨药业有限公司 3 CYHS2403055 硫酸沙丁胺醇注射液河南普瑞药业有限公司 3 CYHS2402782 门冬氨酸钾注射液山东如至生物医药科技有限公司 3 CYHS2402363 米诺地尔搽剂武汉华尔生物科技有限公司 3 CYHS2402064 双氯芬酸钠缓释片江苏万高药业股份有限公司 4 CYHS2501252 精氨酸布洛芬颗粒海南赛立克药业有限公司 4 CYHS2501055 盐酸帕洛诺司琼软胶囊正大天晴药业集团股份有限公司 4 CYHS2501009 格列吡嗪控释片天津力生制药股份有限公司 4 CYHS2500833 阿戈美拉汀片河南福森药业有限公司 4 CYHS2500602 罗沙司他胶囊上海医药集团青岛国风药业股份有限公司 4 CYHS2500420 罗沙司他胶囊上海医药集团青岛国风药业股份有限公司 4 CYHS2500419 精氨酸布洛芬片海南赛立克药业有限公司 4 CYHS2500294 碘佛醇注射液山东齐都药业有限公司 4 CYHS2500275 注射用盐酸美法仑齐鲁制药(海南)有限公司 4 CYHS2500220 依托考昔片浙江昂利康制药股份有限公司 4 CYHS2500179 依托考昔片浙江昂利康制药股份有限公司 4 CYHS2500178 依托考昔片浙江昂利康制药股份有限公司 4 CYHS2500175 盐酸阿莫罗芬乳膏江苏盈科生物制药有限公司 4 CYHS2500121 盐酸托莫西汀胶囊西南药业股份有限公司 4 CYHS2500035 艾拉莫德片浙江华海药业股份有限公司 4 CYHS2404667 头孢克洛缓释片(II) 广州白云山医药集团股份有限公司白云山制药总厂 4 CYHS2404597 拉西地平片湖南普道医药技术有限公司 4 CYHS2404593 甲磺酸沙非胺片齐鲁制药有限公司 4 CYHS2404587 甲磺酸沙非胺片齐鲁制药有限公司 4 CYHS2404586 夫西地酸乳膏广东科泓药业有限公司 4 CYHS2404370 丙戊酸钠缓释片华益药业科技(安徽)有限公司 4 CYHS2404332 左乙拉西坦口服溶液温岭市创新生物医药科技股份有限公司 4 CYHS2404134 沙格列汀二甲双胍缓释片(III) 山西同达药业有限公司 4 CYHS2404005 沙格列汀二甲双胍缓释片(II) 山西同达药业有限公司 4 CYHS2404004 枸橼酸托法替布缓释片浙江尖峰药业有限公司 4 CYHS2403990 乳酸钠林格注射液江苏长江药业有限公司 4 CYHS2403821 噻托溴铵吸入粉雾剂正大天晴药业集团南京顺欣制药有限公司 4 CYHS2403755 聚乙烯醇滴眼液国药控股鑫烨(湖北)医药有限公司 4 CYHS2403586 西甲硅油乳剂浙江佰奥医药科技有限公司 4 CYHS2403510 利丙双卡因乳膏安徽四环科宝制药有限公司 4 CYHS2403467 氢溴酸伏硫西汀片吉林四环制药有限公司 4 CYHS2403270 左卡尼汀注射液吉林敖东药业集团延吉股份有限公司 4 CYHS2402946 利奈唑胺片浙江杭康药业有限公司 4 CYHS2402930 雷贝拉唑钠肠溶片上海理想制药有限公司 4 CYHS2402786 间苯三酚口服冻干片南京艾德凯腾生物医药有限责任公司 4 CYHS2402223 甲硝唑凝胶湖南状元制药有限公司 4 CYHS2402202 盐酸乌拉地尔注射液湖南恒生制药股份有限公司 4 CYHS2401235 皮下注射人免疫球蛋白成都蓉生药业有限责任公司 3.2 CXSS2400133 地舒单抗注射液泰州迈博太科药业有限公司 3.3 CXSS2500018 托吡酯缓释胶囊昆药集团股份有限公司 3 CYHL2600041 托吡酯缓释胶囊昆药集团股份有限公司 3 CYHL2600040 托吡酯缓释胶囊昆药集团股份有限公司 3 CYHL2600039 盐酸他喷他多口服溶液宜昌人福药业有限责任公司 3 CYHL2600038 进口申请药品名称企业注册分类受理号比美替尼片 PIERRE FABRE MEDICAMENT 5.1 JXHS2500032 斯贝利单抗注射液 Otsuka Pharmaceutical Co., Ltd. 1 JXSS2500118 注射用维替索妥尤单抗 Seagen Inc. 3.1 JXSS2500023 瑞玛奈珠单抗注射液 TEVA GmbH 3.1 JXSS2500003 GSK6042981片 GlaxoSmithKline Research & Development Limited 1 JXHL2600104 PF-07799933片 Pfizer Inc. 1 JXHL2600103 PF-07799933片 Pfizer Inc. 1 JXHL2600101 AZD8965片 AstraZeneca AB 1 JXHL2600098 AZD8965片 AstraZeneca AB 1 JXHL2600097 ASP3082注射液 Astellas Pharma Global Development, Inc. 1 JXHL2600095 他舒替尼片 Eisai Co., Ltd. 5.1 JXHL2600100 PF-08634404 Pfizer Inc. 1 JXSL2600089 注射用维恩妥尤单抗 Astellas Pharma Global Development, Inc. 2.2 JXSL2600091 注射用维恩妥尤单抗 Astellas Pharma Global Development, Inc. 2.2 JXSL2600090 Depemokimab注射液 GlaxoSmithKline Research & Development Limited 2.2 JXSL2600088 阿伏利尤单抗注射液 AstraZeneca AB 2.2 JXSL2600086 中药相关申请药品名称企业注册分类受理号香术调脾和中颗粒山西省中医药研究院(山西省中医院) 1.1 CXZL2600032 三皮强心颗粒为因医药科技有限公司 1.1 CXZL2600031 安神滴丸天士力医药集团股份有限公司 1.1 CXZS2500002 大建中膏华润三九(雅安)药业有限公司 3.1 CXZS2400041 注：橙色字体部分结论为不批准或收到通知件；

申请上市

2026-06-09

·谈医说药

2026年06月09日药品临床试验默示许可

序号受理号药品名称申请人名称适应症注册分类 1 CXSL2600364 BBT001注射液杉竹曜（北京）生物医药科技有限公司慢性自发性荨麻疹 1 2 CXSL2600367 特瑞普利单抗注射液上海君实生物医药科技股份有限公司;苏州众合生物医药科技有限公司;上海君实生物工程有限公司本品联合GT101注射液一线治疗复发或转移性头颈部鳞状细胞癌。 2.2 3 CXSL2600366 特瑞普利单抗注射液上海君实生物医药科技股份有限公司;苏州众合生物医药科技有限公司;上海君实生物工程有限公司本品联合GT101注射液一线治疗复发或转移性头颈部鳞状细胞癌。 2.2 4 CXHL2600395 注射用WP1302 百明信康生物技术（浙江）股份有限公司甲状腺眼病 1 5 CXHL2600365 ODV混悬滴眼液深圳若见辉瞳生物科技有限公司拟用于由角膜炎及角膜移植术后诱发的角膜新生血管患者的治疗。 1 6 CXHL2600366 ODV混悬滴眼液深圳若见辉瞳生物科技有限公司拟用于由角膜炎及角膜移植术后诱发的角膜新生血管患者的治疗。 1 7 CXSL2600371 注射用GenSci136 长春金赛药业有限责任公司眼肌型重症肌无力（oMG） 1 8 CXHL2600364 ODV混悬滴眼液深圳若见辉瞳生物科技有限公司拟用于由角膜炎及角膜移植术后诱发的角膜新生血管患者的治疗。 1 9 JXSB2600055 GSK3862995B注射液 GlaxoSmithKline Research & Development Limited 本品适用于治疗非囊性纤维化支气管扩张症 1 10 CXSL2600375 注射用DXC018 杭州多禧生物科技有限公司晚期实体瘤。 1 11 JXSL2600088 Depemokimab注射液 GlaxoSmithKline Research & Development Limited 有风险的中重度成人和青少年2型哮喘患者 2.2 12 JXHL2600095 ASP3082注射液 Astellas Pharma Global Development, Inc. ASP3082注射液联合以氟尿嘧啶为基础的化疗方案，用于转移性KRAS G12D突变型胰腺导管腺癌患者的一线治疗。 1 13 CXHB2600091 TRD303溶液北京泰德制药股份有限公司术后镇痛。 2.2 14 CXHB2600090 TRD303溶液北京泰德制药股份有限公司术后镇痛。 2.2 15 CXHL2600400 HRS9531注射液福建盛迪医药有限公司肥胖合并膝骨关节炎 1 16 CXHL2600399 HRS9531注射液福建盛迪医药有限公司肥胖合并膝骨关节炎 1 17 CXHL2600398 HRS9531注射液福建盛迪医药有限公司肥胖合并膝骨关节炎 1 18 CXHL2600401 ARD-489AD片科辉智药（深圳）新药研究中心有限公司化疗诱导的周围神经病变 1 19 CXSL2600363 注射用QLF4113 齐鲁制药有限公司晚期前列腺癌 1 20 CXSL2600360 IBI354 信达生物医药科技（杭州）有限公司本品联合内分泌治疗±CDK4/6抑制剂用于治疗不可切除的局部晚期或转移性HR阳性、HER2低表达/超低表达乳腺癌 1 21 CXHL2600397 DMET25001缓释片武汉龙升医药科技有限责任公司癌症患者顺铂化疗期间的听力保护。 2.2;2.4 22 CXHL2600402 ARD-489AD片科辉智药（深圳）新药研究中心有限公司化疗诱导的周围神经病变 1 23 CXHL2600396 DMET25001缓释片武汉龙升医药科技有限责任公司癌症患者顺铂化疗期间的听力保护。 2.2;2.4 24 JXHB2600049 TAK-360片 Takeda Development Center Americas, Inc. 不伴猝倒的发作性睡病（II型发作性睡病） 1 25 CXHL2600382 INV-6452片广东省创新药转化医学研究院有限公司;深圳市原力生命科学有限公司;佛山市原力生物科技有限公司;上海聚原生物科技有限公司联合内分泌治疗药物治疗激素受体阳性、人表皮生长因子受体2阴性的（HR+/HER2-）晚期/转移性乳腺癌或其他局部晚期/转移性实体瘤 1 26 CXHL2600374 APH03571片广州一品红制药有限公司用于携带FLT3突变的复发性或难治性急性髓系白血病（AML）成人患者的治疗。 1 27 CXHL2600381 INV-6452片广东省创新药转化医学研究院有限公司;深圳市原力生命科学有限公司;佛山市原力生物科技有限公司;上海聚原生物科技有限公司联合内分泌治疗药物治疗激素受体阳性、人表皮生长因子受体2阴性的（HR+/HER2-）晚期/转移性乳腺癌或其他局部晚期/转移性实体瘤 1 28 CXSL2600349 ATG-201注射液德琪（杭州）生物有限公司系统性红斑狼疮（SLE） 1 29 CXHL2600376 TUL321胶囊珠海联邦制药股份有限公司;珠海联邦制药股份有限公司中山分公司本品拟用于治疗阵发性睡眠性血红蛋白尿症（PNH）。 1 30 CXHL2600377 TUL321胶囊珠海联邦制药股份有限公司;珠海联邦制药股份有限公司中山分公司本品拟用于治疗阵发性睡眠性血红蛋白尿症（PNH）。 1 31 CXHL2600375 TUL321胶囊珠海联邦制药股份有限公司;珠海联邦制药股份有限公司中山分公司本品拟用于治疗阵发性睡眠性血红蛋白尿症（PNH）。 1 32 CXHL2600373 APH03571片广州一品红制药有限公司用于携带FLT3突变的复发性或难治性急性髓系白血病（AML）成人患者的治疗。 1 33 CXSL2600488 注射用AX-023（冻干）北京安信怀德生物技术有限公司晚期实体瘤 1 34 CXZL2600031 三皮强心颗粒为因医药科技有限公司补气利水强心。用于治疗慢性心力衰竭，属气虚兼水饮证；症见：乏力气短，心悸浮肿，小便不利，喘促不得卧，活动易劳累，咳吐清稀或泡沫痰。中药:1.1类 35 JXHB2600047 TAK-360片 Takeda Development Center Americas, Inc. 不伴猝倒的发作性睡病（II型发作性睡病） 1 36 JXHB2600050 TAK-360片 Takeda Development Center Americas, Inc. 不伴猝倒的发作性睡病（II型发作性睡病） 1 37 JXHB2600046 TAK-360片 Takeda Development Center Americas, Inc. 不伴猝倒的发作性睡病（II型发作性睡病） 1 38 JXHB2600048 TAK-360片 Takeda Development Center Americas, Inc. 不伴猝倒的发作性睡病（II型发作性睡病） 1 39 JXHB2600038 AMG 410 Amgen Inc. 携带 KRAS 改变的晚期或转移性实体瘤。 1 40 JXHB2600037 AMG 410 Amgen Inc. 携带 KRAS 改变的晚期或转移性实体瘤。 1 41 JXHB2600036 AMG 410 Amgen Inc. 携带 KRAS 改变的晚期或转移性实体瘤。 1

2017-09-11

·BioSpace

Johnson & Johnson Quits Multibillion-Dollar Hep C Drug Program, Partners’ Stocks Fall

September 11, 2017 By Mark Terry , BioSpace.com Breaking News Staff Cork, Ireland – Janssen Sciences Ireland UC , a Johnson & Johnson company, announced today that it has decided to halt development of its hepatitis C treatment combination JNJ-4178. It expects to wrap up its Phase II trials, but stop the program at that point, not continuing onward. The company indicates that the decision was made because of an overfilled market of effective therapies. “Going forward, our hepatitis R&D efforts will focus on chronic hepatitis B, where a high unmet medical need still exists,” said Lawrence Blatt , Janssen’s Global Therapeutic Area Head, Infectious Disease Therapeutics, in a statement. “Our scientists are energized by this challenge and our research ambition is to achieve a functional cure of hepatitis B which affects over a quarter of a billion people globally. At Janssen, we focus our research and development on areas of greatest unmet medical need where we can combine our excellent internal science with the best available external innovation to bring optimized solutions and maximum benefit to patients.” J&J got into the hepatitis C market at a time when it was undergoing major changes, largely led by Gilead Sciences . Gilead’s drugs for hepatitis C essentially cure the disease, and the other companies that followed in its path primarily differentiated themselves by being cheaper or requiring fewer doses or shortening the timeline of the regimens. John Carroll, writing for Endpoints News , notes , “That’s a disaster for Achillion , which partnered its NS5A drug odalasvir (ACH-3102) with the pharma giant in a $1.1 billion pact. The pharma giant also bought out Alios for $1.75 billion, gaining the nucleotide NS5B inhibitor AL-335, which was added to a portfolio that also included the NS3/4A protease inhibitor Olysio, an approved therapy in-licensed from Medivir .” Medivir says J&J’s abandonment of the hepatitis C cocktail program won’t change the terms of its licensing agreement with J&J, although Carroll says, “it certainly will have an impact on its potential in this crowded market.” Medivir may have tried to put a positive spin on it, but investors weren’t in agreement. Medivir AB stock lost 8 percent in trading in Stockholm. Nasdaq indicated, “The company noted that the discontinuation of development f JNJ-4178, the triple combination of semeprevir, odalasvir and AL-335, does not affect the ongoing partnership with Janssen on Olysio (simeprevir), or the existing licensing agreement with Janssen in which semeprevir is included.” “Although Janssen’s decision not to progress this promising treatment further is unfortunate, Medivir’s focus does not change,” said Christine Lind , Medivir’s chief executive officer, in a statement. “We continue to develop our proprietary pipeline in oncology and look forward to completing the ongoing Phase IIa studies in osteoarthritis.” In a statement, Milind Deshpande , Achillion’s chief executive officer, said, “While we believe that patients worldwide would benefit from convenient, short-duration therapies like JNJ-4178, we remain fully focused on advancing our factor D portfolio of complement alternative pathway inhibitors in areas where patient needs are greatest, and using our strong balance sheet of almost $370 million in cash and cash equivalents at June 30, 2017 to do so.”

引进/卖出并购临床2期寡核苷酸

100 项与 Odalasvir 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Odalasvir	-	DB13041

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
慢性丙型肝炎	临床3期	加拿大	Janssen Research & Development LLC	2017-04-10
慢性丙型肝炎	临床3期	新西兰	Janssen Research & Development LLC	2017-04-10
慢性丙型肝炎	临床3期	波兰	Janssen Research & Development LLC	2017-04-10
慢性丙型肝炎	临床3期	新加坡	Janssen Research & Development LLC	2017-04-10
代偿期肝硬化	临床2期	日本	Janssen Pharmaceuticals, Inc.	2016-12-21
慢性丙型肝炎基因型 3	临床2期	毛里求斯	Alios BioPharma, Inc.	2015-10-31
慢性丙型肝炎基因型 3	临床2期	摩尔多瓦	Alios BioPharma, Inc.	2015-10-31
慢性丙型肝炎基因型 3	临床2期	新西兰	Alios BioPharma, Inc.	2015-10-31
慢性丙型肝炎基因型 3	临床2期	英国	Alios BioPharma, Inc.	2015-10-31
纤维化	临床2期	毛里求斯	Alios BioPharma, Inc.	2015-10-31

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02993250 (OMEGA-3, Pubmed \| J Gastroenterol) 人工标引	临床2期	纤维化 \| 慢性丙型肝炎	33	JNJ-4178 (non-cirrhotic patients)	醖鹹選憲襯壓襯鹹繭觸(簾衊衊願鏇簾膚獵簾構) = 積獵衊築廠淵窪衊糧窪鹽顧糧襯襯憲鑰醖壓築 (範簾鏇鬱淵築襯顧膚顧 ) 更多	积极	2020-06-01
				JNJ-4178 (cirrhotic patients)	醖鹹選憲襯壓襯鹹繭觸(簾衊衊願鏇簾膚獵簾構) = 衊鏇壓繭醖蓋窪衊觸鹹鹽顧糧襯襯憲鑰醖壓築 (範簾鏇鬱淵築襯顧膚顧 ) 更多
NCT02993250 (OMEGA-3, CTgov)	临床2期	纤维化 \| 慢性丙型肝炎 \| 代偿期肝硬化	33	simeprevir (SMV)+odalasvir (ODV)+AL-335 (Cohort 1: Chronic Hepatitis C Without Cirrhosis)	餘構獵膚窪艱獵膚壓顧 = 製網範醖構觸醖願選鹹壓築網鬱網積選願鹹觸 (鬱壓餘廠夢艱鑰顧窪淵, 願膚膚壓觸艱顧鬱糧簾 ~ 齋選遞襯願築簾網獵積) 更多	-	2019-09-11
				SMV+ODV+AL-335 (Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis)	餘構獵膚窪艱獵膚壓顧 = 襯構獵蓋繭壓簾築醖繭壓築網鬱網積選願鹹觸 (鬱壓餘廠夢艱鑰顧窪淵, 遞鏇膚築鏇範糧鏇構廠 ~ 衊簾齋簾夢選網鏇窪鏇) 更多
NCT02765490 (OMEGA-1, Pubmed) 人工标引	临床2期	纤维化 \| 丙型肝炎	365	JNJ-4178 (6 weeks)	壓鹽顧廠廠廠選醖觸廠(繭簾觸鏇選壓鏇鏇窪窪) = 網餘餘顧齋願鹹鑰構顧顧窪窪襯鏇範鏇膚鹹衊 (憲窪鹹積憲選遞範遞網 )	积极	2019-06-01
				JNJ-4178 (8 weeks)	壓鹽顧廠廠廠選醖觸廠(繭簾觸鏇選壓鏇鏇窪窪) = 窪糧積選壓鹽製鹽鹹簾顧窪窪襯鏇範鏇膚鹹衊 (憲窪鹹積憲選遞範遞網 )
NCT02765490 (OMEGA-1, CTgov)	临床2期	慢性丙型肝炎	365	SMV+ODV+AL-335 (Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks)	繭窪選積艱蓋憲鏇襯築 = 鏇網選獵簾艱襯壓膚築衊衊蓋淵範鏇夢製艱艱 (積鑰製積鏇繭簾網構廠, 餘選觸艱選窪憲願糧鏇 ~ 簾夢範網糧艱窪鹹淵鹽) 更多	-	2019-01-22
				SMV+ODV+AL-335 (Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks)	繭窪選積艱蓋憲鏇襯築 = 廠淵鹹醖鏇糧簾積襯繭衊衊蓋淵範鏇夢製艱艱 (積鑰製積鏇繭簾網構廠, 遞鏇膚築襯鬱夢夢壓齋 ~ 積鹹壓鏇鹹遞壓觸遞鹽) 更多
NCT01849562 (CTgov)	临床2期	慢性丙型肝炎基因型 1	30	Placebo	衊鹹廠鬱蓋艱廠齋憲淵 = 簾膚簾齋顧襯壓鹹糧築構憲廠襯鏇鹹糧遞窪鬱 (構夢獵觸獵鏇憲願觸簾, 淵鑰廠顧鹽製顧獵鹹願 ~ 餘鹽鑰壓製憲淵窪簾糧) 更多	-	2015-02-04
NCT01700179 (CTgov)	临床1期	慢性丙型肝炎基因型 1b	8	Ribavirin	選醖積憲襯築廠糧願鬱 = 憲醖觸齋願繭積壓構選鏇壓蓋憲襯鑰夢構築蓋 (窪鬱觸構選鹹願蓋鏇膚, 繭鹽艱衊構襯積淵齋簾 ~ 膚積壓膚餘積築壓築窪) 更多	-	2014-10-03