A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Tolerability of Cenerimod in Adult Patients With Systemic Lupus Erythematosus and Active Lupus Nephritis in Combination With Background Therapy

The goal of this clinical trial is to learn if cenerimod, on top of regular treatment, works to treat active lupus nephritis in adults with systemic lupus erythematosus and active lupus nephritis. It will also learn about the safety of cenerimod. The main questions it aims to answer are:
* Does cenerimod improve kidney function in participants?
* What medical problems do participants have when taking cenerimod?
Researchers will compare cenerimod to a placebo (a look-alike substance that contains no drug) to see how well cenerimod works when it is added to regular treatment.
Participants will:
* Take cenerimod or a placebo every day for 76 weeks (approximately 1.5 years), on top of regular treatment.
* Visit the clinic every 1 to 3 months for checkups and tests.

开始日期2026-02-09

申办/合作机构

Viatris, Inc.

NCT07266090

/ Enrolling by invitation临床2期

A Multicenter,Open-label,Single Arm,Multiple-dose Study to Evaluate the Safety,Tolerability,Pharmacokinetics and Pharmacodynamics of Cenerimod in Adult Chinese Participants With Moderate-to-severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy

The goal of this clinical trial is to learn about the safety, how the body processes the drug, and its effects of a drug called cenerimod in adult Chinese participants (aged 18-75) with moderate to severe Systemic Lupus Erythematosus (SLE) who are already receiving standard background therapy.
The main questions it aims to answer are:
* What is the safety and tolerability of a daily 4 mg dose of cenerimod in Chinese participants with SLE?
* How is cenerimod processed by the body (pharmacokinetics) in this population?
* What is the effect of cenerimod on the level of lymphocytes in the blood (pharmacodynamics)? This is a single-arm study without a comparison group.
Participants will:
* Take one 4 mg cenerimod tablet by mouth once daily for up to 12 months.
* Continue their stable, pre-existing background SLE medications throughout the study.
* Attend regular clinic visits over a period of up to 22 months for tests and check-ups, including blood draws, heart monitoring (12-lead electrocardiogram), vital signs(blood pressure),and physical examinations.
* Undergo a final safety follow-up 6 months after their last dose of the study drug.

开始日期2026-01-14

申办/合作机构

晖致医药有限公司

NCT07301723

/ Completed临床1期

A Single-center, Open-label Trial to Determine the Absolute Bioavailability of Cenerimod Using an Intravenous 14C-radiolabeled Cenerimod Microtracer in Healthy Male Participants

The goal of this clinical trial is to learn about the absolute bioavailability of cenerimod in healthy participants. It will also provide information about the safety of cenerimod.
Participants will receive one tablet with cenerimod, followed by an intravenous (i.v.) infusion with a 14C-radiolabeled cenerimod microtracer (cenerimod with a very low dose of radioactivity) 6 hours later.
Participants will stay at the clinic for a total of 4 days, and will return to the clinic for further tests over the course of approximately 3 months.

开始日期2025-12-11

申办/合作机构

Viatris, Inc.

100 项与 Cenerimod 相关的临床结果

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100 项与 Cenerimod 相关的转化医学

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100 项与 Cenerimod 相关的专利（医药）

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项与 Cenerimod 相关的文献（医药）

2025-02-01·ANNALS OF THE RHEUMATIC DISEASES

Pharmacodynamics of the S1P₁ receptor modulator cenerimod in a phase 2b randomised clinical trial in patients with moderate to severe SLE.

Article

作者: Murphy, Mark Joseph ; Suffiotti, Madeleine ; Keller, Marcel Peter ; Seifer, Gustavo ; Strasser, Daniel Stefan ; Berkani, Ouali ; Cornelisse, Peter ; Brazauskas, Pijus

BACKGROUND:

Systemic lupus erythematosus (SLE) is a complex autoimmune disease characterised by autoreactive T and B lymphocytes. Sphingosine-1- phosphate (S1P) is involved in lymphocyte egress from peripheral lymphoid organs into the circulation. In phase 2a clinical trial, the potent, selective S1P₁ receptor modulator cenerimod reduced circulating antibody-secreting cells and interferon (IFN)-associated biomarkers.

OBJECTIVES:

Pharmacodynamic effects of 2 and 4 mg cenerimod were evaluated in the phase 2b clinical trial (CARE) in moderate to severe patients with SLE (NCT03742037).

METHODS:

Blood samples were collected at baseline and after 6 months of treatment with cenerimod or placebo from CARE. The gene expression signatures for type 1 interferon (IFN-1), IFN-γ and plasma cells were used to assess dose-dependent pharmacodynamic effects of cenerimod. Cell-type deconvolution was performed to estimate cell abundance.

RESULTS:

Cenerimod 4 mg reduced IFN-associated protein and gene signature biomarkers after 6 months compared with placebo. A larger decrease of IFN proteins was evident in IFN-1 high patients compared with IFN-1 low patients. The median IFN-1 score in the IFN-1 high patients was reduced after 6 months of cenerimod 4 mg and the transition from IFN-1 low to high status compared with placebo was prevented. Cenerimod 4 mg exhibited a larger effect size on the pharmacodynamic biomarkers IFN-1, IFN-γ and plasma cells compared with cenerimod 2 mg.

CONCLUSIONS:

This study further characterised the mechanism of action of cenerimod in patients with SLE and substantiated the scientific rationale for cenerimod 4 mg in the phase 3 clinical trials in moderate to severe SLE (OPUS-1/-2).

2025-01-01·Lancet Rheumatology

Cenerimod, a sphingosine-1-phosphate receptor modulator, versus placebo in patients with moderate-to-severe systemic lupus erythematosus (CARE): an international, double-blind, randomised, placebo-controlled, phase 2 trial

Article

作者: Trokan, Luba ; Cahuzac, Clélia ; Merrill, Joan T ; Murphy, Mark J ; Kalunian, Kenneth ; Berkani, Ouali ; Askanase, Anca D ; Navarra, Sandra V ; D'Cruz, David ; Cornelisse, Peter ; Strasser, Daniel S

BACKGROUND:

Sphingosine-1-phosphate (S1P) is a signalling molecule that has an inhibitory role in atherosclerosis, inflammation, cell proliferation, and immunity. Cenerimod is a selective S1P₁ receptor modulator under investigation for the treatment of systemic lupus erythematosus (SLE). We aimed to determine the efficacy, safety, and tolerability of four doses of cenerimod in adults with moderate-to-severe SLE receiving standard of care background therapy.

METHODS:

CARE was a double-blind, randomised, placebo-controlled, phase 2 trial, in adults (aged 18-75 years) with moderate-to-severe SLE (a score of at least 6 out of 105 on the SLE disease activity index-2000, modified to exclude leukopenia [mSLEDAI-2K] score). Participants were recruited from 189 hospitals, specialist centres, and outpatient clinics in 22 countries in Asia Pacific, Latin America, Europe, and the USA. Participants were randomly assigned (1:1:1:1:1), using an interactive response technology via balanced block randomisation (block size of 5) and stratified by oral glucocorticoid dose at randomisation and disease activity at screening, to once-daily oral cenerimod at 0·5 mg, 1·0 mg, 2·0 mg, or 4·0 mg or placebo, in addition to stable background SLE therapy, and followed up for 12 months. After 6 months, participants assigned to cenerimod 4·0 mg were randomly assigned again (1:1) to either cenerimod 2.0 mg or placebo for a further 6 months. The primary endpoint was change from baseline to month 6 in mSLEDAI-2K score, assessed in all participants randomly assigned to treatment (full analysis set). To meet the primary endpoint, the doses had to show a significant improvement over placebo, when adjusting for multiplicity, considering the hierarchical testing strategy, per a prespecified plan. Safety analyses included all participants who received at least one dose of study treatment. This study is registered with ClinicalTrials.gov, NCT03742037, and is complete.

FINDINGS:

Between Dec 21, 2018, and Aug 25, 2022, 810 patients were screened and 427 were randomly assigned to 0·5 mg (n=85), 1·0 mg (n=85), 2·0 mg (n=86), and 4·0 mg (n=85) cenerimod or placebo (n=86). Median age was 42 years (IQR 33-51), 406 (95%) of 427 participants were women, 21 (5%) were men, and 337 (79%) were White. At month 6, the least squares mean change from baseline in mSLEDAI-2K score was -2·85 (95% CI -3·60 to -2·10) for the placebo group and -3·24 (-3·98 to -2·49; difference vs placebo -0·39 [95% CI -1·45 to 0·68]; p=0·47) for the cenerimod 0·5 mg group, -3·41 (-4·16 to -2·67; difference vs placebo -0·57 [-1·62 to 0·49]; p=0·29) for the 1·0 mg group, -2·84 (-3·58 to -2·09; difference vs placebo 0·01 [-1·05 to 1·08]; p=0·98) for the 2·0 mg group, and -4·04 (-4·79 to -3·28; difference vs placebo -1·19 [-2·25 to -0·12]; p=0·029) for the 4·0 mg group; hence, the primary endpoint was not met. Treatment-emergent adverse events up to 12 months had no clear treatment-related or dose-related pattern across the groups. At month 6, treatment-emergent lymphopenia was reported in one (1%) of 85 patients who received cenerimod 0·5 mg, five (6%) of 85 patients who received 1·0 mg, nine (10%) of 86 patients who received 2·0 mg, 12 (14%) of 84 patients who received 4·0 mg, and no patients who received placebo. Two deaths due to adverse events occurred (both in the cenerimod 1·0 mg group; one due to acute coronary syndrome and the other due to upper gastrointestinal haemorrhage), and were determined to be unrelated to study treatment.

INTERPRETATION:

The primary endpoint was not met. Cenerimod was well tolerated over 12 months. Cenerimod 4·0 mg is being investigated for the treatment of SLE in two ongoing phase 3 trials (NCT05648500, NCT05672576).

FUNDING:

Idorsia Pharmaceuticals.

2024-12-03·Cureus Journal of Medical Science

Evolving Treatment Strategies for Systemic Lupus Erythematosus in Clinical Practice: A Narrative Review

Review

作者: Upshaw, William C ; Varrassi, Giustino ; Burroughs, Caroline R ; Mosieri, Chizoba N ; Tassin, Joseph P ; Patel, Chandni R ; Shekoohi, Sahar ; Bembenick, Kristin Nicole ; Kaye, Alan D ; Kaye, Adam M ; Ahmadzadeh, Shahab ; Hawkins, Alison M

Systemic lupus erythematosus (SLE) is an autoimmune disease that more commonly affects African American people, although it is seen in people of all racial backgrounds. This condition is characterized by a dysregulated immune response resulting in widespread inflammation. Clinical manifestations caused by this inflammation include arthritis, anemia, cutaneous rashes, pleuritis, and nephritis. Treatment for SLE aims to reduce disease activity and maintain a state of low inflammation. In this regard, numerous treatments are used, such as hydroxychloroquine, glucocorticoids, and non-glucocorticoid immunosuppressants such as methotrexate. Related to these drugs resulting in significant adverse effects and being ineffective in controlling SLE symptoms in some patients, new biologic agents have been created in hopes of better treating SLE. This includes belimumab and anifrolumab, monoclonal antibodies directed against the cytokine, and type 1 interferon receptor, respectively. These agents are indicated in patients with SLE whose symptoms are inadequately controlled by standard therapy alone. Clinical trials have shown that these agents effectively reduce SLE symptoms as judged using standardized metrics of disease activity. These biological agents have also been shown to have generally mild side effects when taken by patients with SLE, making them safe for use. In addition to the above medications, new treatments are being developed for SLE patients, such as cenerimod, litifilimab, chimeric antigen receptor T cells, and DS-7011a (anti-toll-like receptor 7 monoclonal antibody). These new treatments have shown promise in clinical trials. However, more information regarding their safety and efficacy is needed before they are available for the treatment of SLE.

项与 Cenerimod 相关的新闻（医药）

2026-04-05

·信狐药迅

佛山瑞迪奥RDC及其冷药盒、珠海润都去甲乌药碱获批上市| 新获批(3.30-4.5）

每周药品注册获批数据，分门别类呈现，一目了然。(3.30-4.5）新药上市申请药品名称企业注册分类受理号锝[99mTc]肼基烟酰胺聚乙二醇双环RGD肽注射液佛山瑞迪奥医药有限公司 1 CXHS2500065 注射用甲苯磺酸钠烟酰胺腙聚乙二醇双环RGD肽佛山瑞迪奥医药有限公司 1 CXHS2500064 盐酸去甲乌药碱注射液珠海润都制药股份有限公司 1 CXHS2400019 注射用重组巴曲酶上海腾瑞制药股份有限公司 1 CXSS2500050 注射用重组人透明质酸酶上海宝济药业股份有限公司 2.4 CXSS2400095 新药临床申请药品名称企业注册分类受理号 YKYY018雾化吸入剂北京悦康科创医药科技股份有限公司 1 CXHL2600254 YKYY018雾化吸入剂北京悦康科创医药科技股份有限公司 1 CXHL2600252 ICP-054片北京诺诚健华医药科技有限公司 1 CXHL2600251 ICP-054片北京诺诚健华医药科技有限公司 1 CXHL2600250 ICP-054片北京诺诚健华医药科技有限公司 1 CXHL2600249 AHB-171注射液杭州浩博医药有限公司 1 CXHL2600240 ACC085注射液江苏艾迪药业集团股份有限公司 1 CXHL2600114 D-2570片益方生物科技(上海)股份有限公司 1 CXHL2600111 KBD104409片康百达(四川)生物医药科技有限公司 1 CXHL2600093 KBD104409片康百达(四川)生物医药科技有限公司 1 CXHL2600092 RFUS-1646片宜昌人福药业有限责任公司 1 CXHL2600097 RFUS-1646片宜昌人福药业有限责任公司 1 CXHL2600096 ABA001注射液北京阳光诺和药物研究股份有限公司 1 CXHL2600091 LY4268989片礼来苏州制药有限公司 1 CXHL2600088 LY4268989片礼来苏州制药有限公司 1 CXHL2600087 BSA204注射液倍臻生物技术(苏州)有限公司 1 CXHL2600071 盐酸左沙丁胺醇异丙托溴铵吸入溶液济南景笙科技有限公司 2.1 CXHL2600094 布南色林口崩片力品药业(厦门)股份有限公司 2.2 CXHL2600086 ZYG24004 江苏知原药业股份有限公司 2.2;2.4 CXHL2600085 ZYG24004 江苏知原药业股份有限公司 2.2;2.4 CXHL2600084 泽布替尼胶囊百济神州(苏州)生物科技有限公司 2.4 CXHL2600102 MI226注射液南京迈诺威医药科技有限公司 2.4 CXHL2600077 MI226注射液南京迈诺威医药科技有限公司 2.4 CXHL2600076 MI226注射液南京迈诺威医药科技有限公司 2.4 CXHL2600075 注射用RC288 荣昌生物制药(烟台)股份有限公司 1 CXSL2600288 注射用BG-C0979 广州百济神州生物制药有限公司 1 CXSL2600291 GenSci161注射液长春金赛药业有限责任公司 1 CXSL2600283 GenSci161注射液长春金赛药业有限责任公司 1 CXSL2600282 CRPA1A2注射液北京可瑞生物科技有限公司 1 CXSL2600286 INB301注射液云南白药集团股份有限公司 1 CXSL2600238 注射用BAT8008 百奥泰生物制药股份有限公司 1 CXSL2600116 注射用SSGJ-612 沈阳三生制药有限责任公司 1 CXSL2600105 LPJT-026 注射液乐普健糖药业(重庆)有限公司 1 CXSL2600110 LPJT-026 注射液乐普健糖药业(重庆)有限公司 1 CXSL2600109 TST001注射液苏州创胜医药集团有限公司 1 CXSL2600103 SCTB41注射液神州细胞工程有限公司 1 CXSL2600099 注射用BR113 杭州博之锐生物制药有限公司 1 CXSL2600108 SHR-2173注射液广东恒瑞医药有限公司 1 CXSL2600098 HLXTE-HAase02重组人透明质酸酶注射液复星汉霖(成都)生物技术有限公司 1 CXSL2600095 注射用QLS5132 齐鲁制药有限公司 1 CXSL2600093 注射用BL-B01D1 成都百利多特生物药业有限责任公司 1 CXSL2600091 注射用RGL-236 上海瑞宏迪医药有限公司 1 CXSL2600012 DSL201注射液苏州星核迪赛生物技术有限公司 1 CXSL2501184 人脐带间充质基质细胞注射液京东方再生医学科技有限公司 1 CXSL2501180 SND002细胞注射液贵州生诺生物科技有限公司 1 CXSL2501177 KN5501细胞注射液深圳恩瑞恺诺生物技术有限公司 1 CXSL2501183 KN5501细胞注射液深圳恩瑞恺诺生物技术有限公司 1 CXSL2501181 KN5501细胞注射液深圳恩瑞恺诺生物技术有限公司 1 CXSL2501182 帕博利珠单抗注射液百奥泰生物制药股份有限公司 2.2 CXSL2600114 恩朗苏拜单抗注射液石药集团巨石生物制药有限公司 2.2 CXSL2600097 QL2107注射液齐鲁制药有限公司 2.2 CXSL2600092 仿制药申请药品名称企业注册分类受理号舒林酸片福安药业集团庆余堂制药有限公司 3 CYHS2404001 舒林酸片福安药业集团庆余堂制药有限公司 3 CYHS2404000 盐酸溴己新口服溶液江苏开元药业有限公司 3 CYHS2403730 氯化钾口服溶液江西博泰药业有限公司 3 CYHS2403332 盐酸氯普鲁卡因注射液成都欣捷高新技术开发股份有限公司 3 CYHS2403257 盐酸氯普鲁卡因注射液成都欣捷高新技术开发股份有限公司 3 CYHS2403256 枸橼酸芬太尼口腔贴片宜昌人福药业有限责任公司 3 CYHS2403172 枸橼酸芬太尼口腔贴片宜昌人福药业有限责任公司 3 CYHS2403171 枸橼酸芬太尼口腔贴片宜昌人福药业有限责任公司 3 CYHS2403170 枸橼酸芬太尼口腔贴片宜昌人福药业有限责任公司 3 CYHS2403169 枸橼酸芬太尼口腔贴片宜昌人福药业有限责任公司 3 CYHS2403168 枸橼酸芬太尼口腔贴片宜昌人福药业有限责任公司 3 CYHS2403167 注射用硫酸多黏菌素B 齐鲁制药(海南)有限公司 3 CYHS2403113 盐酸左沙丁胺醇雾化吸入溶液江苏万高药业股份有限公司 3 CYHS2403064 硫代硫酸钠注射液海南倍康医药科技有限公司 3 CYHS2403037 舒林酸片成都通德药业有限公司 3 CYHS2402986 卡络磺钠片仁合益康集团有限公司 3 CYHS2402929 卡络磺钠片仁合益康集团有限公司 3 CYHS2402928 氯化钾注射液绪必迪药业(河北)有限公司 3 CYHS2402622 对乙酰氨基酚片江苏贝佳制药有限公司 3 CYHS2402290 舒必利注射液华夏生生药业(北京)有限公司 3 CYHS2401964 吡格列酮二甲双胍片浙江易泽达医药科技有限公司 3 CYHS2401882 钠钾镁钙注射用浓溶液北京民康百草医药科技有限公司 3 CYHS2401763 注射用吲哚菁绿海南紫程众投生物科技有限公司 3 CYHS2401375 盐酸甲氧氯普胺注射液北京柏雅联合药物研究所有限公司 3 CYHS2401169 米诺地尔搽剂乐信乐美(海南)生物科技有限公司 3 CYHS2302972 氧(液态) 玉得气体有限责任公司 4 CYHS2501861 硫酸氨基葡萄糖胶囊西洲医药科技(浙江)有限公司 4 CYHS2404645 吸入用乙酰半胱氨酸溶液山西普恒制药有限公司 4 CYHS2404284 达格列净二甲双胍缓释片(I) 江苏德源药业股份有限公司 4 CYHS2404249 他达拉非片四川新斯顿制药股份有限公司 4 CYHS2404199 他达拉非片四川新斯顿制药股份有限公司 4 CYHS2404198 硫酸氨基葡萄糖胶囊海南海力制药有限公司 4 CYHS2404102 硫酸镁钠钾口服用浓溶液江西博泰药业有限公司 4 CYHS2404063 氨甲环酸片石家庄四药有限公司 4 CYHS2404049 马来酸氟伏沙明片安徽正善生物药业有限公司 4 CYHS2403968 培哚普利氨氯地平片(III) 海南皇隆制药股份有限公司 4 CYHS2403963 硫酸氨基葡萄糖胶囊浙江领创优品药业有限公司 4 CYHS2403946 乙酰半胱氨酸颗粒海南广升誉制药有限公司 4 CYHS2403913 乙酰半胱氨酸颗粒海南广升誉制药有限公司 4 CYHS2403912 硫酸特布他林雾化吸入用溶液湖南醇健制药科技有限公司 4 CYHS2403895 比索洛尔氨氯地平片宁波科尔康美诺华药业有限公司 4 CYHS2403884 盐酸莫西沙星片辰欣药业股份有限公司 4 CYHS2403827 非奈利酮片山东朗诺制药有限公司 4 CYHS2403673 非奈利酮片山东朗诺制药有限公司 4 CYHS2403672 盐酸特比萘芬喷雾剂辽宁新高制药有限公司 4 CYHS2403640 艾拉莫德片北京福元医药股份有限公司 4 CYHS2403598 吸入用乙酰半胱氨酸溶液四川美大康华康药业有限公司 4 CYHS2403564 苯磺酸阿曲库铵注射液华夏生生药业(北京)有限公司 4 CYHS2403552 缬沙坦氢氯噻嗪片深圳奥萨制药有限公司 4 CYHS2403509 注射用伏立康唑悦康药业集团股份有限公司 4 CYHS2403514 结构脂肪乳注射液(C6-24) 广东嘉博制药有限公司 4 CYHS2403472 盐酸奥洛他定滴眼液长春迪瑞制药有限公司 4 CYHS2403439 盐酸奥洛他定滴眼液长春迪瑞制药有限公司 4 CYHS2403438 硫酸镁钠钾口服用浓溶液天津恒翊药业有限公司 4 CYHS2403422 西格列汀二甲双胍片(Ⅱ) 甘李药业山东有限公司 4 CYHS2403373 聚乙烯醇滴眼液海南斯达制药有限公司 4 CYHS2403312 注射用醋酸西曲瑞克武汉人福利康药业有限公司 4 CYHS2403238 替米沙坦氨氯地平片(II) 杭州康恩贝制药有限公司 4 CYHS2403197 依达拉奉氯化钠注射液安徽誉恒生物科技有限公司 4 CYHS2403195 他克莫司软膏浙江众延医药科技有限公司 4 CYHS2403207 他克莫司软膏浙江众延医药科技有限公司 4 CYHS2403206 帕拉米韦氯化钠注射液南京恒道医药科技股份有限公司 4 CYHS2403038 乳果糖口服溶液西洲医药科技(浙江)有限公司 4 CYHS2402971 盐酸尼卡地平注射液扬州中宝药业股份有限公司 4 CYHS2402947 他达拉非片贵州瑞和制药有限公司 4 CYHS2402924 他达拉非片贵州瑞和制药有限公司 4 CYHS2402923 布洛芬混悬液石家庄凯达生物工程有限公司 4 CYHS2402917 盐酸奥洛他定滴眼液呋欧医药科技(湖州)有限公司 4 CYHS2402800 二十碳五烯酸乙酯软胶囊江苏万高药业股份有限公司 4 CYHS2402773 注射用头孢哌酮钠舒巴坦钠海南全星制药有限公司 4 CYHS2402471 丁二磺酸腺苷蛋氨酸肠溶片北京福元医药股份有限公司 4 CYHS2402422 酒石酸溴莫尼定滴眼液沈阳兴齐眼药股份有限公司 4 CYHS2402421 左卡尼汀注射液国药一心制药有限公司 4 CYHS2402333 左卡尼汀注射液国药一心制药有限公司 4 CYHS2402332 酒石酸西尼必利片浙江远力健药业有限责任公司 4 CYHS2402264 他达拉非片迪沙药业集团有限公司 4 CYHS2401871 他达拉非片迪沙药业集团有限公司 4 CYHS2401870 美沙拉秦肠溶片浙江华海药业股份有限公司 4 CYHS2400127 马昔腾坦片山东华铂凯盛生物科技有限公司 4 CYHS2303558 米拉贝隆缓释片广东东阳光药业股份有限公司 4 CYHS2200741国;CYHS2200741 米拉贝隆缓释片广东东阳光药业股份有限公司 4 CYHS2200740国;CYHS2200740 吸附破伤风疫苗北京民海生物科技有限公司 3.3 CXSS2500049 注射用乳糖酸克拉霉素上海博志研新药物研究有限公司 3 CYHL2600012 阿普昔腾坦片石药集团中诺药业(石家庄)有限公司 3 CYHL2600013 抗D人免疫球蛋白新疆德源生物工程有限公司 3.2 CXSL2600013 帕妥珠曲妥珠单抗注射液(皮下注射) 复星汉霖(成都)生物技术有限公司 3.3 CXSL2600101 帕妥珠曲妥珠单抗注射液(皮下注射) 复星汉霖(成都)生物技术有限公司 3.3 CXSL2600100 进口申请药品名称企业注册分类受理号德莫奇单抗注射液 GlaxoSmithKline Trading Services Limited 1 JXSS2500002 德莫奇单抗注射液 GlaxoSmithKline Trading Services Limited 1 JXSS2500001 洛匹那韦利托那韦片 Hetero Labs limited 5.2 JYHS2300031 洛匹那韦利托那韦片 Hetero Labs limited 5.2 JYHS2300030 BMS-986458片 Bristol-Myers Squibb Company 1 JXHL2600077 BMS-986458片 Bristol-Myers Squibb Company 1 JXHL2600076 HTT227片 Novartis Pharma AG 1 JXHL2600027 AZD3470薄膜衣片 Astrazeneca AB 1 JXHL2600023 AZD3470薄膜衣片 Astrazeneca AB 1 JXHL2600022 AZD3470薄膜衣片 Astrazeneca AB 1 JXHL2600021 AZD3470薄膜衣片 Astrazeneca AB 1 JXHL2600020 Cenerimod片 Viatris Innovation GmbH 1 JXHL2600024 Enpatoran Merck Healthcare KGaA 1 JXHL2600015 RO7771950肠溶片 F. Hoffmann-La Roche Ltd. 1 JXHL2600014 RO7771950片 F. Hoffmann-La Roche Ltd. 1 JXHL2600013 BI764198 片 Boehringer Ingelheim International GmbH 1 JXHL2600016 JNJ-88549968注射液 Janssen Research & Development, LLC 1 JXSL2600059 Cevostamab F.Hoffmann-La Roche Ltd. 1 JXSL2600022 Cevostamab F.Hoffmann-La Roche Ltd. 1 JXSL2600021 PF-08634404 Pfizer Inc. 1 JXSL2600019 PF-08634404 Pfizer Inc. 1 JXSL2600018 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600017 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600016 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600015 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600014 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600013 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600012 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600011 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600010 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600009 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600008 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600007 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600006 IMGN151注射液 AbbVie Inc. 1 JXSL2600020 FXB0871 Fosun Industrial Co., Limited 1 JXSL2600005 Budoprutug注射液 Climb Bio, Inc. 1 JXSL2600004 中药相关申请药品名称企业注册分类受理号丹元糖痹软膏杏林中医药科技(广州)有限公司 1.1 CXZL2600012 十味安神颗粒河北平安健康集团股份有限公司 1.1 CXZL2600011 固表通窍颗粒九华华源药业股份有限公司 1.1 CXZL2600004 注：橙色字体部分结论为不批准或收到通知件；

上市批准临床申请

2026-04-02

·谈医说药

2026年04月02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 CXHB2600020 TQ-A3334 片正大天晴药业集团股份有限公司拟用于治疗慢性乙型肝炎。 1 2 JXSB2600016 Ziltivekimab 注射液 Novo Nordisk A/S 拟定用于治疗左室射血分数＞40%且hs-CPR≥2mg/L的成人症状性慢性心力衰竭。 1 3 CXHL2600111 D-2570片益方生物科技（上海）股份有限公司本品拟用于白癜风的治疗。 1 4 CXSL2600116 注射用BAT8008 百奥泰生物制药股份有限公司拟联合BAT3306用于治疗晚期实体瘤 1 5 CXSL2600114 帕博利珠单抗注射液百奥泰生物制药股份有限公司本品拟联合注射用BAT8008用于治疗晚期实体瘤患者。 2.2 6 CXSL2600110 LPJT-026 注射液乐普健糖药业（重庆）有限公司用于治疗成人2型糖尿病。 1 7 CXSL2600109 LPJT-026 注射液乐普健糖药业（重庆）有限公司用于治疗成人2型糖尿病。 1 8 JXHL2600024 Cenerimod片 Viatris Innovation GmbH 用于治疗系统性红斑狼疮合并活动性狼疮肾炎成人患者。 1 9 CXHL2600091 ABA001注射液北京阳光诺和药物研究股份有限公司;北京阿尔纳科技有限公司;北京安龙生物医药有限公司高血压 1 10 CXSL2600098 SHR-2173注射液广东恒瑞医药有限公司全身型重症肌无力 1 11 CXSB2600011 GC012F注射液苏州亘喜生物科技有限公司;亘喜生物科技（上海）有限公司适应症1：复发难治性多发性骨髓瘤；适应症2：复发或难治性 B 细胞非霍奇金淋巴瘤；适应症3：难治性系统性红斑狼疮；适应症4：复发或难治性轻链型淀粉样变性 1

临床研究

2026-03-23

·PRNewswire

Viatris Advances Innovative Portfolio with Approval of Effexor® in Japan for Adults with Generalized Anxiety Disorder (GAD)

Addresses a Significant Unmet Need in Japan as First and Only Approved Treatment Option for GAD PITTSBURGH, March 23, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Effexor® SR 37.5 mg / 75 mg capsules (venlafaxine hydrochloride), a serotonin-noradrenaline reuptake inhibitor (SNRI), for the treatment of adults with generalized anxiety disorder (GAD). Following the MHLW's decision, Effexor® becomes the first and only approved treatment option in Japan for adults living with GAD, addressing a long-standing unmet medical need in mental health and enabling new access to care. Effexor® is currently approved in Japan for the indication of major depressive disorder in adults, and with this approval, is now available to patients with GAD. GAD is among the most prevalent and highly disabling mental health conditions, negatively impacting patients' quality of life and disrupting activities of daily living. A recent study reported the prevalence of probable GAD in Japan as 7.6% of the general population.1 "The approval of Effexor® in Japan for generalized anxiety disorder demonstrates the successful execution of our strategy to advance a differentiated and increasingly innovative portfolio in Japan, bringing forward value-added therapies that address a significant unmet need," said Philippe Martin, Viatris Chief R&D Officer. "This approval also reflects our ability to effectively implement an optimized lifecycle strategy for our established brands and to leverage our deep local expertise." "This approval marks the introduction of a new treatment option for adults in Japan living with GAD," said Corinne Le Goff, Viatris Chief Commercial Officer. "We look forward to leveraging our strong infrastructure and deep expertise in central nervous system therapies in Japan to bring access to this much needed treatment to patients." The approval of Effexor® for GAD is based on a Phase 3 placebo-controlled, randomized, double-blind, multicenter study of venlafaxine in patients with GAD conducted in Japan (Study B2411367), which achieved its primary objective of superiority of anxiolytic effects of venlafaxine compared to placebo at 8 weeks, based on the change in the Hamilton Anxiety Rating Scale (HAM-A) total score from baseline (two-sided p-value=0.012). All seven secondary efficacy endpoints as defined by the trial protocol were met. Effexor® was generally well tolerated with a profile consistent with its known safety profile in non-Japanese patients. In particular: Low discontinuation rates due to treatment emergent adverse events (TEAEs) were seen (7.3% vs 1.7% in placebo) with 3.9% vs 0.6% assessed as related to treatment. No serious TEAEs or TEAEs with severe intensity were observed (0% vs 1.1% and 0.6%, respectively, in placebo). These results and the results of a long-term extension study of venlafaxine in Japanese outpatients with GAD were included as part of the applications for approval. Effexor® is currently approved to treat GAD in more than 80 countries outside of Japan. About Generalized Anxiety Disorder (GAD) Generalized Anxiety Disorder (GAD) is a mental health disorder whose central symptom is chronic and uncontrollable "anxiety" or "worry" about everyday life events or activities. Other symptoms include difficulty to get enough sleep, muscle tension/stiffness, feeling restless, irritable, or finding it difficult to concentrate, which may cause impairment in social, occupational, or other areas of functioning. In Japan, the World Health Organization reports that 2.6% of the population will suffer from GAD in their lifetime. A recent study in Japan reported the prevalence of probable GAD is 7.6%1, suggesting that this condition may be significantly underdiagnosed. About Viatris' Innovative Portfolio in Japan Viatris' portfolio of innovative products in Japan includes approved products such as Spydia ® Nasal Spray (diazepam) for the treatment of status epilepticus. The company's pipeline in Japan includes investigational products such as pitolisant for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea syndrome and narcolepsy, and products in pivotal Phase 3 trials which are currently ongoing, such as selatogrel in acute myocardial infarction (AMI), Nefecon in IgA nephropathy, and cenerimod in systemic lupus erythematosus (SLE). About Viatris Viatris Inc. (Nasdaq: VTRS) is a global healthcare company whose mission is to empower people worldwide to live healthier at every stage of life. We meet the needs of patients around the world by acting decisively with ingenuity and resolve. Whether we're developing new medicines, working to maintain a resilient supply of needed therapies, or pursuing bold innovation, we deliver solutions that are effective at scale and built to endure. We're purpose-built to make an impact with a dynamic portfolio that spans generics, established brands and innovative medicines that address areas of significant unmet need. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai, China, and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X. References: Matsuyama S, Otsubo T, Nomoto K, Higa S, Takashio O. Prevalence of Generalized Anxiety Disorder in Japan: A General Population Survey. Neuropsychiatr Dis Treat. 2024;20:1355-1366. Forward-Looking Statements This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements that Viatris advances innovative portfolio with approval of Effexor® in Japan for adults with GAD; addresses a significant unmet need in Japan as first and only approved treatment option for GAD; the approval of Effexor® in Japan for generalized anxiety disorder demonstrates the successful execution of our strategy to advance a differentiated and increasingly innovative portfolio in Japan, bringing forward value-added therapies that address a significant unmet need; this approval also reflects our ability to effectively implement an optimized life cycle strategy for our established brands and leverage our deep local expertise; we look forward to leveraging our strong infrastructure and deep expertise in central nervous system therapies in Japan to bring access to this much needed treatment to patients; and the outcome of clinical trials. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the uncertainties inherent in research and development, including the outcomes of clinical trials; the ability to meet anticipated clinical endpoints; the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from clinical studies; failure to achieve the intended benefits of our strategic initiatives and priorities; goodwill or impairment charges or other losses; any changes in or difficulties with the Company's manufacturing facilities; failure to achieve expected or targeted future financial and operating performance and results; Viatris' or its partners' ability to develop, manufacture, and commercialize products; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; products in development and/or that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; any significant breach of data security or data privacy or disruptions to our IT systems; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ("SEC"). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law. SOURCE Viatris Inc. 21% more press release views with Request a Demo

临床结果临床3期上市批准

100 项与 Cenerimod 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D11283	-	-	DB12705

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
狼疮性肾炎	临床3期	中国	Corden Pharma GmbH	2026-01-16
狼疮性肾炎	临床3期	中国	爱多希（北京）医药有限公司	2026-01-16
狼疮性肾炎	临床3期	中国	Viatris, Inc.	2026-01-16
系统性红斑狼疮	临床3期	日本	Viatris, Inc.	2022-12-13
系统性红斑狼疮	临床3期	阿根廷	Viatris, Inc.	2022-12-13
系统性红斑狼疮	临床3期	巴西	Viatris, Inc.	2022-12-13
系统性红斑狼疮	临床3期	保加利亚	Viatris, Inc.	2022-12-13
系统性红斑狼疮	临床3期	哥伦比亚	Viatris, Inc.	2022-12-13
系统性红斑狼疮	临床3期	法国	Viatris, Inc.	2022-12-13
系统性红斑狼疮	临床3期	希腊	Viatris, Inc.	2022-12-13

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临床结果

适应症

分期

评价

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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


NCT03742037 (CARE, ACR2025)	临床2期	系统性红斑狼疮	427	Cenerimod 4 mg	構鬱築選製糧廠繭鏇鹽(選齋繭鑰觸蓋夢膚製鏇) = 艱壓願遞顧範遞憲醖網鑰蓋壓網淵淵繭觸醖範 (醖醖夢憲選鑰衊鑰廠廠 ) 更多	积极	2025-10-24
				Placebo	構鬱築選製糧廠繭鏇鹽(選齋繭鑰觸蓋夢膚製鏇) = 糧顧築範繭鬱顧繭鬱淵鑰蓋壓網淵淵繭觸醖範 (醖醖夢憲選鑰衊鑰廠廠 ) 更多
NCT03742037 (CARE, EULAR2025)	临床2期	系统性红斑狼疮	427	Cenerimod 0.5 mg	願淵範觸鏇鏇鏇獵艱積(繭廠製鏇簾憲廠鹽願糧) = 遞鬱憲鹹築膚願積鬱簾積廠齋鬱窪獵齋餘獵膚 (顧網選廠蓋鑰顧夢夢觸 )	积极	2025-06-11
				Placebo	願淵範觸鏇鏇鏇獵艱積(繭廠製鏇簾憲廠鹽願糧) = 壓繭鹹願繭艱膚製願窪積廠齋鬱窪獵齋餘獵膚 (顧網選廠蓋鑰顧夢夢觸 )
NCT03742037 (CARE, EULAR2023)	临床2期	IFN-1 gene expression signature \| anti-dsDNA antibody levels	427	Cenerimod 4 mg	齋鹹廠鏇簾構製製願觸(鬱壓範鏇蓋構積齋製窪) = 繭餘願醖獵選壓廠願顧糧選壓壓獵窪憲夢構鹹 (淵選艱醖網衊製選觸齋 ) 更多	积极	2023-05-31
				Placebo	齋鹹廠鏇簾構製製願觸(鬱壓範鏇蓋構積齋製窪) = 顧積簾鹽憲窪鹽餘膚簾糧選壓壓獵窪憲夢構鹹 (淵選艱醖網衊製選觸齋 ) 更多
NCT03742037 (ACR2022) 人工标引	临床2期	系统性红斑狼疮	427	Cenerimod	簾築鑰網構觸蓋鹹鹽鬱(窪廠糧壓憲積餘醖鏇淵) = AEs were similar across treatment groups. The % of reported hypertension AEs was higher in the cenerimod 1 and 4 mg groups vs PBO 獵鬱顧積糧簾廠壓遞壓 (齋範憲襯積廠願糧遞積 )	-	2022-09-12
NCT02472795 (CTgov)	临床1/2期	系统性红斑狼疮	105	Cenerimod (Cenerimod 0.5 mg (Part A))	積夢醖獵顧構艱淵觸鹽(網淵簾鹽顧築構憲繭壓) = 鹽網獵獵觸憲廠衊遞築築廠願願衊網製構鏇鑰 (願積鹹遞積廠構觸鑰簾, 0.48) 更多	-	2020-02-26
				Cenerimod (Cenerimod 1 mg (Part A))	積夢醖獵顧構艱淵觸鹽(網淵簾鹽顧築構憲繭壓) = 夢醖艱夢獵淵艱積齋壓築廠願願衊網製構鏇鑰 (願積鹹遞積廠構觸鑰簾, 0.68) 更多
NCT02472795 (Pubmed \| Lupus Sci Med)	临床1/2期	系统性红斑狼疮	105	Cenerimod 0.5 mg	窪製範網選衊繭淵積網(繭衊鑰齋廠願壓壓築鬱) = 襯繭鏇鹹鬱製遞淵衊觸艱遞簾鹽製鏇顧觸鹽繭 (襯願繭糧遞鏇膚蓋構構 )	积极	2019-01-01
				Cenerimod 1 mg	窪製範網選衊繭淵積網(繭衊鑰齋廠願壓壓築鬱) = 獵遞廠齋製蓋遞繭淵艱艱遞簾鹽製鏇顧觸鹽繭 (襯願繭糧遞鏇膚蓋構構 )