PALETTE- Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Bayesian Basket Trial"

PALETTE is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. Treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. PALETTE Bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. PALETTE's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pandemic context.

开始日期2026-04-01

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

NCT07028385

/ Not yet recruiting临床2期IIT

Exploratory Phase 2 Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Impact on HIV-1 Reservoir of Baricitinib in Virologically Suppressed People With HIV-1

The goal of this exploratory clinical trial is to evaluate the safety and tolerability of bariticinib administered at 2 mg once daily during 12 weeks in 30 people living with HIV-1 (PWH) on suppressive antiretroviral therapy (ART) and to evaluate changes in levels of phosphorylated STAT (pSTAT) after 12 weeks of treatment with bariticinib. The main questions it aims to answer are:
* The safety and tolerability of bariticinib
* To evaluate the effects of bariticinib on T-cells (HIV-1 reservoirs, apoptosis, inflamation, activation and exhaustion).
* To characterize bariticinib pharmacokinetics in plasma.
Participants will be treated with pral Barticinib 2mg or matched Placebo daily for 12 weeks. Suppressive cART will remain unchanged during the entire study. Participants will be followed until week 24, in a total of 8 visits.

开始日期2025-09-01

申办/合作机构

University of Turin

[+3]

NCT06923072

/ Recruiting临床2期IIT

A Phase IIa Trial of Baricitinib in the Treatment of Kohlmeier-Degos Disease Patients With Neurological Involvement

Background:
Kohlmeier-Degos (KD) is a rare disease that causes inflammation and blood clots, leading to blockages in small blood vessels. These blockages can result in K-D lesions throughout the body, affecting the skin, lungs, heart, spinal cord, and brain. KD can be fatal. No treatment exists for this disease.
Objective:
To test a study drug (baricitinib) in people with brain and spine lesions caused by KD disease. Baricitinib is FDA approved to treat other disorders but has not yet been tried in people with KD.
Eligibility:
People aged 18 years or older with KD-related lesions in the brain and spine.
Design:
Participants will be screened; they will have a physical exam with blood tests. They will also have a baseline visit that may include multiple tests, such as imaging scans of the brain and spine; a lumbar puncture to collect fluid from the spinal canal; and a meeting with a neurologist. They will fill out a questionnaire about their health. They will continue to take their normal medications throughout the study.
Baricitinib is a tablet taken by mouth. Participants will remain on their normal medications for 12 weeks after their baseline visit. Then they will also take the study drug once a day at home for 24 weeks.
Participants will have clinic visits every few weeks for up to 40 weeks. Some visits may take 1 to 4 days. Baseline tests will be repeated 3 more times during study visits. Other visits will require only blood tests; these may be done by local labs that will send the samples to NIH; 2 visits may be done via telehealth....

开始日期2025-07-16

申办/合作机构

National Heart, Lung & Blood Institute

100 项与巴瑞替尼相关的临床结果

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100 项与巴瑞替尼相关的转化医学

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100 项与巴瑞替尼相关的专利（医药）

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3,678

项与巴瑞替尼相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Risk of serious infection with JAK inhibitors in immune-mediated inflammatory skin diseases: a meta-analysis of randomized clinical trials

Review

作者: Lv, Xiaoqing ; Ji, Chao ; Mao, Jing ; Qin, Kun ; Ou, Yushan ; Ruan, Shifan ; Su, Xinhong

BACKGROUND:

Emerging research suggests that Janus kinase-signal transducer and activator of transcription (JAK-STAT) inhibitors may be associated with a higher risk of serious infection for patients with rheumatoid arthritis. However, there is no consensus on whether JAK inhibitors increase the risk of serious infection in patients with Immune-mediated inflammatory skin diseases (IMISDs).

OBJECTIVES:

To ascertain the correlation between JAK inhibitor use and the risk of serious infection in patients with IMISDs.

METHODS:

PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and registered Clinical Trials were searched up to June 1, 2024, using specific search terms related to JAK inhibitors and IMISDs. Randomized clinical trials (RCTs) comparing JAK inhibitors with a control group in patients with IMISDs were included. Studies focusing on cohort studies, case reports, case series, review articles, pooled analysis studies, post hoc analyses and topical JAK inhibitors were excluded. Data were extracted independently by two authors, focusing on serious infections defined according to each study's criteria. Crude numbers for serious infections were pooled and underwent meta-analysis. We assessed the primary outcome regarding the occurrence of severe infections for each study.

RESULTS:

Thirty-two randomized clinical trials involving 11,917 patients were included. Serious infections were reported in 0.62% of patients receiving JAK inhibitors and 0.51% of controls. Meta-analysis found no significant increase in risk of serious infection (I²=0.00%, RR, 0.68; 95% CI, 0.43-1.07). Subgroup analyses revealed no significant heterogeneity based on condition (p = .56) or medication (p = .69).

CONCLUSIONS:

This meta-analysis demonstrates that JAK inhibitors do not significantly increase the risk of serious infections in IMISD patients compared to control treatments. These findings support the safety of JAK inhibitors in this population. Future research should focus on real-world evidence to further assess their risk-benefit profile in dermatological practice.

2025-12-01·JOURNAL OF CLINICAL IMMUNOLOGY

Baricitinib-Induced Remission of Alopecia Universalis in a Child with NFKB2-Associated Immune Dysregulation

Letter

作者: Flinn, A M ; Browne, F ; Blokhuis, C ; Irvine, A D ; Leahy, T R

2025-12-01·Current Hematologic Malignancy Reports

Emerging Therapeutic Approaches for Anemia in Myelofibrosis

Review

作者: Harrington, Patrick ; Palumbo, Giuseppe A ; Chifotides, Helen T ; Duminuco, Andrea ; Bose, Prithviraj ; Torre, Elena ; Vetro, Calogero

PURPOSE OF REVIEW:

In this review, we highlight conventional agents and novel emerging therapeutic strategies to treat anemia in MF.

RECENT FINDINGS:

Anemia is a common and challenging feature of myelofibrosis (MF). The pathobiology of anemia is multifactorial, including progressive bone marrow fibrosis, decreased erythropoiesis due to high hepcidin levels leading to iron sequestration in the reticuloendothelial system, hypersplenism, erythropoiesis inhibition by myelosuppressive JAK inhibitors (ruxolitinib, fedratinib), and others. MF-associated anemia has a negative impact on survival. Conventional agents to manage anemia include erythropoiesis-stimulating agents, danazol, corticosteroids, and immunomodulatory agents, but responses are infrequent and lack durability. Notable advancements have emerged in developing novel treatments for anemia in MF, including the regulatory approval of momelotinib (ACVR1/JAK1/2 inhibitor) in 2023 and development of novel promising agents targeting hemojuvelin and activins. Momelotinib and pacritinib (ACVR1/JAK2 inhibitor) are the preferred JAK inhibitors for patients with cytopenias (anemia, thrombocytopenia). Luspatercept and elritercept are activin receptor ligand traps, promoting erythroid maturation and late-stage erythropoiesis. Currently, luspatercept is being evaluated in a phase 3 trial (INDEPENDENCE™) for anemia in MF patients who are on a JAK2 inhibitor and require transfusions, and in a phase 2 trial (ODYSSEY) in combination with momelotinib in MF patients who are transfusion dependent, whether or not on a JAK inhibitor. Interim results of the RESTORE trial demonstrated that elritercept significantly decreased transfusions in MF patients. DISC-0974 is a first-in-class anti-hemojuvelin (positive hepcidin regulator) monoclonal antibody that decreased hepcidin expression, increased serum iron, and enhanced erythropoiesis in anemic patients with MF in a phase 1b/2 study. Burgeoning studies of novel anemia-targeted agents and combinations are significantly improving the quality of life and outcomes of patients with MF. The recent approval of momelotinib to treat MF with anemia and the emerging novel anemia-directed strategies in early and advanced clinical development have ushered in a new era in the treatment of MF-related anemia.

997

项与巴瑞替尼相关的新闻（医药）

2025-07-13

·信狐药迅

三个1类新药：天晴库莫西利、信诺维亚胺培南西司他丁钠福诺巴坦和先声乐德奇拜单抗提交上市申请|新受理（7.7-7.13）

本周药品注册受理数据，分门别类呈现，一目了然。(7.7-7.13）新药上市申请药品名称企业注册分类受理号库莫西利胶囊正大天晴药业集团股份有限公司1CXHS2500076库莫西利胶囊正大天晴药业集团股份有限公司1CXHS2500075注射用亚胺培南西司他丁钠福诺巴坦苏州信诺维医药科技股份有限公司1CXHS2500074多西他赛注射用浓溶液(自乳化型)北京德立英捷医药科技有限公司2.2CXHS2500079硫酸阿托品滴眼液兆科(广州)眼科药物有限公司2.2CXHS2500078氟维司群注射液正大天晴药业集团股份有限公司2.4CXHS2500077示踪用盐酸米托蒽醌注射液深圳华润九创医药有限公司2.4CXHS2500073乐德奇拜单抗注射液先声药业有限公司1CXSS2500074乐德奇拜单抗注射液先声药业有限公司1CXSS2500073注射用维迪西妥单抗荣昌生物制药(烟台)股份有限公司2.2CXSS2500072新药临床申请药品名称企业注册分类受理号IMP9064片上海瑛派药业有限公司1CXHL2500694BGB-16673片百济神州(苏州)生物科技有限公司1CXHL2500693BGB-16673片百济神州(苏州)生物科技有限公司1CXHL2500692HRS-4642注射液上海恒瑞医药有限公司1CXHL2500691HRS-7058胶囊山东盛迪医药有限公司1CXHL2500689HRS-7058胶囊山东盛迪医药有限公司1CXHL2500688HRS-7058片山东盛迪医药有限公司1CXHL2500687HRS-7058片山东盛迪医药有限公司1CXHL2500686225Ac-LNC1011注射液烟台蓝纳成生物技术股份有限公司1CXHL2500697HJ-004-02片和径医药科技(上海)有限公司1CXHL2500696HJ-004-02片和径医药科技(上海)有限公司1CXHL2500695DF-006口服溶液浙江药苑生物科技有限公司1CXHL2500690GFH375片劲方医药科技(上海)股份有限公司1CXHL2500685HRS-2329片江苏恒瑞医药股份有限公司1CXHL2500684HRS-2329片江苏恒瑞医药股份有限公司1CXHL2500683HRS-2329片江苏恒瑞医药股份有限公司1CXHL2500682CA111注射液重庆宸安生物制药有限公司1CXHL2500678CA111注射液重庆宸安生物制药有限公司1CXHL2500677BIOS-0623-Z4片杭州百诚医药科技股份有限公司1CXHL2500676BIOS-0623-Z4片杭州百诚医药科技股份有限公司1CXHL2500675LXH-1211片山东新华制药股份有限公司1CXHL2500674LXH-1211片山东新华制药股份有限公司1CXHL2500673LXH-1211片山东新华制药股份有限公司1CXHL2500672LXH-1211片山东新华制药股份有限公司1CXHL2500671SGB-3383注射液苏州圣因生物医药有限公司1CXHL2500667BGM0504片博瑞制药(苏州)有限公司1CXHL2500681BGM0504片博瑞制药(苏州)有限公司1CXHL2500680BGM0504片博瑞制药(苏州)有限公司1CXHL2500679注射用TRD208北京泰德制药股份有限公司1CXHL2500666BW-40202注射液上海舶望制药有限公司1CXHL2500668HRS-2129片山东盛迪医药有限公司1CXHL2500664HRS-2129片山东盛迪医药有限公司1CXHL2500663HRS-2129片山东盛迪医药有限公司1CXHL2500662HRS-2129片山东盛迪医药有限公司1CXHL2500661注射用HTMC0769上海壹典医药科技开发有限公司1CXHL2500660注射用HTMC0769上海壹典医药科技开发有限公司1CXHL2500659TT-00420片药捷安康(南京)科技股份有限公司1CXHL2500658TT-00420片药捷安康(南京)科技股份有限公司1CXHL2500657TT-00420 片药捷安康(南京)科技股份有限公司1CXHL2500656HRS-3095片成都盛迪医药有限公司1CXHL2500655HRS-3095片成都盛迪医药有限公司1CXHL2500654LSCCB-PtNNN注射液金铂药业(深圳)有限公司1CXHL2500653EP-0206SI成都苑东生物制药股份有限公司2.2CXHL2500670EP-0206SI成都苑东生物制药股份有限公司2.2CXHL2500669尼莫地平脂肪乳注射液江苏九旭药业有限公司2.2CXHL2500665盐酸右美托咪定微针贴剂广州新济药业科技有限公司2.2CXHL2500652盐酸右美托咪定微针贴剂广州新济药业科技有限公司2.2CXHL2500651吸附无细胞百白破b型流感嗜血杆菌联合疫苗长春百克生物科技股份公司2.2CXSL2500582人脐带间充质干细胞注射液北京葆来生物科技有限公司1CXSL2500581注射用FH-006江苏恒瑞医药股份有限公司1CXSL2500573注射用IBB0979盛禾(中国)生物制药有限公司1CXSL2500580注射用SHR-A2102苏州盛迪亚生物医药有限公司1CXSL2500583注射用SHR-A2102上海恒瑞医药有限公司1CXSL2500575SHR-1701注射液苏州盛迪亚生物医药有限公司1CXSL2500579匹康奇拜单抗注射液信达生物医药科技(杭州)有限公司1CXSL2500571匹康奇拜单抗注射液信达生物医药科技(杭州)有限公司1CXSL2500570GR2301注射液重庆智翔金泰生物制药股份有限公司1CXSL2500569注射用SHR-1802上海恒瑞医药有限公司1CXSL2500572DCTY0801注射液北京鼎成肽源生物技术有限公司1CXSL2500568VGN-R08b上海天泽云泰生物医药有限公司1CXSL2500565Astem-101人脐带间充质干细胞(hUC-MSCs)注射液上海昂昇生物医药科技有限公司1CXSL2500564VGN-R08b上海天泽云泰生物医药有限公司1CXSL2500563脐带间充质干细胞注射液山东佰鸿干细胞生物技术有限公司1CXSL2500562LBM801上海利康瑞生物工程有限公司1CXSL2500560NGGT006注射液苏州诺洁贝生物技术有限公司1CXSL2500559SHR-4298注射液苏州盛迪亚生物医药有限公司1CXSL2500558HC006注射液上海宏成药业有限公司1CXSL2500567注射用HC010上海宏成药业有限公司1CXSL2500566GR1803注射液智翔(上海)医药科技有限公司1CXSL2500553自体自然杀伤细胞注射液广州达博生物制品有限公司1CXSL2500552注射用ZGGS34苏州泽璟生物制药股份有限公司1CXSL2500561SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2500577阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500578贝伐珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2500574阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500576仿制药申请药品名称企业注册分类受理号吸入用盐酸氨溴索溶液北京韩美药品有限公司3CYHS2502485吸入用盐酸氨溴索溶液北京韩美药品有限公司3CYHS2502484西咪替丁注射液森淼(山东)药业有限公司3CYHS2502505复方聚乙二醇电解质散(II)上海朝晖药业有限公司3CYHS2502504复方电解质醋酸钠葡萄糖注射液山东化药医药科技有限公司3CYHS2502503复方电解质醋酸钠葡萄糖注射液山东化药医药科技有限公司3CYHS2502502米诺地尔搽剂科笛生物医药(无锡)有限公司3CYHS2502500米诺地尔搽剂科笛生物医药(无锡)有限公司3CYHS2502499复方电解质醋酸钠葡萄糖注射液南京正大天晴制药有限公司3CYHS2502498复方电解质醋酸钠葡萄糖注射液南京正大天晴制药有限公司3CYHS2502497碳酸氢钠林格注射液(I)南京正科医药股份有限公司3CYHS2502496米诺地尔搽剂湖北午时药业股份有限公司3CYHS2502494米诺地尔搽剂湖北午时药业股份有限公司3CYHS2502493注射用乳糖酸红霉素苏州朗科生物技术股份有限公司3CYHS2502490注射用乳糖酸红霉素苏州朗科生物技术股份有限公司3CYHS2502489盐酸西替利嗪干糖浆海南元盈医药科技有限公司3CYHS2502516注射用苯唑西林钠北京元延医药科技股份有限公司3CYHS2502475注射用苯唑西林钠北京元延医药科技股份有限公司3CYHS2502474盐酸胍法辛缓释片宜昌人福药业有限责任公司3CYHS2502473盐酸胍法辛缓释片宜昌人福药业有限责任公司3CYHS2502472盐酸胍法辛缓释片宜昌人福药业有限责任公司3CYHS2502471盐酸胍法辛缓释片宜昌人福药业有限责任公司3CYHS2502470比拉斯汀口服溶液珠海北杉生物科技有限公司3CYHS2502467利格列汀二甲双胍缓释片北京福元医药股份有限公司3CYHS2502482利格列汀二甲双胍缓释片北京福元医药股份有限公司3CYHS2502481马来酸曲美布汀片平光制药股份有限公司3CYHS2502462马来酸曲美布汀片平光制药股份有限公司3CYHS2502461醋酸特利加压素注射液武汉人福药业有限责任公司3CYHS2502457醋酸钠林格葡萄糖注射液(I)南京正科医药股份有限公司3CYHS2502456盐酸毛果芸香碱滴眼液山东华铂凯盛生物科技有限公司3CYHS2502428地拉罗司颗粒裕松源药业有限公司3CYHS2502427洛索洛芬钠凝胶上海延安医药洋浦股份有限公司3CYHS2502451硝酸咪康唑乳膏江苏盈科生物制药有限公司3CYHS2502449复方聚乙二醇电解质散(儿童型)郑州泰丰制药有限公司3CYHS2502447腺苷钴胺胶囊国药集团容生制药有限公司3CYHS2502444钠钾镁钙注射用浓溶液西安安健药业有限公司3CYHS2502439维生素K1注射液江苏安必生制药有限公司3CYHS2502437生理氯化钠溶液四川青山利康药业有限公司3CYHS2502453普瑞巴林口服溶液浙江致新医药科技有限公司3CYHS2502452醋酸钠林格葡萄糖注射液(I)南京正大天晴制药有限公司3CYHS2502429福多司坦口服溶液海南全星制药有限公司3CYHS2502419注射用氢化可的松琥珀酸钠南京泽恒医药技术开发有限公司3CYHS2502416注射用硫酸多黏菌素B烟台鲁银药业有限公司3CYHS2502410葡萄糖酸钙注射液河南普瑞药业有限公司3CYHS2502405盐酸甲氧氯普胺注射液广东南国药业有限公司3CYHS2502403盐酸溴己新注射液成都华宇制药有限公司3CYHS2502423比拉斯汀口服溶液江苏长泰药业股份有限公司3CYHS2502424氯雷他定片华益药业科技(安徽)有限公司4CYHS2502486二十碳五烯酸乙酯软胶囊华北制药股份有限公司4CYHS2502483瑞维那新吸入溶液遂成药业股份有限公司4CYHS2502515腹膜透析液(乳酸盐-G4.25%)四川青山利康药业有限公司4CYHS2502514腹膜透析液(乳酸盐-G4.25%)四川青山利康药业有限公司4CYHS2502513腹膜透析液(乳酸盐-G2.5%)四川青山利康药业有限公司4CYHS2502512腹膜透析液(乳酸盐-G2.5%)四川青山利康药业有限公司4CYHS2502511腹膜透析液(乳酸盐-G1.5%)四川青山利康药业有限公司4CYHS2502510腹膜透析液(乳酸盐-G1.5%)四川青山利康药业有限公司4CYHS2502509恩格列净片广东彼迪药业有限公司4CYHS2502508双氯芬酸二乙胺乳胶剂浙江寰领医药科技有限公司4CYHS2502507恩格列净片广东彼迪药业有限公司4CYHS2502506玻璃酸钠注射液重庆药友制药有限责任公司4CYHS2502501盐酸尼卡地平注射液上海葆隆生物科技有限公司4CYHS2502495替米沙坦氢氯噻嗪片南京黄龙生物科技有限公司4CYHS2502492利格列汀二甲双胍片(II)山东朗诺制药有限公司4CYHS2502491沙库巴曲缬沙坦钠片复星万邦(江苏)医药集团有限公司4CYHS2502488艾拉莫德片璟济生物医药科技(泰州)股份有限公司4CYHS2502487米格列醇片北京北陆药业股份有限公司4CYHS2502479利那洛肽胶囊湖北远大永晟药业有限公司4CYHS2502478巴瑞替尼片海化生命(厦门)科技有限公司4CYHS2502477甲磺酸多沙唑嗪缓释片常州制药厂有限公司4CYHS2502476甲氨蝶呤注射液四川汇宇海玥医药科技有限公司4CYHS2502469甲氨蝶呤注射液四川汇宇海玥医药科技有限公司4CYHS2502468艾普拉唑肠溶片江苏飞马药业有限公司4CYHS2502466双氯芬酸钠盐酸利多卡因注射液山西威奇达光明制药有限公司4CYHS2502465酒石酸溴莫尼定滴眼液成都普什制药有限公司4CYHS2502464噻托溴铵吸入喷雾剂浙江仙琚制药股份有限公司4CYHS2502480吗啉硝唑氯化钠注射液浙江康吉尔药业有限公司4CYHS2502463培哚普利氨氯地平片(III)山东朗诺制药有限公司4CYHS2502460恩格列净片江西施美药业股份有限公司4CYHS2502459恩格列净片江西施美药业股份有限公司4CYHS2502458聚乙烯醇滴眼液合肥利民制药有限公司4CYHS2502433艾普拉唑肠溶片宁波科尔康美诺华药业有限公司4CYHS2502430盐酸曲唑酮缓释片华益泰康药业股份有限公司4CYHS2502426注射用磷丙泊酚二钠成都苑东生物制药股份有限公司4CYHS2502450瑞维那新吸入溶液山东达因金控儿童制药有限公司4CYHS2502448注射用甲泼尼龙琥珀酸钠海南倍特药业有限公司4CYHS2502446注射用甲泼尼龙琥珀酸钠海南倍特药业有限公司4CYHS2502445哌柏西利片浙江麒正药业有限公司4CYHS2502443哌柏西利片浙江麒正药业有限公司4CYHS2502441左氧氟沙星滴眼液重庆药谷制药有限公司4CYHS2502440注射用盐酸表柔比星吉斯美(武汉)制药有限公司4CYHS2502438戊酸雌二醇片扬州奥锐特药业有限公司4CYHS2502436富马酸伏诺拉生片江西山香药业有限公司4CYHS2502455富马酸伏诺拉生片江西山香药业有限公司4CYHS2502454瑞舒伐他汀依折麦布片(I)烟台鲁银药业有限公司4CYHS2502442富马酸喹硫平缓释片山东绿叶制药有限公司4CYHS2502435富马酸喹硫平缓释片山东绿叶制药有限公司4CYHS2502434富马酸喹硫平缓释片山东绿叶制药有限公司4CYHS2502432富马酸喹硫平缓释片山东绿叶制药有限公司4CYHS2502431二甲硅油乳剂江苏广承药业有限公司4CYHS2502422依伏卡塞片南京正大天晴制药有限公司4CYHS2502421依伏卡塞片南京正大天晴制药有限公司4CYHS2502420达格列净片浙江麒正药业有限公司4CYHS2502418达格列净片浙江麒正药业有限公司4CYHS2502417甲硝唑凝胶杭州呋欧医药科技有限公司4CYHS2502415甲硝唑凝胶杭州呋欧医药科技有限公司4CYHS2502414恩格列净片江西迪赛诺医药集团有限公司4CYHS2502413恩格列净片江西迪赛诺医药集团有限公司4CYHS2502412氟比洛芬凝胶贴膏中曦(福建)药业有限公司4CYHS2502411癸酸氟哌啶醇注射液四川尚锐生物医药有限公司4CYHS2502409癸酸氟哌啶醇注射液四川尚锐生物医药有限公司4CYHS2502408非奈利酮片石家庄四药有限公司4CYHS2502407瑞维那新吸入溶液海南斯达制药有限公司4CYHS2502406非奈利酮片复星万邦(江苏)医药集团有限公司4CYHS2502404比索洛尔氨氯地平片广东大鹏医药科技有限公司4CYHS2502402氟马西尼注射液岳阳新华达制药有限公司4CYHS2502401盐酸达泊西汀片江苏润邦药业有限公司4CYHS2502400盐酸达泊西汀片江苏润邦药业有限公司4CYHS2502399盐酸替罗非班注射用浓溶液安徽丰原药业股份有限公司4CYHS2502398洛索洛芬钠凝胶贴膏河南羚锐制药股份有限公司4CYHS2502397瑞维那新吸入溶液南京力成药业有限公司4CYHS2502396艾拉莫德片东阳祥昇医药科技有限公司4CYHS2502395瑞维那新吸入溶液江西科伦药业有限公司4CYHS2502394丁溴东莨菪碱注射液石家庄四药有限公司4CYHS2502393盐酸维洛沙秦缓释胶囊西安远大科创医药科技有限公司3CYHL2500127盐酸维洛沙秦缓释胶囊西安远大科创医药科技有限公司3CYHL2500126艾氟洛芬贴剂湖南华纳大药厂股份有限公司3CYHL2500125克霉唑阴道片株洲千金药业股份有限公司4CYHL2500124甲型肝炎灭活疫苗(人二倍体细胞)北京科兴生物制品有限公司3.3CXSL2500554仑卡奈单抗注射液石药集团巨石生物制药有限公司3.3CXSL2500555QL2106注射液齐鲁制药有限公司3.3CXSL2500545人纤维蛋白原国药集团昆明血液制品有限公司3.4CXSL2500557人纤维蛋白原国药集团昆明血液制品有限公司3.4CXSL2500556进口申请药品名称企业注册分类受理号洛索洛芬钠凝胶膏LEAD CHEMICAL CO., LTD.5.1JXHS2500076醋酸锌片Nobelpharma Co., Ltd.5.1JXHS2500075醋酸锌片Nobelpharma Co., Ltd.5.1JXHS2500074羧基麦芽糖铁注射液M/s MSN LABORATORIES PRIVATE LIMITED5.2JYHS2500027羧基麦芽糖铁注射液M/s MSN LABORATORIES PRIVATE LIMITED5.2JYHS2500026AZD9574AstraZeneca AB1JXHL2500182AZD9574AstraZeneca AB1JXHL2500181AZD9574AstraZeneca AB1JXHL2500180AZD9574AstraZeneca AB1JXHL2500179RO7435846片F. Hoffmann-La Roche Ltd.1JXHL2500178RO7435846片F. Hoffmann-La Roche Ltd.1JXHL2500177RO7435846片F. Hoffmann-La Roche Ltd.1JXHL2500176RO7435846片F. Hoffmann-La Roche Ltd.1JXHL2500175Orforglipron片Eli Lilly and Company1JXHL2500174Orforglipron片Eli Lilly and Company1JXHL2500173Orforglipron片Eli Lilly and Company1JXHL2500172Orforglipron片Eli Lilly and Company1JXHL2500171Orforglipron片Eli Lilly and Company1JXHL2500170Orforglipron片Eli Lilly and Company1JXHL2500169Mezigdomide胶囊Celgene Corporation1JXHL2500168Mezigdomide胶囊Celgene Corporation1JXHL2500167Mezigdomide胶囊Celgene Corporation1JXHL2500166Mezigdomide胶囊Celgene Corporation1JXHL2500165Mezigdomide胶囊Celgene Corporation1JXHL2500164Mezigdomide胶囊Celgene Corporation1JXHL2500163ALXN2420注射液Alexion Pharmaceuticals, Inc.1JXHL2500162注射用六氟化硫微泡Bracco International B.V.2.4JXHL2500183AZD5335AstraZeneca AB1JXSL2500121替利珠单抗注射液Sanofi-Aventis Recherche & Développement2.2JXSL2500120中药相关申请药品名称企业注册分类受理号JIZM01湖南九典制药股份有限公司1.1CXZL2500053JIZM01湖南九典制药股份有限公司1.1CXZL2500052和肤止痒凝胶广东省中医院1.1CXZL2500051JIZM02湖南九典制药股份有限公司1.1CXZL2500050JIZM02湖南九典制药股份有限公司1.1CXZL2500049柴胡鼻腔喷雾剂河南利欣制药股份有限公司2.1CXZS2500029扶正通淋丸山东康众宏医药科技开发有限公司1.1CXZL2500047ZY-A002亚宝药业集团股份有限公司1.1CXZL2500046馥感啉颗粒广州一品红制药有限公司2.2CXZL2500048半夏白术天麻颗粒石家庄以岭药业股份有限公司3.1CXZS2500028淫羊藿素软胶囊北京珅诺基医药科技有限公司2.3CXZL2500045真武颗粒武汉康乐药业股份有限公司3.1CXZS2500027注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市临床申请

2025-07-10

·ETPharma

Experimental Bayer drug eases menopause-like symptoms from breast cancer therapy

London: The hot flashes and night sweats that plague breast cancer survivors during years-long hormone-suppressing therapy are eased by an experimental non-hormonal drug being developed by Bayer, according to results from a late-stage trial. The participants in the trial - similar to two-thirds of breast cancer patients overall - had tumors that use the hormones estrogen and progesterone to grow. The goal of so-called endocrine therapy is to block those hormones, which reproduces the uncomfortable menopause symptoms. The most effective way to relieve these symptoms in healthy women is to replace the hormones, which is not feasible when tumors use the hormones to grow. In a year-long trial involving 474 breast cancer patients experiencing daily hot flashes due to hormone-suppressing therapy, 316 received Bayer's elinzanetant and 158 received a placebo. Within three months, more than 70% of those on elinzanetant reported at least a 50% reduction in moderate-to-severe hot flashes, compared to about 36% of the placebo group, the researchers reported at a recent meeting of cancer doctors and in The New England Journal of Medicine. The Bayer drug also significantly improved sleep quality and menopausal quality of life by week 12. "It is important to treat vasomotor symptoms because they can negatively impact quality of life and lead to women prematurely stopping their breast cancer treatment," said study leader Dr. Fatima Cardoso of the Champalimaud Clinical Center in Lisbon. Elinzanetant belongs to a new class of drugs called neurokinin receptor antagonists that target the neurobiological mechanisms in the brain involved in hot flashes and night sweats. The U.S. Food and Drug Administration recently approved an Astellas Pharma drug from the class under the brand name Vezoah for easing symptoms of menopause. It is not approved for treating breast cancer patients, so that use would be off-label, the study authors noted. Doctors can prescribe any approved medicine as they see fit, but companies can only promote them for approved uses. An editorial published with the study notes that up to 90% of women with early breast cancer treated with endocrine therapy experience hot flashes and other vasomotor symptoms, which may impact their survival if the symptoms lead them to quit taking the medications. In one large study of breast cancer survivors, half the participants reported non-adherence to endocrine therapy, the editorial says. Bayer is awaiting approval of elinzanetant from the FDA and the European Medicines Agency. AVAILABLE DRUGS CAN PREVENT IMMUNOTHERAPY-RELATED DIABETES Cases of type 1 diabetes caused by cancer immunotherapy drugs can be controlled - and even reversed - by treatment with already approved medicines for autoimmune conditions like psoriasis and rheumatoid arthritis, laboratory studies suggest. Type 1 diabetes, in which the body mistakenly attacks and destroys insulin-producing cells in the pancreas, occurs in 1% to 2% of patients receiving immunotherapies known as checkpoint inhibitors, such as Merck's Keytruda and Bristol Myers Squibb's Opdivo. The condition is often permanent, requiring insulin therapy for life. With the increased use of the blockbuster cancer drugs, "preventing long-term autoimmune damage is becoming a critical part of survivorship care," study leader Dr. Melissa Lechner of the David Geffen School of Medicine at UCLA said in a statement. "This is one of the first times we've found a way to intervene in these toxicities in a meaningful way," she added. Her team identified a new group of immune cells called CD4+ T follicular helper cells, or Tfh cells, which produce signaling molecules called IL-21 and IFN-gamma that fuel the immune attack on the pancreas. In experiments in mice, the researchers found that a class of drugs known as JAK inhibitors, which block the IL-21 and IFN-gamma pathways, not only blocked the effects of the two signaling molecules but also reduced the number of Tfh cells and, in some cases, restored normal blood sugar levels. The results were reported in JCI Insight. Available JAK inhibitors include Pfizer's Xeljanz, Rinvoq from AbbVie and Eli Lilly's Olumiant. "This is the first study to identify Tfh cells and the IL-21/IFN-gamma pathway as key drivers of checkpoint inhibitor-induced type 1 diabetes," said Lechner. "Importantly, we show that this pathway can be therapeutically targeted with a drug that is already FDA-approved and widely available without weakening the immune system's ability to fight cancer." (Reporting by Nancy Lapid; editing by Bill Berkrot)

临床结果上市批准免疫疗法

2025-07-08

·activebiotech.com

Active Biotech provides status update of its development programs

In the laquinimod project, we announced topline data from the biodistribution LION study in early May, and most recently an interview with the principal investigators of the study was published. The results from the LION study convincingly demonstrate that laquinimod, at a therapeutic concentration, reaches the back of the eye when administered topically as an eye drop formulation. There is a high unmet need for non-invasive local delivery of therapeutic agents for use in the treatment of inflammatory eye diseases such as non-infectious uveitis and diseases with excessive neovascularisation like wet AMD. Our key priority for the laquinimod program is now to secure a commercial partnership for the continued clinical development of laquinimod in inflammatory eye diseases with significant medical need. In June, a publication titled Laquinimod treatment attenuates EAU by inhibiting both the inductive and effector phases in an APC-dependent manner was released (preview available at bioRxiv). The work was carried out in collaboration with Dr. Rachel Caspi’s world leading group of at the NEI/NIH and provides the mechanistic basis for the effect of laquinimod in inflammatory eye disorders. In the myelofibrosis studies with tasquinimod in US and Europe, the first patients were recruited in the beginning of 2025. The protocols for both studies are presently being amended to allow an initial dose-titration regimen with both up- and down-regulation of dosing for increased flexibility in the clinical management of the patients. In the US study the combination of tasquinimod with the newly marketed JAK inhibitor momelotinib is included in the combination cohort. During this process recruitment is paused. Enrollment to the studies will be restarted as soon as we have clearance from the Regulatory Authorities and Ethical Committees in the US and Europe. Myelofibrosis is a very rare haematological malignancy with low patient recruitment rate and thus we do not foresee major changes to the projected study times lines. Data from the multiple myeloma study at Abramson Cancer center were reported in early June at ASCO, the world’s leading cancer congress. The data from the combination with a standard oral treatment IRd demonstrate the effect of tasquinimod on the tumor microenvironment in the bone marrow and support a role for tasquinimod also in myelofibrosis. The full study data will be submitted for publication in a peer reviewed Journal. Presentations from the recently reported events are available on Active Biotech’s website.

临床研究临床结果

100 项与巴瑞替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10308	巴瑞替尼	L04AA37	DB11817

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
附着点炎相关关节炎	欧盟	Eli Lilly Nederland BV	2023-09-21
附着点炎相关关节炎	冰岛	Eli Lilly Nederland BV	2023-09-21
附着点炎相关关节炎	列支敦士登	Eli Lilly Nederland BV	2023-09-21
附着点炎相关关节炎	挪威	Eli Lilly Nederland BV	2023-09-21
幼年特发性关节炎	欧盟	Eli Lilly Nederland BV	2023-09-21
幼年特发性关节炎	冰岛	Eli Lilly Nederland BV	2023-09-21
幼年特发性关节炎	列支敦士登	Eli Lilly Nederland BV	2023-09-21
幼年特发性关节炎	挪威	Eli Lilly Nederland BV	2023-09-21
少关节关节炎	欧盟	Eli Lilly Nederland BV	2023-09-21
少关节关节炎	冰岛	Eli Lilly Nederland BV	2023-09-21
少关节关节炎	列支敦士登	Eli Lilly Nederland BV	2023-09-21
少关节关节炎	挪威	Eli Lilly Nederland BV	2023-09-21
多关节型幼年特发性关节炎	欧盟	Eli Lilly Nederland BV	2023-09-21
多关节型幼年特发性关节炎	冰岛	Eli Lilly Nederland BV	2023-09-21
多关节型幼年特发性关节炎	列支敦士登	Eli Lilly Nederland BV	2023-09-21
多关节型幼年特发性关节炎	挪威	Eli Lilly Nederland BV	2023-09-21
新型冠状病毒感染	瑞士	Eli Lilly & Co.	2017-06-19
斑秃	欧盟	Eli Lilly Nederland BV	2017-02-13
斑秃	冰岛	Eli Lilly Nederland BV	2017-02-13
斑秃	列支敦士登	Eli Lilly Nederland BV	2017-02-13

未上市

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适应症	最高研发状态	国家/地区	公司	日期
Aicardi-Goutieres综合征	临床3期	日本	Eli Lilly & Co.	2020-10-27
慢性非典型中性粒细胞性皮肤病伴脂肪营养不良和体温升高	临床3期	日本	Eli Lilly & Co.	2020-10-27
肢骨纹状肥大	临床3期	日本	Eli Lilly & Co.	2020-10-27
Nakajo综合征	临床3期	日本	Eli Lilly & Co.	2020-10-27
婴儿期发病的STING相关血管病变	临床3期	日本	Eli Lilly & Co.	2020-10-27
全身型幼年特发性关节炎	临床3期	日本	Eli Lilly & Co.	2020-02-12
全身型幼年特发性关节炎	临床3期	阿根廷	Eli Lilly & Co.	2020-02-12
全身型幼年特发性关节炎	临床3期	比利时	Eli Lilly & Co.	2020-02-12
全身型幼年特发性关节炎	临床3期	巴西	Eli Lilly & Co.	2020-02-12
全身型幼年特发性关节炎	临床3期	捷克	Eli Lilly & Co.	2020-02-12

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临床结果

适应症

分期

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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


NCT06662721 (Pubmed \| Rheumatology (Oxford))	临床2期	大动脉炎 TNF-α inhibitors	10	Baricitinib 4 mg daily	繭糧網憲願繭襯艱蓋鑰(壓網範淵餘夢餘構鹽餘) = 壓壓獵夢積醖鬱積簾簾壓簾鹽鹹鹹窪憲鑰繭獵 (選築築遞廠選網衊願遞 ) 更多	积极	2025-05-24
SLE-BRAVE-I and SLE-BRAVE-II (Pubmed \| PLoS One)	临床3期	系统性红斑狼疮	1,535	Baricitinib 4 mg	鏇簾窪鏇範艱蓋憲淵遞(觸憲網衊積鬱衊願簾製) = 衊壓網襯網願廠積醖遞鏇憲醖獵齋顧膚鹽餘鬱 (築憲淵齋醖積製遞製網 )	不佳	2025-04-30
				Baricitinib 2 mg	鏇簾窪鏇範艱蓋憲淵遞(觸憲網衊積鬱衊願簾製) = 壓夢選願製餘鏇衊淵衊鏇憲醖獵齋顧膚鹽餘鬱 (築憲淵齋醖積製遞製網 )
BRAVE-AA1 and BRAVE-AA2 (Pubmed \| Am J Clin Dermatol)	临床3期	斑秃	1,303	Baricitinib 2 mg	鹽襯鏇範艱鏇鏇鏇簾蓋(淵顧顧觸範觸選衊鹽餘) = 積觸艱壓鏇襯艱網夢膚齋積鹹鑰鑰積製膚繭簾 (簾願鬱糧蓋蓋築製網鏇 ) 更多	积极	2025-04-11
				Baricitinib 4 mg	鹽襯鏇範艱鏇鏇鏇簾蓋(淵顧顧觸範觸選衊鹽餘) = 襯積網蓋製鑰壓夢淵衊齋積鹹鑰鑰積製膚繭簾 (簾願鬱糧蓋蓋築製網鏇 ) 更多
BRAVE-AA1; BRAVE-AA2 (Pubmed \| Br J Dermatol)	N/A	斑秃	-	Baricitinib 2 mg	淵鑰餘築遞顧蓋窪鏇鏇(繭憲夢獵觸獵築築壓獵) = 網夢繭衊構廠糧艱觸製壓鹹鏇鏇願觸範餘簾範 (鏇壓鹹衊鹽窪鹹鬱窪鹹 )	积极	2025-04-03
				Baricitinib 4 mg	淵鑰餘築遞顧蓋窪鏇鏇(繭憲夢獵觸獵築築壓獵) = 淵遞蓋蓋觸獵蓋構積壓壓鹹鏇鏇願觸範餘簾範 (鏇壓鹹衊鹽窪鹹鬱窪鹹 )
NCT05723198 (BRAVE-AA-PEDS, Company_Website) 人工标引	临床3期	斑秃	257	Baricitinib 4 mg	觸構積夢獵醖觸醖構繭(鏇膚遞壓選範遞醖蓋餘) = 廠餘鏇鏇觸憲觸繭壓餘遞願窪鹹窪顧膚淵顧齋 (簾鬱簾鹽觸築醖艱構鹹 ) 更多	积极	2025-03-08
				Baricitinib 2 mg	觸構積夢獵醖觸醖構繭(鏇膚遞壓選範遞醖蓋餘) = 選鑰衊蓋餘繭鏇窪願顧遞願窪鹹窪顧膚淵顧齋 (簾鬱簾鹽觸築醖艱構鹹 ) 更多
NCT05188521 (Pubmed \| J Clin Invest)	临床2期	扁平苔藓 IFN-γ \| CD8+ \| CXCL13+	-	Baricitinib 2 mg	製憲繭築壓艱觸窪艱齋(糧夢衊觸齋鏇糧構壓簾) = 廠鏇餘簾顧選願鹹鬱廠膚齋艱築鹹積糧襯鹹廠 (選鹹積衊鹽衊構醖艱壓 )	积极	2025-01-16
NCT03952559 (BREEZE-AD-PEDS, Pubmed \| J Dermatolog Treat)	临床3期	中度特应性皮炎 \| 重度特应性皮炎	467	Baricitinib 4-mg equivalent	醖製鑰觸鏇繭積簾鑰築(觸膚糧膚蓋鹽積齋艱夢) = 齋膚蓋襯觸築壓遞鬱鏇網鬱顧築鑰餘廠簾廠範 (壓觸繭獵鬱鑰鹽遞鑰遞 )	积极	2024-12-31
NCT01885078 (RA-BEYOND, Pubmed \| Rheumatology (Oxford)) 人工标引	临床3期	类风湿关节炎	-	Baricitinib 4 mg	餘獵顧膚壓艱觸遞鹹壓(顧餘製簾獵衊襯窪衊餘) = 膚鑰壓製觸鬱獵觸憲選膚構餘願壓醖範鏇鹹鬱 (鹹製膚醖願齋範憲鏇膚 ) 更多	积极	2024-10-01
				Baricitinib 2 mg	餘獵顧膚壓艱觸遞鹹壓(顧餘製簾獵衊襯窪衊餘) = 獵憲範繭膚夢憲選夢築膚構餘願壓醖範鏇鹹鬱 (鹹製膚醖願齋範憲鏇膚 ) 更多
NCT04088409 (CTgov)	临床3期	前葡萄膜炎 \| 葡萄膜炎 \| 幼年特发性关节炎	30	Baricitinib (Baricitinib)	範糧範願壓積鹹廠衊齋 = 繭築鑰鏇蓋淵範築願鑰選窪構積憲醖築積顧遞 (鹹鬱壓衊蓋鏇範積簾膚, 鏇鬱餘餘網觸憲淵壓獵 ~ 齋鑰膚糧觸構簾網鬱衊) 更多	-	2024-08-13
				Adalimumab (Adalimumab)	積醖鑰鹹築獵齋膚蓋觸(餘衊願簾醖築積鑰選醖) = 範蓋窪遞壓獵衊繭窪顧鑰選鬱衊蓋繭範襯襯範 (壓鏇願窪範築壓壓範鹽, 選憲醖製窪餘遞觸醖鬱 ~ 簾膚願窪簾餘醖鏇艱繭) 更多
NCT03570749 \| NCT03899259 (BRAVE-AA1; BRAVE-AA2, Pubmed)	临床3期	斑秃	131	Baricitinib 4 mg	壓餘齋顧遞憲網憲簾觸(鏇遞醖選願廠顧構蓋醖) = progressive improvements 襯窪願淵繭願簾鬱構鏇 (繭簾簾襯構遞觸窪顧顧 ) 更多	积极	2024-06-21
				Baricitinib 2 mg