排名前五的靶点	数量

SGLT2(钠-葡萄糖协同转运蛋白-2)	1
Proteasome(蛋白酶体)	1
GR(糖皮质激素受体)	1
Factor XIa(凝血因子XIa)	1
FGFR1 x FGFR2 x FGFR3 x FGFR4	1

关联

项与 Janssen-Cilag SpA 相关的药物

Lazertinib

甲磺酸兰泽替尼

靶点

EGFR L858R x EGFR-Ex19del

作用机制

EGFR19外显子缺失突变抑制剂 [+1]

在研机构

Janssen Research & Development LLC [+8]

原研机构

Janssen Biotech, Inc.

在研适应症

EGFR外显子21替代突变非小细胞肺癌 [+13]

非在研适应症

肝损伤

最高研发阶段批准上市

首次获批国家/地区

韩国

首次获批日期2021-01-18

Erdafitinib

厄达替尼

靶点

FGFR1 x FGFR2 x FGFR3 x FGFR4

作用机制

FGFR1拮抗剂 [+3]

在研机构

Janssen Research & Development LLC [+10]

原研机构

Astex Pharmaceuticals, Inc.

在研适应症

转移性尿路上皮癌 [+23]

非在研适应症

前列腺腺癌 [+2]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2019-04-12

Daratumumab

达雷妥尤单抗

靶点

CD38

作用机制

CD38抑制剂 [+3]

在研机构

西安杨森制药有限公司 [+16]

原研机构

Janssen Global Services LLC

在研适应症

免疫球蛋白轻链淀粉样变性 [+19]

非在研适应症

结外NK-T细胞淋巴瘤 [+10]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2015-11-16

项与 Janssen-Cilag SpA 相关的临床试验

CTR20240725 / Recruiting临床3期

一项在房颤受试者中评价因子XIa口服抑制剂Milvexian与阿哌沙班相比的疗效和安全性的III期、随机、双盲、双模拟、平行组、阳性对照研究

1.根据“卒中和非中枢神经系统（CNS）系统性体循环栓塞” 复合终点，评估Milvexian是否非劣效于阿哌沙班。 2. 评价Milvexian在降低系列主要安全性终点风险方面是否优于阿哌沙班： ·ISTH大出血 ·“ISTH大出血和CRNM出血”复合终点 3. 根据“CV死亡、MI、卒中和非CNS系统性栓塞”复合终点，评价Milvexian是否优于阿哌沙班。 4. 根据CV死亡，评价Milvexian是否优于阿哌沙班。 5. 根据“全因死亡、MI、卒中和非CNS系统性栓塞”复合终点，评价Milvexian是否优于阿哌沙班。 6.根据由以下各项构成的复合终点，评价Milvexian是否优于阿哌沙班：CV死亡、MI、卒中、任何非预期的血运重建术（包括缺血性肢体截肢）和因缺血性血管原因而紧急住院（包括血栓形成事件：深静脉血栓形成[DVT]和肺栓塞[PE]）。

开始日期2024-03-11

申办/合作机构

Janssen Pharmaceutica NV

[+7]

CTR20233526 / Recruiting临床3期

一项旨在证明急性缺血性卒中或高危短暂性脑缺血性发作后因子XIa口服抑制剂Milvexian预防卒中的疗效和安全性的III期、随机、双盲、平行组、安慰剂对照研究。

本研究的目的是评价Milvexian与安慰剂相比是否可降低缺血性卒中的风险。

开始日期2023-12-03

申办/合作机构

Janssen Pharmaceutica NV

[+6]

CTR20233529 / Recruiting临床3期

一项旨在证明近期发生急性冠脉综合征后使用因子XIa口服抑制剂Milvexian的疗效和安全性的III期、随机、双盲、安慰剂对照、事件驱动研究

1. 证明在标准治疗的基础上加用Milvexian 在降低MACE（“CV 死亡、MI 和缺血性卒中”复合终点）风险方面优于安慰剂 2. 证明在标准治疗的基础上加用Milvexian 在降低MAVE（“CV 死亡、MI、缺血性卒中、MALE 和症状性VTE”复合终点）风险方面优于安慰剂 3. 确定Milvexian 与安慰剂相比是否可降低ACM、MI 和缺血性卒中复合终点的风险 4. 确定Milvexian 与安慰剂相比是否可降低CV死亡的风险 5. 确定Milvexian 与安慰剂相比是否可降低ACM风险

开始日期2023-11-24

申办/合作机构

Janssen Pharmaceutica NV

[+6]

100 项与 Janssen-Cilag SpA 相关的临床结果

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0 项与 Janssen-Cilag SpA 相关的专利（医药）

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1,022

项与 Janssen-Cilag SpA 相关的文献（医药）

2024-06-01·European Journal of Haematology

Outcomes with ibrutinib in patients with chronic lymphocytic leukaemia: Results from the German multicentre REALITY study

Article

作者: Schulz, Holger ; Welslau, Manfred ; Nejad-Asgari, Sonja ; Gerhardt, Anke ; Dörfel, Steffen ; Vornholz, Lukas ; Schlag, Rudolf

AbstractObjectivesTo assess treatment adherence, effectiveness and safety outcomes of patients with chronic lymphocytic leukaemia (CLL) receiving ibrutinib in a real‐world setting.MethodsPatients enrolled in REALITY were ≥18 years with a confirmed diagnosis of CLL and were receiving ibrutinib as a first‐line (1L), 2L or ≥3L therapy. Treatment retention, adherence, progression‐free survival (PFS), overall survival (OS) and time to next therapy were assessed at 1 and 2 years overall, by typology and by cytogenetic subgroups. PFS and OS were analysed using Kaplan–Meier methods.ResultsExactly 302 patients were enrolled across 57 sites in Germany, from January 2017 to July 2021. One‐year retention rates were 69.9% overall (primary endpoint), 77.9% for 1L patients, and 77.6%/78.8% for high‐risk patients with del17p/TP53. At 2 years, PFS/OS rates were 77.8%/90.7% overall (1L, 82.7%/90.4%), and were consistent across cytogenetic subgroups. PFS rates were higher for 1L versus ≥3L patients. Patients with the low‐acceptance/low‐control typology at baseline were less likely to retain treatment at 1 year versus the high‐acceptance/high‐control typology. No new safety signals were observed.ConclusionsThe REALITY study provides further evidence of the effectiveness and safety of ibrutinib in patients with CLL in a real‐world setting, particularly in earlier treatment lines.

2024-03-01·American Journal of Clinical Dermatology

Guselkumab-Treated Patients with Plaque Psoriasis Who Achieved Complete Skin Clearance for ≥ 156 Consecutive Weeks: A Post-Hoc Analysis From the VOYAGE 1 Clinical Trial

Article

作者: Costanzo, Antonio ; Puig, Luis ; Wegner, Sven ; de Jong, Elke M G J ; Torres, Tiago ; Conrad, Curdin ; Wapenaar, Robert ; Jazra, Maria ; Gorecki, Patricia ; Warren, Richard B ; Buyze, Jozefien ; Gramiccia, Talia

BACKGROUNDTreatment of moderate-to-severe plaque psoriasis with biologics, such as guselkumab, has demonstrated greater efficacy over traditional non-biologic treatments. However, given patient diversity, greater understanding of the relationship between patient characteristics, positive clinical outcomes, and long-term response to biologics is crucial for optimizing treatment choices.MATERIALS AND METHODSThis post-hoc analysis of the 5-year VOYAGE 1 clinical trial compares baseline characteristics of patients maintaining a Psoriasis Area and Severity Index (PASI) score of 0 at all visits for ≥ 156 consecutive weeks (PASI = 0 group) with those that never achieve PASI = 0 (comparator group), using descriptive statistics and a multiple logistic regression model. Guselkumab plasma trough concentrations in both response groups were assessed from Weeks 4-156.RESULTSOf patients who started guselkumab treatment at Week 0 or at Week 16 after switching from placebo, 22.7% (112/494) maintained PASI = 0 for ≥ 156 consecutive weeks. Numerical differences in baseline characteristics, including age, obesity, diabetes, PASI score, disease duration, smoking status, and psoriatic arthritis comorbidity, were identified between the PASI = 0 group and comparator group. Plasma guselkumab levels were consistently higher in the PASI = 0 group. Multiple logistic regression analysis revealed absence of diabetes, lower Dermatology Life Quality Index score at baseline, and higher Week 4 guselkumab plasma concentration as significantly (p < 0.05) associated with the PASI = 0 group.CONCLUSIONA substantial (22.7%) number of guselkumab-treated patients in the VOYAGE 1 clinical trial maintained complete skin clearance for a consecutive period of ≥ 156 weeks. Factors associated with this outcome may suggest clinical benefits of holistic treatment approaches.TRIAL REGISTRATIONNCT02207231.

2024-01-01·PharmacoEconomics - Open

Economic Burden of Delayed Diagnosis in Patients with Pulmonary Arterial Hypertension (PAH)

Article

作者: Satija, Ambika ; Gauthier-Loiselle, Marjolaine ; Germack, Hayley D ; Linder, Jörg ; Frantz, Robert P ; Cloutier, Martin ; DuBrock, Hilary M ; Panjabi, Sumeet ; Lefebvre, Patrick ; Manceur, Ameur M

BACKGROUNDThe aim of this study was to assess health care resource utilization (HRU) and costs associated with delayed pulmonary arterial hypertension (PAH) diagnosis in the United States.METHODSEligible adults with newly diagnosed PAH from Optum's de-identified Clinformatics^® Data Mart Database (2016-2021) were assigned to mutually exclusive cohorts based on time between first PAH-related symptom and first PAH diagnosis (i.e., ≤12 months' delay, >12 to ≤24 months' delay, >24 months' delay). All-cause HRU and health care costs per patient per month (PPPM) were assessed during the first year following diagnosis and compared across cohorts using regression analysis adjusted for baseline covariates. Sensitivity analyses were conducted to assess outcomes during all available follow-up post-diagnosis.RESULTSAmong 538 patients (mean age: 65.6 years; 60.6% female), 60.8% had ≤12 months' delay, 23.4% had a delay of >12 to ≤24 months, and 15.8% had >24 months' delay. Compared with ≤12 months, delays of >12 to ≤24 months and >24 months were associated with increased hospitalizations (incidence rate ratio [95% confidence interval]: 1.40 [1.11-1.71] vs 1.71 [1.29-2.12]) and outpatient visits (1.17 [1.06-1.30] vs 1.26 [1.08-1.41]). Longer delays were also associated with more intensive care unit (ICU) stays and 30-day readmissions. Diagnosis delays translated into excess costs PPPM of US$3986 [1439-6436] for >12 to ≤24 months and US$5366 [2107-8524] for >24 months compared with ≤12 months' delay; increased hospitalization costs (US$3248 [1108-5135] and US$4048 [1401-6342], respectively) being the driver. Sensitivity analyses yielded similar trends.CONCLUSIONSDelayed PAH diagnosis is associated with significant incremental economic burden post-diagnosis, driven by hospitalizations including ICU stays and 30-day readmissions, highlighting the need for increased awareness and a potential benefit of earlier screening.

100 项与 Janssen-Cilag SpA 相关的药物交易

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100 项与 Janssen-Cilag SpA 相关的转化医学

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药物(靶点)	适应症	全球最高研发状态

厄达替尼 ( FGFR1 x FGFR2 x FGFR3 x FGFR4 )	晚期尿路上皮癌更多	申请上市
甲磺酸兰泽替尼 ( EGFR L858R x EGFR-Ex19del )	EGFR突变的非小细胞肺癌更多	申请上市
Milvexian ( Factor XIa )	急性缺血性卒中更多	临床3期
卡格列净 ( SGLT2 )	2型糖尿病更多	临床3期
达雷妥尤单抗 ( CD38 )	浆母细胞淋巴瘤更多	临床2期