替瑞奇珠单抗(Tildrakizumab-ASMN) - 药物靶点：IL-23p19_在研适应症：斑块状银屑病，银屑病关节炎_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Ilumetri、ILUMYA、tildrakizumab

+ [20]

靶点

IL-23p19

作用机制

IL-23p19抑制剂(白细胞介素-23亚单位p19抑制剂)

治疗领域

免疫系统疾病皮肤和肌肉骨骼疾病感染

在研适应症

斑块状银屑病银屑病关节炎

非在研适应症

强直性脊柱炎转移性去势抵抗性前列腺癌非放射性轴性脊柱关节炎+ [1]

原研机构

Merck Sharp & Dohme Corp.

在研机构

Sun Pharmaceutical Industries Ltd.

Almirall SAAlmirall AG

+ [4]

非在研机构

深圳市康哲生物科技有限公司

最高研发阶段批准上市

首次获批日期

美国 (2018-03-20),

斑块状银屑病

最高研发阶段(中国)批准上市

特殊审评-

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序列信息

Sequence Code 21253H

来源: *****

Sequence Code 21308L

来源: *****

关联

45

项与替瑞奇珠单抗相关的临床试验

NCT06488170 / RecruitingN/A

Patient-Reported Wellbeing Using Tildrakizumab in a Live Setting - Light Version

The main purpose of this study to investigate the relationship between clinical symptoms and quality of life (QoL) in participants who receive Tildrakizumab in the frame of clinical routine for the treatment of moderate to severe plaque psoriasis in accordance with the summary of product characteristics (SmPC).

开始日期2024-04-04

申办/合作机构

Almirall SA

NCT06029257 / RecruitingN/A

Effectiveness and Safety of Tildrakizumab in the Treatment of Genital Psoriasis in Austria, Switzerland, and the Czech Republic

The main aim of this study is to check the safety and effectiveness of tildrakizumab regarding the alleviation of symptoms in the genital area after administration according to the summary of product characteristics (SmPC) and to access overall treatment safety and quality of life assessed on multiple scales.

开始日期2023-11-14

申办/合作机构

Almirall SA

CTRI/2023/06/053784 / Completed临床3期

A Single-Arm, Multi-Centric Study to Evaluate Efficacy, Safety and Immunogenicity of Tildrakizumab in Patients With Moderate-to-Severe Plaque Psoriasis

开始日期2023-06-18

申办/合作机构

Sun Pharmaceutical Industries Ltd.

100 项与替瑞奇珠单抗相关的临床结果

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100 项与替瑞奇珠单抗相关的转化医学

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100 项与替瑞奇珠单抗相关的专利（医药）

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242

项与替瑞奇珠单抗相关的文献（医药）

2024-12-31·The Journal of dermatological treatment

The effect of tildrakizumab on adipokines production in patients affected by psoriasis and obesity: preliminary results from a single center real-life study

Article

作者: Salza, Emanuela ; Caiazzo, Giuseppina ; Potestio, Luca ; Cacciapuoti, Sara ; Megna, Matteo

2024-03-01·The Annals of pharmacotherapy

Choosing Systemic Agents for Psoriasis

作者: Kontzias, Christina ; Chandy, Rithi ; Feldman, Steven R

Treatment options for moderate-to-severe psoriasis depend on drug efficacy and safety, patient preferences, comorbidities, and cost—no drug dominates across all dimensions. Interleukin (IL)-17 inhibitors may be preferred for fast-acting treatment, while the 3-month schedule of risankizumab, ustekinumab, or tildrakizumab may be attractive for patients who prioritize fewer injections. Phototherapy is suitable for patients who wish to avoid systemic agents or when cost is a concern. For patients with poor adherence, infliximab or tildrakizumab may be well suited as they require in-office administration. Dermatologists can educate patients on available therapies to find a regimen best suited to their needs.

2024-03-01·American journal of clinical dermatology

Advancements in Bullous Pemphigoid Treatment: A Comprehensive Pipeline Update

Review

作者: Patsatsi, Aikaterini ; Karakioulaki, Meropi ; Eyerich, Kilian

ABASTRACT:

Bullous pemphigoid (BP) is a common autoimmune bullous disease affecting mainly the elderly, with rising incidence due to increased life expectancy. This disease is characterized by tense bullous lesions on normal or erythematous skin, accompanied by pruritus. BP pathogenesis involves autoantibodies against hemidesmosomal proteins BP180 and BP230, leading to detachment at the dermo-epidermal junction as well as blister formation. BP is associated with coexisting comorbidities and drug exposure, and its management often requires high doses or chronic use of systemic glucocorticoids, posing risks of adverse effects. This review focuses on novel treatment options for BP, exploring therapies targeting different immune pathways. Rituximab, a CD20 monoclonal antibody, depletes B-lymphocytes and has shown efficacy in severe cases. Dupilumab, targeting interleukin (IL)-4 receptor α and thus blocking IL-4 and IL-13, downregulates type 2 helper (Th2) responses and has demonstrated promising results. Targeting eosinophil-related molecules using bertilimumab and AKST4290 has yielded positive results in clinical trials. Omalizumab, an immunoglobulin (Ig) E antibody, can reduce disease severity and allows corticosteroid tapering in a number of cases. Complement inhibitors such as nomacopan and avdoralimab are being investigated. IL-17 and IL-23 inhibitors such as secukinumab and tildrakizumab have shown potential in a limited number of case reports. Neonatal Fc receptor antagonists such as efgartigimod are under investigation. Additionally, topical therapies and Janus kinase inhibitors are being explored as potential treatments for BP. These novel therapies offer promising alternatives for managing BP, with potential to improve outcomes and reduce high cumulative doses of systemic corticosteroids and related toxicities. Further research, including controlled clinical trials, is needed to establish their efficacy, safety, and optimal dosing regimens for BP management.

90

项与替瑞奇珠单抗相关的新闻（医药）

2024-07-22

·Pharmaceutical Technology

Ilumetri and Ebglyss spur Almirall’s growth in dermatology

Almirall expects EBITDA of between €175m and €190m this year. Image credit: Shutterstock/ T. Schneider. Almirall has reported a 6.7% increase in total net sales for the first half of 2024, with the company’s European dermatology business spurring much of the company’s revenue streams. Almirall generated a total of €497.2m ($541.4m) in H1 this year, a year-over-year (YOY) sales increase of 3.2%. The results meant the Spanish pharma reiterated its growth guidance for 2024, estimating an EBITDA of between €175m and €190m, as per a 22 July press release. Shares in the company opened 3.9% higher based on the financial results. Almirall has a €2bn market cap. Almirall’s dermatology business in Europe was the engine for much of the company’s growth, propped up by higher sales of the psoriasis treatment Ilumetri (tildrakizumab) and the recent launch of Ebglyss (lebrikizumab) for atopic dermatitis. In an earnings call on 22 July, Almirall CEO Carlos Gallardo said: “It’s still early days, but we are very encouraged by the strong progress of the product sales [for Ebgylss].” See Also: Rusan Pharma’s API Plant in Ankleshwar Receives USFDA GMP Approval UK MHRA approves Lupin and Zentiva’s raltegravir for HIV Gallardo added that the company expects to “capture a significant share of the advanced therapies market in atopic dermatitis”. Ilumetri, an anti-interleukin-23 (IL-23) antibody, is Almirall’s best-selling product. The drug reached over €100m in sales in H1 this year, representing a 25% increase compared to the same period in 2023. Almirall said it forecasts €250m in peak sales for the drug in 2024. Ilumetri is the European brand name for Ilumya – Almirall having licensed European rights for the drug from Sun Pharma in 2016. European sales for the drug are estimated to reach $300m by 2030, whilst US sales are expected to soar past $1.2bn by the same year, according to analysis by GlobalData. GlobalData is the parent company of Pharmaceutical Technology. Ebgylss meanwhile was recently launched in Germany, the UK, and Norway, and was recommended by England’s National Institute for Health and Care Excellence ( Nice ) for use on the NHS last month. Further rollouts in Denmark, Spain, and Austria are expected later this year for the drug. Almirall licensed the rights to develop and commercialise Ebglyss in dermatology indications, including atopic dermatitis, in Europe from Dermira in 2019. Dermira was then acquired by Eli Lilly, the latter retaining drug rights in the US and the rest of the world. Globally, Ebglyss is forecast to reach blockbuster status by 2026, according to GlobalData’s Pharma Intelligence Centre. Unlike its European counterpart, Almirall’s US dermatology business sales decreased by 4.1%, though CFO Mike McClellan said the business is showing “nearly stable results”, but it is under pressure from “ongoing generic erosion” in the country.

上市批准并购生物类似药财报

2024-07-02

·PMLiVE

Almirall’s Ilumetri shown to improve and maintain well-being in plaque psoriasis patients

Almirall has presented positive results for Ilumetri (tildrakizumab) in patients with moderate-to-severe plaque psoriasis at the International Federation of Psoriasis Association Conference 2024 in Sweden. The POSITIVE clinical study has been evaluating the impact and skin clearance of Ilumetri in 782 adults with moderate-to-severe psoriasis and is the first dermatological study to use the five-item World Health Organization Wellbeing Index, a questionnaire widely used to assess health-related subjective psychological well-being in a variety of chronic diseases. Affecting around 60 million people globally, psoriasis is characterised by flaky patches of skin, of which nearly 77% of patients reported that it negatively affects their normal daily activities and well-being. Ilumetri is a humanised monoclonal antibody that works to inhibit the release of proinflammatory cytokines and chemokines without affecting the rest of the immune system. Interim results showed that Ilumetri demonstrated notable improvements in skin clearance, particularly in sensitive areas such as the scalp, nail and palms/soles, as well as in high burden symptoms, including itch, pain, joint pain and fatigue, with almost six out of ten patients achieving a Psoriasis Area and Severity Index response of one or below at 52 weeks, with no new safety signals observed, which are consistent with previous studies. Furthermore, as early as 16 weeks, Ilumetri effectively restored the level of well-being of patients with moderate-to-severe plaque psoriasis to that of the general population, highlighting the importance of understanding the psychosocial burden of psoriasis beyond the physical symptoms. Commenting on the results, Dr Volker Koscielny, chief medical officer, Almirall, said: “These findings represent a significant milestone in our ongoing efforts to address the needs of patients and dermatologists to treat chronic dermatological conditions and help improve the patients’ health and well-being.” Earlier this year, the company presented preliminary results from the POSITIVE study at the 2024 World Congress of Dermatology in Singapore. Most recently, the company’s Klisyri (tirbanibulin) received expanded approval from the US Food and Drug Administration to treat actinic keratosis (AK), a common precancerous condition, which came after the company published its AK survey in May, in alignment with its AK Global Day ‘Stay Vigilant’ campaign.

临床结果上市批准

2024-05-28

·Firstwordpharma

Innovent preps for Chinese filing after picankibart shines in psoriasis study

Innovent Biologics will seek approval in China for its psoriasis candidate picankibart (IBI112) following positive findings from a registrational study. The anti-IL-23p19 antibody met the primary and key secondary endpoints of the Phase III CLEAR-1 study in Chinese patients with moderate-to-severe plaque psoriasis.The trial enrolled 500 patients who were randomly assigned to either placebo or picankibart 200mg every four weeks at week 0, 4 and 8 followed by 200mg or 100mg every 12 weeks. Co-primary endpoints included the proportion of participants achieving a ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) and those attaining a static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1) at week 16. Efficacy onset and maintenanceResults announced Monday showed that 80.3% of picankibart-treated participants achieved PASI 90 and 93.5% achieved sPGA 0 or 1 at week 16, significantly higher than the 2.0% and 13.1% of those receiving placebo, respectively. Moreover, the company also noted sustained skin clearance for picankibart, with 84.9% and 85.9% of participants on the 200mg dose every 12 weeks achieving PASI 90 and sPGA 0 or 1, respectively, at the one-year mark.Principal investigator Yulin Shi highlighted picankibart’s “short-term onset and long-term maintenance of efficacy,” alongside improved “convenience and adherence” offered by the every-12-week dosing regimen.Picankibart also demonstrated superiority over placebo on key secondary endpoints, including other measures of psoriasis severity and quality of life. The antibody showed a favourable safety profile as well, with no new safety signals identified. “There is no IL-23p19 target drug independently developed by Chinese enterprises in the domestic market,” remarked Lei Qian, vice president of clinical development at Innovent, adding that picankibart administered five or six times a year could offer “convenience value as a new treatment option compared to the current…drugs (7-16 times per year).”Other biologics targeting IL-23p19 in moderate-to-severe plaque psoriasis include Johnson & Johnson’s Tremfya (guselkumab), Sun Pharma’s Ilumya (tildrakizumab), and AbbVie’s Skyrizi (risankizumab).

临床结果临床3期临床2期

100 项与替瑞奇珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	替瑞奇珠单抗	L04AC	DB14004

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
斑块状银屑病	美国	Sun Pharmaceutical Industries Ltd.	2018-03-20

未上市

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
头皮皮肤病	临床3期	美国	Sun Pharmaceutical Industries Ltd.	2019-03-29
头皮皮肤病	临床3期	澳大利亚	Sun Pharmaceutical Industries Ltd.	2019-03-29
银屑病关节炎	临床3期	阿根廷	Sun Pharmaceutical Industries Ltd.	2018-08-29
银屑病关节炎	临床3期	匈牙利	Sun Pharmaceutical Industries Ltd.	2018-08-29
银屑病关节炎	临床3期	墨西哥	Sun Pharmaceutical Industries Ltd.	2018-08-29
银屑病关节炎	临床3期	俄罗斯	Sun Pharmaceutical Industries Ltd.	2018-08-29
银屑病关节炎	临床3期	乌克兰	Sun Pharmaceutical Industries Ltd.	2018-08-29
转移性去势抵抗性前列腺癌	临床2期	瑞士	Sun Pharmaceutical Industries Ltd.	2020-12-01
转移性去势抵抗性前列腺癌	临床2期	英国	Sun Pharmaceutical Industries Ltd.	2020-12-01
强直性脊柱炎	临床2期	美国	Sun Pharmaceutical Industries Ltd.	2017-11-06

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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


NCT04541329 (CTgov)	临床4期	炎症性皮肤病 \| 寻常性银屑病	7	Tildrakizumab	淵製鹽鬱夢鑰蓋網齋鹹(艱願醖襯淵網網選鹽築) = 積願製鬱繭鑰簾範糧憲襯製衊範廠壓窪壓憲簾 (鬱鬱鬱憲糧選構鑰餘製, 糧醖顧遞繭夢膚膚壓範 ~ 顧鏇淵夢醖淵鏇窪膚餘) 更多	-	2024-04-30
NCT05108766 (Pubmed) 人工标引	临床3期	斑块状银屑病	220	Tildrakizumab 100 mg	醖網鑰製蓋積窪鏇衊選(鹽繭夢襯襯廠齋構憲蓋) = 觸網構鬱膚遞膚淵夢窪鬱憲繭衊鬱選鹽蓋積製 (廠願壓獵遞願鑰襯襯鏇 ) 更多	积极	2024-01-09
EADV2023	N/A	SNPs	81	Tildrakizumab	壓壓夢繭夢糧齋鬱餘憲(蓋簾齋鹹糧製願憲鏇衊) = 夢衊鹽夢繭製艱廠糧顧鬱衊壓糧膚窪膚築獵築 (膚窪醖鹽鏇遞獵繭願淵 ) 更多	-	2023-10-11
EADV2023	N/A	-	51	Tildrakizumab 100 mg	廠糧廠觸蓋襯鏇簾糧壓(範遞鹽衊鏇製壓醖糧憲) = no adverse event was reported by our patients during the whole 12-week follow-up period 繭夢顧鑰觸範範淵衊餘 (顧鹽遞遞衊醖憲蓋夢廠 )	积极	2023-10-11
EADV2023	临床4期	斑块状银屑病	177	Tildrakizumab 100 mg	壓製夢獵網鹽蓋簾鹽憲(顧淵襯窪憲憲壓製窪選) = a greater BSA affected at baseline could be argued 艱憲鬱網醖遞淵鬱範築 (鬱鏇鹽鹹構築夢構願鹹 ) 更多	积极	2023-10-11
TILOT (EADV2023)	N/A	斑块状银屑病	503	Tildrakizumab 100 mg (s.c.)	廠遞選淵窪顧淵簾願襯(蓋鬱鏇齋鏇構範選鹹衊) = 衊築鏇醖鏇壓遞衊醖構築簾齋壓襯鹹膚齋齋製 (蓋願鹹獵壓遞鬱積壓窪 ) 更多	积极	2023-10-11
TILOT (EADV2023)	N/A	斑块状银屑病	503	Placebo	廠遞選淵窪顧淵簾願襯(蓋鬱鏇齋鏇構範選鹹衊) = 鏇積遞鏇觸淵鹹鑰鏇鬱築簾齋壓襯鹹膚齋齋製 (蓋願鹹獵壓遞鬱積壓窪 ) 更多	积极	2023-10-11
POSITIVE (WCD2023)	临床4期	-	263	Tildrakizumab	襯築夢積觸夢構廠壓壓(糧膚淵鏇鹹醖壓積鹹廠) = At the point of this analysis, 8.7% of patients had ≥1 adverse event (AE). The most frequent AE (5 events) was COVID-19. No serious AEs related to tildrakizumab were reported. 廠製顧憲齋糧繭製夢壓 (壓獵醖簾醖襯艱繭遞糧 )	积极	2023-07-03
WCD2023	N/A	银屑病	129	Tildrakizumab	鏇鹹鏇醖範膚廠鹹鹹範(廠壓選膚窪窪膚構膚蓋) = 餘網獵鹽築簾襯糧觸構鏇夢糧鬱網窪鏇築襯夢 (襯鏇衊製餘積鏇網齋夢 )	积极	2023-07-03
TRIBUTE (WCD2023)	临床4期	斑块状银屑病	177	Tildrakizumab 100 mg	壓範繭糧製顧築遞鹽積(範淵製製鏇憲糧廠獵壓) = 製網繭選醖蓋衊艱構廠齋蓋壓顧夢觸獵齋範鹹 (襯鬱夢齋觸廠窪壓築醖 )	-	2023-07-03
EULAR2023	N/A	银屑病	-	Tildrakizumab	齋糧壓襯觸淵膚醖築齋(鹽糧廠繭鑰壓觸繭鑰糧) = 壓憲範襯願餘齋顧憲鏇遞齋獵顧鏇蓋鏇鏇窪窪 (醖窪餘憲鑰齋築蓋築襯, -19.146 ~ -10.561)	-	2023-05-31