A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis

This is a Phase 3, long term extension study to evaluate the safety and efficacy of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

开始日期2022-04-21

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT05352893

/ Completed临床3期

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

开始日期2022-04-14

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT04856930

/ Completed临床2期

A Phase 2, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With Hidradenitis Suppurativa

Efficacy and safety of imsidolimab (ANB019) in participants with Hidradenitis Suppurativa

开始日期2021-07-07

申办/合作机构

Vanda Pharmaceuticals, Inc.

100 项与 Imsidolimab 相关的临床结果

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100 项与 Imsidolimab 相关的转化医学

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100 项与 Imsidolimab 相关的专利（医药）

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项与 Imsidolimab 相关的文献（医药）

2026-04-28·NEJM evidence

Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis

Article

作者: Randazzo, Bruce ; Dahl, Martin ; Parmley, Stephen ; Johnson, Caroline ; Lizzul, Paul ; Brzezynski, Jennifer ; Birznieks, Gunther ; Tyner, Christina ; Bachelez, Hervé ; Polymeropoulos, Christos ; Bushman, Margaret ; Xiao, Changfu ; Polymeropoulos, Mihael ; Saikali, Khalil ; Gudjonsson, Johann E. ; Severtson, Anne ; Yap, Evelyn Wen Yee ; Denguezli, Mohamed ; Borlu, Murat ; Przychodzen, Bartlomiej ; Smieszek, Sandra ; Reich, Adam ; Chaowattanapanit, Suteeraporn ; Raina, Priya

BACKGROUND:

Generalized pustular psoriasis (GPP) is a rare, life-threatening disease attributed to aberrant interleukin-36 (IL-36) activity, often due to variants in the IL-36 receptor antagonist gene. Imsidolimab is a novel, humanized, affinity-matured immunoglobulin G4 monoclonal antibody that binds the IL-36 receptor and antagonizes IL-36 signaling.

METHODS:

Two phase 3 trials were conducted at 26 clinical sites within 11 countries investigating imsidolimab treatment for GPP. GEMINI-1 was a double-blind, placebo-controlled trial that randomly assigned 45 patients (18-80 years of age) with a GPP flare to receive either a single intravenous dose of 300 mg of imsidolimab, 750 mg of imsidolimab, or placebo. The primary endpoint was GPP Physician Global Assessment (GPPPGA) scores of clear (0) or almost clear (1) at week 4 (range: 0 [clear] to 4 [severe]; minimally clinically important difference, 1.4). GEMINI-2 was a follow-on relapse prevention trial with a primary objective of evaluating the safety of imsidolimab up to 104 weeks. Patients who improved with treatment in GEMINI-1 were randomly assigned to receive either 200 mg of subcutaneous imsidolimab or placebo monthly, whereas partial responders received open-label 200 mg of subcutaneous imsidolimab monthly.

RESULTS:

In GEMINI-1, 53% of patients in the groups that received either 300 mg (n=8/15) or 750 mg (n=8/15) of imsidolimab had GPPPGA scores of 0 or 1 at week 4, compared to 13% in the placebo group (n=2/15) (P=0.023 for both the 300 mg vs. placebo comparison and 750 mg vs. placebo comparison). In GEMINI-2, no serious adverse events led to imsidolimab discontinuation.

CONCLUSIONS:

Compared with placebo, a significantly higher proportion of patients with GPP randomly assigned to receive a single intravenous dose of imsidolimab were clear or almost clear of the disease after 4 weeks based on the GPPPGA. There were no serious adverse events that led to treatment discontinuation with imsidolimab up to 104 weeks of treatment. (Funded by AnaptysBio; ClinicalTrials.gov number, NCT05352893 for GEMINI-1 and NCT05366855 for GEMINI-2.).

2024-05-01·American journal of clinical dermatology

Small-Molecule Inhibitors and Biologics for Palmoplantar Psoriasis and Palmoplantar Pustulosis: A Systematic Review and Network Meta-Analysis

Review

作者: Wu, Po-Chien ; Huang, Yu-Huei ; Huang, I-Hsin ; Chiu, Hsien-Yi

BACKGROUND:

The comparative efficacy of biologics and small-molecule inhibitors in treating palmoplantar psoriasis (PP) and palmoplantar pustulosis (PPP) remains uncertain.

OBJECTIVE:

The aim was to perform a systematic review and network meta-analysis (NMA) to compare the efficacy of biologics and small-molecule inhibitors for the treatment of PP and PPP.

METHODS:

MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched for eligible studies from inception to May 13, 2023. This NMA was conducted and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension Statement for Network Meta-Analyses guidelines. Frequentist random-effects models NMA was performed with the surface under the cumulative ranking curve calculated for ranking. Our primary outcome was the proportion of patients achieving a clear/minimal Palmoplantar Psoriasis/Pustulosis Physician Global Assessment score (PPPGA 0/1 or PPPPGA 0/1) response at 12-16 weeks. Secondary outcomes consisted of the percentage of overall improvement in palmoplantar score and of improvement ≥ 75%, at 12-16 weeks.

RESULTS:

The study comprised a total of 29 randomized controlled trials (RCTs), involving 4798 psoriasis patients with palmoplantar diseases. For PP, 16 RCTs with nine different treatments, including adalimumab, apremilast, bimekizumab, etanercept, guselkumab, infliximab, ixekizumab, secukinumab, and ustekinumab were included for the analysis. In the NMA of PP, secukinumab 300 mg ranked highest (odds ratio [OR] 33.50, 95% confidence interval [CI] 4.37-256.86) in achieving PPPGA 0/1, followed by guselkumab 100 mg (OR 18.68, 95% CI 10.07-34.65). In the case of PPP, seven RCTs with six treatments, including apremilast, etanercept, guselkumab, imsidolimab, spesolimab, and ustekinumab, were included for the analysis. In the NMA of PPP, although no treatment demonstrated a significant difference compared to placebo in achieving PPPPGA 0/1, guselkumab 100 mg showed the greatest statistically significant improvement in the palmoplantar score (weighted mean difference 31.73, 95% CI 19.89-43.57) as a secondary outcome.

CONCLUSION:

Among all available biologics and small-molecule inhibitors, secukinumab 300 mg and guselkumab 100 mg had the most favorable efficacy in treating PP and PPP, respectively.

2024-04-01·Journal of the American Academy of Dermatology

The expanding horizon of anti-IL-36 therapy

作者: Heymann, Warren R

A review.The IL-36 signaling pathway dermatol. revolution is underway.This pathway is key in the pathogenesis of generalized pustular psoriasis (GPP).The IL-36 receptor (IL-36R) antagonist spesolimab effectively manages GPP, rapidly controlling GPP flares and preventing their recurrence.A phase II trial of imsidolimab, a humanized IgG4 monoclonal antibody specifically binding IL-36R, demonstrated a rapid resolution of pustular eruptions in GPP patients.In this issue of the Journal of the American Academy of Dermatol. , the National Psoriasis Foundation asserts that 'GPP is a life-threatening disease that needs to be treated as quickly as possible'.A controversial point regarding spesolimab focuses on (whether) screening for tuberculosis should be performed when the drug has been prescribed.Ahmad et al state that 'IL-36 comprises 4 isoforms: the proinflammatory IL-36α, IL-36β, and IL-36γ, and the anti-inflammatory IL-36R antagonist.An imbalance between proinflammatory and anti-inflammatory IL-36 isoforms can contribute to the inflammatory fate of cells and tissues.Cutaneous IL-36 signaling is crucial for the immunopathol. outcome of various skin diseases.Consequently, the IL-36/IL-36R axis has recently been recognized as a promising drug target for the treatment of inflammatory disorders beyond psoriasis.A safe prediction is that IL-36 antagonists will be broadly used in medical dermatol. beyond the realm of GPP.

132

项与 Imsidolimab 相关的新闻（医药）

2026-07-16

·PRNewswire

Vanda Pharmaceuticals Announces EMA Positive Opinion for Orphan Drug Designation of Imsidolimab for Generalized Pustular Psoriasis - A Milestone Recognition of GPP as a Distinct Rare Disease in Europe

WASHINGTON, July 16, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the Committee for Orphan Medicinal Products at the European Medicines Agency (EMA) has adopted a positive opinion recommending orphan drug designation for imsidolimab, the company's investigational medicinal product, a high-affinity humanized immunoglobulin G4 (IgG4) monoclonal antibody, for the treatment of generalized pustular psoriasis (GPP). This marks the first time the EMA has granted orphan drug designation recognition for a drug to treat GPP in the European Union (EU). GPP is a severe, chronic, and potentially life-threatening inflammatory skin disease, genetically and clinically distinct from plaque psoriasis, driven by dysregulation in the interleukin-36 (IL-36) signaling pathway.1 It is characterized by widespread pustular eruptions, systemic inflammation, and serious complications that can lead to increased mortality.234 Imsidolimab inhibits IL-36 receptor signaling, addressing the deficiency in the endogenous IL-36 receptor antagonist commonly observed in patients with GPP. The EMA's orphan drug designation is granted to medicines intended for the treatment of life-threatening or chronically debilitating rare conditions affecting fewer than 5 in 10,000 people in the EU. Benefits include protocol assistance, reduced regulatory fees, and market exclusivity provisions in the EU following approval. "The EMA's positive opinion is a significant milestone that reinforces the highly encouraging clinical data supporting the imsidolimab program and formally recognizes GPP as an orphan disease in the EU for the first time," said Dr. Mihael H. Polymeropoulos, "This designation highlights the urgent unmet medical need in GPP and brings us one step closer to delivering a meaningful new therapy to patients in the EU." This designation follows similar regulatory recognitions in the United States and Japan. Additionally, the imsidolimab Biologics License Application (BLA) for GPP is currently under review by the FDA with a target action date of December 12, 2026. References Smieszek, S. et al. Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis. NEJM Evidence 5, (2026). Ministry of Health Labour and Welfare (MHLW), "Pustular psoriasis (generalized type) (Designated Intractable Disease 37)," Japan Intractable Diseases Information Center. Accessed: Mar. 10, 2026. [Online]. Available: H. Fujita, R. Iwasaki, S. Tsuboi, Y. Murashiuma, and M. Akiyama, "Regional differences in the prevalence of generalized pustular psoriasis in Japan," J. Dermatol., vol. 51, no. 3, pp. 380–390, Mar. 2024, doi: 10.1111/1346-8138.17089. H. Miyachi et al., "Treatments and outcomes of generalized pustular psoriasis: A cohort of 1516 patients in a nationwide inpatient database in Japan," J. Am. Acad. Dermatol., vol. 86, no. 6, pp. 1266–1274, Jun. 2022, doi: 10.1016/j.jaad.2021.06.008. About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS Various statements in this press release, including but not limited to statements regarding the potential benefits associated with EMA approval of an orphan drug, the therapeutic potential of imsidolimab for patients with GPP in the EU, and the anticipated timing of the completion of the FDA's review of the imsidolimab BLA are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to obtain approval of, and to successfully commercialize, imsidolimab in the EU for the treatment of patients with GPP, Vanda's ability to satisfy the conditions necessary to receive the benefits associated with EMA approval of an orphan drug, and the FDA's ability to complete its review of, and reach a decision with respect to, the imsidolimab BLA by December 12, 2026. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] Follow us on X @vandapharma SOURCE Vanda Pharmaceuticals Inc. 21% more press release views with Request a Demo

2026-07-13

·知乎专栏

从打针到口服！盘点2026银屑病新药上市、医保调价、前沿临床等动向

【科学战银前言】如今，银屑病的治疗已经进入靶向治疗时代，生物制剂和小分子药物的应用显著改善了中重度银屑病患者的生活质量。我国批准上市并已用于治疗银屑病的生物制剂包括TNF-α抑制剂、IL-12/23抑制剂、IL-23抑制剂、IL-17A抑制剂及IL-36 抑制剂五大类；小分子药物包括PDE4抑制剂、JAK抑制剂等不同环节共两类药物。2026年上半年，银屑病在新药上市、医保准入、基药配备与临床研发上，均有新动向。本文将按照靶点梳理相关资讯。IL-17A靶点⭕️ IL-17赛道在2026年上半年迎来多款国产新药上市，时间线也很密集。⭕️ 2026年1月1日：赛立奇单抗（金立希®）、夫那奇珠单抗（安达静®）正式执行医保新价，分别为756元/支、743.5元/支，医保价用于中重度斑块状银屑病及强直性脊柱炎成人患者。⭕️ 2026年2月13日：三生国健安沐奇塔单抗（益赛拓®）获NMPA批准用于成人中重度斑块状银屑病，是首个维持期可每8周给药一次的IL-17A抑制剂。同年6月29日通过国家医保目录外初步形式审查。⭕️ 2026年3月27日：优时比比奇珠单抗（倍捷乐®）获NMPA批准新增适应症—成人中重度斑块状银屑病及中重度化脓性汗腺炎，是全球首个IL-17A/F双靶点生物制剂。目前也通过了医保目录外初步形式审查。⭕️ 2026年6月11日：康方生物古莫奇单抗（奇佑康®）获NMPA批准用于成人中重度斑块状银屑病，维持期每月仅需1针，进一步提升PASI 100应答率；因获批时间在6月10日申报截止后，列入2026年医保目录外预申报名单。⭕️ 另外，司库奇尤单抗生物类似药：百奥泰BAT2306、石药SYS6012也相继申报上市，均获NMPA受理。⭕️ 临床方面，口服IL-17A抑制剂研发正在开始发力推进，多项临床研究在开展。有望革新IL-17A靶向治疗方式。IL-23靶点⭕️ 2025年11月：信达生物匹康奇拜单抗（信美悦®）获NMPA批准上市；2026年正式商业化上市，维持期每12周给药一次，是国产首个IL-23 p19单抗。2026年6月26日获中国澳门药监局批准上市；2026年6月29日通过国家医保目录外初步形式审查。⭕️ 2026年3月：强生Icotrokinra（ICOTYDE），获美国FDA批准上市，用于≥12岁、体重≥40kg中重度斑块状银屑病的治疗，是全球首款口服IL-23受体拮抗剂，实现了IL-23从注射到口服的剂型突破；目前正开展成人银屑病关节炎Ⅲ期临床。IL-12/23靶点⭕️康方生物自主研发的国内首款IL-12/23 抑制剂依若奇单抗（爱达罗®），2026年1月1日执行医保价，用于中重度斑块状银屑病成人患者。医保价为3830元/支。⭕️ 2026年5月21日—22日，乌司奴单抗国产类似药，连发批件：华东医药（克罗恩病）、百奥泰（同原研药适应症）、石药集团恩益克（斑块状银屑病）相继获批。其他靶向生物制剂+小分子靶向药⭕️IL-36R（脓疱型）：2026年2月25日，AnaptysBio的IL-36抑制剂Imsidolimab获FDA受理BLA（加速通道）；正大天晴研发的TQH2929国产IL-36抑制剂正开展泛发性脓疱型银屑病Ⅱ期临床。⭕️ 2026年6月15日，口服靶向药TYK2抑制剂氘可来昔替尼（颂狄多®），获NMPA新增成人银屑病关节炎适应症，并通过2026年6月29日医保目录内新增适应症预申报。⭕️ TYK2同靶点抑制剂，武田Zasocitinib、Alumis EnvudeucitinibⅢ期取得积极数据。⭕️ 国产TYK2抑制剂，如诺诚健华ICP-488（Ⅲ期完成）、益方生物D-2570、文达医药WD-890、翰森HS-10374、正大天晴TQH3906临床均进行至Ⅲ期，或即将完成。⭕️ 2026年7月9日：卫健委发布《国家基本药物目录（2026年版）》，TNF-α抑制剂阿达木单抗和JAK抑制剂托法替布明确纳入，并在9月1日施行，即医疗机构优先配备和使用的药物，在一些基层医院也能买到，进一步解决“能不能买到”的问题。总结2026 年上半年银屑病靶向药迎来密集突破，五大生物靶点、两类口服小分子均有更新，国产创新药也在快速前进，医保准入、基药下沉等政策进一步打通临床用药通道，为银屑病患者提升用药可及性。长效单抗、口服小分子成为研发主流方向。现阶段多项靶向药国内多中心 III 期临床持续发力。感谢阅读，希望内容能对你有所帮助！参考文献1.国家药品监督管理局.关于批准安沐奇塔单抗注射液（益赛拓®）上市公告.2026-02-13；关于批准古莫奇单抗注射液（奇佑康®）上市公告. 2026-06-11；关于比奇珠单抗注射液（倍捷乐®）新增适应症批件. 2026-03-27.2.国家医疗保障局.关于通过2026年国家基本医疗保险、生育保险和工伤保险药品目录及商保创新药目录调整初步形式审查的药品及相关信息的公示2026-06-29.3.国家药品监督管理局.关于批准氘可来昔替尼片（颂狄多®）新增银屑病关节炎适应症批件2026-06-15.4. Johnson & Johnson. FDA Approves Icotrokinra (ICOTYDE™) for Moderate-to-SeverePlaque Psoriasis[EB/OL]. 2026-03-18.5.Vanda Pharmaceuticals. FDA Accepts BLA for Imsidolimab for Generalized PustularPsoriasis (GPP)[EB/OL]. 2026-02-25.6.中华医学会皮肤性病学分会银屑病专业委员会.中国银屑病生物制剂及小分子药物治疗指南(2024版)[J].中华皮肤科杂志, 2024, 57(11):976-997.

上市批准临床3期生物类似药申请上市

2026-07-06

·知乎专栏

2026年上半年银屑病新药进展汇总（上市·医保·临床）

伊顿健康前言：2026年已过去半年，过去半年国内银屑病领域快速发展，生物制剂和小分子靶点药又迎来了不少新药和临床突破，本文就这些新药的上市、医保、临床等等信息进行了汇总。银屑病生物制剂类上市信息与医保进展⭕️ 2026年1月1日，IL-17A抑制剂赛立奇单抗和夫那奇珠单抗，以及IL-12/23抑制剂依若奇单抗正式执行医保价。⭕️ 匹康奇拜单抗（信美悦®）：由信达生物研发的国产首个IL-23 p19单抗，2025年11月获NMPA批准，2026年正式商业化上市，实现维持期每12周给药一次的突破。6月26日，另外获得中国澳门特别行政区药品监管部门批准上市。目前，匹康奇拜单抗，针对青少年银屑病和银屑病关节炎的临床正在进行中。⭕️ 安沐奇塔单抗（益赛拓®）：三生国健研发的国产新一代IL-17A人源化单抗，2026年2月13日，获NMPA批准用于成人中重度斑块状银屑病，首个维持期可每8周给药一次的IL-17A抑制剂。⭕️ 比奇珠单抗（倍捷乐®）：优时比研发，全球首个IL-17A/F双靶点生物制剂，2026年3月27日，获NMPA批准新适应症，成人中重度斑块状银屑病及成人中重度化脓性汗腺炎适应症。⭕️ 古莫奇单抗（奇佑康®）：由康方生物研发的IL-17A人源化单抗，2026年6月11日，获NMPA批准用于成人中重度斑块状银屑病，维持期每月仅需1针，提升了PASI 100的应答率。⭕️ 乌司奴单抗国产类似药，2026年5月21日—22日，三天之内NMPA连发批件：华东医药→ 克罗恩病适应症获批百奥泰→ 同药同剂型同步获批石药集团（恩益克®）→ 斑块状银屑病适应症获批⭕️ 司库奇尤单抗生物类似药：百奥泰BAT2306、石药SYS6012相继申报上市申请获NMPA受理，预计进一步压低IL-17A类药物用药成本。⭕️6月29日，国家医疗保障局发布《关于通过2026年国家基本医疗保险、生育保险和工伤保险药品目录及商保创新药目录调整初步形式审查的药品及相关信息的公示》。其中匹康奇拜单抗、安沐奇塔单抗、比奇珠单抗均已通过2026年国家医保目录外药品初步形式审查；古莫奇单抗列入2026年医保目录外预申报名单。银屑病小分子类上市信息和医保进展⭕️氘可来昔替尼（颂狄多®）：由百时美施贵宝研发的选择性TYK2抑制剂，2026年6月15日，新增成人银屑病关节炎的适应症。并通过2026年国家医保目录外药品初步形式审查。⭕️强生首个口服IL-23受体拮抗剂Icotrokinra（Icotyde®），于2026年3月获美国FDA批准上市，用于≥12岁、体重≥40kg青少年患者及中重度斑块状银屑病成人患者。该药的获批实现了IL-23靶向抑制剂从注射给药到口服给药的剂型突破。现在，关于Icotrokinra，为进一步拓展适应症，针对成人银屑病关节炎，正在开展 III期临床研究。前沿临床汇总⭕️从以上的资讯来看，IL-17A靶向赛道很卷，是目前银屑病领域上市最多的靶向药，基于首个IL-23靶向抑制剂，已成功上市，所以口服剂型可能会是IL-17A靶向研发的新方向。截至2026年上半年，口服IL-17A抑制剂已有多项研究在开展，比如，礼来开发的Simepdekinra（LY4100511）治疗中重度斑块状银屑病处于Ⅱ期临床；歌礼制药ASC50、祐森健恒UA026（口服IL-17A小分子）、诺诚健华ICP-054（口服IL-17A/AF抑制剂）均处于Ⅰ期或Ⅱ期临床阶段。⭕️IL-17和IL-23靶点是目前银屑病治疗的主流选择，目前已上市的IL-23的生物制剂仅三款，包括古塞奇尤单抗、替瑞奇珠单抗、匹康奇拜单抗。针对这一靶点的打针间隔时间长特点，临床上也仍有新药在发力，如齐鲁制药的IL-23抑制剂QL2106注射液针对中重度银屑病成人患者，正在开展与古塞奇尤单抗头对头的Ⅲ期临床。⭕️银屑病小分子靶向药未来的研发方向，TYK2靶向可能是研发重点。多款新药研发数据发布，如武田的zasocitinib、Alumis的Envudeucitinib的Ⅲ期临床均取得积极结果。⭕️还有多项TYK2抑制剂的口服研究Ⅲ期临床已结束或者正在推进。⭕️针对脓疱型银屑病，目前在国内上市的药物仅一款佩索利单抗，价格较高，市场有待继续开发。2026年2月，美国AnaptysBio公司研发的IL-36抑制剂Imsidolimab获FDA受理BLA，走加速通道。国产IL-36抑制剂，也在加快发展，正大天晴的TQH2929注射液，针对泛发性脓疱型银屑病正在开展II期临床研究。如需参与相关临床用药、了解更多前沿资讯，看下图右上角。以上是对2026年上半年银屑病新药进展的一些总结，越来越多的新药上市，从“有什么选择”到“更精准的靶向选择”，原有银屑病一线治疗的生物制剂也在向口服靶向研发，银屑病的治疗将进一步根据个性化方案进行匹配。感谢阅读，希望内容能对你有所帮助！参考文献1.国家药品监督管理局.关于批准安沐奇塔单抗注射液（益赛拓®）上市公告. 2026-02-13；关于批准古莫奇单抗注射液（奇佑康®）上市公告. 2026-06-11；关于比奇珠单抗注射液（倍捷乐®）新增适应症批件. 2026-03-27.2.国家医疗保障局.关于通过2026年国家基本医疗保险、生育保险和工伤保险药品目录及商保创新药目录调整初步形式审查的药品及相关信息的公示2026-06-29.3.国家药品监督管理局.关于批准氘可来昔替尼片（颂狄多®）新增银屑病关节炎适应症批件2026-06-15.4.Johnson & Johnson. FDA Approves Icotrokinra (ICOTYDE™) for Moderate-to-Severe Plaque Psoriasis[EB/OL]. 2026-03-18.5.Vanda Pharmaceuticals. FDA Accepts BLA for Imsidolimab for Generalized Pustular Psoriasis (GPP)[EB/OL]. 2026-02-25.6.中华医学会皮肤性病学分会银屑病专业委员会.中国银屑病生物制剂及小分子药物治疗指南(2024版)[J].中华皮肤科杂志, 2024, 57(11):976-997.

上市批准生物类似药

100 项与 Imsidolimab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11892	-	-	-

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
泛发性脓疱型银屑病	申请上市	美国	Vanda Pharmaceuticals, Inc.	2025-12-17
化脓性汗腺炎	临床2期	美国	AnaptysBio, Inc.	2021-07-07
化脓性汗腺炎	临床2期	美国	Vanda Pharmaceuticals, Inc.	2021-07-07
化脓性汗腺炎	临床2期	加拿大	Vanda Pharmaceuticals, Inc.	2021-07-07
化脓性汗腺炎	临床2期	加拿大	AnaptysBio, Inc.	2021-07-07
化脓性汗腺炎	临床2期	格鲁吉亚	AnaptysBio, Inc.	2021-07-07
化脓性汗腺炎	临床2期	波兰	AnaptysBio, Inc.	2021-07-07
化脓性汗腺炎	临床2期	波兰	Vanda Pharmaceuticals, Inc.	2021-07-07
寻常痤疮	临床2期	美国	Vanda Pharmaceuticals, Inc.	2021-05-15
寻常痤疮	临床2期	加拿大	Vanda Pharmaceuticals, Inc.	2021-05-15

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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


NCT05352893 \| NCT05366855 (GEMINI-2, Pubmed \| NEJM Evid)	临床3期	泛发性脓疱型银屑病	45	Imsidolimab 300 mg	膚範鏇製鹽製壓獵鹹淵(夢觸壓築鏇鏇築簾願構) = 鏇衊顧膚鹽遞範餘選遞襯鹽獵衊廠積繭糧鹹壓 (襯築構餘範簾鑰蓋築顧 )	积极	2026-04-28
				Imsidolimab 750 mg	膚範鏇製鹽製壓獵鹹淵(夢觸壓築鏇鏇築簾願構) = 鑰鏇鬱網膚顧觸壓艱鹽襯鹽獵衊廠積繭糧鹹壓 (襯築構餘範簾鑰蓋築顧 )
NCT05366855 (GEMINI-2, CTgov)	临床3期	泛发性脓疱型银屑病	42	imsidol (ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC)	壓廠鑰夢憲鏇築鬱築鏇 = 醖積製積齋艱網夢築築鏇簾鹹膚願憲窪簾蓋構 (鹹簾鑰醖壓蓋淵顧蓋襯, 繭觸廠顧繭廠醖鏇鏇選 ~ 襯醖製簾積範壓願窪鏇) 更多	-	2026-03-27
				Placebo (ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC)	壓廠鑰夢憲鏇築鬱築鏇 = 鹽鹹範繭鏇糧鹽積鹽壓鏇簾鹹膚願憲窪簾蓋構 (鹹簾鑰醖壓蓋淵顧蓋襯, 壓觸憲觸餘繭衊憲廠衊 ~ 窪廠壓壓艱選願觸襯憲) 更多
NCT05352893 (GEMINI1 \| GEMINI-1, CTgov)	临床3期	泛发性脓疱型银屑病	45	Placebo	齋襯觸鏇蓋顧夢艱夢膚 = 醖淵獵繭襯簾簾願鏇糧糧鏇醖蓋鏇選淵襯築鬱 (繭觸網鑰廠鏇鹽齋遞淵, 顧餘齋廠糧蓋遞選範積 ~ 廠夢構鹹壓簾蓋衊構夢) 更多	-	2026-03-17
NCT04856930 (CTgov)	临床2期	化脓性汗腺炎	149	Imsidolimab (Placebo-Controlled Period: Imsidolimab 400/200 mg)	壓鬱獵積鑰選鏇範鹹鏇(齋獵夢鏇醖鑰選選遞蓋) = 衊淵遞襯齋構遞廠夢積艱糧憲鹹構遞鑰簾餘糧 (醖蓋繭艱觸蓋選遞夢簾, 6.05) 更多	-	2025-09-22
				Imsidolimab (Placebo-Controlled Period: Imsidolimab 200/100 mg)	壓鬱獵積鑰選鏇範鹹鏇(齋獵夢鏇醖鑰選選遞蓋) = 憲鏇願蓋憲鏇衊艱顧壓艱糧憲鹹構遞鑰簾餘糧 (醖蓋繭艱觸蓋選遞夢簾, 4.63) 更多
NCT05352893 (GEMINI1, GlobeNewswire) 人工标引	临床3期	泛发性脓疱型银屑病	45	Imsidolimab 750mg (GEMINI-1)	遞艱鏇襯夢襯襯網願夢(繭鬱鏇衊繭積醖顧餘襯) = 網淵製顧餘構簾築鹽夢鹹憲鹽鏇遞觸淵鹹觸鬱 (鑰糧鑰蓋繭壓憲鬱鏇顧 )	积极	2024-05-09
				Imsidolimab 300mg (GEMINI-1)	遞艱鏇襯夢襯襯網願夢(繭鬱鏇衊繭積醖顧餘襯) = 顧鹽鏇鑰範艱鏇築構選鹹憲鹽鏇遞觸淵鹹觸鬱 (鑰糧鑰蓋繭壓憲鬱鏇顧 )
NCT05366855 (GEMINI-2, GlobeNewswire) 人工标引	临床3期	泛发性脓疱型银屑病维持	16	imsidolimab (GEMINI-2 + GPPPGA 0/1 responder patients from GEMINI-1)	膚願積膚選夢獵選簾艱(築鑰製淵壓製衊壓簾選) = 膚網鹽遞鏇壓選積構構簾淵製衊鏇構廠繭廠廠 (鏇鏇鑰獵夢醖觸襯淵膚 )	积极	2024-05-09
NCT05352893 (GEMINI1, Corporate Publications) 人工标引	临床3期	泛发性脓疱型银屑病	45	Imsidolimab	廠鏇窪憲衊艱願鑰遞積(衊糧膚獵鹹構餘齋構衊) = 齋餘醖襯簾蓋窪壓淵艱鏇壓繭選積鹽製鬱鬱範 (繭範鹹膚糧淵糧膚糧繭 ) 达到更多	积极	2023-10-09
				Placebo	廠鏇窪憲衊艱願鑰遞積(衊糧膚獵鹹構餘齋構衊) = 夢壓繭範構積壓網膚蓋鏇壓繭選積鹽製鬱鬱範 (繭範鹹膚糧淵糧膚糧繭 ) 达到
NCT04856917 (CTgov)	临床2期	寻常痤疮	123	Imsidolimab (Imsidolimab 400/200 mg)	膚顧膚積願餘鏇積觸夢(繭顧膚廠膚衊遞餘夢觸) = 壓淵網繭鹽積淵衊憲鹹襯窪醖鹽衊簾襯鏇觸鬱 (齋廠選齋鬱齋鏇糧夢鑰, 13.63) 更多	-	2023-06-15
				Imsidolimab (Imsidolimab 200/100 mg)	膚顧膚積願餘鏇積觸夢(繭顧膚廠膚衊遞餘夢觸) = 顧選觸鹹夢餘網鑰製廠襯窪醖鹽衊簾襯鏇觸鬱 (齋廠選齋鬱齋鏇糧夢鑰, 16.38) 更多
NCT04697056 (CTgov)	临床2期	鱼鳞病	5	Imsidolimab (Imsidolimab)	壓鹽簾遞鑰獵築築鏇願 = 築選製鏇網壓選鬱繭積鬱鬱衊願觸製遞鬱獵憲 (艱餘襯選糧壓選築餘製, 衊獵顧構衊鏇繭鏇簾簾 ~ 鏇製獵網遞鏇觸構積夢) 更多	-	2023-03-02
				placebo (Placebo)	壓鹽簾遞鑰獵築築鏇願 = 鑰鏇膚鹽願淵鹹廠壓選鬱鬱衊願觸製遞鬱獵憲 (艱餘襯選糧壓選築餘製, 獵醖獵憲觸顧鹹淵憲夢 ~ 選鏇築齋衊廠鹽簾築窪) 更多
NCT03633396 (POPLAR, CTgov)	临床2期	手掌和足底脓疱病	59	Placebo (Placebo)	衊夢範廠醖壓憲窪繭糧(鑰齋願鏇遞廠壓繭蓋觸) = 夢鹽窪艱構蓋鑰鬱獵艱範築築鑰淵膚蓋觸壓衊 (選構窪齋製鏇窪鹹蓋築, 1.48) 更多	-	2022-05-31
				Imsidolimab (Imsidolimab)	衊夢範廠醖壓憲窪繭糧(鑰齋願鏇遞廠壓繭蓋觸) = 選齋糧衊觸鹹網鏇壓夢範築築鑰淵膚蓋觸壓衊 (選構窪齋製鏇窪鹹蓋築, 1.46) 更多