A Phase 3, Double-blinded, Vehicle-controlled Trial to Investigate the Efficacy and Safety of Twice Daily Delgocitinib Cream in Adult Participants With Lichen Sclerosus During a 12-Week Initial Treatment Period Followed by a 40-Week Continuation Treatment Period

The main objective of the study is to evaluate the efficacy of twice daily applications of delgocitinib cream compared with cream vehicle in the treatment of adult participants with mild to severe lichen sclerosus (LS). The researchers are focusing on female participants because LS is more likely to affect females compared to males.
The trial is conducted in 2 parts. Part 1 of the trial enrolls female participants with LS and results in the selection of the optimal dose for Part 2. The selected dose will then be evaluated in Part 2, which will enroll both female and male participants. Assessment of efficacy and safety of delgocitinib cream in male participants with LS will be evaluated in a substudy.
For each participant, the trial will last at least 55 weeks and up to 60 weeks.

开始日期2026-05-06

申办/合作机构

Leo Pharma, Inc.

NCT07487948

/ Not yet recruiting临床2期IIT

A Pilot Study to Assess Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris

This study evaluates the safety, tolerability, and biomarker effects of twice-daily topical delgocitinib 2% cream in adults with lichen planopilaris (LPP) or central centrifugal cicatricial alopecia (CCCA) over a 48-week treatment period. Approximately 30 participants will be enrolled: 15 CCCA and 15 LPP. The study will take place at the Icahn School of Medicine at Mount Sinai (ISMMS).

开始日期2026-05-04

申办/合作机构

Icahn School of Medicine at Mount Sinai

[+1]

NCT07203274

/ Not yet recruitingN/AIIT

The Role of Janus Kinase (JAK) and Voltage-gated Sodium Channels (Nav) on Pain and Itch Sensitivity in Healthy Volunteers

It is well known that itch and pain have many communalities in terms of pathways and molecules involved. Therefore, it is very important to investi-gate different substances that work against both pain and itching. The substances delgocitinib and lidocaine have both been shown to relieve various types of pain. We therefore assume that these creams will be also able to relieve itching. The purpose of this trial experiment is therefore to investigate the effect of delgocitinib, lidocaine and their combination on experimentally induced itching.

开始日期2026-05-01

申办/合作机构

University of Aalborg

100 项与德戈替尼相关的临床结果

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100 项与德戈替尼相关的转化医学

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100 项与德戈替尼相关的专利（医药）

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146

项与德戈替尼相关的文献（医药）

2026-04-01·EXPERIMENTAL DERMATOLOGY

Efficacy and Safety of Topical Delgocitinib for Chronic Hand Eczema: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

Review

作者: Piscazzi, Francesco ; Bornia, Maria Júlia Pilau ; de Moraes‐Souza, Rafaela ; Lapenda, Izadora ; Servera‐Negre, Guillermo ; Hernández‐Cano, Natalia ; Sarto, Rubiana ; Mesquita, Yasmin ; Herranz‐Pinto, Pedro ; Chater, Regina Chahine ; de Albuquerque, Matheus Barros

ABSTRACT:

Chronic hand eczema (CHE) is associated with substantial functional impairment and reduced quality of life. Delgocitinib, a pan‐Janus kinase (JAK) inhibitor, has emerged as a promising topical treatment for CHE. A systematic review and meta‐analysis of randomized controlled trials (RCTs) was conducted to assess the efficacy and safety of topical delgocitinib 20–30 mg/g compared with vehicle in patients with CHE. PubMed, Embase, Cochrane Library, ClinicalTrials.gov , EU CTR, and WHO ICTRP were searched up to 15 February 2026. The primary outcome was treatment success at week 16, defined as clear or almost clear skin with a ≥ 2‐point improvement on the Investigator's or Physician's Global Assessment (IGA/PGA). Secondary outcomes included treatment success at weeks 4 and 8, changes in Hand Eczema Symptom Diary (HESD) itch and pain scores, and safety outcomes. Relative risks (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were calculated using random‐effects models. Three publications reporting four RCTs involving 1154 patients were included, with 752 receiving delgocitinib and 402 receiving vehicle. At week 16, treatment success was significantly higher with delgocitinib (RR 3.17; 95% CI 1.78–5.65; p < 0.01), corresponding to an absolute risk difference of 16.9% and a number needed to treat (NNT) of 6 (95% CI 3–16). Similar results at weeks 4 and 8. Delgocitinib also led to significantly greater improvements in HESD itch and pain scores. No significant differences were found in overall adverse events (AEs), treatment‐related AEs, or serious AEs. Discontinuation due to AEs was lower in the delgocitinib group. Delgocitinib 20–30 mg/g demonstrated greater efficacy than vehicle and a favourable safety profile, supporting its use as a topical treatment for CHE.

2026-03-01·JOURNAL OF DERMATOLOGY

Treatment Satisfaction, Efficacy, and Safety of Delgocitinib Ointment Following Switch From Topical Corticosteroids for Trunk and Extremity Rash in Atopic Dermatitis

Article

作者: Igarashi, Atsuyuki ; Saeki, Hidehisa ; Abe, Masatoshi ; Kitajima, Hiroyuki ; Toyama, Hiroyuki ; Kabashima, Kenji

ABSTRACT:

Atopic dermatitis (AD) is a chronic inflammatory disease characterized by recurrent remissions and relapses. Topical anti‐inflammatory steroids are commonly used for treatment, but their long‐term use poses concerns because of potential side effects. Delgocitinib ointment, a Janus kinase inhibitor, has demonstrated efficacy in several clinical studies and is expected to be a viable alternative to topical corticosteroids (TCS). To evaluate the real‐world safety and efficacy of delgocitinib in Japanese patients, we assessed the benefits of switching from TCS to delgocitinib ointment in AD patients with rashes on the trunk and extremities. Overall, data from 93 patients (mean age: 35 years) were analyzed. Patients switched from TCS to delgocitinib ointment and were followed for up to 12 weeks. Treatment outcomes were assessed using the treatment Satisfaction questionnaire for medication‐9 (TSQM‐9), Eczema Area and Severity Index (EASI), modified EASI (mEASI), Numerical Rating Scale (NRS) for itching, Atopic Dermatitis Control Tool (ADCT), and Patient Preference Questionnaire (PPQ). During the observation period, TSQM‐9 scores were significantly improved (effectiveness 68.3 to 72.9, p < 0.05; global satisfaction 61.7 to 67.9, p < 0.01). Additionally, mEASI (8.82 to 6.92, p < 0.05), EASI (9.60 to 7.43, p < 0.001), NRS (5.6 to 4.5, p < 0.001), and ADCT (8.8 to 5.5, p < 0.001) scores were decreased during treatment. Moreover, local side effects were improved, with a > 20% reduction in the severity of skin atrophy and telangiectasia. Approximately 72% of patients reported that “the study drug is more effective” using the PPQ. Taken together, our study demonstrates that delgocitinib ointment is an effective treatment option for AD patients with rashes of the trunk and extremities, as well as for those concerned about the potential side effects of TCS. Trial Registration: The study was registered at the Japan Registry of Clinical Trials (jRCTs031230102).

2026-03-01·AMERICAN JOURNAL OF CLINICAL DERMATOLOGY

Expert Recommendations for the Diagnosis and Management of Chronic Hand Eczema in the United States

Review

作者: Bunick, Christopher G ; Yu, JiaDe ; Simpson, Eric L ; Ehst, Benjamin D ; Stein-Gold, Linda ; Armstrong, April ; Guttman-Yassky, Emma ; Silverberg, Jonathan I ; Begolka, Wendy Smith ; Eichenfield, Lawrence F ; Cohen, David ; Chovatiya, Raj

Chronic hand eczema (CHE) is an inflammatory skin disease localized to the hands and wrists that lasts for more than 3 months or relapses at least twice per year. The diagnosis, treatment, and management of CHE presents clinical challenges owing to its multifactorial etiology, heterogeneous presentation, and the absence of a standardized classification system. In the USA there are no specific International Classification of Disease-10 (ICD-10) diagnostic codes, which makes tracking the diagnosis and resultant treatments difficult. Topical delgocitinib is currently the only Food and Drug Administration approved medication for CHE, for patients who have not responded adequately to, or are unable to use, topical corticosteroids. This article provides an overview of the diagnostic and therapeutic considerations of CHE, while presenting practical recommendations to help improve management of the disease within the USA. Diagnostic assessments focusing on detailed patient history and physical examination are proposed, followed by a multi-step approach to treatment. The importance of both clinician, and patient, reported outcome measures are emphasized, to encompass not only disease presentation and severity, but also the impact on patient quality of life.

191

项与德戈替尼相关的新闻（医药）

2026-04-22

·酷炫z

2025年美国FDA批准新药简析

前言：这几天美国加州宜居城市圣地亚哥正在热闹召开美国癌症研究协会（AACR）2026年度会议，各路大咖纷纷到场。AACR每年发布的前沿成果，尤其是关于新靶点发现、临床前研究数据和早期临床数据，预示了未来癌症治疗的发展方向。AACR年会不仅是全球肿瘤研究领域的权威学术盛会，更是新药审批和临床研发的风向标。圣地亚哥是全球三大生命科学中心之一，在生物技术集中度、资金投入和人才储备方面，与波士顿、旧金山湾区并列为全球生命科学高地。尽管近几年资本市场下滑导致行业普遍裁员，但圣地亚哥仍然是新药研发重镇。 2025年，美国 FDA 药品评价与研究中心（CDER）批准了 46 种此前从未在美国获批或上市的新药，即所谓的创新药物。尽管较2024年的 50 种和2023年的 55 种新药获批数略有下降，但仍延续了高获批数量的趋势。2025年获批的药物包括 34 种新分子实体（NME）和 12 种生物制剂，其中肿瘤（占获批药物总数的35%）和罕见病领域尤为突出。小分子药物仍然占据主导地位（67%），许多小分子药物具有全新的作用机制。主要审批趋势：肿瘤领域领先地位：精准肿瘤治疗，尤其是在非小细胞肺癌 (NSCLC) 领域，是重点关注方向。罕见病领域推进：FDA 批准了 23 种疗法（占总数的 50%）获得孤儿药资格认定，用于治疗罕见且特殊的疾病。生物制剂和先进疗法：生物制剂占获批药物的 26%，其中包括 7 种单克隆抗体 (mAb)，2 种抗体药物偶联物 (ADC)，以及 1 种双特异性抗体。 TIDES药物创新：4 种创新TIDES药物（寡核苷酸和肽）获得批准，占获批药物总数的 9%。审批速度：尽管内部人员流动以及政府停摆对各机构造成影响，FDA 仍保持了高效及时的审批速度，70% 的新药快于其他国家获批上市。 2025年美国新药审批监管分类： 21种（46%）新获批的疗法获得了优先审评资格，这是 FDA 授予那些预期疗效优于现有标准疗法的药物的监管认定。这一比例低于过去五年平均水平57%。获得优先审评资格的药物通常在提交申请后6个月内完成审评，而获得标准审评资格的药物则需要10个月。 23种（50%）新获批的药物获得了孤儿药资格认定，该资格适用于美国境内患病人数少于20万的罕见病。这些药物的申请、资助单位可获得各种激励措施，包括部分临床试验的税收抵免、免除用户费用以及潜在的市场独占权。 15种（33%）新获批的药物获得了突破性疗法资格认定，该资格适用于那些疗效优于现有疗法的药物。这些药物的申请、资助单位可获得与 FDA 更频繁的会面机会，以及在整个药物研发过程中更深入的监管指导。 11种（24%）新药获得了加速审批，其依据是替代终点指标的改善，FDA 认为这些指标“极有可能”预测临床获益。加速审批缩短了新药的整体研发周期。药企需要开展验证性试验，以提供实际临床获益的证据。 2025年美国新药列表: Drug (brand name) Sponsor Properties Indication Datopotamab deruxtecan (Datroway) Daiichi Sankyo TROP2-targeted ADC; topoisomerase inhibitor payload HR-positive, HER2-negative breast cancer Treosulfan (Grafapex) Medexus DNA alkylating drug Preparative regimen for haematopoietic stem cell transplantation for cancers Suzetrigine (Journavx) Vertex NaV1.8 inhibitor Acute pain Mirdametinib (Gomekli) SpringWorks/Merck KGaA MEK1/2 kinase inhibitor Neurofibromatosis type 1 Vimseltinib (Romvimza) Deciphera/Ono CSF1R kinase inhibitor Tenosynovial giant cell tumours Gepotidacin (Blujepa) GSK Triazaacenaphthylene bacterial type II topoisomerase inhibitor Uncomplicated urinary tract infections Fitusiran (Qfitlia) Genzyme/Sanofi Antithrombin-targeted siRNA Bleeding episodes in haemophilia A or B Atrasentan (Vanrafia) Novartis Endothelin receptor antagonist Proteinuria in adults with primary IgAN Penpulimab (Penpulimab) Akeso Biopharma PD1-targeted mAb Nasopharyngeal carcinoma Nipocalimab (Imaavy) Janssen/J&J Neonatal Fc receptor-targeted mAb Generalized myasthenia gravis Avutometinib plus defactinib (Avmapki Fakzynja Co-Pack) Verastem MEK1 inhibitor plus FAK kinase inhibitor KRAS-mutated recurrent low-grade serous ovarian cancer Telisotuzumab vedotin (Emrelis) AbbVie c-Met-targeted ADC; microtubule inhibitor payload Non-squamous NSCLC with high c-Met protein overexpression Acoltremon (Tryptyr) Alcon Labs TRPM8 thermoreceptor agonist Dry eye disease Clesrovimab (Enflonsia) Merck & Co. RSV fusion protein-targeted mAb RSV lower respiratory tract disease prevention in neonates and infants Taletrectinib (Ibtrozi) Nuvation ROS1 kinase inhibitor ROS1-positive NSCLC Garadacimab (Andembry) CSL Behring Activated factor XII-targeted mAb Hereditary angioedema prevention Linvoseltamab (Lynozyfic) Regeneron BCMA × CD3 bispecific T cell engager Multiple myeloma Sunvozertinib (Zegfrovy) Dizal Jiangsu EGFR kinase inhibitor NSCLC with EGFR exon 20 mutations Sebetralstat (Ekterly) KalVista Plasma kallikrein inhibitor Hereditary angioedema attacks Delgocitinib (Anzupgo) Leo Pharma Janus kinase inhibitor Hand eczema Sepiapterin (Sephience) PTC Phenylalanine hydroxylase activator Hyperphenylalaninemia Aceclidine (Vizz) Lenz Cholinergic agonist Presbyopia Dordaviprone (Modeyso) Chimerix/Jazz ClpP protease activator Diffuse midline glioma with H3 K27M mutations Zongertinib (Hernexeos) Boehringer Ingelheim HER2 kinase inhibitor Non-squamous NSCLC with HER2 activating mutations Brensocatib (Brinsupri) Insmed DPP1 inhibitor Non-cystic fibrosis bronchiectasis Donidalorsen (Dawnzera) Ionis Prekallikrein-targeted ASO Hereditary angioedema prevention Rilzabrutinib (Wayrilz) Genzyme/Sanofi BTK kinase inhibitor Immune thrombocytopenia Pembrolizumab plus berahyaluronidase alfa (Keytruda Qlex)a Merck & Co. PD1-targeted mAb and an endoglycosidase to enable subcutaneous delivery Solid tumours approved for the intravenous formulation of pembrolizumab Elamipretide (Forzinity) Stealth Mitochondrial cardiolipin binder Muscle strength in Barth syndrome Imlunestrant (Inluriyo) Eli Lilly Selective oestrogen receptor degrader ER-positive, EGFR2-negative, ER1-mutated breast cancer Paltusotine (Palsonify) Crinetics Somatostatin receptor agonist Acromegaly Remibrutinib (Rhapsido) Novartis BTK kinase inhibitor Spontaneous urticaria Nerandomilast (Jascayd) Boehringer Ingelheim PDE4 inhibitor Idiopathic pulmonary fibrosis Elinzanetant (Lynkuet) Bayer Healthcare NK1 and NK3 receptor antagonist Vasomotor symptoms due to menopause Doxecitine plus doxribtimine (Kygevvi) UCB Pyrimidine nucleosides Thymidine kinase 2 deficiency Ziftomenib (Komzifti) Kura Menin inhibitor AML with a susceptible NPM1 mutation Plozasiran (Redemplo) Arrowhead ApoC-III-targeted siRNA Triglycerides in familial chylomicronemia syndrome Sevabertinib (Hyrnuo) Bayer Healthcare HER2 kinase inhibitor Non-squamous NSCLC with HER2 activating mutations Sibeprenlimab (Voyxact) Otsuka APRIL-targeted mAb Proteinuria in primary IgAN Lerodalcibep (Lerochol) LIB Therapeutics PCSK9-targeted adnectin LDL-C-lowering in hypercholesterolaemia Etripamil (Cardamyst) Milestone Calcium channel blocker Paroxysmal supraventricular tachycardia Zoliflodacin (Nuzolvence) Entasis/Innoviva Spiropyrimidinetrione bacterial type II topoisomerase inhibitor Urogenital gonorrhea due to Neisseria gonorrhoeae Depemokimab (Exdensur) GSK IL-5-targeted mAb Severe asthma, eosinophilic phenotype Aficamten (Myqorzo) Cytokinetics Cardiac myosin inhibitor Obstructive hypertrophic cardiomyopathy Narsoplimab (Yartemlea) Omeros MASP2-directed mAb Haematopoietic stem cell transplant-associated thrombotic microangiopathy Tradipitant (Nereus) Vanda NK1 receptor antagonist Vomiting induced by motion 主要参考资料： 1) Nature Reviews Drug Discovery 25, 163 (2026) 2) Nature Reviews Drug Discovery 25, 81-87 (2026) 3) fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 4) AACR.org

2026-04-20

·药通社

这款独家乳膏，卖爆了！

近期，有一款乳膏，在电商平台销售非常火爆，来自康哲药业的磷酸芦可替尼乳膏。据其新闻稿所言，2026年3月，磷酸芦可替尼乳膏在京东健康上市当天销量就已突破5000+，近15天内，仅京东健康销量就已突破1万+，势头相当迅猛。磷酸芦可替尼乳膏是国内首款用于白癜风治疗的外用JAK抑制剂，2026年1月在国内获批，3月正式开售，售价5800元/支，价格并不算平价，这样的价格还能有这样的销量，可见需求很大。芦可替尼来头不小，全球第一款JAK抑制剂，由INCYTE公司研发，片剂2011年就在美国上市，除美国外的商业和开发由诺华负责，2017年在中国上市。 2021年，芦可替尼乳膏乳膏剂在美国获批，成为首个在美国获批的外用JAK抑制剂，2022年，康哲药业子公司德镁医药与Incyte达成合作，拿下了这款乳膏在中国及东南亚的独家研发、注册及商业化权利，2026年1月在中国获批。从靶点上看，JAK是自免领域当之无愧的大爆靶点，近些年出过多个爆款。比如JAK抑制剂家族当之无愧的超级大佬——艾伯维公司的乌帕替尼，全球销售额超83亿美元。芦可替尼本身表现也很优秀，2025年芦可替尼片剂全球销售额总计超50亿美元，中国境内医院端销售额6.7亿；乳膏剂的市场同样不差，在2025年全球销售额6.78亿美元，同比增长33%。从适应症上看，磷酸芦可替尼乳膏是中国首个且目前唯一获批的白癜风靶向药。中国约有1000万人患有白癜风，其中820万人患有非节段型白癜风，而且近年来整体呈增加趋势。此前白癜风治疗主要是用激素类药物外用，糖皮质激素不可大面积长时间使用，会扰乱血糖、血压及儿童生长。根据《中国白癜风诊疗专家共识（2024年版）》，系统性与局部外用糖皮质激素及JAK抑制剂被列为首选治疗方案，而国内唯一的外用JAK抑制剂就是芦可替尼乳膏。磷酸芦可替尼乳膏不单可以用于治疗白癜风，还可以针对性治疗特异质皮炎（AD），美国该适应症已上市，国内已提交了上市申请，预测2027年年初将获批。根据信达证券销售预测，磷酸芦可替尼乳膏销售峰值有望突破60亿元。再从竞争格局上看，目前全球主流国家已上市的外用JAK抑制剂只有2个，磷酸芦可替尼乳膏和LEO药业的德戈替尼乳膏，后者尚未在国内上市，主适应症是湿疹，暂时不属于竞品。芦可替尼的片剂上市太早，其核心化合物专利即将在2026年12月12日过期，剩余结晶盐和组合物专利可以规避，片剂已有5家企业仿制过评，15家企业提交了上市申请，就等着化合物专利到期。至于乳膏剂，重庆华邦已于2024年11月获得了临床批件，虽然重庆华邦已获得临床批件，但一直没有登记临床。 INCYTE公司给芦可替尼乳膏单独设置了一个专利（CN 103002875B)，芦可替尼及其磷酸盐的局部用制剂水包油乳膏专利，其包含水、油组分、乳化剂组分和溶剂组分等，十分详细规避起来有些难度，这一专利的到期日要到2031年。如此看来芦可替尼乳膏可以在国内独占很久的市场。图：专利内容（部分）然而实际上并没有那么乐观，目前业内在研的可以用于治疗白癜风和特异质皮炎的外用JAK抑制剂可不少。据不完全统计，全球共有43款外用JAK抑制剂在持续研发（含两款已上市新增适应症），仅国内就有15家企业在研，恒瑞、齐鲁、明慧医药等都有品种在研。其中恒瑞和明慧医药品种的特异性皮炎适应症已提交了上市，白癜风适应症正在进行临床，这两款药的适应症跟芦可替尼乳膏基本重合。以这样的速度，这个市场很快也要卷起来了。附：外用JAK抑制剂研发情况，标红色为已上市适应症，仅供参考 ↓⭐关注药通社，洞见行业趋势↓ 投稿/企业合作/内容沟通：药通社总编—华籍美人（Ww_150525） *添加请注明备注及来意

2026-04-19

·说给AD特皮

【前沿速递】《特应性皮炎外用治疗与管理专家共识（2025 版）》发布！一文盘点核心要点！

前沿速递特应性皮炎（AD）作为慢性复发性炎症性皮肤病，困扰着我国 3%-8% 的成人与 10%-15% 的儿童，疾病负担在非致命性皮肤病中居首。近日，《特应性皮炎外用治疗与管理专家共识（2025 版）》（以下简称共识）在《中华皮肤科杂志》正式发布。该共识由皮肤科、变态反应科、儿科等领域的32位多学科专家联合编写，结合AD循证医学证据、国内外指南、专家临床经验及中国AD患者疾病特征，为AD外用治疗提供了更贴合国人的规范化指导。今天就带大家快速get这份共识的核心要点！来源：中华皮肤科杂志官网常用外用药及应用外用糖皮质激素（TCS） TCS属于一线抗炎治疗药物。AD急性发作期首选，快速控制炎症，适用于所有AD患者。分级用药：按药效分4级，薄嫩部位（面部、腋窝等）禁用强效/超强效，儿童优先中弱效（如0.1%丁酸氢化可的松乳膏）。用法细节：按“指尖单位”用药（0.5g可涂2个手掌面积），强效/超强效连续用不超过2周，儿童中弱效不超过4-6周。注意事项：长期用可能致皮肤萎缩、毛细血管扩张，薄嫩部位需严格控制。常用外用糖皮质激素分级可参考下图：来源：《特应性皮炎外用治疗与管理专家共识（2025 版）》指尖单位用药参考：来源：《特应性皮炎365问》钙调磷酸酶抑制剂（TCI）非激素药物，无激素相关副作用，安全选手。通过抑制钙调磷酸酶的活性，抑制T淋巴细胞的活化，从而抑制AD的免疫反应，达到治疗作用。优势：无TCS的萎缩风险，适合长期主动维持治疗，尤其适合薄嫩部位。国内已获批外用药膏及适用范围：他克莫司软膏：0.03%浓度适合2岁及以上AD患者；0.1%浓度适合成人患者。吡美莫司乳膏：3个月及以上婴幼儿（国内首个批准用于3月龄以上婴幼儿的非激素药物）。温馨提示：初期用可能有灼热/刺痛感，冷藏后使用可缓解，连续用数天会消失。磷酸二酯酶4（PDE-4）抑制剂非激素药物，安全选手。PDE⁃4抑制剂可通过提高细胞内环磷酸腺苷水平，降低细胞因子的释放而发挥抗炎作用。国内已获批药物及适用范围：克立硼罗软膏：适用于3月龄及以上轻中度AD，皮损消退后可停药或长期维持。安全性：不良反应以轻中度灼热感为主（一般可自行减退，冷藏后使用可缓解），无激素相关风险。温馨提示：初期用可能有灼热/刺痛感，冷藏后使用可缓解，连续用数天会消失。芳香烃受体（AhR）调节剂非激素药物，轻中度AD患者“新选择”。多重通路调节，既能抑制炎症，又能修复表皮屏障（减少 IL-4/IL-13 导致的屏障损伤）。国内已获批药物及适用范围：本维莫德乳膏：适用于2岁及以上轻中度AD 安全性：整体安全性良好，适用于皮肤薄嫩部位。非激素药膏，无激素相关副作用。不良反应：不良反应大多数为轻中度，包括用药部位瘙痒、红斑和毛囊炎等。 Janus激酶（JAK）抑制剂 JAK家族是一类细胞质酪氨酸激酶，JAK和信号转导和转录激活因子（STAT）构成JAK⁃STAT通路，参与细胞因子的信号转导，包括IL⁃4、IL⁃13、IL⁃31等2型炎症细胞因子，在AD的发生和发展中发挥重要作用。目前临床试验显示，外用JAK抑制剂安全性较好。进展：芦可替尼、迪高替尼已在美国、日本和欧盟上市，国内Ⅲ期试验进行中。优势：起效快，可明显改善皮损和瘙痒情况，局部不良反应少。目前研究显示，芦可替尼第2周即改善皮损与瘙痒并持续至第8周；迪高替尼在治疗成人手部中重度AD方面也有出色表现。抗微生物制剂当存在明显感染倾向时，需要联合抗微生物制剂进行治疗。细菌感染：当皮疹处出现脓疱、脓痂时，需考虑联合外用抗生素或其他抗菌制剂以控制感染（如2%莫匹罗星软膏、2%夫西地酸乳膏、复方多黏菌素B软膏等），疗程7-14天，不建议长期使用，无明显皮肤感染者亦不建议使用。对于糖皮质激素治疗效果不佳的患者，可尝试外用抗菌药物联合TCS治疗。渗出明显时，也可联合湿敷，如生理氯化钠溶液、2%~4%硼酸溶液、0.1%乳酸依沙吖啶溶液等。真菌感染：脂溢区（头面、胸背）合并马拉色菌感染，可联合外用抗真菌制剂，如2%酮康唑洗剂等。病毒感染：合并单纯疱疹病毒感染，需口服+外用抗病毒药（如1%喷昔洛韦乳膏、3%昔洛韦乳膏等）1-2周。保湿润肤剂 AD特皮的基础治疗，日常保湿需长期坚持。作用：修复屏障、缓解瘙痒、减少复发。对于皮肤干燥的AD患者，特别是低龄儿童与老年患者坚持使用保湿剂，以维持正常的皮肤屏障功能。用法：一般建议跟其他外用药物分开使用，不建议混合使用，如与抗炎药间隔1小时以上。外用药应用原则阶梯用药&主动维持 AD特皮应根据疾病严重程度，遵循“阶梯治疗原则”。外用药物是AD的主要治疗手段。治疗中要合理应用外用药物，综合考虑疗效、安全性、患者年龄、皮损部位、皮损分期、皮损性质以及制剂类型等因素。阶梯治疗：一般治疗早期通常选择TCS。随着皮损改善，可逐步降低TCS的强度和频率，维持治疗可采用每周2~3次中弱效TCS或替换为非糖皮质激素类药物；皮肤薄嫩部位也可在治疗初始阶段使用TCI。研究证实，每周2~3次TCI可减少AD发作并能降低TCS使用频率。举个例子：以吡美莫司为例，皮损完全消退后，可在医生的指导下逐步降低给药频率，从每日2次减为每日1次、每2日1次，直至每周2~3次的最低维持剂量；或采用周末2日每日1次的方案，依从性更佳。主动维持治疗：建议12个月或更长，以减少复发。方案：皮损消退后，可在容易复发的部位，每周2-3次外用TCI以预防皮疹。监测：每12个月评估疗效与安全性，TCI安全窗可延伸至5 年以上，需结合患者情况个性化调整。剂型选择：根据AD皮损特点选择适当的剂型。皮肤干燥可使用保湿剂。急性非渗出性皮炎可使用乳膏或凝胶。急性皮损有渗出时，可选择湿敷。慢性角化性肥厚性皮损，可选择软膏联合封包或外贴硬膏。儿童与老年患者、薄嫩部位皮疹宜使用中弱效TCS或TCI。特殊部位/人群特殊部位薄嫩部位（面部、腋窝、肛周等）：禁用强效/超强效TCS，优先选TCI（如吡美莫司），中效TCS不建议大面积长期用。手足部位：皮肤厚、吸收差，首选TCS，肥厚皮损可用药后封包1-8小时（促进吸收），维持期换中弱效TCS/TCI。毛发部位：选酊剂、洗剂（如中弱效TCS洗剂），合并真菌感染联用抗真菌药，避免长期用强效TCS。特殊人群婴幼儿/儿童：优先中弱效TCS或TCI，避免强效/超强效TCS；急性渗出性皮疹可联用湿包疗法（WWT），但需注意防寒冷、毛囊炎；老年人：选刺激性小、修复屏障的药物（中弱效TCS/TCI/PDE-4抑制剂），肥厚皲裂皮损可短期用强效TCS+封包；孕期/哺乳期：孕期用中弱效TCS+润肤剂，薄嫩部位选TCI；哺乳期乳房AD，哺乳后用药，下次哺乳前清洁乳头。患者/家属须知患者/家属教育 AD的控制离不开患者与家属的参与，希望大家可以科学认识AD、合理用药、科学控制、减少复发。了解AD病因与诱发因素（如避免搔抓、刺激物）。正确用药：清楚用药量、疗程、不良反应应对（如TCI灼热感可冷藏）。定期复诊：出现复发或不良反应及时调整方案，不自行加药/停药。左右滑动查看完整文献原文链接：点击下方“阅读原文”即可跳转往期推荐: 外用糖皮质激素干货！一文说清！皮损处渗液怎么办？完整攻略！如何科学主动维持治疗？一文搞懂！特应性皮炎秋冬保湿护肤品怎么选？一文说清！附日常护肤攻略！特应性皮炎生物制剂：度普利尤单抗（达必妥）起效时间？跟司普奇拜单抗（康悦达）有什么区别？目前微信已开放新的互助交流群欢迎大家进入社群交流讨论，一起科学战胜AD！（P.S.群二维码动态更新，如过期可联系小助理进入）声明：本文为相关文献整合形成的知识科普内容，不涉及医疗建议。如有不适，建议咨询专业人士。参考文献： 1、高兴华,崔勇主编,特应性皮炎 365问,北京:人民卫生出版社,2025.6 2、《特应性皮炎外用治疗与管理专家共识（版）》编写专家组. 特应性皮炎外用治疗与管理专家共识（2025版）[J]. 中华皮肤科杂志, 2025,58(10):903-909. DOI:10.35541/cjd.20250247. 找到我们 1V1专属顾问特皮问题即问即答说给AD特皮特皮资讯互助交流 AI智能知识库 AD特皮问题快问快答

临床结果申请上市AHA会议临床研究

100 项与德戈替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11046	-	D11AH	DB16133

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
慢性湿疹	英国	LEO Pharma A/S	2024-11-29
慢性手湿疹	欧盟	LEO Pharma A/S	2024-09-19
慢性手湿疹	冰岛	LEO Pharma A/S	2024-09-19
慢性手湿疹	列支敦士登	LEO Pharma A/S	2024-09-19
慢性手湿疹	挪威	LEO Pharma A/S	2024-09-19
特应性皮炎	日本	Shionogi & Co., Ltd.	2020-01-23
特应性皮炎	日本	Japan Tobacco, Inc.	2020-01-23

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
硬化萎缩苔癣	临床3期	美国	Leo Pharma, Inc.	2026-02-11
硬化萎缩苔癣	临床3期	加拿大	Leo Pharma, Inc.	2026-02-11
硬化萎缩苔癣	临床3期	法国	Leo Pharma, Inc.	2026-02-11
硬化萎缩苔癣	临床3期	德国	Leo Pharma, Inc.	2026-02-11
硬化萎缩苔癣	临床3期	意大利	Leo Pharma, Inc.	2026-02-11
硬化萎缩苔癣	临床3期	波兰	Leo Pharma, Inc.	2026-02-11
硬化萎缩苔癣	临床3期	西班牙	Leo Pharma, Inc.	2026-02-11
硬化萎缩苔癣	临床3期	英国	Leo Pharma, Inc.	2026-02-11
汗疱疹	临床3期	丹麦	LEO Pharma A/S	2022-01-30
汗疱疹	临床3期	丹麦	Japan Tobacco, Inc.	2022-01-30

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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


NCT04949841 (DELTA 3, AAD2026)	临床3期	慢性手湿疹	560	Delgocitinib 20 mg/g Cream (Chronic Hand Eczema)	願獵鏇餘構鏇簾窪製簾(糧鑰選選遞壓網鬱願鏇) = 淵繭醖獵窪網築顧網襯鑰廠鬱顧遞夢製願鑰顧 (壓製齋願遞鹽淵壓簾襯, 0.18 ~ 0.22) 更多	积极	2026-03-27
NCT05355818 (DELTA TEEN, AAD2026)	临床3期	慢性手湿疹	98	delgocitinib cream 20 mg/g	鹹蓋鹽衊鏇醖網糧鹽願(獵窪艱選獵鏇襯襯衊壓) = 鬱膚觸願蓋製積鏇蓋廠鬱構鑰衊觸鬱鏇簾獵積 (鹽構齋願鑰鹹遞蓋願鹹 ) 更多	积极	2026-03-27
				cream vehicle	鹹蓋鹽衊鏇醖網糧鹽願(獵窪艱選獵鏇襯襯衊壓) = 遞襯網醖範憲淵襯鹹鹹鬱構鑰衊觸鬱鏇簾獵積 (鹽構齋願鑰鹹遞蓋願鹹 ) 更多
DELTA-1/2 (AAD2026)	临床3期	慢性手湿疹	1,017	Delgocitinib cream	-	积极	2026-03-27
				Delgocitinib cream (systemic-experienced)	繭齋遞顧窪夢襯醖壓蓋(鏇壓憲膚願齋膚襯遞選) = 襯鏇觸淵獵廠網簾膚鹽願網衊製遞築築構觸觸 (襯淵襯範製壓蓋簾願艱 )
NCT04872101 \| NCT04871711 (DELTA 1, Pubmed \| Contact Dermatitis)	临床3期	慢性手湿疹	960	Delgocitinib cream 20 mg/g	構鹽簾願鹽壓鑰獵遞範(齋簾憲網獵鏇觸廠鹽遞) = 壓築範積壓淵壓築淵醖艱網廠願簾齋積鏇廠夢 (淵鑰遞餘繭壓憲網鑰築 )	积极	2026-03-03
				Cream vehicle	選觸廠範製夢鑰衊餘觸(願憲夢憲鹹選壓憲簾鬱) = 範繭衊衊窪襯範觸壓構鏇鑰選製窪膚鬱糧顧製 (齋選鏇簾獵網選膚鹹鏇 ) 更多
NCT05332366 (Pubmed \| J Invest Dermatol)	临床2期	前额纤维化脱发 CXCL9 \| CXCL10 \| IFN-γ	30	Delgocitinib cream	壓壓構繭繭製餘顧憲艱(膚膚蓋網鬱遞憲製選衊) = 構簾夢齋蓋窪鏇膚遞製觸製選繭鹽夢選鹹製選 (鹽餘鹽蓋蓋淵衊憲選淵 )	积极	2025-10-01
NCT05486117 (Pubmed \| J Eur Acad Dermatol Venereol)	临床1期	慢性手湿疹	16	Delgocitinib cream 20 mg/g	鬱鹹壓醖齋艱選範艱蓋(鹽壓窪繭夢齋鹽簾鑰鏇) = 製鏇壓鑰壓憲範繭憲獵遞鹹齋齋遞簾網簾膚壓 (憲選繭糧窪蓋齋蓋糧膚 ) 更多	积极	2025-09-01
NCT04872101 \| NCT04871711 (FDA_CDER) 人工标引	临床3期	慢性手湿疹	960	ANZUPGO (TRIAL 1)	選餘顧獵顧襯繭鹹鏇顧(餘糧憲構糧願製壓構獵) = 蓋積壓鬱網膚艱築鬱範窪獵鏇艱醖餘網鑰膚膚 (網壓蓋簾蓋網壓構鑰廠 ) 更多	积极	2025-07-23
				Vehicle (TRIAL 1)	選餘顧獵顧襯繭鹹鏇顧(餘糧憲構糧願製壓構獵) = 餘獵範製網壓遞衊選構窪獵鏇艱醖餘網鑰膚膚 (網壓蓋簾蓋網壓構鑰廠 ) 更多
NCT05355818 (DELTA TEEN, CTgov)	临床3期	慢性手湿疹	98	Delgocitinib (Delgocitinib Cream)	餘醖鏇觸範廠鏇憲製積 = 衊製鏇選夢壓膚選製壓壓齋積鑰膚鬱鏇願壓構 (鑰範鏇蓋餘網願衊鬱觸, 艱製餘鹹獵觸顧廠積築 ~ 願鑰鹽鹹範鑰築艱餘蓋) 更多	-	2025-07-02
				Cream vehicle (Cream Vehicle)	餘醖鏇觸範廠鏇憲製積 = 鏇選獵願網構糧壓選衊壓齋積鑰膚鬱鏇願壓構 (鑰範鏇蓋餘網願衊鬱觸, 淵膚衊衊醖艱艱膚選窪 ~ 醖製選鬱構選醖襯憲製) 更多
NCT05259722 (DELTA FORCE, Pubmed) 人工标引	临床3期	慢性湿疹	513	delgocitinib cream	遞鏇製齋憲憲鹹餘範繭(齋製淵鑰齋窪遞鏇廠繭) = 鏇觸鏇膚獵簾顧窪糧齋窪鏇繭齋製夢選廠衊選 (觸淵積繭鹹夢壓築齋廠, 3.4) 更多	优效	2025-04-01
				alitretinoin	遞鏇製齋憲憲鹹餘範繭(齋製淵鑰齋窪遞鏇廠繭) = 鹹鹽憲遞醖簾簾醖艱鏇窪鏇繭齋製夢選廠衊選 (觸淵積繭鹹夢壓築齋廠, 3.4) 更多
NCT05259722 (DELTA FORCE, CTgov)	临床3期	慢性湿疹	513	Delgocitinib (Delgocitinib Cream 20 mg/g)	淵廠顧淵構範獵鏇顧憲(築觸糧鬱範淵鑰選選繭) = 網築鑰網鏇繭廠廠範廠鹹餘壓鏇餘壓鑰蓋築淵 (鹽壓壓襯網夢鏇膚糧構, 3.37) 更多	-	2025-03-14
				Toctino (Alitretinoin Capsules 30 mg Per Capsule)	淵廠顧淵構範獵鏇顧憲(築觸糧鬱範淵鑰選選繭) = 廠襯觸網廠願簾願糧淵鹹餘壓鏇餘壓鑰蓋築淵 (鹽壓壓襯網夢鏇膚糧構, 3.36) 更多