A Multicenter, Randomized, Double Blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Gel 2% for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Gorlin Syndrome

The aim of this clinical study is to find out how well Patidegib Gel 2% works in preventing new basal cell carcinomas (BCCs) developing on the face of adults with Gorlin syndrome, and how safe Patidegib Gel 2% is to use.
People who take part will apply either Patidegib Gel 2% or a Vehicle Gel (with no active drug substance) to their face twice a day for a year (12 months). The number of new BCCs on the face will be compared between those who used Patidegib Gel 2% or Vehicle Gel after 12 months.

开始日期2024-03-17

申办/合作机构

Sol-Gel Technologies Ltd.

EUCTR2020-000253-27-BE

/ Terminated临床3期

A Phase 3, Multicenter, Open-Label Extension Study of Patidegib Topical Gel, 2% in Subjects with Gorlin Syndrome (Basal Cell Nevus Syndrome)

开始日期2020-07-02

申办/合作机构

PellePharm, Inc.

NCT04308395

/ Terminated临床3期

A Phase 3, Multicenter, Open-Label Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)

This is a multicenter, open label extension study evaluating the safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult subjects with Gorlin syndrome.

开始日期2020-06-03

申办/合作机构

Sol-Gel Technologies Ltd.

100 项与 Patidegib 相关的临床结果

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100 项与 Patidegib 相关的转化医学

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100 项与 Patidegib 相关的专利（医药）

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项与 Patidegib 相关的文献（医药）

2026-03-01·CURRENT OPINION IN ONCOLOGY

Evolving paradigms in the management of basal cell carcinoma

Review

作者: Traini, Daniele Omar ; Palmisano, Gerardo ; Caponi, Federico ; Di Stefani, Alessandro ; Brunetti, Francesco ; D’Amore, Alessandra

Purpose of review:

Basal cell carcinoma (BCC) remains the most common malignancy worldwide. While the majority of tumors are curable with surgery, a subset of locally advanced or metastatic cases requires systemic therapy. Over the last few years, a surge of translational and clinical advances has reshaped management, from Hedgehog pathway inhibition to immune checkpoint blockade and perioperative integration. This review summarizes these developments and their implications for clinical practice.

Recent findings:

Updated evidence confirms Hedgehog pathway inhibitors (HHIs) as the standard first-line therapy for advanced BCC, while programmed death-1 (PD-1) blockade with cemiplimab has established durable responses after HHI failure. Real-world studies suggest potential benefit of earlier immunotherapy use. Emerging topical and neoadjuvant strategies, including patidegib and combined systemic-local approaches, highlight a transition toward functional preservation. Concurrently, imaging technologies such as line-field confocal optical coherence tomography and ex vivo confocal microscopy improve preoperative assessment and response monitoring, while clinical trials explore multimodal and perioperative regimens.

Summary:

The modern management of BCC is evolving toward a precision-oncology model integrating molecular targeting, immunotherapy, and advanced imaging. These developments are redefining therapeutic sequencing and the boundaries between surgery and systemic treatment.

2025-09-14·Journal of Drug Targeting

Hedgehog signalling pathway inhibitors in the treatment of basal cell carcinoma: an updated review

Review

作者: Adela Markota Cagalj ; Zrinka Bukvic Mokos ; Ljiljana Serman ; Valentina Karin-Kujundzic ; Semir Vranic ; Alan Serman ; Mislav Glibo ; Lucija Skara Abramovic

Basal cell carcinoma (BCC) is the most common type of skin cancer that usually appears in sun-exposed body regions such as the head, trunk, and extremities. There are four main clinicopathological subtypes of BCC: nodular, superficial, morpheaform, and fibroepithelial. BCC's molecular basis includes inherited genetic susceptibility and somatic mutations, often induced by exposure to UV radiation. The aberrant activation of the hedgehog (Hh) signalling pathway, caused by mutations in the Hh components, plays a central role in the molecular pathogenesis of this carcinoma. This led to the development of Hh signalling pathway inhibitors as a new treatment option for patients with advanced disease. In this review, we summarise BCC's clinical presentation and histopathology and present knowledge on the most studied Hh signalling inhibitors, vismodegib and sonidegib, and other inhibitors of this signalling, such as itraconazole, patidegib, taladegib, and arsenic trioxide, in the treatment of BCC. We also present the most common Hh signalling inhibitor adverse events and their management options, which could improve patients' quality of life during treatment.

2025-03-18·BRITISH JOURNAL OF DERMATOLOGY

Patidegib: a novel, promising treatment for basal cell carcinoma lesions in patients with Gorlin syndrome

Communications

作者: Peris, Ketty

项与 Patidegib 相关的新闻（医药）

2026-09-30

·BioSpace

Sol-Gel Technologies to Host KOL Investor Day for SGT-610 on October 14, 2026

NESS ZIONA, Israel, Sept. 30, 2026 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company, pioneering treatments for patients with rare and severe skin conditions, today announced it will host a KOL Investor Event on SGT-610 (patidegib gel, 2%) on Wednesday, October 14, 2026 in New York. The event will feature Julie Breneiser, PA-C (Gorlin Syndrome Alliance), Ervin Epstein Jr., MD (Alta Bates Summit Medical Center), Kavita Sarin, MD, PhD (Stanford Cancer Institute), and Elizabeth M. Billingsley, MD, FAAD, FACMS, FASDS (Penn State College of Medicine), who will discuss the significant disease burden of Gorlin Syndrome patients and lack of effective therapies. A live webcast of the event will be available through the Sol-Gel Investor Relations website beginning at 12:00 p.m. ET. A replay of the webcast and supporting materials will be available after the conclusion of the event. Investors and other interested parties may email sol-gel@gilmartinir.com to register for in-person attendance. About Julie Breneiser, PA-C Julie Breneiser is the Associate Director of the Gorlin Syndrome Alliance (GSA). Prior to this, she was Executive Director for five years, and President of the Board of Directors. Her early career began as a Physician Assistant. Julie and her two children are affected with Gorlin Syndrome, a rare genetic disorder caused by a tumor suppressant mutation that can affect every organ system. Julie’s work with the GSA focuses on collaboration with industry to bring potential treatments to clinical trial. Under her leadership, the GSA conducted a Listening Session and Patient Focused Drug Development Meeting for the FDA. Julie previously served as a consumer reviewer for the National Institutes of Health (NIH) and the Department of Defense’s Congressionally Directed Medical Research Programs (DOD-CDMRP). She speaks nationally and internationally, raising awareness of Gorlin Syndrome and the burdens of this multi-system disorder as well as advancing drug development for rare diseases. About Ervin Epstein, Jr., MD Dr. Ervin Epstein, Jr., MD was a practicing dermatologist for more than 50 years in the San Francisco Bay Area. He led an academic research lab funded by the National Institutes of Health for 45 years. He served as the Co-Founder, Medical Advisor, and Director at PellePharm, Inc. He also served as Research Dermatologist and Clinical Professor of Dermatology at the University of California, San Francisco, and as President of the Society for Investigative Dermatology. His research interests have focused on the molecular biology of inherited and neoplastic skin diseases. Ervin Epstein has also served on the boards of numerous dermatological organizations including the American Dermatological Association. His publications have appeared in New England Journal of Medicine, Nature, and Science. He received his medical degree from University of California (San Francisco) School of Medicine. About Kavita Sarin, MD, PhD Dr. Kavita Sarin, MD, PhD is a Professor of Dermatology and is the Director of the Stanford Skin Cancer Genetics Program at the Stanford Cancer Institute. She received her medical degree from Stanford University School of Medicine and holds a PhD in Genetics from Stanford University. She has an academic interest in Precision Medicine, focused on the integration of genetic and clinical patient data to inform susceptibility, prognosis, and treatments in skin cancer and other rare dermatologic disorders. Her lab applies cutting-edge sequencing and imaging technologies to better understand skin cancer and rare immunologic skin diseases. About Elizabeth M. Billingsley, MD, FAAD, FACMS, FASDS Dr. Elizabeth M. Billingsley, MD, FAAD, FACMS, FASDS is a Professor of Dermatology at Penn State University College of Medicine and practices dermatologic surgery and Mohs micrographic surgery with Penn State Health. She received her medical degree from Penn State College of Medicine. She does clinical research and trials in cutaneous oncology and Gorlin Syndrome and is a past President of the American College of Mohs Surgery. Dr. Billingsley is a Fellow of the American Academy of Dermatology (FAAD), the American College of Mohs Surgery (FACMS), and the American Society for Dermatologic Surgery (FASDS), and her clinical practice focuses on the surgical management of skin cancer. About Sol-Gel Technologies Sol-Gel is a specialized dermatology company advancing innovative therapies for rare and serios skin diseases. Its lead investigational candidate, SGT-610 (patidegib gel 2%), is a Phase 3, orphan- and breakthrough-designated topical hedgehog inhibitor being developed for the prevention of new basal cell carcinoma (BCC) lesions in patients with Gorlin Syndrome, with the potential to offer an improved safety pro to oral hedgehog inhibitors. Subject to regulatory approval in Gorlin Syndrome, SGT-610 may also represent a future opportunity in high-frequency BCC. Sol-Gel is also advancing SGT-210, and investigational topical EGFR inhibitor for indications with significant unmet need, and has developed two FDA-approved dermatology products, TWYNEO ® and EPSOLAY ® . Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information we have when those statements are made or our management’s current expectations and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to, the risk of a delay in reporting the top-line results of Sol-Gel’s pivotal Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, that we will not successfully complete the Gorlin Phase 3 clinical trial or that such clinical trial will fail to meet its primary endpoint or one or more of its secondary endpoints as well as the following factors: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets, the potential delay in receiving such regulatory approvals and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our collaborators’ ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our collaborators’ ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our collaborators’ ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third-party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, China, Europe or Israel; and (xv) loss or retirement of key executives and research scientists; (xvi) general market, political and economic conditions in the countries in which the Company operates; and, (xvii) the security situation in Israel. These factors and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 19, 2026, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Except as required by law, we undertake no obligation to update any forward-looking statements in this press release. Sol-Gel Investor Relations: Eyal Ben-Or Chief Financial Officer ir@sol-gel.com For Investor Event Inquiries: Ami Bavishi or Nick Colangelo Gilmartin Group, LLC Sol-gel@gilmartinir.com

高管变更临床3期

2026-09-28

·爱学习爱睡觉

皮肤领域医药动态｜2026年9月第4期（总第18期）

皮肤领域医药动态｜2026年9月第4期（总第18期） ——伊可白滞素欧盟获批 · 抗KIT新药CSU III期全达终点 · 一年一针ORKA-001疗效持续加深 · EADV 2026维也纳倒计时核心病种：银屑病 · 白癜风 · 特应性皮炎 · 慢性自发性荨麻疹 · 斑秃 · 皮肤狼疮重点机制：IL-23R（口服）/ IL-23 / KIT / MRGPRX2 / IL-13×IL-18 / IL-7Rα / JAK / TYK2一、本期核心看点（10条速览） # 类别事件时间 1 🟢 **银屑病重磅** **强生伊可白滞素（Icotrokinra，艾特雅®）9/21获欧盟委员会正式批准**——全球首个且唯一口服IL-23受体拮抗肽获欧洲上市许可（≥12岁、体重≥40kg中重度斑块状银屑病），继8/27中国NMPA获批后再下一城 9.21 2 🟢 **CSU重磅** **Cellarity/VIATRIS系抗KIT单抗Barzolvolimab 9/22宣布CSU两项III期（EMBARQ-CSU1/2）全部主要终点达标**——12周UAS7显著改善，24周完全应答率最高达54%，"肥大细胞耗竭"新机制赛道里程碑 9.22 3 🟡 **银屑病/长效** **Oruka Therapeutics ORKA-001（一年一针IL-23单抗）9/23公布28周延展数据**——IIa期EVERLAST-A试验中PASI 100应答率升至**71.4%**，且第4周后未再给药，疗效"停药后持续加深" 9.23 4 🟢 **斑秃** **FDA 9/25批准巴瑞替尼（Olumiant®）扩展至12岁及以上重度斑秃儿童及青少年**——基于III期BRAVE-AA-PEDS研究36周数据，JAK抑制剂儿科适应症再扩容 9.25 5 🟡 **学术会议** **EADV 2026（9/30-10/3维也纳）LBA名单公布28项**——中国学者牵头2项（张建中Oturkibart结节性痒疹52周、吴文育Golidocitinib联合方案MF/SS），Zasocitinib vs 氘可来昔替尼头对头III期将揭盲 9.30起 6 🟡 **EADV/国产** **恒瑞医药39项研究入选EADV 2026**——2项口头报告：SHR-1819（卓托奇拜单抗）结节性痒疹II期、SHR-1139（IL-23p19/IL-36R双抗）银屑病II期中期；夫那奇珠单抗18篇+艾玛昔替尼17篇证据矩阵 9.30起 7 🟡 **AD/资本** **North Immunology与Aethlon Medical 9/21宣布合并**——超额认购1.8亿美元私募融资，推进NOR-101（IL-13×IL-18双特异性抗体）2027年初进入AD I期临床 9.21 8 🔴 **负面案例** **Immunovant IMVT-1402（FcRn抑制剂）9/23皮肤红斑狼疮IIb期未达主要终点**——公司宣布终止imeroprubart在皮肤狼疮的开发，提示FcRn路径外用拓展受挫 9.23 9 🟡 **政策** **2026医保目录现场谈判9/5-9/9已收官，最终结果预计11月下旬公布、2027/1/1执行**——124个目录外药品+12个商保创新药目录品种；芦可替尼乳膏（百卢妥®）白癜风适应症谈判结果进入倒计时持续 10 🟡 **罕见病** **Quoin Pharmaceuticals 9/22获FDA剥脱性皮肤综合征（PSS）疗法Fast Track认定**——QRX003外用丝氨酸蛋白酶抑制剂洗剂，为该病史上首个Fast Track，II/III期2026下半年启动 9.22二、银屑病：口服IL-23R"双城记"落定，长效赛道竞速2.1 【重磅】伊可白滞素获欧盟批准——口服IL-23R全球版图再扩 2026年9月21日，强生（Johnson & Johnson）宣布欧盟委员会（EC）正式授予ICOTYDE™（icotrokinra，伊可白滞素）上市许可，用于治疗12岁及以上、体重≥40 kg、适合接受系统治疗的中重度斑块状银屑病成人及青少年患者。这是伊可白滞素继8月27日获中国NMPA批准（商品名：艾特雅®）之后，拿下的又一个主要市场监管批准——全球首个且唯一的口服IL-23受体靶向药，在东西方两大市场同步落地。关键信息速览维度内容获批时间中国2026.8.27（NMPA）；欧盟2026.9.21（EC）适应症 ≥12岁且体重≥40kg的中重度斑块状银屑病（适合系统治疗者）用法用量每日一次口服多肽上市申请与Protagonist Therapeutics联合发现，强生拥有全球独家权益后续管线 ICONIC-PsA 1/2（银屑病关节炎）、UC、CD适应症在研ICONIC III期项目数据（约2,500例患者、4项随机对照试验）全部主要终点达标，覆盖头皮、生殖器等高影响部位人群两项头对头氘可来昔替尼研究：16周IGA 0/1约70%、PASI 90约55% 安全性：16周内不良事件率与安慰剂差异在1.1个百分点以内，52周无新安全信号 EADV 2026上，ICONIC-TOTAL的2年长期数据（含高影响部位）将作为LBA重磅揭晓竞争格局影响伊可白滞素以"每日一次口服多肽"的形态，把IL-23通路的"注射级疗效"带入口服赛道，直接冲击两个市场：口服小分子赛道：对氘可来昔替尼（颂狄多®）形成头对头优效压制，也挤压武田Zasocitinib、翰森HS-20118/HS-10374等口服TYK2的想象空间注射生物制剂赛道：为"拒绝打针"的中重度患者提供系统治疗新入口，可善挺、特诺雅等IL-23/IL-17注射剂需强化长效与便利性差异对中国市场：伊可白滞素中国上市节奏领先欧盟两周，目前未进医保（预估年治疗费用1.5-2万元）。其放量曲线与2027年医保谈判动向，将决定口服IL-23R能否复制氘可来昔替尼的准入路径。2.2 ORKA-001：停药后PASI 100升至71.4%，"一年一针"逻辑再获支撑 9月23日，Oruka Therapeutics公布ORKA-001（长效IL-23单抗，目标一年一针）IIa期EVERLAST-A试验的28周延展数据：PASI 100应答率升至71.4% （此前Week 12数据约50%级别）PASI 90应答持续加深，且患者在第4周单次给药后未再接受任何额外给药安全性无新信号这一"给药一次、疗效持续加深"的模式，与Oruka另一在研资产（半年一针的ORKA-002）共同构成超长效IL-23管线。在信迪利单抗级别的Q12W（匹康奇拜单抗）已属长间隔的当下，"给药频率战"正在向年度极端延伸——若III期成功，将重新定义银屑病维持治疗的依从性标准。国内厂商（康方、三生国健、丽珠等）在跟进生物类似药与双靶点（IL-17A/F）的同时，超长效差异化布局仍属空白，值得关注。2.3 EADV 2026前瞻：TYK2口服头对头将揭盲本届EADV（9/30-10/3维也纳）银屑病LBA看点：Zasocitinib（武田，高选择性TYK2）vs 氘可来昔替尼头对头III期LATITUDE Atlas （LB-312）——继PASI100/sPGA0/1优效读出后首次国际会议正式披露，或坐实"二代TYK2"地位Icotrokinra高影响部位（头皮/生殖器/掌跖）2年数据（ICONIC-TOTAL，LB-245）乌帕替尼掌跖脓疱病可行性试验JAKPPPOT （LB-155）Upadacitinib获欧盟新增幼年特发性关节炎（pJIA）适应症（9/23），JAK1管线继续扩科三、慢性自发性荨麻疹（CSU）：抗KIT"肥大细胞耗竭"III期全胜3.1 【里程碑】Barzolvolimab两项III期全部达主要终点 9月22日，Barzolvolimab（抗KIT单抗，Cellarity/原Celldex）公布慢性自发性荨麻疹两项III期EMBARQ-CSU1与EMBARQ-CSU2的顶线结果：两个剂量组12周UAS7较安慰剂均显著改善，全部主要终点达标；至24周，完全应答率（UAS7=0）最高达54%。为什么重要机制代际跨越：奥马珠单抗（抗IgE）上市20余年来，CSU系统性新机制长期空窗。Barzolvolimab通过结合KIT受体（CSU患者肥大细胞上异常高表达）清除外周及组织肥大细胞，直击"组胺不依赖IgE的自反应通路"，是首个从"细胞源头"解决问题的获批候选路径应答深度前所未有：奥马珠单抗真实世界完全应答约30%-40%且起效需8-12周；Barzolvolimab 54%的完全应答率+肥大细胞可再生带来的"停药持久缓解"潜力，可能改写CSU治疗目标（从"控制"迈向"缓解"）赛道扩容信号：叠加本周EADV LBA中口服MRGPRX2部分反向激动剂的快速剂量相关应答数据（LB-159），CSU领域已形成抗KIT（细胞耗竭）+ BTK（瑞米布替尼/洛布替尼，口服信号阻断）+ MRGPRX2（口服肥大细胞稳定）三条新机制并行格局中国市场关联诺华瑞米布替尼（Rhapsido®）：2026.8 MHRA获批、中国NMPA优先审评中、9/11启动中国III期洛布替尼（麓可达®）：2026.6.4 NMPA获批，全球首个第四代BTK 抗KIT路径暂无中国临床公开，但若III期转化顺利，将成为继BTK后CSU国产跟随研发的下一个靶点高地3.2 CSU治疗格局速览（截至2026.9.28）药物/靶点公司进展备注奥马珠单抗诺华已上市（医保）抗IgE，一线生物制剂瑞米布替尼/BTK 诺华 FDA/EU/UK已批，中国优先审评 12小时起效，CSU+CIndU全覆盖洛布替尼/BTK 麓鹏制药 NMPA已获批（2026.6）全球首个四代BTK **Barzolvolimab/KIT** Cellarity **III期全达终点（9.22）** 肥大细胞耗竭，24周完全应答54% MRGPRX2反向激动剂在研 EADV LBA公布口服，快速剂量相关应答 Barzolvolimab CIndU 同上 CSU适应症先行后续拓展诱导性荨麻疹四、特应性皮炎（AD）：新机制资本化 + EADV八项LBA集中亮相4.1 NOR-101（IL-13×IL-18双抗）借1.8亿美元合并进入临床前夜 9月21日，North Immunology与Aethlon Medical宣布合并，同步完成超额认购的1.8亿美元私募融资，资金将用于推进核心资产NOR-101——IL-13×IL-18双特异性抗体，计划2027年初启动中重度AD的I期临床。机制层面值得关注：IL-13是2型炎症核心效应因子（现有共识靶点），而IL-18是固有免疫/Th1轴的关键驱动者，与AD的瘙痒放大、皮肤屏障损伤及"内型异质性"密切相关。双靶同时覆盖2型+非2型炎症，理论上可触达度普利尤单抗应答不佳的"IL-18高内型"患者——这与国内STAT6降解剂、OX40、T-reg等新机制共同构成AD"后达必妥时代"的第八条新机制赛道。4.2 EADV 2026 LBA：AD领域8项最新突破集中登场本届EADV共公布28项LBA，其中AD占8项，新机制密度为各病种之首： LBA编号药物/机制亮点 LB-169 **Zumilokibart（APG777）抗IL-13，半衰期延长** 2期APEX Part B剂量方案探索主要结果（艾伯维109亿美元收购Apogee的核心资产） LB-32 **EVO301（IL-18结合蛋白）** 2a期概念验证数据——与NOR-101同靶点呼应，IL-18轴成AD新热点 LB-331 **ENV-294（口服RAC2调节剂，"分子胶"）** 首个临床+分子双概念验证（此前Ib期停药14天EASI下降85%） LB-219 **Rezpegaldesleukin（T-reg诱导）** 多组学揭示早期分子应答，III期ZENITH项目推进中 LB-72 **Lunsekimig（TSLP×IL-13双特异纳米抗体）** 2b期VELVET试验结果 LB-349 **Lebrikizumab特应性手足皮炎** ADTouch试验16周结果（新适应症拓展） LB-313 Lebrikizumab 5年长期疗效 ADlong扩展试验 LB-315 阿布昔替尼 vs 度普利尤单抗差异蛋白组学 JADE COMPARE探索分析趋势解读：AD新药研发正从"成熟的2型炎症通路"向"更上游、更精准的免疫节点"（IL-18、RAC2、OX40、T-reg）延伸；长效化（延长半衰期）与口服化（分子胶、RAC2）是剂型/频次两大主线。4.3 恒瑞军团EADV"两大Oral+35篇"——国产创新矩阵出海亮相恒瑞医药在本届EADV共有39项研究入选（2项口头+37项电子壁报）：Oral 1｜SHR-1819（卓托奇拜单抗，IL-4Rα）结节性痒疹II/III期II期部分结果（张建中教授，FC06.1B，10/2 10:25）——该产品成人中重度AD的NDA已于9/2获NMPA受理Oral 2｜SHR-1139（IL-23p19/IL-36R双抗）中重度斑块状银屑病II期中期结果（史玉玲教授，FC05.1A，10/2 8:30）——全球唯一同时靶向IL-23p19与IL-36R的双抗e-Poster ：SHR-1819儿童/青少年AD Ib/II期（高兴华/徐子刚）、RSS0393外用PDE4银屑病II期（晋红中）夫那奇珠单抗（安达静®）18篇：真实世界、高体重、老年、头皮、HIV合并感染、GPP/红皮病型等全场景证据矩阵艾玛昔替尼（艾速达®）17篇：斑秃眉毛/睫毛、白癜风及共病拓展此外，EADV官方LBA名单中，北京大学人民医院张建中教授牵头的Oturkibart（抗TL1A）结节性痒疹3期52周结果（LB-1）与华山医院吴文育教授牵头的Golidocitinib联合Brentuximab Vedotin治疗MF/SS研究（LB-146）两项中国牵头研究将登台——中国学者从"参与者"走向"牵头者"的信号明确。4.4 国内AD注册格局提醒（本周无新增受理）截至9/28，国产IL-4Rα格局维持"上市2款（度普利尤单抗、司普奇拜单抗）+ NDA排队6款（泰利奇拜/SSGJ-611/卓托奇拜/TQH2722等）+ 在研10+"；百卢妥®（芦可替尼乳膏）AD适应症9/2获批后，外用赛道面临克立硼罗仿制药（26家获批）的价格挤压，差异化"儿童优先审评+双适应症"仍是核心壁垒。五、白癜风：EADV两场重头戏 + 医保结果倒计时5.1 EADV LBA：利特昔替尼Tranquillo III期正式登台（项蕾红教授参与） Ritlecitinib（利特昔替尼）治疗非节段型白癜风的两项III期TRANQUILLO/TRANQUILLO 2结果将以LBA形式在EADV公布（LB-161，华山医院项蕾红教授深度参与）——2,174例、迄今最大规模白癜风口服系统治疗III期，52周F-VASI75+T-VASI50双终点此前已官宣达标。全球递交上市申请后，白癜风口服JAK"五强"的卡位战将进入注册审批竞速阶段：口服药物靶点全球进展乌帕替尼 JAK1 **欧盟已获批（全球首个白癜风全身药物）**；柳叶刀发表；FDA审评中利特昔替尼 JAK3/TEC III期达标，全球申报中，EADV LBA揭晓完整数据 Povorcitinib JAK1 III期STOP-V1/V2达标，2027H1申报 Soficitinib（ICP-332） TYK2 国内II期阳性，III期推进 VC005 JAK1 国内II期阳性，AS III期收尾机制端，IL-15/CD122阻断（清除TRM记忆T细胞防复发）持续升温：Argenx 22亿美元收购Forte（FB102）后，奥司奇单抗（Ordesekimab）与芦可替尼的"复发防线"对比成为讨论焦点——白癜风治疗正从"止炎复色"走向"免疫记忆清除"的范式迁移。5.2 百卢妥®：医保谈判结果进入最后倒计时 2026医保目录现场谈判9/5-9/9收官，芦可替尼乳膏（百卢妥®）白癜风适应症结果预计11月下旬公布，纳入后2027/1/1执行现市售价约5,800元/支（100g），市场预估纳入价2,300-3,500元/支区间 9/2 AD适应症获批+9/17天津医大总医院空港医院落地后，"白癜风（谈判中）+AD（已获批）"双适应症若叠加医保准入，将显著放大轻中度患者池的商业转化华东医药HDM3010芦可替尼凝胶III期推进（全身暴露降70%），外用JAK的国产替代窗口已开六、斑秃与皮肤免疫其他领域6.1 FDA批准巴瑞替尼≥12岁重度斑秃——儿科JAK再下一城 9月25日，礼来/Incyte巴瑞替尼（Olumiant®）获FDA批准扩展至12岁及以上重度斑秃儿童及青少年患者，基于III期BRAVE-AA-PEDS研究36周数据。至此，斑秃系统治疗形成利特昔替尼（≥12岁，FDA首批）+ 巴瑞替尼（≥12岁扩龄）+ ritlecitinib ALLEGRO-LT 5年长期数据（EADV LBA LB-208）的成熟梯队；国产端，艾玛昔替尼斑秃适应症已获批，真实世界数据在EADV集中展示。值得关注的下一代机制：Bempikibart（新型IL-7Rα抗体）2a期SIGNAL-AA Part B将公布"停药后毛发再生持续"数据（LB-375）——若坐实，将冲击JAK抑制剂"停药即复发"的软肋。6.2 负面案例：IMVT-1402皮肤红斑狼疮IIb失败 9月23日，Immunovant宣布IMVT-1402（imeroprubart，FcRn抑制剂）治疗皮肤红斑狼疮（CLE）的IIb期概念验证试验未达主要终点，公司将终止该适应症开发。FcRn阻断在IgG介导的自免疾病（甲状腺眼病、天疱疮等）中仍有空间，但CLE的皮肤原位免疫复合物机制可能不依赖系统性IgG循环清除——提示自免靶点到皮肤适应症的"跨病种外推"存在生物学边界。6.3 罕见病速递QRX003（外用丝氨酸蛋白酶抑制剂洗剂）9/22获FDA剥脱性皮肤综合征（PSS）Fast Track认定 ——该病史上首个Fast Track，II/III期2026下半年启动（Up to 12例儿科+成人）Dersimelagon（红细胞生成性原卟啉症EPP/XLP）NDA获FDA受理并优先审评，LEO Pharma完成收购，PDUFA 2027年2月底Patidegib凝胶（Gorlin综合征）III期随访完成，顶线结果11月底公布七、竞争格局与医保价格盘点（2026.9.28更新）7.1 皮肤科主要创新药价格与准入状态产品公司医保状态参考价格备注芦可替尼乳膏（百卢妥®）康哲/德镁 **白癜风适应症谈判完成，结果11月公布** ~5,800元/支（100g），预估纳入价2,300-3,500元双适应症（白癜风+AD）司普奇拜单抗（康悦达®）康诺亚已入医保（三适应症） 1,039元/支 2026H1收入3.9亿+（+132%）度普利尤单抗（达必妥®）赛诺菲已入医保年费约2-3万（中重度AD） Q2全球销售52亿欧元氘可来昔替尼（颂狄多®） BMS 已入医保口服年费约1.2-1.5万面临伊可白滞素+Zasocitinib双线冲击伊可白滞素（艾特雅®）强生未进医保预估年费1.5-2万口服IL-23R，9/21欧盟获批莱康奇塔单抗（丽倍坦®）丽珠未进医保预估年费3-5万 IL-17A/F双靶古莫奇单抗（奇佑康®）康方申报2026医保 — IL-17A，52周PASI100 68.9% 匹康奇拜单抗（信美悦®）信达申报2026医保 — 首个国产IL-23p19，Q12W 瑞米布替尼诺华中国优先审评 — CSU首个口服BTK 洛布替尼（麓可达®）麓鹏未进医保 — 2026.6获批，全球首个四代BTK7.2 2026医保时间轴提醒 ✅ 9/5-9/9：现场谈判竞价+商保价格协商收官（124个目录外药品+12个商保创新药） ⏳ 11月下旬：新版目录及商保目录公布 ⏳ 2027/1/1：正式执行本年度关键机制：首次预申报+参照药预沟通+8年价格保护窗口+"商保目录三除外"进院政策八、流行病学与发病机制速览病种患病率/患者数（最新）机制认知更新银屑病全球约6,400万；中国650-780万（患病率0.55%），中重度约32.6% Th17/I型IFN/中性粒细胞三大免疫内型；IL-23轴上游化（口服IL-23R可及性革命）特应性皮炎中国超5,400万，轻中度占98% 2型炎症为轴心，IL-18/固有免疫、神经-免疫轴、皮脂-巨噬细胞轴、口腔微生态等新维度进入临床验证白癜风全球0.36%-2%（超2,000万）；中国约800万黑素细胞"休眠/去分化"而非死亡（Nat Commun 2026）；TRM记忆T细胞为复发核心；高血糖/琥珀酸轴（JCI 2026）与CGRP神经免疫轴（Immunity）确认加重通路 CSU 全球0.5%-1% 从抗IgE单一范式走向"肥大细胞生命周期管理"：KIT耗竭/BTK阻断/MRGPRX2三线并进斑秃中国患病率约0.2%-0.3% JAK一线系统治疗地位确立（2026版指南）；IL-7Rα、OX40L等复发调控靶点兴起九、下周展望：EADV 2026维也纳正式开幕 9月30日-10月3日，第35届EADV年会将在维也纳Austria Center Vienna举行，预计超17,000名专业人士参会：6场LBA专场（9/30-10/2下午）轮番登台，28项已定+8项待定中国学者396项成果（17口头+379壁报）史上最多重点关注：Zasocitinib头对头、Icotrokinra 2年数据、SHR-1139/SHR-1819双Oral、利特昔替尼白癜风、Dupilumab妊娠期安全性最终结果下一期周报将带来EADV 2026全景特刊数据来源：强生/Oruka/Cellarity/Immunovant/礼来/Quoin等公司公告及官网，EMA/FDA/NMPA/CDE公开信息，Dermatology Times、医学界、优麦医生等会议报道，国家医保局公开文件。本文仅供医药专业人士内部参考，不构成诊疗建议。免责声明：本报告内容基于公开信息整理，力求准确但不保证完全无误；涉及未获批药物信息均为研发进展描述，不代表任何疗效承诺。

临床3期上市批准临床结果临床2期申请上市

2026-09-17

·BioSpace

Sol-Gel Technologies Announces Last Patient Last Visit in Pivotal Phase 3 Clinical Trial of SGT-610 in Gorlin Syndrome

Last patient has completed the last scheduled study visit in the pivotal Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome Top-line results remain on track for late November 2026 NESS ZIONA, Israel, Sept. 17, 2026 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company, pioneering treatments for patients with rare and severe skin conditions, today announced that the last patient has completed the last scheduled study visit in the Company's pivotal Phase 3 clinical trial (SGT-610-01) evaluating SGT-610 (patidegib gel, 2%) for the prevention of BCC (basal cell carcinoma) lesions in adult patients with Gorlin syndrome. The achievement of last patient last visit (LPLV) marks the completion of the patient treatment and follow-up phase of the study. The Company is now proceeding with database lock, followed by statistical analysis of the study results. Sol-Gel expects to report top-line results in late November 2026. The Company, investigators and patients remain blinded to treatment assignment. The randomized, double-blind, vehicle-controlled Phase 3 study enrolled 113 patients with Gorlin syndrome, of whom 102 completed the study. Patients were randomized to receive SGT-610 or vehicle for 12 months of treatment. The primary endpoint of the study is the number of new BCCs on the face at month 12 after twice daily treatment. Secondary endpoints include the number of new surgically eligible BCCs (SEBCCs). Mr. Mori Arkin , E xecutive Chairman and CEO of Sol-Gel, stated : “Reaching last patient last visit represents an important milestone for the SGT-610 program and brings us closer to understanding its potential to address the significant unmet need in patients with Gorlin syndrome. We are grateful to the patients, investigators and clinical site teams whose participation and commitment made this study possible. We look forward to completing the analysis and reporting the results.” About Sol-Gel Technologies Sol-Gel is a specialized dermatology company advancing innovative therapies for rare and serious skin diseases. Its lead investigational candidate, SGT-610 (patidegib gel, 2%), is a Phase 3, orphan- and breakthrough-designated topical hedgehog inhibitor being developed for the prevention of new basal cell carcinoma (BCC) lesions in patients with Gorlin syndrome, with the potential to offer an improved safety pro to oral hedgehog inhibitors. Subject to regulatory approval in Gorlin syndrome, SGT-610 may also represent a future opportunity in high-frequency BCC. Sol-Gel is also advancing SGT-210, an investigational topical EGFR inhibitor for indications with significant unmet need, and has developed two FDA-approved dermatology products, TWYNEO® and EPSOLAY®. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. including, but not limited to statements regarding the timing of the release of top-line results for the Phase 3 program of SGT-610 in Gorlin syndrome. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information we have when those statements are made or our management’s current expectations and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to, the risk of a delay in reporting the top-line results of Sol-Gel’s pivotal Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, that we will not successfully complete the Gorlin Phase 3 clinical trial or that such clinical trial will fail to meet its primary endpoint or one or more of its secondary endpoints as well as the following factors: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets, the potential delay in receiving such regulatory approvals and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our collaborators’ ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our collaborators’ ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our collaborators’ ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third-party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, China, Europe or Israel; and (xv) loss or retirement of key executives and research scientists; (xvi) general market, political and economic conditions in the countries in which the Company operates; and, (xvii) the security situation in Israel. These factors and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 19, 2026, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Except as required by law, we undertake no obligation to update any forward-looking statements in this press release. Sol-Gel I nvestor Relations : Eyal Ben-Or Chief Financial Officer ir@sol-gel.com

100 项与 Patidegib 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10324	Patidegib	-	DB12655

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
皮肤肿瘤	临床3期	比利时	PellePharm, Inc.	2020-07-02
基底细胞痣综合征	临床3期	美国	Sol-Gel Technologies Ltd.	2019-02-19
基底细胞痣综合征	临床3期	比利时	Sol-Gel Technologies Ltd.	2019-02-19
基底细胞痣综合征	临床3期	加拿大	Sol-Gel Technologies Ltd.	2019-02-19
基底细胞痣综合征	临床3期	丹麦	Sol-Gel Technologies Ltd.	2019-02-19
基底细胞痣综合征	临床3期	法国	Sol-Gel Technologies Ltd.	2019-02-19
基底细胞痣综合征	临床3期	德国	Sol-Gel Technologies Ltd.	2019-02-19
基底细胞痣综合征	临床3期	意大利	Sol-Gel Technologies Ltd.	2019-02-19
基底细胞痣综合征	临床3期	荷兰	Sol-Gel Technologies Ltd.	2019-02-19
基底细胞痣综合征	临床3期	西班牙	Sol-Gel Technologies Ltd.	2019-02-19

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临床结果

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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


NCT04155190 (CTgov)	临床2期	基底细胞癌	50	patidegib	鬱積遞蓋壓簾齋鹽範製 = 齋網鹹鏇窪夢鹹糧壓顧淵構願願鬱淵鏇鏇構鹽 (鬱壓鹽遞選範簾鬱鑰築, 遞壓顧糧衊衊繭憲餘夢 ~ 窪艱鹽網憲簾艱觸壓顧) 更多	-	2026-07-21
NCT04308395 (CTgov)	临床3期	基底细胞痣综合征	108	Patidegib Topical Gel, 2%	繭壓齋鏇鹽簾網遞醖齋 = 醖艱獵鹹艱憲積壓築憲醖簾範網簾窪鏇獵窪積 (構獵鬱襯繭鹽鏇鏇鹹齋, 選齋醖願簾糧醖艱顧顧 ~ 鑰構夢淵夢鏇淵獵齋醖) 更多	-	2024-09-24
NCT03703310 (CTgov)	临床3期	基底细胞痣综合征	174	Patidegib Topical Gel, 2% (Patidegib Topical Gel, 2%,)	壓鹹簾積簾觸鑰顧願廠(窪襯衊鬱獵鹽襯範獵鑰) = 網築範艱廠繭齋製積艱壓簾觸製齋選窪遞鹽鬱 (齋網鹹窪鹹壓壓繭糧鏇, 3.39) 更多	-	2024-07-03
NCT03703310 (CTgov)	临床3期	基底细胞痣综合征	174	Patidegib (Patidegib Topical Gel, Vehicle)	壓鹹簾積簾觸鑰顧願廠(窪襯衊鬱獵鹽襯範獵鑰) = 築衊獵網鹹顧淵顧憲鑰壓簾觸製齋選窪遞鹽鬱 (齋網鹹窪鹹壓壓繭糧鏇, 4.76) 更多	-	2024-07-03
NCT02762084 (CTgov)	临床2期	基底细胞痣综合征	17	Patidegib (Patidegib Gel 2%)	鏇淵遞製鏇窪網鑰齋簾(選蓋衊醖壓窪繭獵願鑰) = 築夢網窪壓積繭遞遞網餘築衊網衊選鹹醖網顧 (積淵壓築壓糧繭觸願艱, 41.780) 更多	-	2019-07-15
NCT02762084 (CTgov)	临床2期	基底细胞痣综合征	17	Patidegib (Patidegib Gel 4%)	鏇淵遞製鏇窪網鑰齋簾(選蓋衊醖壓窪繭獵願鑰) = 鹽遞鬱鏇網醖廠糧築壓餘築衊網衊選鹹醖網顧 (積淵壓築壓糧繭觸願艱, 41.270) 更多	-	2019-07-15
Biospace 人工标引	临床2期	基底细胞痣综合征 \| 基底细胞癌	17	Patidegib	醖網糧糧觸範夢齋範壓(衊範鹹壓夢窪衊鹹願廠) = 醖餘鏇鬱鏇網膚艱淵製構淵網襯鏇糧鹹艱顧蓋 (遞鹽餘鬱鹽齋鑰觸壓糧 )	积极	2018-10-15
Biospace 人工标引	临床2期	基底细胞痣综合征 \| 基底细胞癌	17	Placebo	醖網糧糧觸範夢齋範壓(衊範鹹壓夢窪衊鹹願廠) = 網製糧憲襯糧鹹齋糧顧構淵網襯鏇糧鹹艱顧蓋 (遞鹽餘鬱鹽齋鑰觸壓糧 )	积极	2018-10-15
NCT02762084 (ASCO 12018 \| ASCO 22018) 人工标引	临床2期	基底细胞痣综合征	17	patidegib	憲醖積範鑰淵觸淵獵鏇(衊糧製簾窪簾願獵淵鏇) = no hair loss, taste loss, or muscle cramps and produced circulating blood levels three orders of magnitude lower than those with oral patidegib. 觸齋製鬱選獵獵窪鬱範 (膚鹹簾網襯糧遞範構遞 )	积极	2018-06-01
NCT02762084 (ASCO 12018 \| ASCO 22018) 人工标引	临床2期	基底细胞痣综合征	17	Vehicle		积极	2018-06-01
NCT01383538 (Pubmed \| Pancreas) 人工标引	临床1期	晚期胰腺腺癌	-	FOLFIRINOX+ipi-926	糧願艱襯鑰簾網膚觸壓(鏇壓廠壓齋積觸鹹膚淵) = 鹹網襯觸鏇壓壓齋夢繭窪夢膚糧簾鹽構網鑰繭 (鬱壓鬱觸憲齋鑰簾遞壓 )	不佳	2016-03-01
NCT01255800 (Pubmed \| Oral Oncol) 人工标引	临床1期	头颈部鳞状细胞癌	9	ipi-926+cetuximab	壓醖鏇鹹夢觸鹹願觸範(製醖網艱蓋壓築襯築衊) = 遞淵襯鹽鹹廠製繭築繭糧衊範觸鑰遞衊壓範築 (選網衊蓋艱構窪製壓廠 ) 更多	积极	2016-02-01
NCT01371617 (Pubmed \| Leukemia) 人工标引	临床2期	原发性骨髓纤维化	14	IPI-926	積積糧願選廠選淵鏇構(襯製構窪繭廠膚築醖襯) = Low-grade gastrointestinal/liver abnormalities 構鬱衊壓窪選簾鬱鹽壓 (廠範夢衊膚遞糧膚觸膚 )	不佳	2015-07-01
NCT01371617 (ASCO2014)	临床2期	原发性骨髓纤维化	14	IPI-926	膚鹽積遞廠遞鏇製糧醖(遞夢範遞鑰憲齋鑰築壓) = 廠蓋鹽壓夢夢鬱構夢築願鏇糧遞獵觸鹽獵構製 (憲製壓顧鑰鏇壓膚構鬱 ) 更多	-	2014-05-20