A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

开始日期2025-10-03

申办/合作机构

Janssen Research & Development LLC

NCT07196748

/ Recruiting临床3期

A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults With an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).

开始日期2025-10-01

申办/合作机构

Janssen Research & Development LLC

CTRI/2025/04/084956

/ Not yet recruiting临床3期

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-experienced Participants with Active Psoriatic Arthritis - ICONIC-PsA 2

开始日期2025-05-16

申办/合作机构-

100 项与依可替金拉相关的临床结果

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100 项与依可替金拉相关的转化医学

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100 项与依可替金拉相关的专利（医药）

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项与依可替金拉相关的文献（医药）

2025-11-06·NEW ENGLAND JOURNAL OF MEDICINE

Oral Icotrokinra for Plaque Psoriasis in Adults and Adolescents

Article

作者: Soung, Jennifer ; Pink, Andrew E. ; Lebwohl, Mark G. ; Shi, Yuling ; DeKlotz, Cynthia M.C. ; Jiang, Jingzhi ; Bissonnette, Robert ; Miller-Kassamali, Megan ; Cafone, Joseph ; Wang, Wen-hui ; Hebert, Adelaide A. ; Moore, Angela Y. ; Li, Shu ; Nunes, Fabio ; Pinter, Andreas ; Toth, Darryl P.

BACKGROUND:

Icotrokinra, a targeted oral peptide that selectively binds the interleukin-23 receptor, is under investigation for the treatment of plaque psoriasis.

METHODS:

We conducted a phase 3, double-blind, randomized, placebo-controlled trial involving adults and adolescents (≥12 years of age) with moderate-to-severe plaque psoriasis, as defined by all the following: a total body-surface area of psoriasis involvement of at least 10%, a Psoriasis Area and Severity Index (PASI) score of at least 12 (range, 0 to 72, with higher scores indicating a greater extent or severity of psoriasis), and an Investigator's Global Assessment (IGA) score of at least 3 (range, 0 [clear skin] to 4 [severe disease]). Participants were assigned in a 2:1 ratio to receive icotrokinra at a dose of 200 mg once daily through week 24 or placebo through week 16 followed by transition to icotrokinra. The coprimary end points were an IGA 0/1 response (IGA score of 0 or 1 with ≥2-point reduction from baseline) and a PASI 90 response (≥90% reduction from baseline in the PASI score) at week 16.

RESULTS:

A total of 684 participants underwent randomization (456 to the icotrokinra group and 228 to the placebo group). At week 16, a total of 65% of the participants receiving icotrokinra and 8% of those receiving placebo had an IGA 0/1 response, and 50% and 4%, respectively, had a PASI 90 response (P<0.001 for both comparisons). Complete clearance of skin at week 16 was significantly more likely with icotrokinra than with placebo (IGA score of 0, 33% vs. 1%; PASI 100 response [100% reduction from baseline in the PASI score], 27% vs. <1%; P<0.001 for both comparisons). The percentage of participants with at least one adverse event through week 16 was 49% in each group; the most common adverse events in each group were nasopharyngitis and upper respiratory tract infection. The exposure-adjusted incidence of adverse events was consistent through week 24.

CONCLUSIONS:

Selective blockade of the interleukin-23 receptor with the targeted oral peptide icotrokinra resulted in a significantly higher incidence of skin clearance at week 16 than placebo among adults and adolescents with moderate-to-severe plaque psoriasis. Longer-term data will provide a more complete understanding of the benefit-risk profile of icotrokinra. (Funded by Johnson & Johnson; ICONIC-LEAD ClinicalTrials.gov number, NCT06095115.)See also in NEJM Evidence: Targeted Oral Peptide Icotrokinra for Psoriasis Involving High‑Impact Sites.

2025-09-01·Dermatology and Therapy

Translational Pharmacokinetics of Icotrokinra, a Targeted Oral Peptide that Selectively Blocks Interleukin-23 Receptor and Inhibits Signaling

Article

作者: Patel, Shefali ; Shi, Yifan ; Baguet, Tristan ; Ndifor, Anthony ; Wang, Jianyao ; Somani, Sandeep ; Sensenhauser, Carlo ; Park, Seonghee ; Adriaenssen, Lieve ; Leclercq, Laurent ; Fourie, Anne ; Mardirosian, Saro ; Monshouwer, Mario ; Dallas, Shannon ; Chaudhuri, Siladitya Ray ; Knight, Beverly ; Sukumaran, Siddharth ; Polidori, David ; Patch, Raymond ; Sun, Chengzao ; DiLoreto, Karen ; Barros, Stephanie A ; Tammara, Brinda ; Geist, Brian ; Modi, Nishit B ; Moss, Darren ; Laenen, Aline

INTRODUCTION:

Icotrokinra (formerly JNJ-77242113 or PN-21235) is a targeted oral peptide that selectively inhibits interleukin-23 receptor signaling. The studies described here assessed its absorption, distribution, metabolism, and excretion (ADME), and potential for drug-drug interactions (DDI).

METHODS:

In vitro assays evaluated permeability, plasma protein binding, blood-to-plasma partitioning, metabolic stability, and interactions with drug transporters and metabolic enzymes. The nonclinical pharmacokinetic properties of icotrokinra were studied in vivo in rats and monkeys. Phase 1 studies evaluated the pharmacokinetic profile, metabolic profile and excretion in healthy volunteers.

RESULTS:

Icotrokinra demonstrated oral bioavailability of 0.1-0.3% in animals, with evidence of systemic pharmacodynamic activity, without the use of an absorption enhancer. The compound was stable across species in plasma, gastrointestinal matrices, and hepatocytes. Protein binding was low across species (~ 50% in human plasma), and icotrokinra distributed freely to tissues, including skin, joints, and gastrointestinal tissues. Following oral dosing in both rats and monkeys, fecal excretion of unabsorbed drug was the primary elimination route, and metabolite levels were low (each < 2% of dose) in plasma and excreta, with unchanged icotrokinra being the main circulating component. Icotrokinra was neither a substrate nor an inhibitor of prototypical drug transporters or cytochrome P450 enzymes. Icotrokinra exhibited dose-proportional pharmacokinetics from 25 mg to 1000 mg in a first-in-human study, and no serious adverse events were identified following single and multiple dose administrations. Unchanged icotrokinra was the only drug-related component in human plasma.

CONCLUSIONS:

Icotrokinra exhibited high stability and an ADME profile consistent with that of a small peptide, with no risk of DDI identified on the basis of in vitro studies. Clinical data demonstrated linear pharmacokinetics and no major metabolites.

TRIAL REGISTRATION NUMBER:

ClinicalTrials.gov, NCT04621630. Euclinicaltrials.eu, EUCT: 2023-504720-26-00. A Graphical Abstract is available for this article.

2025-09-01·LANCET

Once-daily oral icotrokinra versus placebo and once-daily oral deucravacitinib in participants with moderate-to-severe plaque psoriasis (ICONIC-ADVANCE 1 & 2): two phase 3, randomised, placebo-controlled and active-comparator-controlled trials

Article

作者: Papp, Kim A ; Bissonnette, Robert ; Magnolo, Nina ; Arnone, Marcelo ; Schwarz, Beate ; Kephart, Lea ; Gonzalez-Cantero, Alvaro ; Galimberti, Maria Laura ; Riera-Monroig, Josep ; Kircik, Leon ; Vender, Ronald B ; Campbell, Jennifer H ; Nunes, Fabio ; Edem, Bassey Effiom ; Tada, Yayoi ; Sebastian, Michael ; Waibel, Jill ; Tsianakas, Athanasios ; DeKlotz, Cynthia M C ; Cecchini, Michael ; Simon, Margrit ; Li, Shu ; Reyes-Servin, Ofelia ; Shen, Yaung-Kaung ; Gold, Linda Stein ; Cresswell, Kellen ; Wallace, Paul ; Gerdes, Sascha ; Armstrong, April W ; Ehst, Benjamin

BACKGROUND:

Monoclonal antibodies targeting interleukin-23 and interleukin-12 are efficacious in treating plaque psoriasis but must be delivered via intravenous or subcutaneous injection. Here, we aimed to evaluate the efficacy and safety of icotrokinra (JNJ-77242113), a targeted oral peptide that selectively binds the interleukin-23 receptor, compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque psoriasis.

METHODS:

The phase 3, randomised, double-blind, placebo-controlled and active-comparator-controlled ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 trials, which are being done at 149 sites across 13 countries and 114 sites across 11 countries, respectively, randomly assigned (2:1:2 and 4:1:4, respectively) adults with moderate-to-severe plaque psoriasis diagnosed for at least 26 weeks (body-surface-area involvement ≤10%, Psoriasis Area and Severity Index [PASI] ≤12, and Investigator's Global Assessment [IGA] ≤3) to once-daily oral icotrokinra 200 mg, placebo, or deucravacitinib 6 mg; participants randomly assigned to placebo or deucravacitinib transitioned to icotrokinra at week 16 or week 24, respectively. Coprimary endpoints were proportions of participants achieving IGA 0 or 1 (clear or almost clear skin) with at least a two-grade improvement and at least 90% improvement in PASI (PASI 90) at week 16 with icotrokinra versus placebo. These studies are registered with ClinicalTrials.gov, NCT06143878 (ADVANCE 1) and NCT06220604 (ADVANCE 2), and are ongoing.

FINDINGS:

ICONIC-ADVANCE 1 enrolled participants from Jan 17, 2024, to May 24, 2024, and ICONIC-ADVANCE 2 enrolled participants from March 9, 2024, to June 13, 2024. Participants (ADVANCE 1: 774 of 988 patients screened; ADVANCE 2: 731 of 917 patients screened) were randomly assigned to icotrokinra (n=311 and 322), placebo (n=156 and 82), or deucravacitinib (n=307 and 327). All coprimary endpoints were met in both trials. Higher proportions of icotrokinra-treated versus placebo-treated participants achieved IGA 0 or 1 (ADVANCE 1: 213 [68%] of 311 vs 17 [11%] of 156, treatment difference 95% CI 58% [50-64]; ADVANCE 2: 227 [70%] of 322 vs seven [9%] of 82, 62% [53-69]; both p<0·0001) and PASI 90 (ADVANCE 1: 171 [55%] of 311 vs six [4%] of 156, treatment difference 95% CI 51% [44-57]; ADVANCE 2: 184 [57%] of 322 vs one [1%] of 82, 56% [48-62]; both p<0·0001) at week 16. Across studies, adverse event rates to week 16 were 303 (48%) of 632 and 136 (57%) of 237 with icotrokinra and placebo, respectively; the most common adverse events were nasopharyngitis (37 [6%] of 632 and 13 [5%] of 237) and upper respiratory tract infection (23 [4%] of 632 and eight [3%] of 237). To week 24, adverse event rates were lower than with icotrokinra (359 [57%] of 632) than deucravacitinib (411 [65%] of 634).

INTERPRETATION:

Icotrokinra showed superior clinical response rates versus placebo and deucravacitinib in phase 3 moderate-to-severe plaque psoriasis trials, with similar adverse event rates to placebo. These findings suggest the potential of once-daily oral icotrokinra to provide robust efficacy and a favourable safety profile.

FUNDING:

Johnson & Johnson.

308

项与依可替金拉相关的新闻（医药）

2025-11-20

·Biotech前瞻

银屑病丨强生IL-23口服多肽国内申报上市，迎击百时美、艾伯维、康方

点击蓝字关注我们本期看点在银屑病治疗领域，一场激烈的市场竞争正在展开。从“静脉注射生物制剂”向“口服靶向药”和“皮下注射剂型”开始范式转移，随着各大药企的不断发力，新的治疗方案和药物不断涌现，为患者带来了更多的选择和希望。然而，竞争也愈发激烈，各大产品之间的优势对比和市场前景成为行业关注的焦点。其中，安全性数据与适应症扩展能力将成为差异化竞争的核心胜负手。本文纵览银屑病领域的近期要闻，以飨读者。本期内容 01 强生丨口服IL-23受体阻断剂 02 康方、艾伯维、施贵宝丨谁主沉浮 03 竞争分析 04 总结与展望【01 强生丨口服IL-23受体阻断剂】乌司奴单抗作为银屑病和免疫疾病领域的“初代生物制剂王者”，正面临口服靶向药与生物类似药的双重夹击，其市场地位取决于强生对产品生命周期管理的策略（如适应症扩展、新兴市场开拓）及内部管线迭代节奏。 2025年11 月 19 日，CDE 官网显示，强生 1 类新药盐酸伊可白滞素片申报上市，适用于治疗适合接受系统性治疗或光疗的中重度斑块状银屑病成人患者和年满 12 岁的儿童患者。同日，该适应症也被 CDE 纳入了拟优先审评。截图来源：CDE 官网作为一种口服IL-23受体阻断剂，icotrokinra在III期临床试验中表现卓越，不仅在清除皮肤病变和缓解症状严重程度方面优于安慰剂，还击败了百时美施贵宝（BMS）的Sotyktu。这一结果让icotrokinra有望成为银屑病治疗的“新标准”。在2025年美国皮肤病学会年会上公布的数据显示，65%的icotrokinra治疗患者在16周内达到皮肤清除或几乎清除，而安慰剂组仅为8%。此外，icotrokinra的安全性与安慰剂相当，不良事件发生率为49%，显示出良好的耐受性。该产品最终上市后，将重新改变当下的银屑病治疗格局。 02 康方、艾伯维、施贵宝丨谁主沉浮康方生物丨依若奇单抗 2025年4月18日，NMPA官网最新公示，康方生物在研IL-12/IL-23全人源单克隆抗体依若奇单抗获批上市，适用于对环孢素、甲氨蝶呤（MTX）等其他系统性治疗或PUVA（补骨脂素和紫外线A）不应答、有禁忌或无法耐受的中度至重度斑块状银屑病的成年患者的治疗。截图来源：NMPA官网作为双抗赛道的领头羊，在肿瘤免疫治疗赛道一骑绝尘的康方生物，在自身免疫性疾病领域也在加速布局。而在银屑病领域，首先面临的将是艾伯维、强生、施贵宝等MNC的竞争高墙。艾伯维的利生奇珠单抗丨皮下剂型 2025年3月10日，艾伯维（AbbVie）宣布其利生奇珠单抗注射液在中国获批上市，用于治疗中重度活动性克罗恩病患者。来源：https://www.skyrizihcp.com/ 利生奇珠单抗（risankizumab）是一种人源化IgG1单克隆抗体，通过选择性拮抗IL-23的p19亚基，抑制炎症反应。该药物最早于2019年在日本获批，随后在美国获批用于银屑病和银屑病关节炎治疗，并被列为2019年最值得关注的新药之一。截至2024年，利生奇珠单抗已获批用于四种免疫介导炎症性疾病，包括银屑病、银屑病关节炎、克罗恩病和溃疡性结肠炎。利生奇珠单抗的给药方案灵活，包括诱导治疗阶段的静脉注射和维持治疗阶段的皮下注射。其随身给药器（OBI）设计为患者提供了便利，可在家中自行完成给药。在临床研究中，利生奇珠单抗在诱导治疗和维持治疗中均显示出显著的内镜应答和临床缓解效果。此次在中国获批，意味着利生奇珠单抗即将惠及更多中国患者，进一步巩固其在银屑病及相关疾病治疗领域的地位。施贵宝的Sotyktu丨口服TYK2抑制剂百时美施贵宝的Sotyktu（通用名：氘可来昔替尼，商品名：颂狄多）也在不断拓展其市场版图。作为一种口服TYK2抑制剂，Sotyktu在银屑病和银屑病关节炎领域取得了显著进展。来源：iStock, JHVEPhoto 其在银屑病关节炎的III期POETYK PsA-2研究中，54.2%的患者在16周内症状改善超过20%，显著优于安慰剂组的39.4%。然而，Sotyktu面临着来自安进（Amgen）Otezla和新兴竞争对手Alumis的TYK2抑制剂ESK-001的双重压力。尽管Sotyktu拥有相对干净的安全性特征，但市场竞争依然激烈。2023年的一份报告显示，Otezla在Sotyktu获批后仍保持市场份额，未受到明显冲击。 03 竞争分析银屑病治疗领域的竞争日益激烈，各大药企纷纷推出创新药物，试图在市场中占据一席之地。强生的icotrokinra凭借其卓越的疗效和安全性，有望成为新的治疗标准；百时美施贵宝的Sotyktu则在拓展适应症的同时，面临着来自Otezla和新兴竞争对手的双重挑战；而艾伯维的利生奇珠单抗凭借其多领域适应症和灵活的给药方案，正在加速布局中国市场。 04 总结与展望未来，随着更多创新药物的推出和市场竞争的加剧，银屑病治疗领域将迎来更多突破和变革。对于患者而言，这意味着更多选择和希望；对于药企而言，则需要不断创新和优化产品，以应对日益激烈的市场竞争。 ★

2025-11-19

·丁香园 Insight 数据库

强生 first-in-class 新药在国内申报上市

11 月 19 日，CDE 官网显示，强生 1 类新药盐酸伊可白滞素片申报上市，适用于治疗适合接受系统性治疗或光疗的中重度斑块状银屑病成人患者和年满 12 岁的儿童患者。同日，该适应症也被 CDE 纳入了拟优先审评。截图来源：CDE 官网盐酸伊可白滞素片（Icotrokinra）是强生斥资近 10 亿美元从 Protagonist 引进的 first-in-class 口服多肽药物（IL-23R 拮抗剂）。今年 7 月该药在美国申报上市，9 月在欧洲申报上市。值得一提的是，Icotrokinra 是当前全球首个也是唯一一个报上市的 IL-23R 靶向药物。强生对此寄予厚望，预计年峰值销售额有望达到 50 亿美元以上。截图来源：企业官网此前该药在美国和欧盟的上市申请包含四项关键性 III 期研究的数据，包括 ICONIC-LEAD、ICONIC-TOTAL 以及 ICONIC-ADVANCE 1 和 ICONIC-ADVANCE 2。截图来源：Insight 数据库 ICONIC-ADVANCE 1 和 2 为随机对照 III 期临床试验，旨在评估 Icotrokinra 与氘可来昔替尼（全球首个获批的 TYK-2 变构抑制剂）和安慰剂相比，在中重度斑块状银屑病患者中的疗效和安全性。共同主要终点是受试者达到 PASI 90 （银屑病面积与严重程度指数改善 90%）和 IGA 评分为 0/1（皮肤症状消除或几乎消除），且至少改善 2 级。在这两项研究中， Icotrokinra 与安慰剂相比，在第 16 周达到了两个共同主要终点，不良事件发生率相似，并且在时间点显示出优于氘可来昔替尼的疗效和安全性。与安慰剂（第 16 周）和氘可来昔替尼（第 16 周和第 24 周）相比，Icotrokinra 显示出更优异的皮肤清除率。 Icotrokinra 的不良事件 (AE) 发生率与安慰剂相似，未发现新的安全信号。截至第 24 周，Icotrokinra 的 AE 发生率在数值上低于氘可来昔替尼。在所有研究中，汇总安全性数据显示，Icotrokinra 组 (49.1%) 和安慰剂组 (51.9%) 之间经历不良事件 (AE) 的患者比例相似，未发现新的安全信号。此外，强生还启动了 III 期 ICONIC-ASCEND 研究，这是首个旨在证明口服药 Icotrokinra 优于注射生物制剂乌司奴单抗的头对头研究。长期数据方面，ICONIC-LEAD 研究中，Icotrokinra 在第 52 周时表现出对成人和青少年患者持续的皮肤清除率和良好的安全性。第 52 周时，达到 PASI 90 的成年患者在第 24 周重新随机分配到 icotrokinra 组，其 PASI 90 维持率优于重新随机分配到安慰剂组的患者（84% vs 21%；p<0.001）。在第 52 周，86% 接受 icotrokinra 治疗 52 周的青少年达到了 PASI 90 ，而 77% 在第 16 周从安慰剂转为 icotrokinra 的青少年达到了 PASI 90。 Insight 数据库整理了 2025 年全球新药申报上市清单，扫描下方二维码 👇，回复关键词新药报上市即可免费获取（每月初更新一次，目前更新至 10 月）。封面来源：企业logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：ccai PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn

临床3期优先审批临床结果

2025-11-19

·今日头条

口服多肽战国时代：巨头们的“针尖到舌尖”争夺战

当强生为口服IL-23受体拮抗剂icotrokinra递出上市申请，当诺和诺德的口服司美格鲁肽持续刷新销售额，一场围绕口服多肽的全球医药巨头较量已全面铺开。兼具小分子药的便捷与生物药的高特异性，这条黄金赛道正从代谢疾病、自身免疫病向肿瘤、罕见病延伸，强生、艾伯维、诺和诺德等玩家的差异化落子，勾勒出千亿市场的竞争轮廓。强生：技术破局，抢滩免疫领域口服首证作为自身免疫治疗领域的老牌玩家，强生在口服多肽赛道的打法直奔核心——拿下细分领域首个口服标杆。其与Protagonist Therapeutics联手打造的icotrokinra（JNJ-2113），是全球首款口服IL-23受体拮抗剂。依托专属多肽递送技术，这款药物突破了生物利用度的关键瓶颈，III期临床数据颇为亮眼：24周时74%患者实现皮肤清除或几乎清除（IGA 0/1），46%达到完全清除（IGA 0），对头皮、生殖器等难治病灶的效果，也明显优于现有口服疗法。目前，该药已向美欧药监机构提交上市申请，同时在推进溃疡性结肠炎适应症的临床研究，市场潜力被看好至50亿美元。强生的思路很明确：用口服多肽技术改造自家优势靶点IL-23，解决传统注射剂的依从性痛点，巩固在银屑病、IBD等领域的地位；同时借外部合作补齐口服递送技术短板，应对核心产品乌司奴单抗专利到期后的竞争压力，完成从“注射多肽巨头”到“口服+注射”双轨布局的转型。艾伯维：资本补位，重构免疫口服多肽版图面对强生的攻势和“药王”修美乐专利到期的压力，艾伯维选择用资本并购快速切入口服多肽赛道。其收购的Nimble Therapeutics，是一家专注口服多肽的企业——不仅带来了一款临床前阶段的口服IL-23抑制剂（与自身重磅注射剂利生奇珠单抗靶点相同），更将其高活性肽合成、半衰期优化平台收入囊中。这套平台能显著提升多肽的口服生物利用度和体内稳定性，与艾伯维现有免疫产品线形成天然协同。艾伯维的算盘很清晰：通过收购快速补上口服多肽技术短板，避免在银屑病口服药市场被强生拉开差距；同时将口服多肽与现有JAK抑制剂、TNFα抑制剂组合，覆盖那些不耐受注射的患者，在265亿美元规模的银屑病市场中守住优势。此外，其布局的口服多肽Relamorelin瞄准胃肠动力障碍等小众适应症，形成“大众市场+小众补充”的差异化结构。诺和诺德：深耕壁垒，坐稳代谢赛道口服龙头作为GLP-1领域的传统强者，诺和诺德在口服多肽赛道的核心是“把技术优势做深做透”。其口服司美格鲁肽片剂（Rybelsus）2024年上半年销售额达15.87亿美元，同比增长32%，关键就在于破解了多肽口服的核心难题——用“SNAC吸收促进剂”技术，解决了多肽易被胃酸降解、生物利用度低的行业痛点，让代谢疾病领域的口服多肽实现了规模化商业化。如今，诺和诺德仍在持续迭代技术，推进每周一次的长效口服制剂研发，进一步提升患者依从性，与自身注射用司美格鲁肽形成“强效+便捷”的互补。其策略很务实：深耕多肽技术壁垒，通过优化递送系统、修饰氨基酸序列，持续降低生产成本、提升药效稳定性，稳稳守住全球代谢疾病口服多肽市场的主导地位。跨界玩家：差异化卡位，瓜分细分赛道蛋糕除了核心玩家，默沙东、诺华等巨头也在口服多肽赛道寻找突破口，聚焦高价值细分领域。默沙东把目光投向肿瘤靶向口服多肽，针对KRAS G12D等难成药突变开发环肽抑制剂。这类药物凭借环形结构的稳定性优势，口服后能精准结合肿瘤靶点，部分候选药在I期临床中展现出皮摩尔级亲和力，可诱导肿瘤消退，作用持续24-48小时，刚好填补了传统小分子药物的靶向空白。诺华则砸下120亿美元收购相关公司，布局肌营养不良等罕见病的口服多肽与RNA联合疗法。这类疗法针对的患者群体虽小，但治疗需求迫切，而且技术壁垒高、毛利率可观，竞争格局相对宽松，能快速建立差异化优势。此外，华东医药、信达生物等国内药企也在加速布局，通过技术引进与自主研发结合，推进口服GLP-1多肽、双/三靶点激动剂，成为赛道中不可忽视的新兴力量。赛道博弈：千亿棋局里的机遇与挑战口服多肽市场的爆发，离不开技术突破与需求升级的双重推动。Frost & Sullivan预测，2028年全球多肽类药物市场规模将达1890亿美元，其中口服制剂占比预计提升至25%-30%，成为核心增长引擎。对巨头而言，口服多肽不仅是应对专利悬崖的“续命方案”，更是开拓新市场、提升患者依从性的关键——从“针尖到舌尖”的转变，正在改写多肽药物的使用逻辑。但赛道热闹的背后，挑战也真实存在。口服多肽仍面临合成精度要求高、生产成本高、稳定性差等技术难题；据行业机构预测，2025年全球多肽原料药产能可能过剩20%，中低端产品或陷入价格竞争；国内仿制药上市后若纳入集采，价格可能下降40-60%，进一步压缩利润空间。未来，口服多肽市场的竞争，终将聚焦在技术壁垒、适应症广度和商业化效率上。谁能持续突破口服递送技术，谁能拓展更多高价值适应症，谁就能在这场千亿赛道的博弈中站稳脚跟。而巨头们的较量，最终会惠及全球患者——从每天注射到口服给药，曾经的医学探索，正在变成日常治疗的常态。

并购专利到期临床3期

100 项与依可替金拉相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
斑块状银屑病	申请上市	美国	Johnson & Johnson	2025-07-21
克罗恩病	临床3期	美国	Janssen Research & Development LLC	2025-10-03
克罗恩病	临床3期	日本	Janssen Research & Development LLC	2025-10-03
克罗恩病	临床3期	澳大利亚	Janssen Research & Development LLC	2025-10-03
克罗恩病	临床3期	加拿大	Janssen Research & Development LLC	2025-10-03
克罗恩病	临床3期	马来西亚	Janssen Research & Development LLC	2025-10-03
克罗恩病	临床3期	英国	Janssen Research & Development LLC	2025-10-03
溃疡性结肠炎	临床3期	美国	Janssen Research & Development LLC	2025-10-01
溃疡性结肠炎	临床3期	日本	Janssen Research & Development LLC	2025-10-01
溃疡性结肠炎	临床3期	澳大利亚	Janssen Research & Development LLC	2025-10-01

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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


NCT06095102 (Pubmed \| NEJM Evid)	临床3期	银屑病	311	Icotrokinra 200 mg daily	繭範範繭網膚鏇選膚襯(遞獵鹹膚淵遞顧廠蓋願) = 糧觸網選膚廠製鹽製夢糧築鑰憲獵構衊獵繭製 (顧糧範簾壓齋鑰膚憲醖 ) 更多	积极	2025-11-05
				Placebo	繭範範繭網膚鏇選膚襯(遞獵鹹膚淵遞顧廠蓋願) = 鹽製窪鏇艱餘夢製鑰構糧築鑰憲獵構衊獵繭製 (顧糧範簾壓齋鑰膚憲醖 ) 更多
NCT06049017 (ANTHEM-UC, Company_Website) 人工标引	临床2期	溃疡性结肠炎	-	Icotrokinra 400 mg once daily	鏇積網淵繭簾願遞簾範(鏇製獵襯積壓鑰鬱膚蓋) = Similar proportions of pts reported AEs and SAEs through Week 28 across all icotrokinra dose groups and the placebo group. 壓範窪繭簾製憲艱範壓 (醖夢獵鑰齋範繭獵齋構 )	积极	2025-10-27
				Placebo
NCT06095102 (ICONIC-TOTAL, ACR2025) 人工标引	临床3期	斑块状银屑病	311	Icotrokinra 200 mg	膚繭網衊顧衊襯鬱網顧(顧獵遞廠積齋淵鹽窪鏇) = 願積築夢願顧鬱簾選鬱壓網醖顧築鬱餘蓋簾蓋 (醖選衊蓋鬱淵鬱膚觸繭 ) 达到更多	积极	2025-10-24
				Placebo	膚繭網衊顧衊襯鬱網顧(顧獵遞廠積齋淵鹽窪鏇) = 夢範築繭壓繭選選繭築壓網醖顧築鬱餘蓋簾蓋 (醖選衊蓋鬱淵鬱膚觸繭 ) 达到更多
NCT06095102 (ICONIC-TOTAL, Company_Website) 人工标引	临床3期	银屑病	-	Icotrokinra	鹹淵窪壓夢廠窪範遞範(鹽襯艱鑰蓋艱廠餘糧醖) = 餘構遞憲積網鏇積遞製襯範衊範壓簾構憲蓋鹽 (遞簾鹽構鑰遞鹹顧鏇構 ) 更多	积极	2025-10-24
NCT06095115 (ICONIC-LEAD, ACR2025)	临床3期	斑块状银屑病	684	Icotrokinra 200 mg	鹹憲襯膚鹽壓鹽淵齋鏇(夢窪構製築構築選鹽襯) = 顧襯積鏇選遞齋憲鑰範鏇夢衊鹹顧鬱網糧顧範 (選襯廠鬱艱鏇淵襯顧齋 ) 更多	积极	2025-10-24
				Placebo	鹹憲襯膚鹽壓鹽淵齋鏇(夢窪構製築構築選鹽襯) = 獵糧窪觸鏇鏇醖鹹淵壓鏇夢衊鹹顧鬱網糧顧範 (選襯廠鬱艱鏇淵襯顧齋 ) 更多
FRONTIER 1 (ACR2025)	临床2期	银屑病关节炎 β-Defensin-2 (BD-2) \| IL-22 \| IL-17A ... 更多	23	Icotrokinra (ICO)	夢膚觸鏇網鑰糧夢範顧(簾膚築構蓋廠遞鹹夢蓋) = 壓鏇製憲製築壓蓋網鹹醖廠鏇膚蓋觸構淵窪鬱 (鏇膚蓋構願製窪鬱襯範 ) 更多	积极	2025-10-24
				Placebo	鏇鹹築製壓艱艱窪鹽艱(願壓憲壓積鏇遞齋糧構) = 餘鑰選艱網鏇鏇衊襯鬱鑰鑰廠鹽襯鬱醖簾鹽築 (蓋鬱淵窪鏇繭齋襯鹽鬱 ) 更多
NCT06049017 (ANTHEM-UC, Company_Website) 人工标引	临床2期	溃疡性结肠炎	-	Icotrokinra 400 mg QD	範鏇壓範觸襯醖製積夢(願糧餘網顧簾蓋襯憲艱) = 積築選廠淵築簾蓋蓋鹽鹽鏇網蓋獵鏇夢鏇觸壓 (衊餘製簾窪蓋窪積觸夢 ) 达到更多	积极	2025-10-07
				Icotrokinra 200 mg QD	範鏇壓範觸襯醖製積夢(願糧餘網顧簾蓋襯憲艱) = 壓獵積廠鹽膚鹽鑰範觸鹽鏇網蓋獵鏇夢鏇觸壓 (衊餘製簾窪蓋窪積觸夢 ) 达到更多
NCT06220604 \| NCT06143878 (ICONIC-ADVANCE 2, PRNewswire) 人工标引	临床3期	斑块状银屑病	-	Icotrokinra	範範壓遞齋廠構鏇築築(構蓋製憲築膚積鏇鏇製) = Icotrokinra showed superior skin clearance vs placebo (Week 16) and deucravacitinib (Weeks 16 and 24). 衊獵繭網鹹壓廠鹽獵艱 (廠蓋淵憲鬱壓膚醖糧糧 ) 达到更多	优效	2025-09-17
				Deucravacitinib
NCT06095115 (ICONIC-LEAD, PRNewswire) 人工标引	临床3期	斑块状银屑病	-	Icotrokinra (re-randomized at Week 24)	鬱窪鏇鹹觸選鬱簾鹽簾(醖襯廠齋鑰鬱遞淵積窪) = 構網範鏇膚憲範觸繭網範餘選蓋壓憲鹹蓋醖淵 (積淵網範糧蓋壓壓襯壓 )	积极	2025-09-17
				Placebo (re-randomized at Week 24)	鬱窪鏇鹹觸選鬱簾鹽簾(醖襯廠齋鑰鬱遞淵積窪) = 積顧憲築簾鬱獵衊膚壓範餘選蓋壓憲鹹蓋醖淵 (積淵網範糧蓋壓壓襯壓 )
NCT06095115 (ICONIC-LEAD, NEWS) 人工标引	临床3期	斑块状银屑病	-	Icotrokinra	遞觸築繭艱蓋願顧夢窪(鏇構構繭淵憲範構憲構) = 鑰構淵蓋製鏇憲範夢淵襯遞襯衊獵觸餘鏇網遞 (憲積鏇積範範夢鬱窪憲 ) 更多	积极	2025-08-04
				Placebo	願遞餘齋淵選齋憲鹹艱(鏇網壓製襯蓋繭鹹醖淵) = 廠築鏇廠鏇窪願膚淵繭鬱衊製淵夢選觸蓋鹹醖 (鹹獵鹹網蓋鹹觸築艱憲 )