Rezpegaldesleukin(Rezpegaldesleukin) - 药物靶点：IL-2Rβ_在研适应症：中度特应性皮炎，斑秃，重度特应性皮炎_专利_临床

概要

基本信息

药物类型

细胞因子、融合蛋白

别名

IL-2 conjugate、Interleukin-2 conjugate、PEG-conjugated rhIL-2

+ [5]

靶点

IL-2Rβ

作用方式

激动剂

作用机制

IL-2Rβ激动剂(白细胞介素-2受体β链激动剂)

治疗领域

免疫系统疾病遗传病与畸形内分泌与代谢疾病+ [1]

在研适应症

中度特应性皮炎斑秃重度特应性皮炎+ [3]

非在研适应症

溃疡性结肠炎湿疹斑块状银屑病+ [1]

原研机构

Nektar Therapeutics

在研机构

Nektar TherapeuticsNektar Therapeutics UK Ltd.

Eli Lilly & Co.

非在研机构-

权益机构

Eli Lilly & Co.

Nektar Therapeutics

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床申请

特殊审评快速通道 (美国)

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结构/序列

Sequence Code 720

来源: *****

关联

14

项与 Rezpegaldesleukin 相关的临床试验

NCT07711418

/ Recruiting临床3期

A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin (NKTR-358) Monotherapy in the Treatment of Patients ≥ 12 Years of Age With Moderate-to- Severe Atopic Dermatitis

This is an interventional, randomized, parallel group, treatment, Phase 3, double blind study to assess the effect of Rezpegaldesleukin in participants 12 years of age or older with moderate to severe atopic dermatitis, as compared to placebo.
The estimated participant overall duration is approximately 15 months.

开始日期2026-08-07

申办/合作机构

Nektar Therapeutics

NCT07690371

/ Recruiting临床3期

A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin (NKTR-358) Monotherapy in the Treatment of Patients ≥ 12 Years of Age With Moderate-to-Severe Atopic Dermatitis

This is an interventional, randomized, parallel group, treatment, Phase 3, double blind study to assess the effect of Rezpegaldesleukin in participants 12 years of age or older with moderate to severe atopic dermatitis, as compared to placebo.
The estimated participant overall duration is approximately 15 months.

开始日期2026-06-29

申办/合作机构

Nektar Therapeutics

NCT07142252

/ Recruiting临床2期IIT

Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus

This Phase 2 study is a 2-arm, multi-center, double-masked (masking of the participant, care provider and investigator), placebo-controlled, 2:1 randomized trial design in new onset T1D participants (within 100 days of diagnosis). Participants will be administered rezpegaldesleukin/placebo once every 14 days over 26 weeks with an additional 6-month follow-up period.

开始日期2026-05-14

申办/合作机构

National Institute of Diabetes & Digestive & Kidney Diseases

100 项与 Rezpegaldesleukin 相关的临床结果

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100 项与 Rezpegaldesleukin 相关的转化医学

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100 项与 Rezpegaldesleukin 相关的专利（医药）

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6

项与 Rezpegaldesleukin 相关的文献（医药）

2026-03-23·Cureus Journal of Medical Science

Biologic Monotherapies for Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Bayesian Network Meta-Analysis of Established and Investigational Agents

Review

作者: Babul, Najib ; Soliman, Yssra ; Babul, Arya ; Mehta, Devina ; Hussain, Momina

Biologic therapies targeting maladaptive type 2 inflammation have transformed the management of moderate‑to‑severe atopic dermatitis (AD); however, comparative evidence integrating both approved and next‑generation investigational agents remains limited. This Bayesian network meta‑analysis (BNMA) provides the first unified evaluation of all biologic monoclonal antibodies approved as monotherapy for AD (dupilumab, lebrikizumab, tralokinumab) together with emerging immunotherapies, including amlitelimab, rademikibart, rezpegaldesleukin, rocatinlimab, telazorlimab, temtokibart, and zumilokibart, across key efficacy measures. A PRISMA‑2020-compliant systematic review and PROSPERO‑registered protocol (CRD420251162704) identified phase 2-3 randomized, double‑blind, placebo‑controlled trials reporting week‑16 outcomes (week‑24 for rocatinlimab). A Bayesian random‑effects NMA estimated relative risks (RRs) for EASI‑75, EASI‑90, IGA‑AD 0/1, and ≥4‑point improvement in itch Numeric Rating Scale (NRS). Treatment hierarchy was evaluated using both Bayesian (SUCRA) and frequentist (P‑score) approaches. Seventeen randomized controlled trials (RCTs) involving more than 6,000 patients were included in the analysis. Dupilumab demonstrated the most consistent and reliable efficacy across all evaluated endpoints, including improvements in EASI-75, EASI-90, IGA-AD 0/1, and itch NRS. Among investigational therapies, rocatinlimab showed a notable signal for deep clinical responses, although the available evidence remains limited and less precise. Other emerging agents, including rademikibart, temtokibart, and zumilokibart, demonstrated encouraging efficacy profiles, whereas telazorlimab showed comparatively modest clinical benefit. Ranking analyses consistently positioned dupilumab as the most reliable and highest-performing therapy overall, followed by rocatinlimab. Overall, biologic therapies were generally well tolerated in the short term; however, dupilumab remains the only agent supported by extensive long-term safety data extending up to a decade. This analysis relied on indirect comparisons anchored to short‑term placebo‑controlled induction periods, limiting assessment of long‑term safety and durability, particularly for mechanistically distinct agents such as rezpegaldesleukin, a regulatory T cell (Treg) pathway agonist, and rocatinlimab, an OXO pathway inhibitor. Evidence for several emerging therapies was restricted to small phase 2 trials, resulting in wide credible intervals (Crls) and lower certainty in comparative rankings. Trial heterogeneity in baseline severity, ethnic composition, and geographic setting may have introduced residual confounding despite sensitivity and meta‑regression analyses. These factors should be considered when interpreting relative efficacy estimates This NMA demonstrates that dupilumab remains the most reliable and effective biologic monotherapy for moderate‑to‑severe AD, supported by the greatest precision, reproducibility, and long‑term safety. Rocatinlimab shows promising investigational efficacy but requires efficacy and long-term safety validation. Zumilokibart, rademikibart, and temtokibart emerge as additional candidates with encouraging activity, whereas telazorlimab showed limited clinical benefit. Collectively, these findings provide a comprehensive comparative framework to inform biologic selection and therapeutic sequencing.

2025-04-18·Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences

[Biological activity and antitumor effect of long-acting recombinant human interleukin-2 drug].

Article

作者: Zhang, Fengxia ; Zhu, Jingjing ; Jin, Ting ; Liang, Xuejun

OBJECTIVE:

To investigate the biological activity and antitumor effect of pegylated recombinant human interleukin 2 (PEG-rhIL-2) obtained by site-specific conjugation of polyethylene glycol (PEG) with non-natural amino acids, and to explore its antitumor mechanism.

METHODS:

The binding activities of PEG-rhIL-2 at three different sites (T41, Y45, and V91) to human interleukin 2 receptors α (IL-2R_α) and β (IL-2R_β) and were detected by surface plasmon resonance (SPR) technology. Western blot was used to detect the levels of the Janus kinase-signal transducer and activator of transcription 5 (JAK-STAT5) signaling pathway activated by different doses of rhIL-2 and PEG-rhIL-2 in CTTL-2 and YT cells. Blood was collected after a single administration in mice to detect the drug concentration at different time points and evaluate the pharmacokinetic parameters of Y45-PEG-rhIL-2. Mouse hepatoma cell line Hepa1-6, pancreatic cancer cell line Pan-02, and colon cancer cell line MC-38 were selected. Tumor models were constructed in C57BL/6 mice. Different doses of Y45-PEG-rhIL-2 and excipient control were administrated respectively to evaluate the tumor suppression effect of the drug. In the MC-38 colon cancer model, the tumor suppression effect of Y45-PEG-rhIL-2 combined with anti-programmed death-1 (PD-1) monoclonal antibody was evaluated. Hepa1-6 mouse tumor models were constructed and rhIL-2, Y45-rhIL-2 and Y45-PEG-rhIL-2 were administrated respectively. The proportion of tumor-infiltrating lymphocytes was analyzed by flow cytometry.

RESULTS:

The SPR detection results showed that the binding activities of PEG-rhIL-2 to IL-2R_α/IL-2R_β were both reduced. The affinity of Y45-PEG-rhIL-2 to IL-2R_α was reduced to approximately 1/250, and its affinity to IL-2R_β was reduced to 1/3. Western blot results showed that the activity of Y45-PEG-rhIL-2 in stimulating JAK-STAT5 signaling in CTLL-2 cells expressing heterotrimeric IL-2 receptor complex IL-2R_αβγwas reduced to approximately 1/300, while its activity in YT cells expressing heterodimeric IL-2 receptor complex IL-2R_βγwas reduced to approximately 1/3. The pharmacokinetic evaluation after a single dose in the mice showed that the elimination half-life of Y45-PEG-rhIL-2 was 17.7 h. Y45-PEG-rhIL-2 has pharmacokinetic characteristics superior to those of rhIL-2. Y45-PEG-rhIL-2 showed dose-dependent tumor suppression activity, and the combination of Y45-PEG-rhIL-2 and anti-PD-1 antibody had a better tumor-inhibiting effect than the single use of Y45-PEG-rhIL-2 or anti-PD-1 antibody. Flow cytometry analysis demonstrated that 72 h after the administration of Y45-PEG-rhIL-2, the proportion of tumor-infiltrating cytotoxic T lymphocytes (CD8⁺T cells) increased by 86.84%. At 120 h after administration, the ratio of CD8⁺T cells to regulatory T cells (Treg) increased by 75.10%.

CONCLUSION:

Y45-PEG-rhIL-2 obtained by site-specific conjugation via non-natural amino acids changed its receptor binding activity and inhibited tumor growth in dose-dependent manner in multiple tumor models by regulating CD8⁺T cells.

2022-01-01·Journal of translational autoimmunity

Selective expansion of regulatory T cells by NKTR-358 in healthy volunteers and patients with systemic lupus erythematosus

Article

作者: Levin, Robert ; Furie, Richard ; Diab, Isam ; Fanton, Christie ; Hanan, Nathan ; Chindalore, Vishala ; Zalevsky, Jonathan ; Dickerson, Daniel ; Dixit, Neha ; Haglund, Cat ; Kotzin, Brian L ; Gibbons, Jacqueline

Objective:

To evaluate NKTR-358, a polyethylene glycol-interleukin-2 conjugate composition designed to selectively induce regulatory T cells (Tregs), in first-in-human studies.

Methods:

Healthy volunteers and patients with systemic lupus erythematosus (SLE) received single- or multiple-dose (biweekly) NKTR-358 or placebo in two sequential, randomized, phase 1 studies (single ascending dose [SAD; NCT04133116] and multiple ascending dose [MAD; NCT03556007]). Primary objectives were safety and tolerability; secondary objectives included pharmacokinetics (PK) and immune effects of NKTR-358; exploratory objectives included effects on SLE disease activity.

Results:

There were eight ascending dose cohorts in the SAD study (0.3-28.0 μg/kg: n = 76; placebo: n = 24) and four in the MAD study (3-24.0 μg/kg: n = 36; placebo: n = 12). Most adverse events (AEs) were grade 1-2 injection-site reactions, with no treatment-related serious or severe AEs, or deaths. PK data showed dose proportionality and prolonged exposure (mean half-life: 7.4-12.9 days). Dose-dependent, selective, and sustained increases in percentages and absolute numbers of total CD4⁺ Tregs and CD25^bright Tregs were observed, with no significant changes in conventional CD4⁺ and CD8⁺ T cells, and low-level increases in natural killer cells. At the highest doses tested, administration of NKTR-358 resulted in a 12-17-fold increase in CD25^bright Tregs over baseline that was sustained for 20-30 days.

Conclusion:

NKTR-358 was well tolerated, had a suitable PK profile for biweekly dosing, and led to marked and selective dose-dependent increases in CD25^bright Tregs, with no significant changes in conventional T cells. These results provide strong support for further testing in SLE and other inflammatory diseases.

247

项与 Rezpegaldesleukin 相关的新闻（医药）

2026-09-07

·蒜哥说

BMS 合作失利、礼来权益收回！Nektar，有望产出全球首个 Treg 选择性 IL-2

Nektar Therapeutics 当前市值约 25.51 亿美元。在 IL-2 靶点投资热度顶峰的 2017 年，公司市值一度达到 94.04 亿美元，市场隐含估值最高触及 200 亿美元。2018 年起，IL-2 候选药物晚期临床数据持续不及预期，叠加核心资产 NKTR-214 在肿瘤领域 III 期临床失利，公司市值一路下行，最低跌至 1.078 亿美元。后续市场重新挖掘 IL-2 在特应性皮炎、斑秃等自身免疫病领域的治疗价值，推动市值修复至 25 亿美元区间。这场堪称过山车的市值波动，也是生物医药行业 “临床决定价值” 的典型案例，充分提示创新药投资风险。公司目前暂无商业化上市产品，管线中仅有 Rezpegaldesleukin（REZPEG）进入 III 期临床。若该药未来成功获批，有望扭转市场对 IL-2 靶点因肿瘤方向失败形成的负面定价，成为全球首款 Treg 选择性 IL-2 疗法；与此同时，公司还布局 IL-15 激动剂 NKTR-255，处于 1/2 期临床阶段，主攻肿瘤适应症。网址：www.nektar.com 成立时间：1990年聚焦：自身免疫 Treg 调节; 核心创始人 John S. Patton：生物学背景，基因泰克经历，大分子递送与生物偶联技术平台； Milton Harris：高分子 / 生物偶联化学知名学者，可控 PEG 化、位点特异性 PEG 偶联开创者之一；PEG不仅可以延长半衰期，还是空间位阻分子开关； Howard W. Robin：战略重构者，主导与BMS合作NKTR-214（IL-2肿瘤），NKTR-214失败后，从礼来收回NKTR-358权益并推动轻资产化，集中资源推进核心资产临床进展； Jonathan Zalevsky：化学背景，武田经历，Nektar 现代免疫管线的核心科学假说：免疫稳态修复（Treg 调控）；下一代 Treg 稳定化管线NKTR-0165；核心技术平台位点特异性聚合物偶联平台获批产品-无 3期及申报上市阶段临床管线；

上市批准临床3期

2026-09-07

·大Ro姐

20260907 医药行业日报

【漫画图解 · Tezepelumab 阻断 TSLP「火警」机制】第1格：上皮细胞拉响红色「TSLP 火警」——过敏或刺激一来，它就像火灾警报器一样狂响，把炎症小兵全招来。第2格：火警不停，一堆橙色嗜酸粒细胞和 2 型炎症细胞涌向食管，结果食管红肿、吞咽困难（这就是嗜酸细胞性食管炎 EoE）。第3格：Y 形抗体英雄 Tezepelumab 登场，一钳剪断警报线——把最上游的 TSLP 信号掐断，炎症还没起跑就被按住。第4格：警报静音，食管恢复平静粉嫩，炎症小兵乖乖撤走。一句话：传统抗炎药多在下游客场「灭火」，Tezepelumab 走的是「剪断最上游火警线」的路线，这也是它从哮喘、鼻窦炎一路扩展到食管炎的核心逻辑。 📅 20260907 医药行业日报（每日速览 · 过敏 / 神经 / 政策） 🔴 过敏速览 1) Nektar Rezpegaldesleukin（IL-2/Treg 调节性T细胞诱导剂）… Nektar Therapeutics 宣布，其 first-in-class 调节性T细胞（Treg）诱导型生物药 rezpegaldesleukin 治疗成人中重度特应性皮炎的 2b 期 REZOLVE-AD（NCT06136741，3 来源 · Nektar / The Lancet · 2026-08-25（REZOLVE-AD） 🔗 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)01143-8/fulltext 2) GSK 超长效 IL-5 抑制剂 Depemokimab（每 6 个月一次）重度嗜酸粒细胞… 据 FDA Access Data 2026 公开文件与腾讯新闻《每日呼吸病学全球动态》（2026-09-03），GSK 的超长效 IL-5 抑制剂 depemokimab（100mg，每 6 个月皮下注射一次）重度嗜酸粒细胞性哮喘上市申请来源 · FDA Access Data / 腾讯新闻《每日呼吸病学全球动态》· 2026-09-03 🔗 https://news.qq.com/rain/a/20260903A031RY00 3) 阿斯利康/安进 Tezepelumab（抗 TSLP）嗜酸细胞性食管炎 III 期 CRO… 阿斯利康与安进宣布，抗 TSLP 单抗 tezepelumab（Tezspire）治疗嗜酸细胞性食管炎（EoE）的 III 期 CROSSING 研究达主要终点：24 周时组织学缓解（食管活检嗜酸粒细胞峰值计数）与吞咽困难频率/严重程度（D 来源 · AstraZeneca / MyChesCo · 2026（CROSSING III期） 🔗 https://www.mychesco.com/a/news/regional/astrazeneca-amgen-drug-hits-phase-iii-eoe-goals 💡 过敏一句话今天过敏线三条新闻，主线是「从『堵炎症』转向『调免疫、控上游』」——rezpegaldesleukin 把身体自带的「和平卫士」Treg 扩编、depemokimab 用超长效 IL-5 让嗜酸粒细胞半年安静一次、tezepelumab 把上皮细胞拉响的「火警」TSLP 掐断。 🔵 神经速览 1) 左旋多巴/卡比多巴缓释胶囊 IPX203（Crexont/Hopledo）获欧盟批准，用于… 欧盟委员会于 2026-08-20 批准赞邦（Zambon）的 Hopledo（研发代号 IPX203，美国商品名 Crexont）上市，用于口服左旋多巴方案仍控制不住中重度运动波动的成年帕金森患者。来源 · Parkinson's News Today / 欧盟委员会 · 2026-08-20（NeurologyLive 2026-09-02 报道） 🔗 https://parkinsonsnewstoday.com/news/parkinsons-treatment-hopledo-now-approved-european-union/ 2) Acadia Remlifanserin（5-HT2A 反向激动剂）获 FDA 快速通道，… Acadia Pharmaceuticals 宣布，其 5-HT2A 受体反向激动剂 remlifanserin（ACP-204）获 FDA 快速通道资格，用于阿尔茨海默病精神病（幻觉/妄想）。来源 · Acadia / Business Wire · 2026-07-20（Patient Care Online） 🔗 https://www.patientcareonline.com/view/fda-fast-tracks-remlifanserin-development-for-alzheimer-disease-psychosis 3) 灵北 Bexicaserin（5-HT2C 超级激动剂）DEEp III 期机制数据亮相欧… 灵北（Lundbeck）将在 2026-09-05 至 09-09 雅典欧洲癫痫大会（EEC）公布 bexicaserin 的临床前机制数据，阐释其在研 III 期 DEEp 项目中的双重作用：bexicaserin 是高选择性 5-HT2 来源 · Lundbeck / Biography-News · 2026-09（EEC 2026-09-05~09） 🔗 https://biography-news.com/article/203091 4) 艾伯维 Tavapadon（D1/D5 部分激动剂）TEMPO-2 全结果登《柳叶刀·神经… 《柳叶刀·神经学》2026-08-20 发表 TEMPO-2 完整结果：艾伯维的口服选择性多巴胺 D1/D5 受体部分激动剂 tavapadon 用于早期帕金森病的灵活剂量方案，较安慰剂显著改善运动症状与日常功能（主要终点 MDS-UPDR 来源 · NeurologyLive / 《柳叶刀·神经学》· 2026-08-20（TEMPO-2） 🔗 https://www.neurologylive.com/clinical/movement-disorders 🟢 政策速览 1) 药审中心发布《化学仿制药滴眼剂研究技术指导原则》和《化学仿制药特殊滴眼剂研究技术指导原则》… 国家药监局药审中心于 2026-09-02 发布《化学仿制药滴眼剂研究技术指导原则》和《化学仿制药特殊滴眼剂研究技术指导原则》（2026 年第 43 号），经国家药监局审查同意、自发布之日起施行。来源 · 国家药监局药审中心（CDE）/ 中国食品药品网 · 2026-09-02（第43号） 🔗 https://finance.sina.com.cn/jjxw/2026-09-02/doc-iniqkzme7862709.shtml 2) 国家药监局核查中心就《中药材供应商审核指导原则（征求意见稿）》公开征求意见，直指中药源头质控国家药监局药品审核查验中心于 2026-09-03 发布《中药材供应商审核指导原则（征求意见稿）》，公开征求意见至 10-04。来源 · 中国食品药品网（国家药监局核查中心）· 2026-09-03（征求意见至10-04） 🔗 https://m.cnpharm.com/c/2026-09-04/1106326.shtml 3) 药审中心就《全身型重症肌无力治疗药物临床试验技术指导原则（征求意见稿）》征求意见，罕见病临… 国家药监局药审中心于 2026-08-28 就《全身型重症肌无力（gMG）治疗药物临床试验技术指导原则（征求意见稿）》公开征求意见（时限 1 个月，至 2026-09-28）。来源 · 国家药监局药审中心（CDE）· 2026-08-28（征求意见至09-28） 🔗 https://www.cde.org.cn/main/news/viewInfoCommon/989de4a6a9bdf38ff60a1f921b2c613f 📖 IL-2 与调节性 T 细胞（Treg） IL-2 全称白细胞介素-2，是一种免疫信号蛋白；调节性 T 细胞（Treg）是身体里专门负责「踩刹车、维持和平」的免疫细胞。 — AI 自动生成 · 数据来自公开报道 · 仅供行业交流 —

临床3期

2026-09-04

·药研苑

安进依洛尤单抗强化降脂降低高心血管风险患者死亡风险

药品营销避坑”试读：药品导入期管理视频课（试听）药品生命周期管理（案例）药品立项需要注意什么（案例） 2026年8月31日，安进Amgen发布了依洛尤单抗用于既往无心肌梗死和卒中史，高心血管疾病风险患者3期临床试验VESALIUS-CV的死亡率影响结果。 VESALIUS-CV研究共纳入12,257名低密度脂蛋白胆固醇（LDL-C）≥90mg/dL，或非高密度脂蛋白胆固醇（non-HDL-C）≥120mg/dL，或载脂蛋白B≥80mg/dL，患有动脉粥样硬化性心血管疾病（ASCVD）或高危糖尿病，但既往无心肌梗死或卒中史患者。入组患者按1:1比例在稳定、优化降脂治疗的基础上接受依洛尤单抗140mg，每2周一次，或安慰剂。至中位随访4.6年，依洛尤单抗组与安慰剂组相比全因死亡率下降20%（7.9% vs 9.7%, HR 0.80; 95% CI 0.70–0.91; P=0.0005）；依洛尤单抗组的安慰剂组的心血管死亡率分别为2.8%和3.6%（HR 0.79; 95% CI, 0.64–0.98），非心血管死亡率分别为4.2%和5.0%（HR 0.85; 95% CI, 0.71–1.01），未明原因死亡率分别为1.1%和1.4%（HR 0.64; 95% CI 0.45–0.92）（Robert P Giugliano., 2026）。依洛尤单抗（Evolocumab，瑞百安Repatha）为抗PCSK9（前蛋白转化酶枯草杆菌素/kexin9型）单克隆抗体，能够耗竭PCSK9，防止PCSK9与LDLR（低密度脂蛋白受体）的结合。LDLR在肝细胞表面，负责清除低密度脂蛋白胆固醇（LDL-C），PCSK9与LDLR结合后，能够阻止进入肝细胞内的LDLR返回到肝细胞表面，减少肝细胞LDLR的数量，降低肝细胞通过LDLR清除LDL-C的能力。目前国内获批上市PCSK9抑制剂类药物包括依洛尤单抗（Evolocumab）、阿利西尤单抗（Alirocumab）、英克司兰（Inclisiran）、托莱西单抗（Tafolecimab）、伊努西单抗（Ebronucimab）、昂戈瑞西单抗（Ongericimab）和瑞卡西单抗（Recaticimab），其中英克司兰为小干扰RNA（siRNA）类药物。目前只有依洛尤单抗被证明能够降低既往无心肌梗死和卒中史，高心血管疾病风险患者的全因死亡率和心血管死亡率。在阿利西尤单抗ODYSSEY OUTCOMES研究中，对于急性冠状动脉综合征患者，阿利西尤单抗降低了全因死亡率，但未能证明能够降低心血管死亡率（Philippe Gabriel Steg., 2019）。推荐指数：★★★ 推荐原因：依洛尤单抗是目前唯一个被证明能够降低既往无心肌梗死和卒中史，高心血管疾病风险患者全因死亡率和心血管死亡率的PCSK9抑制剂类药物。个人观点，仅限参考。相关阅读：和黄医药赛沃替尼联合方案MET/EGFR晚期NSCLC取得积极结果减重增强抗银屑病疗效，礼来发布替尔泊肽3b临床试验数据近98%梗阻解除，玛伐凯泰梗阻性肥厚型心肌病试验长期研究北京斯利安药业降高同型半胱氨酸药物甜菜碱散获批上市欧康维视申请地塞米松眼用混悬注射液本地化生产沐源生物再次提交牛磺熊去氧胆酸胶囊的首仿上市申请 FDA批准礼来替尔泊肽用于降低成人2型糖尿病心血管事件风险智翔金泰BCMA/CD3双抗纬利妥米获批用于多发性骨髓瘤诺华放射配体镥[¹⁷⁷Lu]特昔维匹肽获批用于性激素敏感性前列腺癌同源康EGFR-TKI氘申艾替尼获批一线治疗晚期非小细胞肺癌强生口服IL-23受体拮抗剂伊可白滞素获批治疗斑块状银屑病和黄医药FGFR抑制剂凡瑞格拉替尼获批用于肝内胆管癌石药EGFR ADC（SYS6010）EGFR突变NSCLC三期试验达到终点转移性胰腺癌生存期翻倍，FDA批准泛RAS抑制剂Daraxonrasib Rezpegaldesleukin用于中重度特应性皮炎2b期研究数据发表相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

siRNA临床3期上市批准

100 项与 Rezpegaldesleukin 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12328	-	-	-

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
中度特应性皮炎	临床3期	美国	Nektar Therapeutics	2026-06-29
斑秃	临床2期	美国	Nektar Therapeutics	2024-04-02
斑秃	临床2期	加拿大	Nektar Therapeutics	2024-04-02
斑秃	临床2期	波兰	Nektar Therapeutics	2024-04-02
重度特应性皮炎	临床2期	美国	Nektar Therapeutics	2023-11-15
重度特应性皮炎	临床2期	澳大利亚	Nektar Therapeutics	2023-11-15
重度特应性皮炎	临床2期	保加利亚	Nektar Therapeutics	2023-11-15
重度特应性皮炎	临床2期	加拿大	Nektar Therapeutics	2023-11-15
重度特应性皮炎	临床2期	克罗地亚	Nektar Therapeutics	2023-11-15
重度特应性皮炎	临床2期	捷克	Nektar Therapeutics	2023-11-15

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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


NCT06136741 (REZOLVE AD, AAD2026)	临床2期	特应性皮炎诱导	393	Rezpegaldesleukin 24 g/kg q2w	簾構餘構築繭鹹鏇繭夢(齋築觸餘衊製範鹹製願) = 糧鹽艱齋蓋憲顧夢膚艱壓願淵夢遞鏇淵齋窪積 (襯顧鏇齋鹽壓構獵簾壓 ) 更多	积极	2026-03-27
				Placebo	簾構餘構築繭鹹鏇繭夢(齋築觸餘衊製範鹹製願) = 獵餘壓廠憲簾淵簾憲鬱壓願淵夢遞鏇淵齋窪積 (襯顧鏇齋鹽壓構獵簾壓 ) 更多
NCT06136741 (REZOLVE-AD, Company_Website) 人工标引	临床2期	特应性皮炎	393	Rezpegaldesleukin 24 μg/kg Q4W	餘膚鏇網淵醖網築簾獵(淵築選鬱獵觸遞窪製憲) = 壓遞鏇壓膚淵淵鏇製鑰齋網範艱窪願衊構齋憲 (選齋積淵糧壓繭顧選糧 ) 更多	积极	2026-02-10
				Rezpegaldesleukin 24 μg/kg Q12W	餘膚鏇網淵醖網築簾獵(淵築選鬱獵觸遞窪製憲) = 齋蓋夢簾艱淵遞淵選窪齋網範艱窪願衊構齋憲 (選齋積淵糧壓繭顧選糧 ) 更多
NCT06340360 (REZOLVE-AA, NEWS) 人工标引	临床2期	斑秃	92	rezpegaldesleukin low dose	膚廠衊淵窪網憲廠窪選(顧網鹽鹽齋遞顧鹽獵鬱) = Both treatment arms “more than doubled the SALT score reduction than that observed with placebo, with the majority of patients experiencing hair growth at Week 16 or later.” Participants in the higher-dose group had an average 28% improvement in hair coverage, compared with about 11% in the placebo group. When researchers removed data from four patients who did not meet key eligibility requirements, both drug doses showed statistically significant improvements, with hair regrowth of roughly 30%, compared with just under 6% for placebo. 糧築憲製製鬱鏇網繭憲 (窪衊廠窪餘顧鹽獵艱窪 ) 更多	积极	2025-12-17
				rezpegaldesleukin high dose
NCT06136741 (REZOLVE-AD, PRNewswire \| ACAAI2025) 人工标引	临床2期	哮喘 \| 特应性皮炎	393	Rezpegaldesleukin (24 μg/kg q2w)	遞積鑰廠製顧窪糧獵鏇(築窪糧壓鹹壓顧鹽齋淵) = At least half of the patients (N=53) experienced clinically significant improvement (≥0.5 point reduction) in ACQ-5 at Week 16 across all treatment arms as compared to 13% in the placebo arm. 鹽齋艱製選夢糧鹽顧選 (蓋鑰齋鬱遞獵繭憲獵窪 ) 更多	积极	2025-11-08
				Rezpegaldesleukin (24 μg/kg q4w)
NCT06136741 (REZOLVE-AD, PRNewswire) 人工标引	临床2期	中度特应性皮炎 \| 重度特应性皮炎	393	Rezpegaldesleukin 24 µg/kg q2w	積窪繭願選夢選網餘衊(蓋遞築夢窪遞鹽膚製觸) = 簾簾範艱憲選鑰鹹製壓選構夢淵衊壓鹽積築齋 (壓遞齋醖鹹構鬱襯網齋 ) 达到更多	积极	2025-06-24
				Rezpegaldesleukin 18 µg/kg q2w	積窪繭願選夢選網餘衊(蓋遞築夢窪遞鹽膚製觸) = 積衊夢願廠觸鏇鹽艱獵選構夢淵衊壓鹽積築齋 (壓遞齋醖鹹構鬱襯網齋 ) 达到更多
NCT04380324 (AAD2025)	临床1/2期	银屑病 \| 系统性红斑狼疮 \| 溃疡性结肠炎 ... 更多	746	Rezpegaldesleukin	獵糧壓鬱繭餘夢鑰構範(衊糧簾選鑰衊顧簾獵艱) = 遞鏇齋鹹窪範襯夢夢鏇積夢簾窪鹹糧鏇鬱膚範 (構願齋繭範衊製觸淵膚 ) 更多	积极	2025-03-07
				Placebo	獵糧壓鬱繭餘夢鑰構範(衊糧簾選鑰衊顧簾獵艱) = 齋選窪簾築蓋繭鬱淵壓積夢簾窪鹹糧鏇鬱膚範 (構願齋繭範衊製觸淵膚 ) 更多
NCT04119557 \| NCT04081350 (Pubmed \| Nat Commun)	临床1期	炎症性皮肤病 Eczema Area and Severity Index (EASI) \| Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) \| Psoriasis Area and Severity Index (PASI) ... 更多	-	Rezpegaldesleukin 10-12 µg/kg	窪窪鑰憲鹹夢壓糧積築(獵顧鹽艱壓艱製夢選構) = EASI-75 responses are maintained for 36 weeks after treatment discontinuation in 71% of week 12 responders 醖構築範蓋廠鹹遞積膚 (壓夢餘範蓋糧鬱淵觸獵 ) 更多	积极	2024-10-25
NCT04433585 (ISLAND-SLE, CTgov)	临床2期	系统性红斑狼疮	291	LY3471851 (LY3471851 High Dose)	餘齋鹽膚繭選積製鏇鑰 = 憲淵鑰獵構廠獵積蓋蓋構襯淵餘簾獵鹽顧鹽構 (鬱構簾選鬱蓋鏇淵選餘, 積積簾壓鑰遞餘廠範壓 ~ 壓選夢鹽淵壓壓遞襯範) 更多	-	2024-04-23
				LY3471851 (LY3471851 Mid Dose)	餘齋鹽膚繭選積製鏇鑰 = 範觸獵艱築簾齋夢觸壓構襯淵餘簾獵鹽顧鹽構 (鬱構簾選鬱蓋鏇淵選餘, 膚鹽壓齋選築製衊範網 ~ 夢範憲願獵淵鑰網築簾) 更多
NCT04081350 (Phase 1b study, EADV2023)	临床1期	特应性皮炎 Treg	-	Rezpegaldesleukin 12 µg/kg	廠襯積選繭網蓋衊淵選(構鏇選壓憲齋鹽憲膚願) = 鑰顧憲鏇觸夢鬱網襯廠齋鹽餘範網積鬱夢簾範 (簾襯鹽糧簾衊鑰鏇窪艱 ) 更多	积极	2023-10-11
				Rezpegaldesleukin 24 µg/kg	廠襯積選繭網蓋衊淵選(構鏇選壓憲齋鹽憲膚願) = 顧積簾壓構鹽糧鏇鹹觸齋鹽餘範網積鬱夢簾範 (簾襯鹽糧簾衊鑰鏇窪艱 ) 更多
NCT04677179 (INSTRUCT-UC, CTgov)	临床2期	溃疡性结肠炎	81	Placebo (Placebo (Induction Treatment Period))	製壓膚憲築築襯淵選簾 = 糧鏇淵積艱繭膚顧簾積蓋範鏇鑰獵製糧餘淵廠 (餘鹽糧獵衊齋繭廠鏇積, 膚鬱醖積製壓醖選淵蓋 ~ 鏇願艱鏇壓繭製顧製顧) 更多	-	2023-09-05
				LY3471851 (Low Dose LY3471851 (Induction Treatment Period))	製壓膚憲築築襯淵選簾 = 獵醖窪願淵積繭鹹夢壓蓋範鏇鑰獵製糧餘淵廠 (餘鹽糧獵衊齋繭廠鏇積, 鏇醖襯襯築網構構築鹽 ~ 膚製夢願壓壓廠窪鬱網) 更多