A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) Followed by a Long-Term Extension Evaluating Safety and Efficacy

This Phase 3 study is designed as a 24-week randomized, double-blind, placebo-controlled period (PCP) followed by a 144-week long-term extension (LTE) period. The primary objective of the PCP is to evaluate the effect of seralutinib on improving exercise capacity in subjects with World Health Organization (WHO) Group 3 pulmonary hypertension associated with interstitial lung disease. The primary objective of the LTE is to evaluate the long-term safety and tolerability of seralutinib.

开始日期2026-02-01

申办/合作机构

Gossamer Bio, Inc.

[+1]

NCT06274801

/ Recruiting临床3期

An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)

This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study

开始日期2024-09-03

申办/合作机构

Gossamer Bio, Inc.

NCT05934526

/ Completed临床3期

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH)

The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening.

开始日期2023-12-28

申办/合作机构

Gossamer Bio, Inc.

100 项与 Seralutinib 相关的临床结果

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100 项与 Seralutinib 相关的转化医学

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100 项与 Seralutinib 相关的专利（医药）

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项与 Seralutinib 相关的文献（医药）

2026-07-20·CHINESE MEDICAL JOURNAL

Pulmonary arterial hypertension from a translational perspective: Bridging pathophysiology and treatment

Review

作者: Yang, Taeil ; Chung, Wook-Jin

Abstract:

Pulmonary arterial hypertension (PAH) is a rare, progressive disorder defined by elevated pulmonary arterial pressure and vascular resistance, ultimately leading to right ventricular failure and premature death. Once considered a disease of pure vasoconstriction, PAH is now recognized as a complex vasculopathy involving endothelial dysfunction, inflammation, metabolic dysregulation, and genetic susceptibility. The pulmonary vasculature is dynamically narrowed by vasoconstriction, structurally obstructed by smooth muscle and endothelial proliferation, and pathologically stiffened by fibrosis and extracellular matrix deposition. Multiple cell types including endothelial cells, smooth muscle cells, fibroblasts, and immune cells contribute to this remodeling process. At the molecular level, hyperproliferative, apoptosis-resistant phenotypes emerge through mitochondrial dysfunction, oxidative stress, and endothelial-to-mesenchymal transition, which together drive a Warburg-like metabolic shift favoring glycolysis over oxidative phosphorylation. Chronic immune activation, characterized by cytokine release, T-cell and macrophage infiltration, and disrupted immune regulation, further amplifies vascular injury. Genetic studies have identified mutations in BMPR2, TBX4, SOX17 , and other regulators of the bone morphogenic protein (BMP)/transforming growth factor-β (TGF-β) pathway as key contributors to heritable and idiopathic forms of PAH, highlighting impaired endothelial repair and aberrant signaling as central mechanisms. Recent translational breakthroughs have yielded novel therapeutic strategies beyond traditional vasodilators. Agents targeting the BMP/TGF-β axis (e.g., sotatercept), growth factor signaling (seralutinib), inflammatory pathways (tocilizumab, rituximab), and metabolic remodeling (pyruvate dehydrogenase kinases [PDK] and fatty acid oxidation [FAO] modulators) are redefining treatment paradigms. Concurrently, large-scale multi-omics initiatives such as PVDOMICS and PHOENIKS enable deep phenotyping, which unravels molecular endotypes and informs precision medicine approaches. This review summarizes the pathophysiology of PAH and the ongoing clinical trials in the PAH field.

2026-05-01·Journal of Thoracic Disease

Clinical research on pulmonary hypertension from a 2025 perspective: a narrative review

Review

作者: Deng, Jia ; Liu, Haoyu ; Wang, Hongquan ; Yao, Yao ; Wang, Tao ; Bai, Qianwen

Background and Objective:

Pulmonary hypertension (PH) is a clinical syndrome characterized by progressive elevation of pulmonary vascular resistance (PVR) and subsequent right ventricular (RV) failure. The research of PH has undergone unprecedented transformation in 2025, marked by paradigm-shifting therapeutic advances, refined diagnostic criteria, and sophisticated precision medicine approaches. This narrative review aims to synthesize the recent evidence from pivotal clinical trials, epidemiological studies, and translational research that collectively redefine the management of this complex disease spectrum, providing clinicians and researchers with an overview of current developments and future directions.

Methods:

The literature search was conducted in PubMed with particular focus on publications from January 2025 to December 2025. Inclusion criteria encompassed clinical trials, observational studies, registry analyses, and research articles reporting novel diagnostic approaches, biomarkers, therapeutic interventions, and management strategies for PH. Studies were selected based on their relevance to clinical practice and scientific significance. The selection process was conducted independently, with consensus reached through discussion for any discrepancies.

Key Content and Findings:

The 2025 clinical research on PH evolved towards precision assessment driven by novel biomarkers and artificial intelligence (AI), enhanced imaging [echocardiography, computed tomography (CT), magnetic resonance imaging (MRI)] for improved detection, phenotyping, and risk stratification. Therapeutically, the treatment focus has shifted beyond vasodilation to attenuating pathological remodeling. Most notably, sotatercept, its validation in reduce clinical worsening expanded across diverse patient populations. Alongside, optimized use of classical pathways (endothelin, nitric oxide, prostacyclin) and emerging targeted therapies (e.g., seralutinib, imatinib) may bring more clinical benefits. Interventional therapies have been optimized through large-scale registries and patient-specific factors, while non-pharmacological strategies have gained recognition as essential components of multidisciplinary management. Furthermore, right ventricular targeted therapies have received increasing attention and improved outcomes for patients.

Conclusions:

The convergence of sophisticated risk stratification tools and mechanism-based therapeutics in 2025 established a robust foundation for improving survival and quality of life in PH patients.

2025-10-01·ADVANCES IN THERAPY

Seralutinib for the Treatment of Pulmonary Arterial Hypertension in Adults: TORREY Open-Label Extension Study

Article

作者: Zolty, Ronald L ; Mottola, David ; Howard, Luke S ; Ter Veer, Anna ; Ryan, John J ; Sahay, Sandeep ; Roscigno, Robert F ; Chin, Kelly M ; Sobol, Irina ; Zamanian, Roham T ; Benza, Raymond L ; Escribano Subías, Pilar ; Sood, Namita ; Kingrey, John F ; Parsley, Ed ; Ghofrani, Hossein-Ardeschir ; Sitbon, Olivier ; McLaughlin, Vallerie V ; Frantz, Robert P ; Hemnes, Anna R ; Zisman, Lawrence S ; Aranda, Richard ; Vachiéry, Jean-Luc ; Channick, Richard N

INTRODUCTION:

Seralutinib is an inhaled tyrosine kinase inhibitor targeting platelet-derived growth factor receptor (PDGFR) α/β, colony stimulating factor 1 receptor (CSF1R), and mast/stem cell growth factor receptor kit (c-KIT) kinases. TORREY, a phase 2, double-blind, randomized, placebo-controlled study of seralutinib in pulmonary arterial hypertension (PAH), met its primary endpoint, demonstrating a significant reduction in pulmonary vascular resistance (PVR) over placebo after 24 weeks (NCT04456998; EudraCT 2019-002669-37). We present results (as of December 5, 2024) from an open-label extension (OLE) study evaluating long-term safety, tolerability, and efficacy of seralutinib in adults with PAH (NCT04816604).

METHODS:

Seventy-three of 80 patients who completed TORREY (WHO Group 1 PH on stable PAH medications) and 1/8 patients from a phase 1b study (NCT03926793) enrolled in the OLE. The study design called for dosing of inhaled seralutinib 90 mg twice daily. Treatment-emergent adverse events (TEAEs) were monitored. PVR was measured after 48 weeks (week 72 from TORREY baseline). Analyses are descriptive.

RESULTS:

At OLE entry, 34 patients continued on seralutinib (Seralutinib Continued); 40 switched from placebo to seralutinib (Placebo Crossover). Common TEAEs were headache (28.4%), coronavirus disease (COVID-19) (27.0%), and cough (23.0%). TEAEs led to seralutinib discontinuation in 20 (27.0%) patients; cough was the reason in 9/74 (12.2%). In the Seralutinib Continued group, median change in PVR from TORREY baseline to weeks 24 and 72 was - 94 dyne·s/cm⁵ and - 143 dyne·s/cm⁵, respectively (n = 28). In the Placebo Crossover group, corresponding values were - 32 dyne·s/cm⁵ and - 56 dyne·s/cm⁵, respectively (n = 27). Continued improvement in 6-min walk distance was observed. N-terminal pro-brain natriuretic peptide (NT-proBNP) significantly decreased with seralutinib during TORREY and remained stable throughout the OLE. After an increase in TORREY, NT-proBNP levels in the Placebo Crossover group nearly returned to TORREY baseline at week 72.

CONCLUSIONS:

These OLE data are consistent with TORREY results and support long-term safety and efficacy of inhaled seralutinib in patients with PAH. A phase 3 study of seralutinib in PAH is underway (PROSERA, NCT05934526).

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov identifier NCT04816604. A Graphical Abstract is available for this article.

111

项与 Seralutinib 相关的新闻（医药）

2026-08-30

·Pharmaceutical Technology

Gossamer Bio announces $250m in funding to advance seralutinib

Gossamer Bio has announced a private placement agreement valued at up to $250m, including $150m of committed capital intended to support the development and potential US Food and Drug Administration (FDA) approval of seralutinib. Seralutinib is intended for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The private investment comprises an initial closing, a subsequent closing contingent upon FDA acceptance of a new drug application (NDA) for seralutinib in PAH and warrants exercisable upon FDA approval. The company plans to submit the NDA by September 2026. The proceeds will help advance seralutinib’s clinical development and potential commercialisation, with net funds expected to sustain operations until 2028. Gossamer recently regained global rights to seralutinib. The financing involves key institutional investors, including EcoR1 Capital and RA Capital Management. The initial closing will raise approximately $25m through the sale of pre-funded warrants, priced at $0.14 per share minus a nominal exercise price. A later closing will unlock a further $125m upon NDA acceptance. The terms stipulate that investors must fulfil this commitment if NDA acceptance occurs as planned. The purchase price for the second set of pre-funded warrants will follow the market’s five-day volume-weighted average price, less their nominal exercise cost. Gossamer Bio chairman, co-founder and CEO Faheem Hasnain said: “The committed funding structure aligns capital availability with key regulatory milestones and is expected to support the planned submission and review of our NDA. “We appreciate the support of this group of leading healthcare investors as we work to bring a potentially important new treatment option to patients with PAH.” Additionally, investors will receive warrants exercisable upon FDA approval. If these are fully exercised at $0.187 per share, Gossamer Bio could secure up to $100m more. The warrants will expire either 30 days after achieving the FDA approval milestone or five years from their issuance. Leerink Partners and Cantor are serving as joint placement agents for this financing effort. In May 2024, Gossamer Bio and Chiesi Farmaceutici (the Chiesi Group) announced a worldwide partnership and licence agreement to develop and market seralutinib for pulmonary hypertension. The content above comes from the network. if any infringement, please contact us to modify.

引进/卖出申请上市

2026-08-22

·药研前瞻

生物科技每日资讯 (2026-08-22)

📌 今日要点速览 🤖 Bristol-Myers Squibb (BMY) — 与 AI 制药公司 Chai Discovery 签署抗体发现合作,将 Chai 的分子折叠与设计模型接入全管线,构建"AI 驱动、持续学习"的药物发现系统;Chai 五个月拿下第 5 家大药企客户,收 $67.01 ▲ +2.35% 💔 Capricor (CAPR) — Kaos Capital 发公开信要求治理重置,同日 deramiocel BLA 修订导致 8/22 PDUFA 延期,收 $6.29 ▼ -8.04% 💰 Gossamer Bio (GOSS) — 最高亿结构化私募 1.5 亿承诺资金),为 seralutinib PAH NDA 9 月提交铺路,收 $0.15 ▼ -2.09% 💊 Eli Lilly (LLY) — 与 Amplitude Therapeutics 达成 taRNA 疫苗战略合作,补上疫苗版图的"平台层",收 $1,255.40 ▲ +0.88% 📈 XBI 收 $165.73 ▲ +1.44%,MRNA 反弹 +8.86% 带动板块回暖;SPY +0.84% 重点关注🤖 Bristol-Myers Squibb (BMY) — 携手 Chai Discovery:五个月第 5 家大药企,AI 抗体发现军备竞赛白热化 BMY 将 Chai 的生成式 AI 模型接入全管线抗体发现,这是 Chai 八个月内的第 5 笔大药企平台合作——AI 药物发现已从"讲故事"进入"拼部署"阶段 📅 2026-08-19 宣布 | 🏷️ AI 药物发现 / BD 合作 / 抗体工程交易内容 BMY 与旧金山 AI 制药公司 Chai Discovery 签署合作协议,利用 Chai 的 AI 模型和平台能力——包括其领先的分子折叠与设计模型——支持 BMY 全管线的治疗性抗体候选物发现,目标是构建"AI 驱动、持续学习的药物发现系统"。合作覆盖多个未披露靶点,财务条款未披露(无首付款、里程碑、分成或股权结构公开)。CEO Joshua Meier 表示,双方希望"将从概念到可行候选药物的时间线大幅压缩"。 Chai 的技术为什么值钱 Chai-3(当前一代):多模态扩散模型架构,可在给定靶点蛋白和结合表位的条件下,从零设计完整的抗体序列和结构,治疗级结合亲和力成功率约 50%——约为上一代的两倍 Chai-2(上一代):全球首个在零样本(zero-shot)全 de novo 抗体设计中实现两位数实验成功率(约 16-20%)的生成式平台,而传统计算方法成功率不足 1%——相当于百倍跃升实测数据:Chai 2025 年 11 月公布,在 28 个靶点抗原上测试了 88 个 Chai-2 设计的 IgG,其中 86% 零或仅一项可开发性缺陷,28 个抗原中 24 个产出至少一个完全干净的设计差异化定位:不做化合物库筛选,而是从头生成全新分子设计;尤其擅长多特异性分子(同时结合多个靶点的蛋白)——这恰好是 ADC 和双抗的核心工程挑战,也是 BMY 抗体研究的主战场 Chai 的商业势能:八个月,五家大药企时间客户要点 2026.01 Eli Lilly 生物药发现合作 2026.06 Pfizer 许可协议,Chai-3 早期访问 + 用辉瑞专有数据训练定制模型 2026.07 Novartis 合作协议(C 轮官宣前一天) 2026.07 argenx 免疫领域合作 2026.08BMY 本次,全管线抗体发现大药企极少为未验证的软件付费——连续五家付费客户是 Chai 区别于同类 AI 创业公司的核心壁垒。资本面:11 个月三轮,估值涨 7 倍 2025 年中:A 轮 $7,000 万(Menlo Ventures 的 Anthology Fund,含 Anthropic) 2025.12:B 轮 $1.3 亿,估值 $13 亿 2026.07:C 轮亿估值38 亿——七个月内估值接近三倍,Index Ventures 领投,Kleiner Perkins、红杉、Dimension 跟投;新进 Bain Capital Ventures、Battery、Baillie Gifford 等;OpenAI、Thrive Capital 连续加注累计融资超 $6 亿;创始团队来自 OpenAI、Meta FAIR(ESM 蛋白语言模型)、Stripe、Absci BMY 的 AI 布局:算力—模型—工作流三层栈 BMY 正在快速搭建完整的 AI 发现基础设施,本次合作是第三块拼图: 算力层:一个月前与 Nvidia 合作建设大型 AI 数据中心模型层:本次 Chai 合作(抗体发现)+ 5 月与 Anthropic 签署 Claude 企业协议覆盖全球运营工作流层:8 月部署 Schrödinger (SDGR) 的 agentic 平台 Bunsen 竞争格局:AI 药物发现赛道 2026 年全面升温——Isomorphic Labs(DeepMind 旗下)5 月完成 $21 亿 B 轮且同样绑定 Novartis(诺华同时押注两条技术路线);Xaira Therapeutics 以亿启动累计融资超10 亿;Anthropic 约 $4 亿收购一家药物设计初创。市场规模预计从 2025 年 $23.5 亿增长到 2033 年 $137 亿(CAGR 约 25%),而 Chai 七个月三倍的估值增速表明资本跑在了预测前面。股价反应:BMY 8/21 收 $67.01 ▲ +2.35%(合作宣布于 8/19 盘后,8/20-8/21 两个交易日累计上涨,同期大盘 SPY +0.84%)。 💡 市场影响分析:这笔合作的信号意义远大于财务意义——条款没披露,但它确认了两件事:第一,AI 抗体发现已经从 POC 阶段进入基础设施采购阶段,BMY 用"买发现能力"替代"买管线",理论上一个平台可以产出无限候选分子;第二,Chai 的行业卡位已成——五家大药企、八个月,这是 AI 制药公司里独一无二的商业验证速度,OpenAI 连续加注说明 AI 实验室也认这个方向。但泼一盆冷水:行业至今没有任何一款 AI 发现的药物获批,模型生成的分子仍要面对毒理、临床、监管的漫长绞肉机,$38 亿估值真正考验的是第一波临床失败来临时这个叙事还站不站得住。对 BMY 而言这是长期期权而非催化剂;对 Chai 的竞争对手们,大药企的窗口正在被快速锁死——"拼部署"阶段的赢家通吃效应,可能比想象中来得更快。 💊 Eli Lilly (LLY) — 携手 Amplitude 布局 taRNA:三个月内的第二记疫苗落子,这次买的是"平台"而非"资产" 礼来与 Amplitude Therapeutics 达成战略研究合作及许可协议,共同开发传染病 taRNA(反式扩增 RNA)疫苗——这是礼来 5 月 $38 亿三连收购疫苗公司之后,第一次向底层 RNA 技术平台下注 📅 2026-08-19 宣布 | 🏷️ 疫苗 / RNA 平台 / BD 合作交易内容礼来与波士顿生物技术公司 Amplitude Therapeutics 签署战略研究合作及许可协议,发现和开发用于传染病的 taRNA 疫苗候选产品: 初始项目:若干未披露、高未满足医疗需求的传染病疫苗项目;礼来保留最多追加两个传染病靶点的选择权——这种多靶点期权结构是典型平台型交易,不是单一资产买卖分工:Amplitude 负责 taRNA 优化及部分临床前研究;礼来接管后续临床前开发、临床开发、生产、注册及商业化,并获得合作靶点产品的独家靶点特异性全球开发和商业化权利财务条款未披露(无首付款、里程碑结构公开) taRNA 是什么:把一条长 RNA 拆成两条要理解这笔交易的价值,得先看 RNA 疫苗三代技术的演进: 技术路线结构优势痛点传统 mRNA 一条 RNA 直接表达抗原成熟、验证充分表达量受限于给药量,剂量高 saRNA(自扩增) 复制酶+抗原在同一条长 RNA 上细胞内自我复制,低剂量高表达 RNA 太长,生产、纯化、递送难度陡增taRNA(反式扩增)复制酶和抗原拆成两条 RNA 抗原 RNA 更短,模块化设计双组分共递送比例、质量控制是新工程问题 taRNA 的核心巧思是"拆开":一条 RNA 编码复制酶(可相对固定),另一条短 RNA 编码抗原(可快速更换)。两条 RNA 进入同一细胞后,复制酶识别抗原 RNA 并大量复制,实现低剂量下的高效表达。换抗原不需要重建整条超长 RNA——这正是疫苗快速迭代最需要的特性。Amplitude 的专利进一步把两条 RNA 分别装进不同纳米颗粒,各自独立设计、生产、调整配比。 Amplitude 的底子 2022 年成立,总部波士顿,礼来 Gateway Labs 孵化器成员(礼来不是突然认识它——先入生态、再谈合作,这是大药企 BD 新范式:不等 PoC 出来再谈,最有价值的窗口早就关了) 融资方:ARCH Venture Partners、Newpath Partners、Alta Partners 非稀释性资金:BARDA、CEPI、盖茨基金会——三家全球公共卫生金主的背书,在传染病疫苗领域含金量极高平台延展性:除疫苗外,taRNA 还布局蛋白替代疗法、免疫学、基因药物,并自研 LNP 递送技术礼来的疫苗拼图:资产 + 平台双轨并进三个月前(5/26),礼来一次性宣布三笔疫苗收购,潜在总价值近 $38 亿:Curevo(带状疱疹疫苗,临床资产)、LimmaTech(金葡菌等细菌疫苗)、Vaccine Company(EB 病毒疫苗)。当时礼来说得很明白——重建传染病业务,把疾病预防重新纳入研发版图。这次合作补上了拼图的另一块:前面三笔买的是具体资产,这次买的是能持续产出新项目的 RNA 底盘。四笔动作没有统一技术路线(蛋白疫苗、细菌疫苗、RNA),礼来看的不是某一种形式,而是整个"infectious disease prevention"版图。股价反应:LLY 8/21 收 $1,255.40 ▲ +0.88%,对这笔早期平台交易无明显反应——市场当前定价的是 GLP-1 主线,疫苗版图是远期期权。 💡 市场影响分析:taRNA 解决了 saRNA 的工程问题,但代价是引入一套新的工程问题——双组分意味着共递送比例、质量控制、制剂开发都要重新趟一遍,所谓"更容易制造"要等人体数据说话。真正的信号在于礼来的打法变了:它没有从零建疫苗部门,而是三个月内同时抓"成熟临床资产 + 病原体特异性技术 + 底层平台",这个组合拳说明礼来对传染病是认真的,而 Amplitude 是目前唯一被它选中的 RNA 底盘。对整个 RNA 赛道,2026 年的市场早已不为"mRNA"三个字兴奋,s aRNA/taRNA/环状 RNA 谁能先跑出人体数据,谁才拿到下一代叙事的主导权——礼来愿意现在买票,本质是对 Amplitude 团队和 Gateway Labs 孵化体系的双重下注。对 MRNA/Pfizer 这类把第一代 mRNA 当现金牛的公司,这不是好消息:下一代平台的窗口,正在被别人占位。 📋 今日其他动态 💔 Capricor Therapeutics (CAPR) — 监管与治理双线承压:deramiocel(DMD 细胞疗法)因提交 BLA 修订(纳入 HOPE-3 24 个月 OLE 数据、适应症收窄至上肢功能障碍),FDA 将延长原定 8/22 的 PDUFA 日期(通常延期 3 个月);同日激进股东 Kaos Capital 发公开信要求提名两名独立董事、冻结非必要支出并组建 M&A 委员会,批评上半年 G&A 费用翻倍($2,350 万)。8/21 收 $6.29 ▼ -8.04%,较 7 月 AdCom 前已腰斩。 💰 Gossamer Bio (GOSS) — 宣布最高 $2.5 亿结构化私募:EcoR1、RA Capital 等领投,首笔万第二笔1.25 亿挂钩 FDA 受理 seralutinib PAH NDA(9 月提交),认股权证再解锁约亿。公司现金仅5,700 万,融资后跑道延至 2028 年。收 $0.15 ▼ -2.09%。 📈 市场快照 — MRNA 8/21 收 133 低点反弹,仍处高波动消化期;XBI 收 $165.73 ▲ +1.44%;Amgen、Revolution Medicines、Insmed 等三期试验均为常规招募状态更新,无新数据读出。另据处方调研,Zepbound 医生满意度 80% 领先 Wegovy 的 59%。 ⚠️ 免责声明:本内容不构成任何投资建议。生物科技股票波动剧烈,投资有风险,过往业绩不代表未来表现。

疫苗抗体药物偶联物临床研究

2026-08-21

·药明康德

寻找更优低剂量！口服司美格鲁肽启动新3期试验；最高2.5亿美元！新锐获加码投资，关键新药拟9月申报 | 产业新闻

寻找更优低剂量！口服司美格鲁肽启动新3期试验日前，诺和诺德（Novo Nordisk）已启动一项安慰剂对照3期临床试验OASIS 5，旨在为其口服GLP-1减重药物Wegovy（semaglutide，司美格鲁肽）探索更优的较低剂量方案。该研究将在肥胖或超重人群中评估两种尚未披露的口服司美格鲁肽剂量，受试者同时配合低热量饮食并增加身体活动。根据目前Wegovy口服制剂的用药方案，患者以每日1.5 mg起始，随后经过两个中间剂量逐步递增，并在治疗第91天达到25 mg维持剂量。OASIS 5研究的结果未来有望为该药新的剂量方案提供依据。 OASIS 5计划纳入450名患者，治疗时间为60周。入组对象包括身体质量指数（BMI）≥30的成人，或BMI≥27且同时存在高血压、睡眠呼吸暂停或心血管疾病等体重相关健康问题的成人；糖尿病患者、近期出现体重下降者以及正在接受GLP-1药物治疗者将被排除。该研究的主要目标是评估不同剂量口服司美格鲁肽的减重效果，同时还将观察血压、胆固醇水平、腰围、不良反应以及其他与体重相关的健康指标，以进一步评估较低剂量方案的整体治疗表现。最高2.5亿美元！新锐获加码投资，关键新药拟9月申报 Gossamer Bio今日宣布，已与部分新进及现有机构投资者签署证券购买协议，拟通过私募融资获得最高约2.5亿美元的总募集资金。此次融资安排分为多个阶段，包括首次交割、以seralutinib用于肺动脉高压（PAH）的新药申请（NDA）获美国FDA受理为条件的第二次交割，以及可在seralutinib获FDA批准用于PAH后行使的认股权证。此次融资是在Gossamer Bio近期重新获得seralutinib全球权益后推进的，公司计划于2026年9月提交该药的NDA。其中，此次私募已获得1.5亿美元的承诺资金，包括首次交割预计募集约2500万美元，以及在FDA于2026年受理seralutinib的PAH适应症NDA后进行第二次交割，届时预计再募集约1.25亿美元。此外，在seralutinib获得FDA批准用于PAH后，与该里程碑挂钩的认股权证将可行使；若相关权证全部以现金行使，可为公司带来最高约1亿美元的额外募集资金。参与此次私募的机构投资者包括EcoR1 Capital、683 Capital Partners, LP、RA Capital Management、Coastlands Capital、Samsara BioCapital和Rock Springs Capital等新进及现有机构投资者。参考资料： [1] Gossamer Bio Announces Up to $250 Million Structured Private Placement, Including $150 Million of Committed Capital, to Fund Seralutinib Through Potential FDA Approval. Retrieved August 21, 2026 from https://ir.gossamerbio.com/news-releases/news-release-details/gossamer-bio-announces-250-million-structured-private-placement [2] Research Study on How Well Oral Semaglutide Works for Weight Loss in Adults With Excess Body Weight (OASIS 5). Retrieved August 21, 2026 from https://clinicaltrials.gov/study/NCT07770841 [3] Pursuing patient options, Novo kicks off trial testing smaller doses of Wegovy pill. Retrieved August 21, 2026 from https://www.fiercepharma.com/pharma/novo-nordisk-kicks-trial-testing-smaller-doses-wegovy-pill [4] Novo Nordisk starts trialing lower maintenance doses of oral Wegovy. Retrieved August 21, 2026 from https://www.biospace.com/drug-development/novo-nordisk-starts-trialing-lower-maintenance-doses-of-oral-wegovy 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新……

100 项与 Seralutinib 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12002	-	-	-

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
间质性肺病导致的肺动脉高压	临床3期	美国	CHIESI Farmaceutici SpA	2026-02-01
间质性肺病导致的肺动脉高压	临床3期	美国	Gossamer Bio, Inc.	2026-02-01
间质性肺病导致的肺动脉高压	临床3期	以色列	CHIESI Farmaceutici SpA	2026-02-01
间质性肺病导致的肺动脉高压	临床3期	以色列	Gossamer Bio, Inc.	2026-02-01
家族性肺动脉高压	临床3期	美国	Gossamer Bio, Inc.	2023-12-28
家族性肺动脉高压	临床3期	日本	Gossamer Bio, Inc.	2023-12-28
家族性肺动脉高压	临床3期	阿根廷	Gossamer Bio, Inc.	2023-12-28
家族性肺动脉高压	临床3期	澳大利亚	Gossamer Bio, Inc.	2023-12-28
家族性肺动脉高压	临床3期	奥地利	Gossamer Bio, Inc.	2023-12-28
家族性肺动脉高压	临床3期	比利时	Gossamer Bio, Inc.	2023-12-28

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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


NCT05934526 (PROSERA, Company_Website) 人工标引	临床3期	肺动脉高压	338	Seralutinib	積齋膚淵壓糧願蓋齋糧(壓鹹繭獵餘鹽遞齋獵壓) = 繭觸網遞築鬱醖簾齋網糧選糧膚憲鬱齋築廠艱 (憲衊艱齋獵憲繭願夢選 ) 未达到更多	不佳	2026-02-23
				Placebo	積齋膚淵壓糧願蓋齋糧(壓鹹繭獵餘鹽遞齋獵壓) = 淵衊膚衊餘衊鏇觸淵膚糧選糧膚憲鬱齋築廠艱 (憲衊艱齋獵憲繭願夢選 ) 未达到更多
NCT04816604 (TORREY, ERS2024)	临床2期	肺动脉高压 COL1A1 \| ITGB2 \| FAP ... 更多	43	Seralutinib	憲憲艱鬱鑰淵鏇獵遞繭(願觸膚鬱選範鹹積積襯) = 製顧夢顧廠選鹹製餘範窪憲膚選膚醖蓋膚餘醖 (壓築壓遞遞繭鏇糧製廠 )	积极	2024-09-07
				Seralutinib	廠願襯顧膚選壓窪糧膚(夢糧艱獵繭鑰鏇壓鑰鬱) = 願築憲齋鬱選構獵鹽遞觸願艱遞醖窪淵鹹齋膚 (壓鹽艱艱網選窪積淵鹽 )
NCT04816604 (OLE of the TORREY, ERS2024)	临床2期	肺动脉高压	74	Seralutinib (WHO functional class II + Pulmonary Arterial Hypertension + Baseline 6MWD 413m)	鏇鹽願獵糧鑰餘壓繭餘(餘願選顧齋窪夢簾襯艱) = 廠築鏇蓋積衊範齋鏇鹹鏇憲願製遞蓋鑰簾觸製 (鑰衊簾蓋築遞鹹膚願鏇 ) 更多	积极	2024-09-07
NCT04816604 (ATS2024) 人工标引	临床2期	肺动脉高压	74	seralutinib-to-seralutinib	膚壓餘築蓋鬱艱壓艱獵(簾構糧製鬱顧糧築衊願) = Most common TEAEs were headache (24.3%), COVID-19 (21.6%), and cough (21.6%). 觸鏇製網構觸餘齋範構 (憲廠襯糧衊遞窪廠願醖 ) 更多	积极	2024-05-19
				placebo-to-seralutinib
NCT04456998 (TORREY, CTgov)	临床2期	家族性肺动脉高压 \| 肺动脉高压 \| 特发性肺动脉高压	86	Placebo (Placebo)	窪鹹衊願艱蓋範觸艱繭(鹽網壓窪鑰襯窪遞齋鹹) = 顧鹽蓋廠淵顧壓獵淵憲淵壓壓簾艱繭選遞觸鬱 (獵醖餘網蓋壓廠選選獵, 鏇糧襯憲醖鏇蓋選窪憲 ~ 鏇壓觸壓廠觸餘網範憲) 更多	-	2023-11-07
				Generic Dry Powder Inhaler+GB002 (seralutinib) (GB002 (Seralutinib))	窪鹹衊願艱蓋範觸艱繭(鹽網壓窪鑰襯窪遞齋鹹) = 獵構鬱淵鏇製構艱蓋廠淵壓壓簾艱繭選遞觸鬱 (獵醖餘網蓋壓廠選選獵, 繭鑰鹹網壓範廠壓簾壓 ~ 蓋遞構艱積鹽繭蓋製餘) 更多
NCT04456998 (TORREY, Corporate Publications) 人工标引	临床2期	肺动脉高压	86	Seralutinib	鬱選窪獵膚壓淵鹽願鑰(構鬱餘願衊鬱鏇築憲鹹): P-Value = 0.0310 达到更多	积极	2022-12-06
				placebo
NCT03926793 (GB002, ERS2020)	临床1期	肺动脉高压 BMPR2 expression	-	GB002	積襯繭衊網網夢淵膚糧(鬱艱簾獵築遞窪獵繭憲) = increased in a dose- and time- dependent manner 鹹網膚夢廠遞糧窪鹹餘 (構遞醖餘遞簾夢鹹醖糧 ) 更多	积极	2020-09-07