A Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Paltusotine in Adults With Carcinoid Syndrome Due to Well-Differentiated Neuroendocrine Tumors

A Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of paltusotine treatment vs placebo as well as the long-term safety of paltusotine in adults with carcinoid syndrome due to well-differentiated neuroendocrine tumors. The purpose of this study is to continue the evaluation of the safety, efficacy, and pharmacokinetics (PK) of paltusotine in participants with carcinoid syndrome.

开始日期2025-11-19

申办/合作机构

Crinetics Pharmaceuticals, Inc.

ACTRN12625001148460

/ Not yet recruiting临床1期

A Phase 1, Single-Dose, Open-Label, Randomized, Three-Period, Two-Sequence, Crossover Study to Evaluate the Relative Bioavailability of Paltusotine Low Drug Load (LDL) Tablets 60 mg (2 × 30 mg LDL tablet) and High Drug Load (HDL) Tablet 60 mg (1 × 60 mg HDL tablet) in Healthy Volunteers

开始日期2025-10-21

申办/合作机构

Crinetics Pharmaceuticals, Inc.

CTR20222395

/ Completed临床1期

一项在中国健康志愿者中评价paltusotine的药代动力学和安全性的双盲、随机、安慰剂对照、单次给药随后多次给药的研究

主要目的：在中国人群中评价paltusotine单次给药和多次给药的药代动力学（PK）；次要目的：在中国人群中评价paltusotine的安全性。

开始日期2022-10-24

申办/合作机构

Crinetics Pharmaceuticals, Inc.

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100 项与帕妥索汀相关的临床结果

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100 项与帕妥索汀相关的转化医学

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100 项与帕妥索汀相关的专利（医药）

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项与帕妥索汀相关的文献（医药）

2026-02-10·AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY

Paltusotine Hydrochloride

Article

2026-01-01·Annals of Medicine and Surgery

A new era in oral treatment for acromegaly with the FDA-approved drug paltusotine

Letter

作者: Asghar, Hayat ; Khalid, Muddassir ; Ahmed, Suhail

2025-10-31·Drug Discoveries and Therapeutics

Paltusotine: The first selective nonpeptide agonist of somatostatin receptor 2 (SSTR2) for the treatment of acromegaly

Review

作者: Sun, Yueyi ; Lu, Daoran ; Gao, Jianjun

Acromegaly is an endocrine disorder characterized by abnormal enlargement of the extremities and internal organs resulting from excessive secretion of growth hormone (GH) by the pituitary gland, which in turn leads to elevated levels of insulin-like growth factor 1 (IGF-1). Approximately 45% of patients remain biochemically uncontrolled after surgery and require long-term treatment with injectable somatostatin analogs such as octreotide or lanreotide. These polypeptide drugs generally require monthly administration to maintain disease control; however, many patients experience recurrence of symptoms towards the end of the dosing interval. Moreover, injection-site pain and local reactions are common, significantly impacting patients' quality of life. On September 25, 2025, the U.S. Food and Drug Administration (FDA) approved paltusotine, the first once-daily oral, nonpeptide somatostatin receptor 2 (SSTR2) agonist for the treatment of acromegaly. By enabling oral rather than injectable therapy, paltusotine reduces the treatment burden and enhances patient adherence. With its rapid onset and durable biochemical control, this novel agent has the potential to reshape the current paradigm of acromegaly pharmacotherapy and offer patients a more convenient and effective treatment option. Nevertheless, its long-term safety and efficacy warrant further evaluation in real-world clinical settings.

203

项与帕妥索汀相关的新闻（医药）

2026-03-27

·BioSpace

Crinetics Pharmaceuticals Announces Submission of Marketing Authorization Application in Brazil for Palsonify™ (Paltusotine) in Acromegaly

Application supported by comprehensive clinical program, including two positive Phase 3 trials evaluating once-daily oral paltusotine in acromegaly SAN DIEGO, March 26, 2026 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced the submission of a Marketing Authorization Application (MAA) to Brazil’s National Health Surveillance Agency (ANVISA) for PALSONIFY™ (paltusotine), the first once-daily, oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist, for the proposed treatment of acromegaly in adults. “The submission of our MAA for Palsonify in Brazil represents another important global milestone for this important therapy,” said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. “Once-daily, oral Palsonify is redefining the treatment paradigm as the next generation of acromegaly care in the US, following its approval by the FDA. We now look forward to working with ANVISA as they evaluate our MAA for Palsonify to treat acromegaly in adults in Brazil.” The MAA submission is supported by data from 18 clinical trials, including two Phase 3 trials that evaluated paltusotine for the treatment of acromegaly in medically untreated and treated patients. All primary and secondary endpoints were met in both Phase 3 studies. Treatment with paltusotine was well-tolerated and resulted in statistically significant biochemical control and patient reported symptom control compared to placebo. PALSONIFY is approved in the US to treat adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. In Europe, Crinetics recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for granting the MAA for Palsonify for the proposed treatment of acromegaly in adults. About PALSONIFY ™ (Paltusotine) PALSONIFY, a selectively-targeted somatostatin receptor type 2 (SST2) nonpeptide agonist, is the first and only once-daily, oral therapy approved for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. In Phase 3 studies, once-daily, oral PALSONIFY maintained IGF-1 levels and symptom control in patients with acromegaly who were switched from monthly injectable medications (PATHFNDR-1) and rapidly decreased IGF-1 levels and symptom burden in medically untreated acromegaly patients (PATHFNDR-2). IGF-1 is the primary biomarker endocrinologists use to manage acromegaly patients. Paltusotine is also in Phase 3 clinical development for carcinoid syndrome associated with neuroendocrine tumors (CAREFNDR). Results from a Phase 2 study in carcinoid syndrome demonstrated rapid and sustained reductions in flushing episodes and bowel movement frequency, which are the most common symptoms of carcinoid syndrome. About Crinetics Pharmaceuticals Crinetics Pharmaceuticals is a global pharmaceutical company committed to transforming the treatment of endocrine diseases and endocrine-related tumors through science rooted in patient needs. Crinetics is focused on discovering, developing, and commercializing novel therapies, with a core expertise in targeting G-protein coupled receptors (GPCRs) with small molecules that have specifically tailored pharmacology and properties. Crinetics’ lead product, PALSONIFY™ (paltusotine), is the first once-daily, oral treatment approved by the U.S. FDA for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Paltusotine is also in clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics’ deep pipeline of 10+ disclosed programs includes late-stage investigational candidate atumelnant, which is currently in development for congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome, and CRN09682, a nonpeptide drug conjugate candidate that is being developed to treat SST2 expressing neuroendocrine tumors and other SST2 expressing solid tumors. Additional discovery programs address a variety of endocrine conditions such as neuroendocrine tumors, Graves’ disease (including Graves’ hyperthyroidism and Graves’ orbitopathy, or thyroid eye disease), polycystic kidney disease, hyperparathyroidism, diabetes, obesity, and GPCR-targeted oncology indications. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the plans and timelines for the clinical development of atumelnant and paltusotine for the treatment of carcinoid syndrome; or the potential for our development candidates to transition to clinical development; In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “upcoming” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including, without limitation, we may not be able to obtain, maintain and enforce our patents and other intellectual property rights, and it may be prohibitively difficult or costly to protect such rights; geopolitical events may disrupt Crinetics’ business and that of the third parties on which it depends, including delaying or otherwise disrupting clinical studies and preclinical studies, manufacturing and supply chain, or impairing employee productivity; unexpected adverse side effects, complications and/or drug interactions or inadequate efficacy of the Company’s product candidates that may limit their development, regulatory approval and/or commercialization; the Company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments or political changes, including policies related to pricing and pharmaceutical drug reimbursement, in the United States and foreign countries; the timing and outcome of research, development and regulatory review is uncertain, and Crinetics’ drug candidates may not advance in development or be approved for marketing; Crinetics may use its capital resources sooner than expected or our cash burn rate may accelerate; any future impacts to our business resulting from geopolitical developments outside our control; and the other risks and uncertainties described in the Company’s periodic filings with the Securities and Exchange Commission (SEC). The events and circumstances reflected in the company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Crinetics can be found under the heading “Risk Factors” in Crinetics’ periodic filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, Crinetics does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Investors: Gayathri Diwakar Head of Investor Relations gdiwakar@crinetics.com (858) 345-6340 Media: Natalie Badillo Head of Corporate Communications nbadillo@crinetics.com (858) 345-6075

临床结果临床3期上市批准临床2期

2026-03-26

·北京理工大学生命学院

齐洁玉（系主任）/教授/博士生导师

齐洁玉，北京理工大学生命学院，院长助理，神经生物学系主任，教授，博士生导师联系方式：qijieyu@bit.edu.cn 招生方向：基因治疗/AAV/人工智能/分子生物学/干细胞/生物信息欢迎具有生物学、医学、生物信息学、计算机科学背景的同学加入！ 1、个人简介齐洁玉，1989年10月出生，教授，博士生导师。2025年入选国家级青年人才计划，2024年入选省优青，2020年入选国家“博新计划”。长期致力于遗传性聋的致病机制和内耳基因治疗研究，以一作或通讯作者身份在Lancet，Nature Medicine，Science Advances，Nature Communications（3篇）等有国际影响力的学术期刊。 2、招生专业生物学、生物技术与工程 3、教育背景 2013.09-2020.03：博士，东南大学，生物学 2009.09-2013.07：学士，南阳师范学院，生物科学 4、工作经历 2024.04至今：北京理工大学，生命学院，教授，院长助理，神经生物学系主任 2020.04-2024.03：东南大学，生命科学与技术学院，至善博士后， 5、研究领域和方向以临床耳聋患者治疗需求为导向，聚焦于耳聋发病机制和基因治疗研发与临床应用，打通基因治疗中所用的AAV核酸药物研发、产业化设计、工艺生产、安全评估等通路，建立产学研发展新模式。主要研究内容包括：（1）探究耳聋致病机制，寻找耳聋精准基因治疗的潜在靶点；（2）内耳新型转基因递送载体筛选；（3）开展基因治疗恢复耳聋的基础研究、临床转化研究和临床研究，研发临床可用的耳聋基因治疗药物。 6、获得荣誉 (1) 重庆市科技进步奖一等奖（2025年） (2) 山东省科技进步奖一等奖（2025年） (3) 江苏省科学技术奖一等奖（2024年） (4) 华夏医学科技奖一等奖（2024年） (5) 中华医学会医学科技奖二等奖（2023年） (6) 2023年度江苏省行业领域十大科技进展（2024年） 7、承担项目 (1) 广东省科技创新战略专项资金，基础与应用基础研究重大项目（基石），2025B0303000009，干细胞移植联合人工耳蜗植入重建听力的研究，2025/09-2030/08，500万，在研，主持。 (2) 北京市自然科学基金，面上项目，7252089，基因替代疗法挽救隐形遗传性耳聋DFNB1的研究，2025/01-2027/12，20万，在研，主持。 (3) 国家自然科学基金，面上项目，82371162，AAV介导的Cx1、Rassf2、Sparcl1和Atoh1协同调控再生功能性毛细胞的作用和机制研究，2024/01-2027/12，49万，在研，主持。 (4) 国家自然科学基金，联合基金重点支持项目，U23A200440，协同调控毛细胞和螺旋神经元功能性再生修复受损听觉功能的研究，2024/01/01-2027/12/31，130万/260万，在研，子单位负责人。 (5) 科技部科技创新2030-“脑科学与类脑研究”重大项目，2021ZD0205400，听觉机械转导通道复合物的组装机制及功能研究，2022/01-2026/12，150万/500万，在研，子课题负责人。 (6) 国家自然科学基金，青年项目，82000984，AAV介导GPA，Espin和DKK3协同调控内耳干细胞再生为功能性毛细胞的研究，2021/01-2023/12，24万，结题，主持。 (7) 人力资源和社会保障部、全国博士后管委会，创新人才项目，BX20200082，2020年度博士后创新人才支持计划，2020/07-2022/06，63万，结题，主持。 (8) 中国博士后科学基金，面上项目，2020M681468，耳聋基因Tprn的致聋分子机制及AAV-Tprn介导的基因治疗，2020/12-2022/11，8万，结题，主持。 (9) 科技部国家重点研发计划项目“干细胞及转化研究”重点专项，青年项目，2020YFA0113600，通过三维导电生物材料和电刺激调控神经干细胞构建体外类脑与内耳器官的研究，2020/10-2024/12，135.25万/541万，结题，子课题负责人。 (10) 江苏省博士后科研资助计划，2021/05-2023/05，21万，结题，主持。 8、学术兼职 (1) 《Neuroscience Bulletin》青年编委，2026.01-2030.12 (2) 《Flavour and Fragrance Journal》编委，2024.09-2027.08 (3) 《Sensory Neuroscience》青年编委，2024.04-至今 (4) 中国生物物理学会听觉，言语和交流分会，副秘书长，2025.09-2029.08 (5) 中国妇幼保健协会母胎医学分会，常务委员，2025.11-2029.10 (6) 中国生物物理学会听觉，言语和交流分会，青年分会，秘书，2021.08-2025.08 (7) 江苏省发育生物学会听觉科学专委会副秘书长，常务委员，2023.01.05-2027.01.04 (8) 江苏省研究型医院学会青年科学家分会，委员，2021.12-2025.12 9、发表论文： (1) Jieyu Qi#（第一作者）, Liyan Zhang#, Ling Lu#, Fangzhi Tan#, Cheng Cheng#, Yicheng Lu#, WenXiu Dong, Yinyi Zhou, Xiaolong Fu, Lulu Jiang, Chang Tan, Shanzhong Zhang, Sijie Sun, Huaien Song, Maoli Duan*, Dingjun Zha*, Yu Sun*, Xia Gao*, Lei Xu*, Fan-Gang Zeng*, Renjie Chai*. AAV gene therapy for autosomal recessive deafness 9: a single-arm trial. Nature Medicine, 2025 Sep; 31, 2917–2926. (IF: 50.0) 一区（ESI高被引论文） (2) Jieyu Qi（唯一第一作者）, Lei Xu, Fan-gang Zeng, Renjie Chai*, OTOF-related gene therapy: a new way but a long road ahead. Lancet, 2025 Mar 8;405(10481):777-779. (IF: 88.5)一区 (3) Liyan Zhang#, Yicheng Lu#, Xianmin Wu#, Jinyi Fan#, Xinru Zhang#, Yang Xu#, Hao Wei, Qiuhan Sun, Lulu Jiang, Huawei Tuo, Nianci Li, Hua Jin, Wu Cao, Beibei Ye, Ziyu Zhang, Yunkai Zhang, Fangyi Chen, Ling Lu*, Jieyu Qi*（并列通讯作者）, Renjie Chai*, Fangzhi Tan*. Human Promoter-Driven AAV Tools Enable Precision Gene Therapy Targeting Cochlear Hair Cells. Cell Reports Medicine. 2026, in press. (IF: 10.8) 一区 (4) Xin Chen#, Yuwei Che#, Jieyu Qi#（并列第一作者）, Ming Cen#, Shan Gao#, Bin Zhu, Yiheng Ao, Xiangyu Ma, Cheng Cheng, Rongrong Guo, Xinlin Wang, Tian Shen, Jiheng Wu, Fanliang Kong, Wei Si, Yongchang Chen, Tao Tan, LingLu*, Renjie Chai*. Molecular heterogeneity of the non-human primate cochlea. Nature Communications, 2026 Jan 17;17(1):1633. (IF: 15.7) 一区 (5) Ziyu Zhang#, Man Wang#, Fangzhi Tan#, Liyan Zhang#, Xiaohan Wang, Xiangyan Chen, Jia Han, Nianci Li, Qiuhan Sun, Yicheng Lu, Zhiping Cui, Zuhong He*, Jieyu Qi*（并列通讯作者）, Renjie Chai*. Precise and efficient DNA base editing restores normal hearing in adult DFNB9 mouse model. Med, 2025 27:101001. (IF: 11.8) 一区 (6) Man Wang#, Ziyu Zhang#, Xiaohan Wang#, Liyan Zhang#, Xiangyan Chen, Nianci Li, Qiuhan Sun, Yicheng Lu, Zuhong He, Hongbo Yang*, Fangzhi Tan*, Jieyu Qi*（并列通讯作者）, Renjie Chai*. Optimized in vivo base editing restores auditory function in a DFNA15 mouse model of deafness. Nature Communications, 2025 Sep 18;16(1):8322. (IF: 15.7) 一区 (7) Nianci Li#, Ziyu Zhang#, Liyan Zhang#, Danqi Wu#, Zhe Li#, Changling Xu, Qiuhan Sun, Yicheng Lu, Yinyi Zhou, Xiaoyun Qian, Yangnan Hu*, Fangzhi Tan*, Jieyu Qi*（并列通讯作者）, Renjie Chai*. Establishment of a cochlear organoid platform for remodeling the extracellular matrix. ACS Nano, 2025 Jul 29;19(29):26542-26561. (IF: 16.1) 一区 (8) Jiaming Li, Mengmeng Jiang, Qiaoran Wang, Zikai Zheng, Jianghua Shen, Jingyi Li, Muzhao Xiong, Yandong Zheng, Xiaoyong Lu, Yusheng Cai, Yanling Fan, Lingling Geng, Qianzhao Ji, Qianqian Peng, Shuhui Sun, Yuanyuan Wang, Zijuan Xin, Kaowen Yan, Yuanhan Yang, Jun Yu, Haoteng Yan, Ding Ai*,……, Jieyu Qi*（并列通讯作者）, …… Guanghui Liu. The X-Age Project to Construct a Chinese Aging Clock. Nature Aging, 2025 Sep;5(9):1669-1685. (IF: 19.5) 一区 (9) Zeming Wu , Jing Qu , Weiqi Zhang , ……, Jieyu Qi*（并列通讯作者）, …… Guanghui Liu. Biomarkers of ageing of humans and non-human primates. Nat Rev Mol Cell Biol. 2025 Nov;26(11):826-847. doi: 10.1038/s41580-025-00883-8. (IF: 90.2) 一区 (10) Zhe Li, Ying Zhang, Zhenyu Xiao, Jieyu Qi*（唯一通讯作者）. The Reconstruction of Peripheral Auditory Circuit: Recent Advances and Future Challenges. Advanced Science. 2025 Mar 24:e2410494. (IF: 14.1)一区 (11) Nianci Li#, Fangzhi Tan#, Liyan Zhang#, Xiaoqiong Ding#, Qiuhan Sun, Man Wang, Ziyu Zhang, Yicheng Lu, Yinyi Zhou, Xiaoyun Qian, Fanglei Ye*, Jieyu Qi*（并列通讯作者）, Renjie Chai*. AAV-Sparcl1 Promotes Hair Cell Regeneration By Increasing Supporting Cell Plasticity. Molecular Therapy, 2025 Jul 2;33(7):3022-3035. (IF: 12) 一区 (12) Jieyu Qi#（第一作者）, Liyan Zhang#, Yicheng Lu#, Renjie Chai*. Targeting NLRP3/caspase-1/GSDMD to treat inner ear injury from labyrinthine hemorrhage. Molecular Therapy, 33:10, P4684-4685, 2025. 10.1016/j.ymthe.2025.07.052 (IF:12) 一区 (13) Fangzhi Tan#,*, Yue Dong#, Jieyu Qi#（并列第一作者）, Wenwu Yu*, Renjie Chai*. Artificial Intelligence-Based Approaches for AAV Vector Engineering. Advanced Science, 2025 Mar;12(9):e2411062. (IF:14.1) (14) Fan-Gang Zeng*, Jieyu Qi*（并列通讯作者）, Chen-Chi Wu*, Yilai Shu*, Renjie Chai*. Treating Hearing Loss: From Cochlear Implantation to Gene Therapy. Advanced Science, 2025 Nov;12(41):e09960 (IF:14.1) (15) Qiuhan Sun#, Fangzhi Tan#*, Liyan Zhang#, Yicheng Lu#, Hao Wei#, Nianci Li, Lulu Jiang, Yinyi Zhou, Tian Chen, Ling Lu*, Genglin Li*, Jieyu Qi*（并列通讯作者）, Shiming Yang*, Renjie Chai*, Combined AAV-mediated specific Gjb2 expression restores hearing in DFNB1 mouse models. Molecular Therapy, 2025 Mar 22:S1525-0016(25)00203-5. (IF: 12)一区 (16) Qiuhan Sun#, Fangzhi Tan#, Xinlin Wang#, Xingliang Gu#, Xin Chen#, Yicheng Lu, Nianci Li, Xiaoyun Qian, Yinyi Zhou, Ziyu Zhang, Man Wang, Liyan Zhang*, Busheng Tong, Jieyu Qi*（并列通讯作者）, Renjie Chai*, AAV-regulated Serpine2 overexpression promotes hair cell regeneration. Molecular Therapy Nucleic Acids, 2024 Nov; 17;35(4):102396. (IF: 6.5) 一区 (17) Liyan Zhang#, Fangzhi Tan#, Jieyu Qi#（并列第一作者）, Yicheng Lu#, Xiaohan Wang, XuehanYang, Xiangyan Chen,Xinru Zhang, Jinyi Fan, Yinyi Zhou, Li Peng, Nianci Li, Lei Xu,* Shiming Yang,* Renjie Chai*. AAV-mediated Gene Therapy for Hereditary Deafness: Progress and Perspectives. Advanced Science, 2024 Nov; 18:e2402166. (IF:14.1) 一区 (18) Xiangyu Ma#, Xin Chen#, Yuwei Che#, Siyao Zhu#, Xinlin Wang, Shan Gao, Jiheng Wu, Fanliang Kong, Cheng Cheng, Yunhao Wu, Jiamin Guo, Jieyu Qi*（并列通讯作者）, Renjie Chai, A Single-cell Transcriptomic Landscape of the Topological Differences in Mammalian Auditory Receptor, Science China-Life Science, 2024 Nov;67(11):2398-2410. (IF:8) 二区 (19) Liyan Zhang#, Xin Chen#, Xinlin Wang#, Yinyi Zhou#, Yuan Fang#, Xingliang Gu, Ziyu Zhang, Qiuhan Sun, Nianci Li , Lei Xu*, Fangzhi Tan*, Renjie Chai*, Jieyu Qi*（最后并列通讯作者）. AAV-mediated Gene Cocktails Enhance Supporting Cell Reprogramming and Hair Cell Regeneration. Advanced Science, 2024, Aug;11(29):e2304551. (IF:14.1) 一区 (20) Jieyu Qi#（第一作者）, Liyan Zhang#, Renjie Chai. AAV-based gene replacement: The promise of gene therapy for deafness. Molecular Therapy Nucleic Acids, 2024, 2024 Apr 11;35(2):102181. doi: 10.1016/j.omtn.2024.102181. (IF: 6.5) (21) Changling Xu#, Liyan Zhang#, Yinyi Zhou#, Haoliang Du#, Jieyu Qi#（并列第一作者）, Fangzhi Tan#, Li Peng, Xingliang Gu, Nianci Li, Qiuhan Sun, Ziyu Zhang, Yicheng Lu, Xiaoyun Qian, Busheng Tong*, Jiaqiang Sun*, Renjie Chai*, Yi Shi*. Pcolce2 overexpression promotes supporting cell reprogramming in the neonatal mouse cochlea. 2024, Cell Proliferation, 2024 Mar 25:e13633. (IF: 5.6) 一区 (22) Jieyu Qi#（第一作者），Fangzhi Tan#，Liyan Zhang#，Ling Lu#，Hongyang Wang#，Wenyan Li，Wenwen Liu，Xiaolong Fu，Zuhong He，Xiaoqiong Ding，Shan Sun，Qiaojun Fang，Yaodong Dong，Xuewei Zhu，Busheng Tong，Xianbao Cao，Min Guo，Xinmiao Fan，Qin Wang，Lu Ma，Tianhong Zhang29，Yafeng Yu，Yongxin Li，Jiangang Fan，Yong Cui，Peina Wu，Hongzheng Zhang，Jie Tang, Weiwei Guo，Dingjun Zha，Fanglei Ye，Shuangba He，Wei Cao, Jianming Yang, Xiaoyun Qian，Yu Zhao，Jingwu Sun，Xiaowei Chen，Yu Sun，Ming Xia，Qiuju Wang，Huijun Yuan，Yong Feng，Weijia Kong，Shiming Yang，Haibo Wang，Maoli Duan*, Xia Gao*，Huawei Li*，Lei Xu*，Renjie Chai*, Clinical practice guidelines for gene therapy to treat hereditary hearing loss. Interdisciplinary Medicine, 2024 Mar 2(2): e20240008. (IF:13.6) (23) Qiuhan Sun#, Liyan Zhang#, Tian Chen#, Nianci Li#, Fangzhi Tan#*, Xingliang Gu, Yinyi Zhou, Ziyu Zhang, Yicheng Lu, Jie Lu, Xiaoyun Qian, Bing Guan*, Jieyu Qi*（并列通讯作者）, Fanglei Ye* Renjie Chai*. AAV-mediated Gpm6b expression supports hair cell reprogramming. Cell Proliferation, 2024 Jul; 57(7):e13620. (IF: 5.6) 一区 (24) Jieyu Qi#（第一作者）, Fangzhi Tan#, Liyan Zhang#, Ling Lu#, Shanzhong Zhang#, Yabo Zhai#, Yicheng Lu#, Xiaoyun Qian#, WenXiu Dong, Yinyi Zhou, Ziyu Zhang, Xuehan Yang, Lulu Jiang, Chaorong Yu, Jiancheng Liu, Tian Chen, Lianqiu Wu, Chang Tan, Sijie Sun, Huaien Song, Yilai Shu*, Lei Xu*, Xia Gao*, Huawei Li*, Renjie Chai*. AAV-Mediated Gene Therapy Restores Hearing in Patients with DFNB9 Deafness. Advanced Science, 2024 Jan 8: e2306788. (IF:14.1) （ESI高被引论文） (25) Jieyu Qi#,*（第一作者，并列通讯作者）, Liyan Zhang#, Fangzhi Tan#,*, Yang Zhang#, Yinyi Zhou, Ziyu Zhang, Hongyang Wang, Chaorong Yu, Lulu Jiang, Jiancheng Liu, Tian Chen, Lianqiu Wu, Shanzhong Zhang, Sijie Sun, Shan Sun*, Ling Lu*, Qiuju Wang*, Renjie Chai*. Pre-clinical efficacy and safety evaluation of AAV-OTOF in DFNB9 mouse model and non-human primate. Advanced Science, 2024 Jan;11(3):e2306201. Epub 2023 Nov 28. (IF:14.1) (26) Jieyu Qi#,*（第一作者，并列通讯作者）, Fangzhi Tan#,*, Liyan Zhang#,Yinyi Zhou, Ziyu zhang, Qiuhan Sun, Nianci Li, Yuan Fang, Xin Chen, Yunhao Wu, Guisheng Zhong*, Renjie Chai*. Critical role of TPRN rings in the stereocilia for hearing. Molecular Therapy, 2024, Jan 3;32(1):204-217. Epub 2023 Nov 11. (IF: 12) (27) Jieyu Qi#（第一作者）, Liyan Zhang#, Xiaohan Wang, Xin Chen, Yiyuan Li, Tian Wang*, Peina Wu*, Renjie Chai*. Modeling, applications and challenges of inner ear organoid, Smart Medicine, 2024 Feb; 3(1): e20230028. First published: 16 January 2024 (IF: 11.6) (28) Jieyu Qi#（第一作者）, Wenjuan Huang#, Yicheng Lu, Xuehan Yang, Yinyi Zhou, Tian Chen, Xiaohan Wang, Yafeng Yu*, Jia-Qiang Sun*, Renjie Chai*. Stem cell-based hair cell regeneration and therapy in the inner ear. Neuroscience Bulletin, 2024 Jan;40(1):113-126. Epub 2023 Oct 3. (IF: 5.9) (29) Liyan Zhang#, Jieyu Qi1#,*（并列一作和并列通讯作者）, Yuan Fang#, Fangzhi Tan#, Ziyu Zhang, Yinyi Zhou, Yideng Huang*, Jingwu Sun*, Renjie Chai*,. Rassf2 overexpression mediated by AAV promotes the supporting cell-to-hair cell transformation in the cochlea. Engineered Regeneration, 2023, 4(3): 304-315. Epub 2023 Apr 24. (IF: 0) (30) Jie Zhao#, Hong Fu#, Jingjing Yu#, Weiqi Hong#, Xiaowen Tian#, Jieyu Qi#（并列第一作者）, Suyue Sun, Chang Zhao, Chao Wu, Zheng Xu, Lin Cheng, Renjie Chai*, Wei Yan*, Xiawei Wei, Zhenhua Shao*. Prospect of acromegaly therapy: molecular mechanism of clinical drugs octreotide and paltusotine. Nature Communications. 14(1):962, 2023. Published online 2023 Feb 21. (IF: 14.7) (31) Xuechun Yang#, Jieyu Qi#,*（并列一作和并列通讯作者）, Liyan Zhang#, Fangzhi Tan#, Hongming, Huang, Chunlai Xu, Renjie Chai*, Yong Cui*, Peina Wu*. The role of Espin in the stereocilia regeneration and protection in Atoh1-overexpressed cochlear epithelium. Cell Proliferation, 2023, 56(11): e13483. Epub 2023 Apr 21. (IF: 5.9) (32) Changling Xu#, Jieyu Qi#,*（并列一作和并列通讯作者）, Xiaojie Hu#, Liyan Zhang#, Qiuhan Sun, Nianci Li, Xin Chen, Fangfang Guo, Peina Wu*, Yi Shi*, Renjie Chai*, Rps14 upregulation promotes inner ear progenitor proliferation and hair cell regeneration in the neonatal mouse cochlea. Cell Proliferation, 2023, 56(5); e13458. Epub 2023 Mar 28. (IF: 5.9) (33) Liyan Zhang#, Yuan Fang#, Fangzhi Tan#, Fangfang Guo#, Ziyu Zhang, Nianci Li, Qiuhan Sun, Jieyu Qi*（并列通讯作者）, Renjie Chai*. AAV-Net1 facilitates the trans-differentiation of supporting cells into hair cells in the murine cochlea. Cellular and Molecular Life Sciences, 2023, 80(4):86. Published: 14 March 2023. (IF: 6.2) (34) Cheng Cheng#, Jieyu Qi#（并列第一作者）, Liyan Zhang#, He Li#, Jie Lu, Siyu Li, Zhong Zhang, Yue Qiu, Chen Zhang, Xia Gao*, Phillip I Bird*, Renjie Chai*. Absence of Serpinb6a Causes Progressive Hair Cell Apoptosis and Hearing Loss in Mice. Journal of Genetics and Genomics, 50(2), 126-129, 2023. Available online 8 September 2022, Version of Record 23 February 2023 (IF: 5.9) (35) Jieyu Qi#（第一作者）, Xiaolong Fu#, Liyan Zhang#, Fangzhi Tan#, Nianci Li, Qiuhan Sun, Xiaojie Hu, Lulu Jiang, Zuhong He*, Ming Xia*, Renjie Chai*. Current AAV-mediated gene therapy in sensorineural hearing loss. Fundamental Research. In Press, 2022. Available online 7 September 2022 (IF: 6.2) (国自然基金委官方杂志) (36) Guodong Hong#, Xiaolong Fu#, Jieyu Qi#（并列第一作者）, Buwei Shao#, Xuan Han, Yuan Fang, Shuang Liu, Cheng Cheng,Chengwen Zhu, Junyan Gao, Xia Gao, Jie Chen*, Ming Xia*, Wei Xiong*, Renjie Chai*. Dock4 Is Required for the Maintenance of Cochlear Hair Cells and Hearing Function. Fundamental Research, 3(4): 557-569, 2022. Available online 29 April 2022, Version of Record 21 July 2023. (IF:6.2) (国自然基金委官方杂志) (37) Jieyu Qi#（第一作者）, Yan Liu#, Cenfeng Chu, Xin Chen, Weijie Zhu, Yilai Shu, Shuijin He*, Renjie Chai*, Guisheng Zhong*. A cytoskeleton structure revealed by super-resolution fluorescence imaging in inner ear hair cells. Cell Discovery, 5:12, 2019. 2019年2月19日 (IF: 6.255) (38) Fangzhi Tan#*, Cenfeng Chu#, Jieyu Qi#（并列第一作者）, Wenyan Li#, Dan You, Ke Li, Xing Chen, Weidong Zhao, Cheng Cheng, Xiaoyi Liu, Yunbo Qiao, Bing Su, Shuijin He, Chao Zhong, Huawei Li*, Renjie Chai*, Guisheng Zhong*. AAV-ie enables safe and efficient gene transfer to inner ear cells. Nature Communications, 10(1):3733, 2019. 2019 Aug 19. (IF: 12.121) (39) Yan Liu#, Jieyu Qi#（并列第一作者）, Xin Chen#, Mingliang Tang#, Cenfeng Chu, Weijie Zhu, Hui Li, Cuiping Tian, Guang Yang, Chao Zhong, Zhang Ying, Guangjian Ni, Shuijin He*, Renjie Chai*, Guisheng Zhong*. Critical role of spectrin in hearing development and deafness. Science Advances, 2019, 5(4): eaav7803. 2019 Apr 17. (IF: 13.116)

2026-03-25

·氟档案

【经典综述】2025年美国FDA批准的含氟药物_2026_P14（预印本）

导言本综述重点介绍了美国食品药品监督管理局 (FDA) 于 2025 年批准的 14 种新药，包括 datopotamab deruxtecan、suzetrigine、mirdametinib、avutometinib/defactinib、taletrectinib、sunvozertinib、sebetralstat、rilzabrutinib、imlunestrant、paltusotine、remibrutinib、elinzanetant、ziftomenib 和 zoliflodacin。对于每种化合物，我们考察了其药物化学发现、治疗应用和 FDA 批准时间线，尤其侧重于合成策略和氟引入的作用。本综述旨在为学术界和制药行业的科研人员以及从事药物设计、氟化学和药物化学的学生提供及时的参考和启发。 ➤ 欢迎来到氟叫兽的氟档案馆，微信：dowpont。免费下载，转发本号任一文章后加氟叫兽微信dowpont获取下载密码： Fluorine-containing drugs approved by the US FDA in 2025.pdf 概述含氟药物设计已成为现代药物研发的核心策略之一。氟原子凭借其极高的电负性（鲍林标度3.98）和与氢原子相近的范德华半径（约1.47 Å），在引入药物分子后能够显著改善脂溶性、代谢稳定性、靶点结合亲和力及pKa值，从而全面提升药物的疗效、生物利用度和药代动力学性质。因此，氟原子常被药物化学家誉为"魔法原子"——即便是单个氟原子的引入，也可能彻底改变一个候选药物的命运。本文系统梳理了2025年美国FDA批准上市的14款含氟新药，涵盖其药物化学发现历程、治疗适应症、审批时间线，并重点阐述合成策略与氟原子引入的作用机制。 14款含氟新药概览 1. 达妥珠单抗德鲁替康（Datroway）这是一款靶向TROP2的抗体药物偶联物，于2025年1月获批用于HR+/HER2-不可切除或转移性乳腺癌。其含氟组分为依沙替康，属于喜树碱拓扑异构酶I抑制剂类似物，A环的氟化修饰显著增强了体内外细胞毒性并降低了系统毒性。 2. 苏泽曲金（Journavx）2025年1月获批，是首个获批用于中重度急性疼痛的NaV1.8电压门控钠通道选择性抑制剂，属于非阿片类镇痛药。其结构含三氟甲基和3,4-二氟-2-甲氧基苯基，氟取代基赋予分子对靶点疏水空腔的强结合力，并提升代谢稳定性。 3. 米达美替尼（Gomekli）2025年2月获批，用于2岁及以上有症状性丛状神经纤维瘤的1型神经纤维瘤病患者。作为MEK1/2抑制剂，其二苯胺骨架上的多个氟取代基通过与MEK1结合口袋中Lys97和Ser212形成特异性相互作用，显著提升抑制活性。 4. 阿伏美替尼/德法替尼（Avmapki）2025年5月获批，用于KRAS突变的复发性低级别浆液性卵巢癌。两药联合分别靶向Raf/MEK（阿伏美替尼，吡啶上的氟提升代谢稳定性）和FAK（德法替尼，CF₃基团通过卤键与FAK疏水位点Asp564相互作用）。 5. 他来替尼（Ibtrozi）2025年6月获批，用于ROS1阳性晚期非小细胞肺癌（NSCLC）。SAR研究表明苯环上的氟原子对ROS1激酶抑制活性至关重要，含氟化合物的IC₅₀值（<20 nmol/L）远优于无氟对照物。 6. 孙伏泽替尼（Zegfrovy）2025年7月加速获批，用于EGFR外显子20插入突变的晚期NSCLC。4-氟和5-氯的联合取代将人肝细胞清除率从34 μL/min/10⁶细胞显著降低至7.1 μL/min/10⁶细胞，大幅改善药代动力学特性。 7. 塞贝曲司他（Ekterly）2025年7月获批，用于遗传性血管性水肿的急性发作治疗，通过抑制血浆激肽释放酶阻断缓激肽过度生成。氟原子通过gauche效应调节分子构象，优化亲脂性、膜渗透性和清除率。 8. 利扎布鲁替尼（Wayrilz）2025年8月获批，为可逆性BTK抑制剂，用于对其他疗法无效的慢性免疫性血小板减少症。单个氟原子的引入使BTK抑制活性IC₅₀达1.3 nmol/L，在全血CD69 B细胞激活试验中表现出高效抑制活性。 9. 伊姆奈司坦（Inluriyo）2025年9月获批，为脑渗透性选择性雌激素受体降解剂，用于ESR1突变的ER+/HER2-晚期乳腺癌。CF₃基团的引入使其与ERα的结合亲和力（Ki = 0.64 nmol/L）较非三氟甲基化类似物提高了约12～42倍。 10. 帕图索汀（Palsonify）2025年9月获批，为首个非肽类SST2受体激动剂，用于手术后控制不佳的肢端肥大症。3,5-二氟苯基取代赋予其对hSST2的超高效力（EC₅₀ = 0.25 nmol/L），并实现对其他SST亚型超过1000倍的选择性。 11. 雷米布鲁替尼（Rhapsido）2025年9月获批，为高选择性共价BTK抑制剂，用于慢性自发性荨麻疹。氟化修饰使其BTK抑制活性提升约3倍（IC₅₀从3.8降至1.3 nmol/L），同时改善膜渗透性。 12. 依林扎奈坦（Lynkuet）2025年10月获批，为NK1/NK3双受体拮抗剂，用于更年期中重度血管舒缩症状。CF₃基团的引入将受体结合亲和力较类似物提高约5～50倍，且无激素类副作用。 13. 齐夫托美尼（Komzifti）2025年11月获批，为选择性menin抑制剂，用于NPM1突变的复发难治性急性髓系白血病。含氟噻吩并嘧啶核心结构实现IC₅₀ < 50 nmol/L的高效抑制，代表精准表观遗传靶向治疗的重大突破。 14. 佐利弗洛达星（Nuzolvence）2025年12月获批，为首创口服螺嘧啶三酮类抗生素，用于淋球菌性泌尿生殖道感染，对多药耐药菌株有效，且与氟喹诺酮类无交叉耐药性。总结与展望 14款新药涵盖肿瘤、疼痛、免疫、内分泌及感染性疾病等广泛治疗领域，均含杂环骨架，多数为手性化合物。从氟化模式来看，芳香单氟取代最为常见（10/14），其次为CF₃取代和二氟取代，脂肪族氟化最少。这些规律与历年趋势高度一致，反映了氟原子在微调电子密度、提升代谢稳定性和阻断代谢热点方面的不可替代性。未来的挑战在于开发更绿色高效的氟化合成方法、探索新型氟化模式，并借助人工智能辅助预测氟化位点，同时也需关注含氟药物在环境中的持久性与降解问题。精彩回顾：氟叫兽写的创刊号文章【创刊号系列之三】氟叫兽重写氟的发现历史-3：氟化学的祖师爷_亨利·莫瓦桑(Henri Moissan)—（完）【创刊号系列之三】氟叫兽重写氟的发现历史-2：氟的发现史（莫瓦桑前的悲壮过程）【创刊号系列之三】氟叫兽重写氟的发现历史-1：再识萤石【创刊号系列之二】氟叫兽重写氟的发现历史-2：中日近代氟元素名称起源对比（民国前）【创刊号系列之二】氟叫兽重写氟的发现历史-2：中国近代氟化学知识起源考（民国前）【创刊号系列之二】氟叫兽重写氟的发现历史-2：日本萤石名称考【创刊号系列之二】氟叫兽重写氟的发现历史-1：中国古代萤石名称考（上一篇的补充）【创刊号系列之二】氟叫兽重写氟的发现历史-1：中国古代萤石名称考【创刊号系列之一】氟叫兽带你重新认识“氟” 氟叫兽建的氟档案馆 PTFE PVDF FEP ETFE FKM 氟精细无机氟氟气体氟流体报告手册书籍剪报数据人物综合其它免责声明：本公众号部分文字及图片来源于网络，仅供学习、交流使用，版权归原作者所有，如有问题请及时联系处理，氟叫兽微信：dowpont。本号文章并不代表氟叫兽本人意见，欢迎转发，请注明出处。上面内容直接点进入合集。

100 项与帕妥索汀相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16277

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
肢端肥大症	美国	Crinetics Pharmaceuticals, Inc.	2025-09-25

未上市

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适应症	最高研发状态	国家/地区	公司	日期
大肠类癌	临床3期	美国	Crinetics Pharmaceuticals, Inc.	2025-11-19
大肠类癌	临床3期	阿根廷	Crinetics Pharmaceuticals, Inc.	2025-11-19
大肠类癌	临床3期	巴西	Crinetics Pharmaceuticals, Inc.	2025-11-19
大肠类癌	临床3期	智利	Crinetics Pharmaceuticals, Inc.	2025-11-19
大肠类癌	临床3期	哥伦比亚	Crinetics Pharmaceuticals, Inc.	2025-11-19
大肠类癌	临床3期	法国	Crinetics Pharmaceuticals, Inc.	2025-11-19
大肠类癌	临床3期	西班牙	Crinetics Pharmaceuticals, Inc.	2025-11-19
大肠类癌	临床3期	英国	Crinetics Pharmaceuticals, Inc.	2025-11-19
盲肠肿瘤	临床3期	美国	Crinetics Pharmaceuticals, Inc.	2025-11-19
盲肠肿瘤	临床3期	阿根廷	Crinetics Pharmaceuticals, Inc.	2025-11-19

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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


NCT04837040 (PATHFNDR-1, CTgov)	临床3期	肢端肥大症	58	Paltusotine (Paltusotine)	觸鑰構顧遞顧蓋願艱蓋 = 淵壓憲獵糧簾積鏇鏇艱鹹艱遞衊鹹築淵鹽憲獵 (醖齋繭醖選積夢蓋窪簾, 遞鹹積膚範鑰鬱膚糧廠 ~ 壓糧鑰範醖糧簾鬱鹹鹹) 更多	-	2026-01-13
				Placebo (Placebo)	觸鑰構顧遞顧蓋願艱蓋 = 簾憲觸齋廠鬱餘遞願獵鹹艱遞衊鹹築淵鹽憲獵 (醖齋繭醖選積夢蓋窪簾, 餘蓋獵淵衊構廠蓋膚糧 ~ 獵鹽膚憲製鑰構繭願襯) 更多
NCT05361668 (CTgov)	临床2期	大肠类癌 \| 胰腺神经内分泌肿瘤 \| 恶性类癌综合征 ... 更多	36	Paltusotine (40 mg Paltusotine)	衊鬱鹽窪觸觸窪淵夢艱 = 窪糧膚鬱遞廠網顧選願鏇鹹繭製製壓繭鏇鏇簾 (衊網衊糧築艱鑰築壓製, 簾範窪築願遞鬱鏇鏇製 ~ 鏇遞艱鏇餘餘繭顧壓蓋) 更多	-	2025-10-31
				Paltusotine (80 mg Paltusotine)	衊鬱鹽窪觸觸窪淵夢艱 = 鑰築顧簾醖積範窪鏇製鏇鹹繭製製壓繭鏇鏇簾 (衊網衊糧築艱鑰築壓製, 鏇繭獵觸衊鏇蓋襯願窪 ~ 獵艱鬱選鬱鹹鬱鬱遞範) 更多
NCT03789656 (ACROBAT Edge, CTgov)	临床2期	肢端肥大症	47	octreotide+lanreotide (Group 1)	廠構鹽膚獵構網鹹構觸(顧襯鹹窪繭窪蓋鑰範簾) = 構窪艱鹽壓艱觸蓋鹽窪簾簾觸鹽遞積製鏇範繭 (餘鑰鬱壓醖鑰淵繭廠簾, 製範願糧構積憲壓壓遞 ~ 廠淵壓範壓鬱衊鏇醖壓) 更多	-	2025-02-17
				SRL+bromocriptine+octreotide LAR+cabergoline+lanreotide depot (Group 3)	糧壓夢遞憲夢膚遞衊廠 = 顧鬱淵積鹽鹽鹹膚鹹積範醖夢鏇製構襯鑰醖窪 (選選選鬱壓願網範範築, 顧鏇繭繭顧壓構鑰觸構 ~ 糧積襯繭鑰醖獵簾衊齋) 更多
NCT05192382 (PATHFNDR-2, ENDO2024)	临床3期	肢端肥大症	111	Paltusotine 20 mg	網膚膚夢製網蓋製蓋醖(艱糧窪製壓醖糧衊範壓) = 餘鏇衊製鏇觸壓製繭蓋觸淵鑰襯願製網壓獵範 (簾網顧膚艱鑰鑰鏇襯糧 ) 更多	积极	2024-06-01
				Placebo	網膚膚夢製網蓋製蓋醖(艱糧窪製壓醖糧衊範壓) = 淵簾築齋餘醖襯鬱製糧觸淵鑰襯願製網壓獵範 (簾網顧膚艱鑰鑰鏇襯糧 ) 更多
NCT04837040 (PATHFNDR-1, ENDO2024)	临床3期	肢端肥大症	-	Paltusotine 40 mg	鏇齋獵簾艱艱築鑰範窪(餘觸繭觸醖鬱鬱觸顧構) = At the end of randomized treatment, the ASD total score was significantly increased from baseline (indicating worsening) in the placebo group compared with the paltusotine group 願簾鹹鑰選憲築淵製醖 (觸淵壓積遞網鏇壓鏇糧 ) 更多	积极	2024-06-01
				Placebo
NCT05192382 (PATHFNDR-2, Biospace) 人工标引	临床3期	肢端肥大症	111	Paltusotine	遞鏇繭糧膚鏇蓋蓋遞糧(衊構蓋鹹餘鏇廠憲蓋憲) = 蓋襯壓夢夢鹽繭築糧齋糧顧夢觸鹹顧艱醖鏇醖 (網糧淵鑰繭艱餘繭襯網 ) 达到更多	积极	2024-03-19
				Placebo	遞鏇繭糧膚鏇蓋蓋遞糧(衊構蓋鹹餘鏇廠憲蓋憲) = 廠艱鏇憲膚鬱糧鹹蓋鬱糧顧夢觸鹹顧艱醖鏇醖 (網糧淵鑰繭艱餘繭襯網 ) 达到更多
NCT05361668 (Biospace) 人工标引	临床2期	恶性类癌综合征	36	Paltusotine	獵壓鏇鬱網製衊淵窪鏇(網衊醖構壓膚鑰顧憲淵) = 鹹壓築醖齋蓋壓夢壓顧廠鑰鹹齋鏇壓淵鑰簾網 (願艱鹽窪簾膚願製願餘 ) 更多	积极	2023-12-18
NCT04261712 (ACROBAT Advance, ENDO2023)	临床2期	肢端肥大症	43	Paltusotine 40 mg	鏇廠鏇憲餘鬱壓獵觸遞(醖獵夢衊觸夢繭艱艱鏇) = 廠製積網鹹繭鹽簾選襯鑰壓鹽壓襯觸願構鬱範 (壓繭選範鏇壓糧築鹹鑰 ) 更多	积极	2023-10-05
				Injectable somatostatin-receptor ligands (iSRL)	衊範網壓壓觸衊衊網鑰(壓願繭選蓋鏇夢廠壓獵) = 網襯餘積顧壓願憲鬱構餘遞蓋糧鬱範遞繭蓋構 (窪鹽鹹壓齋網壓鹹鏇築, 0.84 ~ 1.46)
NCT04837040 (PATHFNDR-1, GlobeNewswire) 人工标引	临床3期	肢端肥大症	58	Paltusotine	夢醖壓鏇製鏇憲繭壓構(衊餘衊選壓艱遞鏇鹹網) = 淵膚醖餘壓簾齋窪夢觸範製築餘糧醖襯繭淵製 (願顧鹽淵願艱網憲糧膚 ) 更多	积极	2023-09-10
				Placebo	夢醖壓鏇製鏇憲繭壓構(衊餘衊選壓艱遞鏇鹹網) = 壓艱鹽製築鏇廠鏇鹹糧範製築餘糧醖襯繭淵製 (願顧鹽淵願艱網憲糧膚 ) 更多
NCT03789656 (ACROBAT Edge, Pubmed) 人工标引	临床2期	肢端肥大症	47	Paltusotine	積鹹願襯積憲襯構壓蓋(鹽壓餘糧餘鹹蓋繭網遞) = 憲廠顧壓壓遞襯獵獵窪構鹽衊廠艱鏇範鹹鑰鬱 (艱鹽願願鏇艱艱蓋顧遞 )	积极	2022-11-10