The goal of this clinical trial is to assess long-term safety and efficacy of rusfertide in subjects with polycythemia vera. Subjects who complete dosing with rusfertide until the end-of-treatment visit of a Phase 2 rusfertide study and meet the inclusion/exclusion criteria for this study, are eligible to participate in this open-label study and continue treatment with rusfertide.

开始日期2024-01-22

申办/合作机构

Protagonist Therapeutics, Inc.

NCT05210790

/ Active, not recruiting临床3期

A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients With Polycythemia Vera

The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV.

开始日期2022-04-01

申办/合作机构

Protagonist Therapeutics, Inc.

NCT04767802

/ Completed临床2期

A Phase 2 Study of the Hepcidin Mimetic PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit (PACIFIC)

This is an open label, single arm trial of PTG-300 in subjects with PV who are newly diagnosed or for whom current therapy is not sufficient to control their hematocrit and have hematocrit >48% prior to dosing. The PTG-300 dose and schedule may be adjusted every 2 to 4 weeks to maintain hematocrit <45% with a target of <43%. Subjects may receive PTG-300 treatment for up to 52 weeks.

开始日期2021-02-02

申办/合作机构

Protagonist Therapeutics, Inc.

100 项与 Rusfertide acetate 相关的临床结果

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100 项与 Rusfertide acetate 相关的转化医学

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100 项与 Rusfertide acetate 相关的专利（医药）

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项与 Rusfertide acetate 相关的文献（医药）

2025-12-01·LEUKEMIA RESEARCH

Rusfertide rapidly decreases hematocrit in patients with suboptimally controlled polycythemia vera

Article

作者: Kirubamoorthy, Kamini ; Molina, Arturo ; Valone, Frank ; Khanna, Sarita ; Modi, Nishit B ; Lee, Sung-Eun ; Chew, Lee Ping ; Dinh, Phillip ; Lee, Jae Hoon ; Gupta, Suneel ; Ginzburg, Yelena Z

Polycythemia vera (PV) is characterized by overproduction of erythrocytes, leukocytes, and platelets. Rusfertide is a hepcidin mimetic polypeptide that binds to ferroportin and decreases iron delivery to bone marrow, reducing the production of red blood cells. The primary objective of this study was to evaluate the efficacy and safety of rusfertide in patients with PV and elevated (>48 %) baseline hematocrit. Patients were treated with 40 mg subcutaneous rusfertide twice weekly until their hematocrit reached < 45 %; once achieved, patients received weekly rusfertide dosing. Of the 20 patients enrolled, 15 (75 %) completed 24 weeks of treatment, 13 (65 %) completed 52 weeks, and 7 discontinued rusfertide therapy. Mean baseline hematocrit was 51.6 %. By Week 8, 17 (85 %) patients achieved hematocrit < 45 %, and 19 (95 %) achieved ≥ 5 % absolute reduction from baseline. Median time to first hematocrit < 45 % was 4.9 weeks. Mean hematocrit was < 45 % at Week 4 and subsequently remained < 45 % throughout the study. No patients received phlebotomy during rusfertide treatment. Rusfertide led to a significant reduction in erythrocyte count (5.98 ×10¹²/L to 4.79 ×10¹²/L; nominal p-value 0.0036) and an improvement in iron deficiency markers (eg, ferritin and mean corpuscular volume) relative to baseline. Seventeen patients (85 %) experienced treatment-emergent adverse events, most of which were Grade 1/2. In this open-label phase 2 study, rusfertide resulted in a rapid and sustained improvement in hematocrit and was generally well tolerated. Rapid and sustained control of hematocrit reduces the need for therapeutic phlebotomy and may help reduce thrombotic and cardiovascular events over the long term in patients with PV.

2025-11-01·CLINICAL THERAPEUTICS

Evaluation of Rusfertide, a Hepcidin Mimetic, on Cardiac Repolarization: A Randomized, Placebo- and Positive-Controlled Crossover Thorough QT Study in Healthy Participants

Article

作者: Modi, Nishit B ; Darpo, Borje ; Dinh, Phillip ; Xue, Hongqi

PURPOSE:

Rusfertide, a hepcidin mimetic, is in clinical development for the treatment of polycythemia vera. This study evaluated the effect of rusfertide on cardiac repolarization.

METHODS:

A positive-controlled, randomized, double-blind, crossover study was conducted in healthy adults. Subjects received subcutaneous rusfertide 90 mg, matching subcutaneous placebo, and oral moxifloxacin. Subjects underwent continuous 12-lead Holter recording during each period. A central laboratory extracted up to 10 replicate electrocardiograms (ECGs) at each time point prior to and following treatment, paired with pharmacokinetic sampling. The primary analysis for Fridericia corrected QT interval (QTcF) was a mixed model for repeated measures with change from baseline QTcF (ΔQTcF) as the dependent variable; period, sequence, time, treatment, and time-by-treatment interaction as fixed effects; and baseline QTcF as a covariate. The relationship between rusfertide and metabolite concentrations and change-from-baseline QTcF was quantified using linear mixed-effects modeling.

FINDINGS:

Mean age and body mass index were 40.1 years and 25.4 mg/m², respectively, with a slight majority of female (57%) and White (60%) subjects. Mean rusfertide plasma concentrations increased rapidly, with median peak of 4 hours. The geometric mean rusfertide peak concentration (C_max) was 1100 ng/mL. Rusfertide did not have a clinically relevant effect on heart rate (HR) or cardiac conduction (PR and QRS interval). The least squares (LS) mean ΔQTcF on rusfertide closely followed the placebo pattern, and LS mean placebo-corrected ΔQTcF (ΔΔQTcF) varied from -2.0 to 1.8 ms. After 400 mg oral moxifloxacin, an increase of LS mean ΔΔQTcF was observed with a peak of 12.4, 12.4, and 11.2 ms at 2, 3, and 4 hours, respectively, with all three lower bounds of the 2-sided 90% confidence interval greater than 5 ms. Estimated population slope of the rusfertide concentration-QTc relationship was not statistically significant: 0.00042 ms per ng/mL (90% confidence interval [CI]: -0.001172 to 0.002013; P = 0.6624). Predicted ΔΔQTcF at the geometric mean C_max was 0.04 ms (90% CI: -1.21 to 1.29). Overall, 24 of 60 subjects (40.0%) experienced treatment-emergent adverse events (TEAEs). All TEAEs were mild. TEAEs noted in ≥5% subjects were headache, nausea, injection site erythema, injection site pain, and influenza-like illness. There were no clinically significant changes in clinical laboratory, vital signs, ECG, or physical examination findings.

IMPLICATIONS:

Rusfertide had no clinically relevant effect on HR, cardiac conduction, or QTc. Rusfertide was well tolerated. An effect on ΔΔQTcF exceeding 10 ms could be excluded within the observed rusfertide plasma concentrations up to approximately 2130 ng/mL.

2025-04-01·Clinical Pharmacology in Drug Development

Multiple‐Dose Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Subcutaneous Rusfertide, a Hepcidin Mimetic, in Healthy Subjects

Article

作者: Ifode Ajari ; Nishit B. Modi ; Phillip Dinh

Abstract:

Rusfertide, a peptide hepcidin mimetic, has shown efficacy in polycythemia vera. This trial investigated the multiple‐dose pharmacokinetics, pharmacodynamics, and safety of once‐weekly rusfertide 60 mg for 5 weeks in healthy subjects. Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh. Eighteen subjects were enrolled, and 15 completed the study. Geometric mean peak rusfertide plasma concentrations (Cmax) following the first dose were 547, 387, and 560 ng/mL following injection in the abdomen, thigh, and arm, respectively (P = .0054). There was no difference between injection sites in the rusfertide area under the plasma concentration‐time curve (AUC) following the first dose (P ≥ .179) or in the Cmax or AUC during the dosing interval following the last dose (P ≥ .238). Geometric mean accumulation (Dose 5/Dose 1) for AUC and Cmax was 1.5 and 1.2, respectively, and similar across injection sites. Mechanism‐based decreases in serum iron, transferrin‐iron saturation, hemoglobin, and hematocrit were noted following multiple doses. There were no differences between injection sites in the pharmacodynamic effect as measured by change from baseline in hematocrit values. There were no serious adverse events. Treatment‐emergent adverse events in 2 or more subjects were injection‐site reactions (erythema, induration, pruritus), fatigue, and headache. There were no clinically relevant findings in the safety laboratory parameters, vital signs, electrocardiograms, or physical examination. While a higher incidence of treatment‐emergent adverse events was noted in these healthy participants following multiple doses of 60 mg, rusfertide was generally well tolerated. There were no clinically meaningful differences in rusfertide pharmacokinetics or pharmacodynamics between injection sites.

251

项与 Rusfertide acetate 相关的新闻（医药）

2026-03-31

·药时代

裁员600多人！武田又一轮大规模裁员开始……

合作机会来了！药时代BD团队现有优质项目：具有三重作用的口服小分子 11β-HSD1抑制剂，适应症覆盖MASH,IPF，间质性肺病（PF-ILD），放射性肺纤维化（RIPF）等领域。MASH适应症IIa期已完成，观察到强有力的疗效信号及良好的安全性；IPF适应症处于IND ready阶段。请感兴趣的公司立即联系：药时代BD团队 BD@drugtimes.cn 备注项目代号：DT-20260325-122 正文共：575字预计阅读时间：3分钟 2026年3月25日，日本制药巨头武田制药（Takeda）董事会正式批准新一轮转型计划，尽管公司公告中未明确披露具体裁员人数，但“精简企业职能”“简化流程”等表述，标志着其全球范围内的大规模人员优化正式启动。来源：武田根据该公司向马萨诸塞州提交的《工人调整与再培训通知》（WARN）文件显示，其位于马萨诸塞州剑桥市的美国总部约634个岗位受到影响，其中包括目前在该州的247个职位，以及其他州的387个职位。不过武田在通知中表示，受影响的总人数可能会发生变化，员工可争取在全球范围内接受调岗机会。来源：Biospace 武田指出，此次重组包括“战略性资源优先配置”，预计到2028财年将节省超过2000亿日元（约合12.5亿美元）。公司解释称，这些节省下来的巨额资金并非单纯为了缩减开支，而是将被重新分配，主要用于抵消多款新药上市准备所需的投入。武田正摩拳擦掌准备推出多款新产品，包括用于治疗发作性睡病的oveporexton、治疗罕见血液病真性红细胞增多症的注射液rusfertide，以及旨在对抗百时美施贵宝Sotyktu的TYK2竞争对手zasocitinib。同时推动后期管线进展，并进行战略性技术投资。此次裁员是武田近两年来一系列人员调整的延续。2024年至2025年初，公司已在美国和奥地利裁减近1500名员工；2025年10月，再度裁减137人；今年1月，又有消息显示其美国业务将裁减243个岗位。这一系列调整的背后，既受到重磅药物专利悬崖的持续施压，也反映出企业向技术驱动型转型的迫切需求，同时折射出全球医药行业结构性变革的困境。参考资料： 1.https://www.takeda.com/newsroom/newsreleases/2026/takeda-transformation-strengthen-competitiveness-future-growth/ 2.https://www.biospace.com/job-trends/takeda-restructuring-could-push-more-than-600-us-staffers-out-of-jobs 3.其他公开资料封面图来源：药时代破局三十载垄断：国产内镜从“跟随者”到“定义者” 2026-03-27 沙利文发布《2026全球抗体药物行业发展蓝皮书》（内附全文获取方式） 2026-03-26 不止66.666亿：复宏汉霖公布2025财报，剑指C-MNC 2026-03-23 版权声明/免责声明本文为汇编文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击查看更多精彩内容！

财报高管变更优先审批临床申请申请上市

2026-03-30

·BioSpace

Protagonist Announces Presentation of One-Year Phase 3 Data for ICOTYDE(TM) in Moderate-to-Severe Plaque Psoriasis at the 2026 American Academy of Dermatology (AAD) Annual Meeting

One-year Phase 3 data for ICOTYDE to be presented at AAD 2026 demonstrate lasting skin clearance and a favorable safety pro a once daily pill for moderate-to-severe plaque psoriasis Results further support the differentiated pro ICOTYDE, the first and only IL-23 receptor targeted oral peptide NEWARK, CA / ACCESS Newswire / March 28, 2026 / Protagonist Therapeutics, Inc. (Nasdaq:PTGX) ("Protagonist" or "the Company") today announced new one-year Phase 3 results for ICOTYDE ™ (icotrokinra) were presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting. Data from the Phase 3 ICONIC-ADVANCE 1 and 2 and ICONIC-LEAD studies further support the potential of ICOTYDE as a differentiated oral therapy for patients with moderate-to-severe plaque psoriasis. "The one-year Phase 3 results presented at AAD reinforce our belief that ICOTYDE by virtue of having IL-23 antagonist efficacy, a favorable safety pro the convenience of a once-daily oral pill option, has the potential to meaningfully expand treatment options for people living with moderate-to-severe plaque psoriasis," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of Protagonist Therapeutics . "These findings highlight the power of Protagonist's peptide discovery platform and our ability to create highly differentiated oral medicines against clinically validated biological pathways." ICOTYDE is the first and only targeted oral peptide designed to precisely block the IL-23 receptor, which underpins the inflammatory response in moderate-to-severe plaque PsO. ICOTYDE was developed using Protagonist's proprietary peptide technology platform. The Company continues to invest in its discovery engine and development pipeline, with multiple programs moving towards proof-of-concept trials designed to produce therapeutics with clinically relevant competitive differentiation. Under the license and collaboration agreement established in 2017 between Protagonist and Janssen Biotech, Inc., a Johnson & Johnson company, Johnson & Johnson is responsible for all commercial activities for ICOTYDE. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further development and commercialization. ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2 ICOTYDE demonstrated durable rates of complete skin clearance through Week 52 with no new safety signals identified. Rates of PASI 100 increased from Week 24 to Week 52 in the ICOTYDE treatment arms, and patients who switched from placebo to ICOTYDE at Week 16 achieved similar rates of complete skin clearance by Week 52 as those treated with ICOTYDE continuously for 52 weeks. The ICOTYDE adverse event pro Week 52 was consistent with that observed through Weeks 16 and 24, and no new safety signal was identified through Week 52. ICOTYDE overall adverse event and infection rates were lower than deucravacitinib through Week 24. ICONIC-LEAD ICOTYDE also demonstrated sustained efficacy and a favorable safety pro adolescents through Week 52. Nearly 60% of adolescents treated with ICOTYDE achieved completely clear skin at one year, and 86% achieved PASI 90 , with 92% maintaining that response from Week 24 to Week 52. No new safety signals were identified over one year of treatment. The pivotal ICONIC Phase 3 clinical development program includes five studies in plaque psoriasis: ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, ICONIC-ADVANCE 2, and ICONIC-ASCEND. Additional studies are also underway in psoriatic arthritis, ulcerative colitis, and Crohn's disease. Under Protagonist's collaboration agreement with Johnson & Johnson, the Company is eligible to receive tiered royalties on net sales of ICOTYDE and additional future milestone payments. Protagonist believes the continued advancement of ICOTYDE highlights the strength of its oral peptide platform and its strategy of creating potentially best-in-class medicines through internal innovation and strategic partnerships. About ICOTYDE ™ (icotrokinra) ICOTYDE (icotrokinra) is the first and only targeted oral peptide designed to precisely block the IL-23 receptor, which underpins the inflammatory response in moderate-to-severe plaque PsO. ICOTYDE binds to the IL-23 receptor with high affinity and demonstrated potent inhibition of IL-23 signaling in human T cells. Clinical significance of these findings are unknown. ICOTYDE is currently approved in the U.S. for the treatment of adults, and pediatric patients 12 years of age and older who weigh at least 40 kg, with moderate-to-severe plaque PsO who are candidates for systemic therapy or phototherapy. Patients on ICOTYDE take one pill, once a day with water upon waking, 30 minutes prior to eating food. ICOTYDE is also currently in Phase 3 studies for active psoriatic arthritis, moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists and is being developed and commercialized by Johnson & Johnson. The approval of ICOTYDE triggers a $50 million milestone payment to Protagonist. Protagonist is also eligible for 6 - 10% upward tiering royalties on worldwide net sales, as well as additional regulatory and sales milestone payments of up to $580 million. About Plaque Psoriasis Plaque psoriasis (PsO) is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful. It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease. Nearly one-quarter of all people with plaque PsO have cases that are considered moderate-to-severe. On Caucasian skin, plaques typically appear as raised, red patches covered with a silvery white buildup of dead skin cells or scale. On skin of color, the plaques may appear darker and thicker, and more of a purple, gray, or dark brown color. Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso. Living with plaque PsO can be a challenge and impact life beyond a person's physical health, including emotional health, relationships, and handling the stressors of life. Psoriasis on highly visible areas of the body or sensitive skin, such as the scalp, hands, feet, and genitals, can have an increased negative impact on quality of life. About Protagonist Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. The Company's proprietary peptide technology platform enables de novo discovery of peptide therapeutics . Two novel peptides derived from Protagonist's proprietary discovery platform are at or near commercialization. ICOTYDE ™ (icotrokinra) is approved in the U.S. for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor (IL-23R) licensed to Janssen Biotech, Inc., a Johnson & Johnson company. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further development and commercialization. An NDA for rusfertide, a first-in-class hepcidin mimetic peptide that is being co-developed with Takeda Pharmaceuticals pursuant to a worldwide license and collaboration agreement entered in 2024, is under priority review with the FDA. Protagonist holds an option to co-commercialize rusfertide in the U.S. through a 50/50 profit and loss share structure or can opt-out of this structure. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs. More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at . Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of ICOTYDE and potential revenue from the Company's collaboration with Johnson & Johnson. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of this press release. Investor Relations Contact Corey Davis, Ph.D. LifeSci Advisors cdavis@lifesciadvisors.com +1 212 915 2577 Media Relations Contact Virginia Amann ENTENTE Network of Companies virginiaamann@ententeinc.com +1 833 500 0061 ext 1 ICOTYDE ™ INDICATION AND IMPORTANT SAFETY INFORMATION What is the most important information I should know about ICOTYDE? Infections . Medicines that interact with the immune system, such as ICOTYDE, may lower your ability to fight infections and may increase your risk of infections. Your healthcare provider may check you for infections and tuberculosis (TB) before starting treatment and may treat you for TB before you begin treatment with ICOTYDE if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with ICOTYDE. Tell your healthcare provider right away if you have any infection or have symptoms of an infection, including: fever, sweat, or chills cough shortness of breath blood in your mucus (phlegm) muscle aches warm, red, or painful skin or sores on your body different from your psoriasis weight loss diarrhea or stomach pain burning when you urinate or urinating more often than normal Before taking ICOTYDE, tell your healthcare provider about all of your medical conditions, including if you: have an infection that does not go away or that keeps coming back. have tuberculosis (TB) or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). Avoid receiving live vaccines during treatment with ICOTYDE. have kidney problems. are pregnant or plan to become pregnant. It is not known if ICOTYDE can harm your unborn baby. Pregnancy Safety Study. There is a pregnancy safety study for women who take ICOTYDE during pregnancy. The purpose of this study is to collect information about the health of you and your baby. If you are pregnant or become pregnant during treatment with ICOTYDE, you can report your pregnancy by calling 1-800-526-7736 or visiting . are breastfeeding or plan to breastfeed. It is not known if ICOTYDE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ICOTYDE. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of ICOTYDE? ICOTYDE may cause serious side effects. See "What is the most important information I should know about ICOTYDE?" The most common side effects of ICOTYDE include: headache nausea cough fungal infection tiredness These are not all the possible side effects of ICOTYDE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. How should I take ICOTYDE? Take ICOTYDE exactly as your healthcare provider tells you to take it. Take ICOTYDE 1 time a day when you wake up on an empty stomach with water. Wait at least 30 minutes after taking ICOTYDE before eating food. If you have difficulty swallowing tablets, ICOTYDE can be dispersed in water. For more information, please read the Medication Guide . If you miss a dose of ICOTYDE, take the dose as soon as you remember and go back to your regular schedule the next day. Please read the full Prescribing Information , including Medication Guide , for ICOTYDE and discuss any questions that you have with your doctor. SOURCE: Protagonist Therapeutics View the original press release on ACCESS Newswire

临床3期临床结果引进/卖出

2026-03-26

·药圈俱乐部

武田可能也要大裁员了

2026年3月25日，日本制药巨头武田制药（Takeda）董事会正式敲定转型下一步实施方案，核心目标聚焦于强化核心竞争力、改善长期增长动能，并加速新产品上市进程，为企业下一阶段的发展奠定基础。尽管官方公告未明确披露具体裁员规模，但从计划内容来看，此次转型将通过精简企业职能体系、推动管理层级扁平化、拉近团队与患者及客户的距离，同时借助先进技术优化业务流程，以此实现效率升级——这一过程中，人员结构与组织架构的优化的调整将成为重要支撑。此次重组的核心量化目标十分清晰：截至2028财年，武田制药将实现每年超过2000亿日元（约合12.6亿美元）的年度总节省额。值得注意的是，这笔节省的资金并非单纯用于压缩开支、改善短期财务数据，而是将进行战略性重新分配，重点投向新药上市筹备相关的各项投资，为企业长期增长注入动力。目前，武田制药正全力推进多款重点新药的上市筹备工作，此次节省的资金将重点保障这些产品的落地。其中包括用于治疗发作性睡病的oveporexton、针对罕见血液病真性红细胞增多症的注射剂rusfertide，以及一款TYK2抑制剂zasocitinib——该药物将直接对标百时美施贵宝的明星产品Sotyktu，有望在相关治疗领域形成差异化竞争优势。此外，资金还将用于推进后期研发管线的推进，以及支持战略性技术投资，进一步夯实企业的研发实力。将于2026年6月正式接任武田制药首席执行官的Julie Kim对此表示，此次转型举措是武田为更大程度影响患者生活、实现高质量发展的重要布局，这些经过深思熟虑的调整，将有效增强公司的快速执行能力，同时通过战略层面的资源优先分配，精准定位下一个发展阶段的长期增长与成功方向。大规模转型必然伴随阵痛期成本的投入。武田制药目前预计，2026财年将产生约1500亿日元（约合9.4亿美元）的重组相关费用，后续在2027财年、2028财年还将产生金额相对较低的遣散与分离成本。据悉，这些重组费用将纳入公司2026财年的合并财务预测，不会对2025财年的全年合并财务预测造成重大影响，而武田制药计划于5月13日正式公布2025财年的全年业绩数据。此次3月公布的新举措，并非孤立的转型动作，而是武田制药在2026年1月公布的新业务架构基础上，转型进程的进一步延续，且将于2026年4月武田制药2026财年启动时正式生效。在今年1月的架构调整中，武田制药已做出关键布局：设立国际业务部门，统一管理除美国以外的所有海外市场，整合以往分散的商业团队，实现海外市场运营的集约化；同时成立战略和投资组合开发职能部门，统筹所有相关的投资组合战略制定与业务拓展事宜，提升资源利用效率。回溯来看，武田制药的这一系列组织架构革新，最早可追溯至2024年5月公布的一项改革计划，当时的核心目标是将公司的营业利润率提升至30%以上。促使武田制药启动重组模式的关键诱因，是其重磅多动症药物Vyvanse在专利到期后，收入出现快速下滑，对公司整体营收造成显著冲击。在2024年启动的首轮重组中，武田制药在截至2025年3月的财年内，累计记录了1280亿日元（约合8亿美元）的重组成本，并裁减了超过1800名全职员工，占当时员工总数的3.7%，其核心方向便是简化组织架构、减少管理层级、优化运营模式，实现降本增效。武田制药的“精简转型”之路，并非行业个例。当前，全球制药行业正面临高达3000亿美元的“专利悬崖”逼近压力，为应对这一挑战，诺华、拜耳、辉瑞、百时美施贵宝、默沙东等全球知名制药巨头，均纷纷推出类似的成本削减与组织重组措施。据相关数据分析显示，仅2025年一年，全球年收入超过200亿美元的大型制药企业，就已集体裁减了超过2.2万名员工，降本增效、聚焦核心业务，已成为全球药企应对行业挑战、实现可持续发展的共同选择。地点时间（点击↓链接阅读全文）特惠永久有效【特惠】近200场经验分享录播视频，等你来拿咨询内训永久有效上百名行业资深一线专家，现场一对一指导线上直播 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2022生物制品原液制备GMP管理及符合性检查要点解析和原液工艺验证”专题培训班回放38 2022原料药注册国际法规解读及DMF和CEP文件编写高频缺陷案例解析回放39 今日免费直播课 | ich Q14回放40 2022集采时代的高效药物研发质量管理（暨研发质量管理人员职业生涯规划与能力提升）回放41 新项目立项前调研、评估的重要意义回放42 线上-双抗及多抗新药开发要点及申报策略专题回放43 生物制剂开发策略和IND及临床阶段实施注意事项高级研修班回放44 统计学工具在研发注册、分析方法开发、项目管理及分析评价中的应用回放45 IND注册申请准备工作流程回放46 CAR-T细胞生产工艺优化及合规制备要点回放47 溶瘤病毒工艺开发、质量控制及申报全流程回放48 2022基于化学创新药案例的药物分析人员关键岗位技能提升专题回放49 干细胞制剂临床研究与风险质量控制专题回放50 MAH制度下CMO/CDMO企业如何做好药品研发生产的质量保障、安全及监管合规要求回放51 推荐|新药临床前安全性评价实操专题腾讯会议送回放资料回放52 2022最新细胞治疗产品GMP指南落地实施专题回放53 药品研发质量管理体系构建与执行及项目管理实例分享交流会回放54 2022医药BD与立项的实用基础与全面进阶专题回放55 制药企业高标准的GMP管理体系的搭建、改善及重点实践案例解析回放56 2023多功能原料药车间设计与改造回放57 细胞灌流培养工艺关键点及生物制品工艺表征实战经验分享回放56 符合ICH指导原则的质量标准建立与分析方法策略实施回放57 2023药企合规性自检内审专管人员内部检查技巧实战应用回放58 “2023从研发到临床GMP实施要点”专题培训班的通知回放59 2023稳定细胞株构建与上游工艺技术及实现专题回放60 2023药品研发项目管理全流程实施专题回放61 双抗类药物安全性评价与药代动力学研究专题培训回放62 抗肿瘤双抗开发及申报要点回放63 2023 中美欧生物制品注册递交全流程及资料准备与案例分析专题回放64 AAV基因治疗产品非临床评价研究策略专题培训回放65 实操||药品注册电子申报实操演练及CTD撰写回放66 2023细胞治疗产品开发全流程及申报审评要点专题回放67 【北京】生物药申报资料CTD准备全流程实操演练回放68 DoE实验室管理设计回放69 2023细胞治疗产品全过程质控体系建立与实施专题回放70 2023药品注册专员能力提升及经典案例详解回放71 2023原料药国际注册DMF、ASMF和CEP文件编写最新要求和案例解析回放72 生物制药下游纯化工艺开发、放大及工艺验证和应用实战经验分享回放73 ICH M10《生物样品分析方法验证》解读与实践回放74 2023 mRNA新药研发、生产技术及质控要点专题回放75 药品污染控制策略（CCS）建立与执行策略详解回放76 “GLP实验室质量体系建设专题培训班”的通知回放77 最新中美生物制品原液制备GMP管理及FDA的CGMP符合性7356.002标准检查要点回放78 2023临床试验数据管理实操培训班回放79 2023细胞治疗注册临床与IIT研究全流程案例介绍及临床科研新方向解析专题回放80 2023干细胞与免疫细胞治疗产品非临床评价策略和考虑要点专题回放81 2023新版GMP指南全方位解析及案例分析专题回放82 如何构建研发管理体系中的QA组织主题培训回放83 “2023重组蛋白生物药发酵工艺开发及中试放大技术专题培训班”的回放84 冻干产品配方研发及工艺流程案例解析回放85 2023mRNA疫苗开发、技术转移及IND申请专题回放86 2023 CHO细胞株构建与上游工艺开发、放大与表征专题回放87 化药注册法规要求与IND到NDA注册策略及申报资料撰写演练案例分析回放88 2023原料药工艺研究关键点及研究策略专题回放89 “2023GLP实验室质量体系建设及认证检查全流程专题培训班”的通知回放90 化药注册法规要求与IND到NDA注册策略及申报资料撰写演练案例分析回放91 2023新版GMP指南全面解读和重点内容解读回放92 2023原料药工艺研究关键点及研究策略专题回放93 细胞治疗产品从IND到BLA全流程梳理和各申报阶段细节分析回放94 2023细胞治疗产品质控体系建立、实施与分析方法开发及验证专题回放95 2023药物非临床安全性评价专题负责人（SD）高级研修班回放96 化药分析方法开发全流程实例分析回放97 2023ADC药物IND申报经验分享回放98 张长风||细胞治疗产品注册临床与IIT研究新政策落地介绍及分析回放99 多人听课有证书【线上】2023临床试验数据管理培训班回100 GMP检查法规全梳理及迎检准备实战攻略回101 药物晶型研究案例分析9月21-23日回102 研发QA与生产QA的区别回103 2023药物非临床安全性评价项目负责人高级研修班回104 2023 研发中各阶段原料药工艺开发案例分析专题回105 非临床药效学评价整体策略（创新药药效的试验设计及动物模型）专题培训回106 关于举办“MAH(许可持有人)质量体系合规性重点及110项现场核查缺陷项案例详解高级研修班”的通知回107 医学监查的高效管理与实施要点案例分析及实操回108 2023注册经理能力全面提升实战回109 2023研发质量管理体系不同阶段全框架梳理建立、难点实施、案例分析回110 2023细胞治疗产品技术转移、工艺变更和工艺验证专题回111 线上-关于举办“蛋白纯化工艺开发及放大要点与工艺验证和保存稳定性策略与应用高级研修班”的通知回112 2023临床前药代动力学研究策略回113 2023质量负责人/质量受权人（QP）高级课程回114 【线上直播】2023抗体类药物制剂开发全流程精讲培训班回115 B证许可持有人（MAH）重点实操流程及210项省局现场检查缺陷项解读回116 2023定量药理模型构建与质控及在新药研发中应用案例分析回117 2022细胞与基因治疗病毒载体工艺开发和质量控制要点及法规解读回118 最新生物制品原液GMP管理及现场检查要点解析和原液工艺验证关键点回119 热点||小核酸药物研发要点及注册申报回120 2024欧盟原料药注册法规和GMP检查细节专题回121 2024重组蛋白生物药发酵工艺开发设计、放大策略及关键点应用专题回122 药品研发质量管理体系七大模块从建立到落地实施回123 制剂国际化（美国、欧盟）注册申报和GMP迎检准备高级研讨班回124 实验动物管理与药物安全性评价策略专题培训班回125 化药工艺开发CQA及CPP评估实操演练回126 临床试验数据管理及相关法规介绍回127 2024细胞治疗产品生产工艺优化及合规制备与质控要点专题回128 “2024群体药动学-药效学基础（NONMEM软件）实操培训班”回129 化药新药药学注册申报要求与核查、检验及临床变更策略回130 干细胞及免疫细胞研发要点及注册申报策略回131 2024药物晶型和制剂研究案例分析专题回132 ADC药物IND申报要点与非临床设计及研究策略案例分析回133 研发QA技能全方位提升及竞争力打造专题回134 2024药物非临床安全性评价质量保证（QAU）专题回135 临床试验质量管理体系和新法规下的医学稽查技能提升回136 2024重组蛋白生物药发酵工艺：从高表达系统到小试中试及放大工艺开发回137 新药临床前药效、药代、毒理及临床药理一站式培训——“高性价比路径” 回138 2024细胞治疗IIT临床研究政策落地实施及其开展的全流程解析回139 2024生物制品原液GMP管理及各国检查要点解析和原液工艺验证/持续性工艺验证实战回140 药品申报资料CTD准备全流程及电子递交实操演练回141 2024化学原料药选题立项与合成工艺技术开发回142 贺博士对化药、生物药、CGT、ADC等多品类药物非临床研究系统培训回143 如何科学高效建立药物质量控制的分析方法及典型案例分享回144 李敬来-新药注册的生物分析与创新药、改良药注册非临床药代动力学评价培训回145 清洁方法设计开发及验证实施要点与实例分析回146 2024高表达稳定细胞株开发和高效工艺优化策略及上游工艺表征实战经验培训回147 最新《Q2（R2）：分析方法验证》《Q14：分析方法开发》回148 2024新药开发中的非临床药理毒理研究策略及案例分享回149 2024小核酸药物分子的设计与开发回150 2024临床试验设计与样本量计算关键技术回151 2024生物制品原液GMP管理及各国检查要点解析和原液工艺验证/持续性工艺验证实战回152 2024原料药药学审评与现场检查中常见问题分析回153 ADC临床前研究、模型评价及转化医学专题回154 化学药品注册报批的药学资料编制（原料药与制剂）实例分享回155 线上直播-化学仿制药案例的药物分析人员关键技能提升回156 临床期间生物制品药学变更策略与落地执行及案例分析回157 2024发酵原料药的制备工艺与固定化酶催化工程研究专题回158 2024年最新出海路径和WHO PQ 全流程指导！回159 杂质控制策略与杂质分析方法开发！回160 稳定细胞株构建与上游工艺技术及实现案例分析回161 药厂工程及设备的项目建设、运行管理及GMP相关系统管理回162 2024发酵培养基设计优化与新型碳源、氮源开发应用研讨班” 回163 新药的供试品管理、生物样本分析、毒代动力学研究回164 2024年最新出海路径和WHO PQ 全流程指导！回165 关于举办“发酵工艺设计优化：从小试到中试放大关键技术专题研讨班”的通知回166 2024结晶技术创新与过程强化研讨班回167 药品出海新兴市场注册策略（巴基斯坦、俄罗斯、哈萨克斯坦及巴西）全流程指导回168 研发QA与生产QA的区别回169 2025连续流动化学工艺开发及绿色工艺新技术装备应用论坛回170 合成生物发酵工程工艺设计与设备设施改造及案例分享回171 原料药与仿制药的欧美注册申请及注册现场核查、审计要点回172 【保证质量】2025 药品出海新兴市场（尼日利亚、南非、埃及、巴基斯坦、孟加拉国）路线规划及注册流程指导回173 2025药品研发质量体系构建和执行在新药研发各阶段实践案例分析专题回174 2025药品研发质量体系构建和执行在新药研发各阶段实践案例分析专题回175 2025冻干制品的配方和工艺开发与工艺流程设计和过程控制要点回176 基于ICH相关指导原则的2025版药典新增修订全面解析回177 药物非临床GLP及临床前安评指导原则和案例讲解专题回178 抗体药物靶点立项、分子发现和药物结构设计回179 DOE在原料药工艺设计和工艺研发中的应用专题回180 核酸药物IND到BLA/NDA--从法规到技术要点的全生命周期回181 马璟博士||生物制品非临床研究的关注点及案例分享回182 2025细胞与基因治疗产品CGT申报的成功注册之路与案例分享回183 人工智能（AI）如何赋能药品注册事务：AI相关法规以及典型应用场景和相关工具回184 2025如何构建研发管理体系中的QA组织及实施专题回185 工业级稳定细胞株开发的全流程技术要点与GMP合规要求回186 2025新兴市场（东南亚及港澳）药品注册全流程解析与案例实战专题回187 如何做好新药研发项目经理回188 2025药品注册专员核心能力提升专题回189 MAH委托生产及委托检验全生命周期合规管理回190 DOE在制剂工艺设计与研发中的应用操作回191 生物药在俄罗斯、中东、非洲及巴西注册的法规详解与路径全流程回192 药品注册专员-海外市场回193 GLP机构质量体系全方位提升及合规管理专题回194 体内CAR-T治疗药品CMC关键难点突破与注册申报实战回195 2025版中国药典统计分析指导原则深度解析回196 冻干制剂工艺设计、工艺开发及常见问题应对策略回197 2025 药品审评全周期沟通：从流程到 Pre-NDABLA 回198 2025版《中国药典》抗体药物偶联物（ADC）质量标准深度解读回199 新化学实体药物（NCE）非临床研究专题回200 最新细胞治疗IIT临床研究及运营案例分析回201 从候选分子到临床申报的生物制品成药性评估全流程回202 B证企业质量体系全面提升回203 新药毒代动力学与药代动力学试验设计策略与案例分析回204 从IND到NDA申报：小分子创新药关键质量属性研究与分析方法开发专题回205 首届AI+类器官：药物非临床研究技术进阶与实战回206 南美、西亚、中东及非洲国家药品注册策略和流程

100 项与 Rusfertide acetate 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12064	-	-	-

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
真性红细胞增多症	申请上市	美国	Takeda Pharmaceutical Co., Ltd.	2026-01-05
血色素沉着症	临床2期	美国	Protagonist Therapeutics, Inc.	2020-03-19
血色素沉着症	临床2期	加拿大	Protagonist Therapeutics, Inc.	2020-03-19
β地中海贫血	临床2期	美国	Protagonist Therapeutics, Inc.	2018-12-19
β地中海贫血	临床2期	希腊	Protagonist Therapeutics, Inc.	2018-12-19
β地中海贫血	临床2期	意大利	Protagonist Therapeutics, Inc.	2018-12-19
β地中海贫血	临床2期	黎巴嫩	Protagonist Therapeutics, Inc.	2018-12-19
β地中海贫血	临床2期	马来西亚	Protagonist Therapeutics, Inc.	2018-12-19
β地中海贫血	临床2期	泰国	Protagonist Therapeutics, Inc.	2018-12-19
β地中海贫血	临床2期	突尼斯	Protagonist Therapeutics, Inc.	2018-12-19

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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


NCT05210790 (VERIFY, ASH2025)	临床3期	真性红细胞增多症	293	Rusfertide	窪窪觸獵獵鹽鏇獵築觸(鏇壓廠製窪範選醖築淵) = 夢積網餘鹹獵鏇鹽構淵簾簾衊遞鏇廠壓積觸窪 (蓋鏇鹹選餘鑰願夢鏇衊 )	积极	2025-12-06
				Placebo	餘鏇範憲繭鹹憲觸襯構(築鏇鬱顧夢願鬱夢遞鏇) = 鹹壓醖蓋選蓋繭鬱艱衊廠積簾夢鏇衊鑰憲鬱願 (繭鹽願獵願鬱構壓廠網 ) 更多
NCT06033586 (THRIVE, ASH2025)	临床2期	真性红细胞增多症	46	Rusfertide	窪鹹窪獵糧淵繭顧衊淵(憲廠願廠襯願淵淵築鏇) = the most common AEs in the pts who participated in REVIVE and THRIVE were Grade 1-2 injection site reactions (87%), fatigue (59%), COVID-19 (50%), pruritus (44%), arthralgia (39%), dizziness (35%), anemia (30%), paresthesia (28%), headache (26%), abdominal pain and nausea (24% each), and diarrhea, dyspnea, and upper respiratory tract infection (22% each). 淵觸簾夢願製築艱簾積 (窪窪網構糧襯選窪鹹淵 ) 更多	积极	2025-12-06
NCT05210790 (VERIFY, BusinessWire) 人工标引	临床3期	真性红细胞增多症	293	Rusfertide	鹹觸鬱夢憲夢製憲壓膚(鑰壓醖糧鑰構憲鬱遞範) = 獵積築夢願淵繭觸顧構繭憲淵鏇獵蓋艱鏇選廠 (膚顧製蓋壓築衊夢製衊 ) 达到更多	积极	2025-03-03
				Placebo	鹹觸鬱夢憲夢製憲壓膚(鑰壓醖糧鑰構憲鬱遞範) = 艱觸鏇鹹築願網鑰憲艱繭憲淵鏇獵蓋艱鏇選廠 (膚顧製蓋壓築衊夢製衊 ) 达到更多
NCT04057040 (REVIVE, ASH2024) 人工标引	临床2期	真性红细胞增多症	70	rusfertide	鑰鬱夢壓積憲鹽選膚餘(選鏇鏇襯憲衊糧顧願窪) = The most common (≥20%) treatment-emergent adverse events (TEAEs) were injection site reactions (85.7%), fatigue (38.6%), COVID-19 (32.9%), pruritus (34.3%), arthralgia (30.0%), dizziness (30.0%), nausea (24.3%), headache (24.3%), and anemia (21.4%). 鬱遞鏇鑰衊廠鬱襯夢糧 (淵鬱醖餘願構繭顧鬱觸 )	积极	2024-12-09
NCT04057040 (REVIVE, EHA 12024 \| EHA 22024) 人工标引	临床2期	真性红细胞增多症	70	Rusfertide	鹹鹽鹽齋簾網淵襯選餘(願鹽窪窪簾積淵鏇構築) = Platelets increased by approximately 30% post-baseline within 4 weeks following initiation of rusfertide therapy 壓築觸構鹽構壓夢製積 (窪鏇窪鬱衊膚窪壓壓選 ) 更多	积极	2024-05-14
				Placebo
NCT04057040 (REVIVE, Literature) 人工标引	临床2期	真性红细胞增多症	70	Rusfertide	範觸糧醖襯繭網鏇鑰膚(鏇鹽簾鹽簾顧膚網鏇繭) = 選廠鹽夢鬱齋餘遞廠憲蓋積壓範遞憲壓遞膚選 (鬱觸鹹積製膚淵醖衊鬱 ) 达到	积极	2024-02-22
NCT04767802 (PACIFIC \| REVIVE, Biospace) 人工标引	临床2期	真性红细胞增多症	70	Rusfertide	憲鏇簾製鹹齋廠廠蓋範(蓋願廠糧繭廠觸簾壓簾) = 餘蓋膚膚齋夢選簾餘積築膚糧餘鬱繭鏇鏇獵顧 (鬱窪醖顧選壓製膚觸繭 )	积极	2023-12-12
				Rusfertide	憲鏇簾製鹹齋廠廠蓋範(蓋願廠糧繭廠觸簾壓簾) = 鹹鬱顧憲艱蓋醖範艱築築膚糧餘鬱繭鏇鏇獵顧 (鬱窪醖顧選壓製膚觸繭 )
NCT04202965 (Pubmed \| Lancet Gastroenterol Hepatol)	临床2期	铁过剩	-	Rusfertide 10 mg	膚觸艱鹹窪鑰壓顧糧顧(鹽鑰範醖簾築繭構獵繭) = 12 (75%) patients had at least one TEAE, the most common of which was injection site pain (five [31%] patients). All TEAEs were mild or moderate in severity, except for a serious adverse event of pancreatic adenocarcinoma, which was considered severe and unrelated to treatment and was pre-existing and diagnosed 21 days after starting rusfertide treatment. 積淵築網衊繭夢廠觸襯 (淵廠窪繭觸糧襯鑰遞夢 )	-	2023-12-01
SOHO2023	N/A	真性红细胞增多症	-	Rusfertide	膚觸顧鹹築鹽製簾遞繭(窪網網鑰製齋蓋壓簾餘) = 83% of treatment-emergent adverse events (TEAEs) were grade 1-2, 17% were grade 3, with none grade 4 or 5. Most common TEAEs were localized grade 1-2 injection site reactions. 齋窪繭觸網餘願鑰鹽餘 (艱觸醖網構鹹艱顧餘壓 )	-	2023-09-01
				Placebo
NCT04202965 (CTgov)	临床2期	血色素沉着症	16	PTG-300	構蓋夢鏇構壓選憲獵鬱(鏇繭構艱鹽襯觸構構積) = 觸簾簾淵觸繭繭製鏇糧齋鑰衊鑰夢壓積鹹鏇簾 (選鏇選遞鹹憲構積齋醖, 19.4) 更多	-	2023-06-15