A Phase 1 Study of Repeat PET/CT Imaging in People With CAPS and Anakinra-Induced Amyloidosis Using Amyloid-Reactive Peptide 124I-AT-01 (124I-p5+14, Iodine-124I-Evuzamitide) to Measure Changes in Organ-Specific Amyloid Load

Background:
Anakinra is a drug used to treat people with certain diseases that affect their immune systems. Sometimes anakinra can cause proteins under the skin to clump together. These clumps are called amyloidosis; they can spread to other organs. The only way to diagnose amyloidosis is to remove a piece of tissue (biopsy). Researchers want to find a way to locate amyloidosis in internal organs using positron emission tomography (PET)/computed tomography (CT).
Objective:
To test a new tracer used during PET/CT scans in people with amyloidosis. A tracer is a radioactive dye injected into the body.
Eligibility:
Adults aged 18 years or older with amyloidosis from anakinra injections. They must be enrolled in NIH protocol 17-I-0016.
Design:
Participants will come to the clinic once every 6 months for 2 years. Each visit will be 1 day.
They will have a PET/CT scan with the new tracer at each visit: The tracer will be given through a tube attached to a needle inserted into a vein.
The PET/CT scanner is a machine shaped like a doughnut. Participants will lie still on a padded table. The table will move in and out of the machine. The scan takes about 1 hour.
Radiation from the tracer will remain in the body for 24 hours after each scan. Participants will need to follow rules to avoid exposing pets and other people.
Participants will collect a 24-hour urine sample before each visit. They will also have blood tests and a physical exam at each visit.
Participants will receive a follow-up phone call about 1 week after each visit.

开始日期2025-09-10

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT06907849

/ Enrolling by invitation临床2期IIT

PET/CT Imaging Of Subjects With Lumbar Spinal Stenosis Or Carpal Tunnel Syndrome Using Amyloid-Reactive Peptide 124I-Evuzamitide

This clinical trial will use the amyloid-binding radiotracer, 124I-evuzamitide, to potentially detect amyloid, in the heart and elsewhere, in patients who have a history of lumbar spinal stenosis and/or carpal tunnel syndrome.

开始日期2025-05-01

申办/合作机构

University of Tennessee

[+1]

ACTRN12624000755538

/ RecruitingN/A

Positron Emission Tomography with AT-01 to Diagnose and Monitor Amyloidosis: A Prospective Cohort Pilot Study in Adult Patients.

开始日期2025-02-24

申办/合作机构-

100 项与 Iodine (124I) evuzamitide 相关的临床结果

登录后查看更多信息

100 项与 Iodine (124I) evuzamitide 相关的转化医学

登录后查看更多信息

100 项与 Iodine (124I) evuzamitide 相关的专利（医药）

登录后查看更多信息

项与 Iodine (124I) evuzamitide 相关的文献（医药）

2025-09-01·JOURNAL OF NUCLEAR CARDIOLOGY

A tale of two tracers - Amyloid imaging with investigational radiotracers iodine (124I) evuzamitide and 99mTc-p5+14 (AT-05)

Review

作者: Kassira, Anne ; Wall, Jonathan S ; Kennel, Stephen J ; Guthrie, Spencer ; Stuckey, Alan ; Martin, Emily ; Whittle, Bryan

Systemic amyloidosis is a complex disorder, making early and accurate diagnosis challenging. The most common types are associated with misfolded transthyretin or immunoglobulin light chains, where cardiac and renal amyloidosis portend the worst prognosis. Peptide p5+14 can bind all types of amyloid via multivalent electrostatic interactions. When radiolabeled with either iodine-124 or technetium-99m, it can be used to detect cardiac and extracardiac amyloid deposits using PET/CT or SPECT/CT imaging, respectively. ¹²⁴I-p5+14 (¹²⁴I-evuzamitide) has been evaluated in eight investigator-initiated studies and is now in a pivotal Phase 3 study (REVEAL) for the detection of cardiac amyloidosis. Both radiotracers image cardiac ATTR and AL amyloid; however, due to the characteristics of the radionuclides, the images and image data are similar but uniquely different and complementary. Using data collected from the University of Tennessee Medical Center experiences, herein, we summarize and contrast characteristics of ¹²⁴I-evuzamitide and ^99mTc-p5+14 as radiotracers for amyloid detection.

2024-04-02·Amyloid : the international journal of experimental and clinical investigation : the official journal of the International Society of Amyloidosis

Longitudinal PET/CT imaging with iodine ( ¹²⁴ I) evuzamitide reveals organ response to plasma cell immunotherapy in a patient with AL amyloidosis

Article

作者: Guthrie, Spencer ; Martin, Emily B. ; Stuckey, Alan ; Raj, Renju ; Powell, Dustin ; Whittle, Bryan ; Wall, Jonathan S. ; Kennel, Stephen J. ; Lands, Ronald

"Longitudinal PET/CT imaging with iodine (124I) evuzamitide reveals organ response to plasma cell immunotherapy in a patient with AL amyloidosis." Amyloid, ahead-of-print(ahead-of-print), pp. 1–2 Disclosure statementEBM, AS and SJK are founders and owners of Attralus Inc. JSW is interim CSO, founder and owner of Attralus Inc. SG is COO, founder and owner of Attralus Inc, which holds the licence for 124I-p5 + 14. JSW and SJK are inventors and have patent rights in peptide p5 + 14. Attralus has licenced the 124I-p5 + 14 patent but was not involved in the discovery of the peptide nor the conception or design of this study.Additional informationFundingThis study was supported with services from the National Heart Lung and Blood Institute, National Institutes of Health, Department of Health and Human Services, through the Science Moving TowArds Research Translation and Therapy (SMARTT) program via the following contracts: HHSN268201600011C, HHSN268201600012C and HHSN268201600014C. Clinical studies were funded in part by Attralus, Inc and by contributions to the Amyloidosis and Cancer Theranostics Gift Fund (including CMC/Gerdau, Knoxville) that funded the study. We greatly appreciate the support of all the patients and their families who donated their time and resources to participate in the imaging studies.

2023-11-01·JACC. Cardiovascular imaging

Cardiac Amyloid Detection by PET/CT Imaging of Iodine (124I) Evuzamitide (124I-p5+14)

Article

作者: Williams, Angela D ; Guthrie, Spencer ; Stuckey, Alan ; Richey, Tina ; Foster, James S ; Ramchandren, Radhakrishnan ; Martin, Emily B ; Kennel, Stephen J ; Powell, Dustin ; Whittle, Bryan ; Wall, Jonathan S ; Lands, Ronald ; Heidel, R Eric

BACKGROUND:

The noninvasive detection of cardiac amyloid, as well as deposits in other vital organs, is critical for early diagnosis and quantitative disease monitoring. Positron emission tomography is an intrinsically quantitative imaging modality suitable for high-resolution amyloid detection.

OBJECTIVES:

This study sought to evaluate the safety and efficacy of a novel amyloid-reactive peptide, designated p5+14, labeled with iodine-124 (¹²⁴I), in patients with diverse types of systemic amyloidosis.

METHODS:

In a single-site, open label phase 1/2 study (NCT03678259), the safety, biodistribution, and sensitivity of a single intravenous infusion of ¹²⁴I-evuzamitide was assessed in patients with systemic amyloidosis (n = 50), asymptomatic transthyretin sequence variant carriers (n = 2), and healthy volunteers (n = 5). Subjects were administered 1.4 ± 0.2 mg of ¹²⁴I-evuzamitide (71.5 ± 12.4 MBq) and positron emission tomography/x-ray computed tomography images acquired at 5.2 hours (Q25-Q75: 4.9-5.4 hours) postinfusion. Images were assessed visually and semi-quantitatively for positive uptake of radiotracer in the heart and other major organs.

RESULTS:

Uptake of ¹²⁴I-evuzamitide in the heart and other abdominothoracic organs was consistent with the patient's clinical presentation and the type of amyloidosis. The patient- and cardiac-associated sensitivity for imaging and clinical observations was 93.6% (95% CI: 82.8%-97.8%) and 96.2% (95% CI: 81.8%-99.8%), respectively. Semi-quantitative uptake of the radiotracer correlated significantly with serum N-terminal pro-B-type natriuretic peptide measurements in patients with light chain-associated amyloidosis. Cardiac uptake was not observed in any healthy volunteers. The agent was well tolerated, with 1 drug-related adverse event and no deaths.

CONCLUSIONS:

¹²⁴I-evuzamitide is an amyloid-binding radiotracer capable of detecting cardiac amyloid in patients with high sensitivity.

项与 Iodine (124I) evuzamitide 相关的新闻（医药）

2026-01-16

·拜耳中国

拜耳进军分子影像领域，收购Attralus创新性泛淀粉样蛋白放射性示踪剂

拜耳通过收购Attralus公司的两种在研显像剂（AT-01和AT-05），增强其研发组合，推进心脏淀粉样变性的诊断；其中，正电子发射断层扫描（PET）示踪剂AT-01处于III期临床开发阶段，单光子发射计算机断层扫描（SPECT）示踪剂AT-05处于I期临床开发阶段，两者专门用于诊断心脏淀粉样变性以及其他类型的系统性淀粉样变性；这一举措，有望满足临床对这类常被漏诊疾病的早期精准诊断需求； AT-01（124-Iodine-evuzamitide）是首个获得美国食品药品监督管理局（FDA）突破性疗法认定的用于治疗心脏淀粉样变性的泛淀粉样蛋白显像剂，其还获得了美国和欧盟的孤儿药资格认定；拜耳拥有全面的影像诊断产品组合（包括分子影像领域的先进液体输送装置），通过进军诊断示踪剂领域，进一步巩固其在这一快速增长领域的发展决心，同时强化其在心血管精准医疗领域的地位； Attralus将专注于推进其创新的泛淀粉样蛋白清除疗法，旗下药物AT-02已进入II 期临床开发阶段，下一代候选药物正处于临床前开发阶段。影像诊断和心脏病学领域领导企业拜耳和专注于开发系统性淀粉样变性药物及诊断方法的临床阶段生物制药公司Attralus, Inc.（Attralus）近日宣布，双方已达成最终协议。拜耳将收购AT-01（124-Iodine-evuzamitide）和AT-05（PAR-Peptide+technetium-99m），这两种在研分子影像剂用于诊断心脏淀粉样变性。此次战略收购加强了拜耳在快速增长的分子影像领域发展的决心，同时助力了公司在精准心脏病学领域的发展。 Stefan Oelrich 拜耳集团管理委员会成员、拜耳处方药事业部全球总裁 “通过此次战略收购以及将新型分子示踪剂整合到研发管线，我们正在推进拜耳的创新战略。AT-01和AT-05经过精密设计，能够高精度地检测心脏淀粉样变性，从而实现及时干预并改善患者预后，突显了我们致力于攻克心血管疾病并满足重大未满足医疗需求的承诺。” 此次收购的分子影像产品组合包括处于III期临床开发阶段的AT-01（124-Iodine-evuzamitide，一种PET示踪剂）和处于I期临床开发阶段的AT-05（PAR-Peptide+technetium-99m，一种SPECT示踪剂），专注于心脏淀粉样变性的诊断。这些示踪剂的研发有望满足对系统性（尤其是心脏）淀粉样变性进行早期、精准诊断的迫切需求。心脏淀粉样变性是一种罕见且通常致命的心脏疾病，据估计全球约有40万人受其影响。目前，这些疾病常常被漏诊且难以检测。 Nelson Ambrogio 拜耳影像诊断业务全球总裁 “随着针对心脏淀粉样变性等治疗不足的疾病的新疗法不断涌现，在分子水平上精准检测和监测疾病变得日益重要。此次收购标志着我们正式进军诊断示踪剂领域。拜耳在核医学先进液体输送装置方面的研发管线和产品组合等医学影像领域拥有专长。在此基础上，此次收购将助力我们拓展在蓬勃发展的分子影像领域的决心。依托Attralus的研发实力，我们将进一步推进科学进步，拓宽诊断选择，为心脏淀粉样变性患者带来切实改变。” 2024年，全球放射性诊断示踪剂市场规模约为30亿美元，预计未来几年将显著增长。拜耳凭借其在影像诊断领域的全面产品组合、在医学影像和临床开发方面的专长以及全球商业能力，拥有独特的优势，能够加速创新，提供满足不断变化的临床需求的一体化解决方案，并有望改善全球患者的治疗效果。 Glen Firestone Attralus总裁 “我们很高兴与拜耳达成这项协议。拜耳在影像诊断领域的专长和全球布局将有助于加速AT-01和AT-05这两款新型系统性淀粉样变性诊断显像剂的研发和上市。尽管近年来系统性淀粉样变性治疗取得了进展，但大多数患者仍未确诊，或在病情发展到晚期才被确诊。秉承Attralus的使命，我们相信这些泛淀粉样蛋白显像剂将有助于更早地诊断和治疗，从而改善患者的预后。拜耳对科学严谨性和患者福祉的承诺，使其非常适合将这些药物带给全球的临床医生和患者。Attralus将专注于推进其创新的泛淀粉样蛋白清除疗法。目前AT-02已进入II期临床开发阶段，下一代候选药物也处于临床前开发阶段。” 此次收购的财务细节未予披露。关于拜耳拜耳作为一家跨国企业，在生命科学领域的医疗健康与农业方面具有核心竞争力。秉承“共享健康，消除饥饿”的使命，公司致力于通过产品和服务，帮助人们克服全球人口不断增长和老龄化带来的重大挑战，造福人类和地球繁荣发展。拜耳致力于推动可持续发展并对业务产生积极影响。同时，集团还通过科技创新和业务增长来提升盈利能力并创造价值。在全球，拜耳品牌代表着可信、可靠及优质。在2024财年，拜耳的员工人数约为93,000名，销售额为466亿欧元。不计特殊项目的研究开发投入为62亿欧元。更多信息请见www.bayer.com。前瞻性声明本新闻稿包括拜耳集团管理层基于当前设想和预测所作的前瞻性声明。各种已知和未知的风险、不确定性和其它因素均可能导致公司未来的实际运营结果、财务状况、发展或业绩与上述前瞻性表述中所作出的估计产生重大差异。这些因素包括在拜耳官方网站http://www.bayer.com/上公开的拜耳各项报告。本公司没有责任更新这些前瞻性声明或使其符合未来发生的事件或发展。

2026-01-14

·拜耳中国

拜耳加速处方药业务增长，推进高价值产品组合

拜耳计划向卫生监管机构提交其在研每日一次口服因子XIa抑制剂asundexian的上市申请。该药物已证实与抗血小板疗法联合使用时，在预防卒中方面具有显著优势。III期临床研究的主要结果突显了其重磅药物的潜力；拜耳通过监管部门的批准，扩大了其高价值心脏病产品的市场覆盖范围，进一步加速了收入增长：非奈利酮用于治疗心力衰竭，心脏药物acoramidis用于治疗转甲状腺素蛋白淀粉样变性心肌病（ATTR-CM）；达罗他胺用于治疗前列腺癌的第三个适应症获批后加速增长，推动了市场渗透率的进一步提高；塞伐艾替尼获美国食品药品监督管理局（FDA）批准用于治疗既往接受过治疗的患者，作为HER2突变型非小细胞肺癌患者的一线治疗药物，在美国和中国获得突破性疗法认定。基于此，拜耳巩固了其在精准肿瘤学领域的领先地位； Elinzanetant的获批标志着拜耳在女性健康领域迈出了重要一步。这是拜耳首个用于治疗绝经相关中重度血管舒缩症状的非激素疗法，开辟了巨大的市场机遇；拜耳帕金森病细胞和基因疗法产品线正快速发展，多能干细胞衍生疗法bemdaneprocel正处于关键性III期临床试验阶段。Ametefgene parvec（AB-1005）基因疗法试验已启动II期临床研究，首例患者已在德国随机入组； AB-1002是用于治疗充血性心力衰竭的在研单次给药基因疗法，OpCT-001是用于治疗原发性光感受器疾病的在研诱导多能干细胞（iPSC）衍生细胞疗法。这两项疗法均已进入临床开发阶段，并已获得监管机构的优先审评资格；通过收购用于心脏淀粉样变性的诊断示踪剂AT-01和AT-05，拜耳战略性地拓展了影像诊断产品组合，巩固了在分子影像领域的决心，并强化了精准心脏病学战略。近日，在美国旧金山举行的第44届摩根大通医疗健康大会上，拜耳公布了其处方药事业部2026年的战略重点。凭借新产品上市的强劲势头，拜耳将强化处方药产品组合的全球监管审评，并提升市场渗透率。高价值的商业化产品以及涵盖肿瘤、心脏病、神经学和免疫学等领域不断加速研发的多元化产品线，已为处方药事业部未来几年的增长奠定了坚实的基础。2025年五项关键药物的获批，标志着拜耳处方药事业部战略执行取得了里程碑式的进展，印证了其增长战略的成功实施。 Stefan Oelrich 拜耳集团管理委员会成员、拜耳处方药事业部全球总裁 “公司战略取得了显著成就。通过在肿瘤学、心脏病学和女性健康领域推出多款具有重大影响的产品，我们从根本上加速了拜耳处方药的增长。公司战略重点仍是基于先进的研发专长、灵活的运营模式、合作驱动的创新、人工智能赋能的研发以及对卓越商业化的承诺，更快地为患者提供变革性药物。处方药事业部已做好准备，在未来几年实现可持续增长。” 心脑血管药物：借力创新，把握市场机遇拜耳正凭借世界一流的科学技术、战略合作伙伴关系和高价值的研发管线，巩固其在心血管疾病管理领域的全球领先地位。 Asundexian是在研每日一次口服因子XIa抑制剂，已被研究作为卒中二级预防的潜在疗法。该领域存在巨大的未满足医疗需求：卒中是全球第二大死因，据估计，约十分之一的缺血性卒中患者会在第一年内再次发生卒中，而复发性卒中往往比首次卒中致残率更高，并且具有更高的死亡风险。III期研究OCEANIC-STROKE的主要数据显示，在非心源性缺血性脑卒中或高风险短暂性脑缺血发作的患者中，与安慰剂联合抗血小板治疗相比，每日一次50 mg的asundexian显著降低了缺血性脑卒中的复发风险，且不会显著增加大出血的风险。OCEANIC-STROKE是首个成功完成的XIa因子抑制剂III期研究，其结果突显了 asundexian在二级卒中预防方面的巨大潜力。Asundexian已被美国食品药品监督管理局（FDA）授予快速通道资格，作为一种潜在的治疗方案，用于非心源性缺血性脑卒中患者的卒中二级预防。此外，拜耳正基于其整合能力和强大的合作伙伴关系，巩固其在心血管疾病和肾脏病领域的全球领先地位，并不断创造新价值。美国FDA和日本厚生劳动省（MHLW）等监管机构已批准非甾体类选择性盐皮质激素受体拮抗剂（nsMRA）非奈利酮（可申达®）用于治疗左心室射血分数（LVEF）≥40%的心力衰竭患者。该批准基于关键性III期临床研究 FINEARTS-HF的阳性结果，进一步巩固了其在2型糖尿病相关慢性肾脏病（CKD）方面的有效性。在中国和欧盟等市场，非奈利酮用于治疗LVEF≥40%的心力衰竭的申请正在接受审评。正在进行的专门针对心力衰竭和慢性肾脏病的III期临床试验项目（MOONRAKER和THUNDERBALL）持续评估可申达在心血管-肾脏-代谢（CKM）疾病的各类患者和临床环境中的潜在有效性。在美国肾脏病学会（ASN）肾脏周上公布的III期临床试验FINE-ONE的最新数据显示，与安慰剂相比，非奈利酮显著降低了接受标准治疗的1型糖尿病相关CKD成人患者的尿白蛋白/肌酐比值（UACR）。此外，欧盟委员会已批准Beyonttra™（acoramidis）上市，用于治疗转甲状腺素蛋白淀粉样变性心肌病（ATTR-CM）。Beyonttra™可减缓导致ATTR-CM的淀粉样变性过程。拜耳正积极塑造心脏病学的未来，在已有产品组合上建立更强大且多元化的研发管线，战略性地满足关键的未满足医疗需求，并创造显著的长期价值。这其中包括AB-1002，即拜耳与其全资子公司AskBio Inc.合作开发的用于治疗充血性心力衰竭（CHF）的在研单次给药基因疗法。AB-1002目前正处于II期临床试验阶段，进展顺利。其I期临床试验结果已发表于《自然医学》（Nature Medicine）杂志，并被日本厚生劳动省授予“先进再生医学产品”认定。此外，拜耳已启动BAY-3018250的II期SIRIUS研究。其是first-in-class抗α-2抗纤溶酶（α2AP）抗体，旨在实现深静脉血栓（DVT）的靶向溶栓治疗。同时，拜耳启动了BAY-3670549的I期临床研究。该抗体是在研高选择性G蛋白偶联内向整流钾通道4（GIRK4）抑制剂，有望帮助控制心房颤动患者心脏细胞的电活动。拜耳与Dewpoint Therapeutics合作开发的扩张型心肌病项目进一步彰显了其对领先科学的承诺。此外，拜耳从Cytokinetics公司获得了在日本独家销售aficamten的权利。该药物是正在开发用于治疗肥厚型心肌病的肌球蛋白抑制剂。此举进一步巩固了拜耳在精准心脏病学领域的布局，并拓展了其战略市场准入。肿瘤领域增长引擎：利用重磅药物和精准研发管线，打造领先地位拜耳的肿瘤产品组合正为患者带来显著获益并取得商业成功，其中重磅药物诺倍戈®（达罗他胺）持续在全球范围内保持卓越的市场表现，并朝着市场领先地位迈进。诺倍戈®已在全球治疗超过20万名患者，治疗前列腺癌的第三个适应症已在美国和欧洲获批，预计将于2026年在中国获批。该产品的全球总销售额在所有市场均呈上升趋势。拜耳全面的临床开发项目正在探索诺倍戈®在早期前列腺癌治疗中的潜力，预计将于2027年和2028年公布两项III期临床试验结果。达罗他胺以诺倍戈®为商品名，在多个国家获批用于联合雄激素剥夺疗法（ADT），无论是否联合化疗治疗转移性激素敏感性前列腺癌（mHSPC）。此外，它还获批联合ADT治疗具有高危转移风险的非转移性去势抵抗性前列腺癌（nmCRPC）成年患者。为进一步推动肿瘤治疗领域的进展，美国FDA加速批准拜耳的Hyrnuo™（塞伐艾替尼）用于携带人表皮生长因子受体2（HER2）激活突变的晚期非小细胞肺癌（NSCLC）成人患者的一线治疗。此前，拜耳已获得中国国家药品监督管理局药品审评中心（CDE）和美国FDA的突破性疗法认定。突破性疗法认定基于I/II期临床试验SOHO-01（NCT05099172）研究队列F（既往未接受过治疗的患者）的初步临床证据的支持。塞伐艾替尼满足了治疗选择有限的患者群体未被满足的医疗需求。除SOHO-01外，塞伐艾替尼的临床项目还包括正在进行的其他试验，以评估其作为HER2突变型NSCLC一线治疗药物的有效性，以及在携带HER2激活突变的转移性实体瘤患者中的有效性，但不包括晚期NSCLC。作为靶向放射性核素治疗（TRT）的先驱，拜耳已将靶向α疗法（TAT）确立为骨转移性去势抵抗性前列腺癌（mCRPC）患者的标准治疗方案。EORTC PEACE III研究评估了氯化镭-223（多菲戈®）联合恩杂鲁胺的有效性，该研究达到了其主要终点，证实了总生存期（OS）的改善。目前，两项氯化镭-223的关键性试验正在进行中，并将成为未来接受潜在审评的基础。氯化镭-223拥有超过12年的真实世界临床经验，并且是目前唯一获批的 TAT，已被证实能够延长mCRPC患者的OS，并延缓症状性骨骼事件的发生。氯化镭-223 以多菲戈®的商品名，在50多个国家获批用于治疗伴有症状性骨转移且无已知内脏转移的mCRPC患者。拜耳的肿瘤产品线正致力于推进精准治疗，通过靶向具有挑战性的肿瘤类型和以往难以成药的机制，取得了关键性进展。这其中包括多种针对KRAS突变型癌症的在研药物（一种自主研发的SOS1抑制剂，以及与Kumquat合作开发的KRAS G12D抑制剂）、新一代TAT（用于治疗晚期肝细胞癌的225Ac-GPC3），以及一种用于治疗MTAP缺失型肿瘤的PRMT5抑制剂（来自苏州浦合医药）。这些药物均已进入I期临床试验。为了进一步加强研发实力，拜耳通过Vividion获得了临床阶段Werner解旋酶抑制剂（VVD 214）的全球权益。Vividion通过新建研发设施和收购Tavros Therapeutics，进一步提升了其研发能力。这些战略投资彰显了拜耳致力于推动突破性创新并确保肿瘤领域长期发展的决心。绝经管理：提供优质护理，满足女性个性化需求拜耳在女性健康领域的产品Lynkuet™（elinzanetant）近期在获得监管部门批准方面取得重大进展。Lynkuet™在美国获批用于治疗绝经相关的中重度血管舒缩症状（VMS），在欧盟目前是唯一获批用于治疗绝经相关或乳腺癌辅助内分泌治疗引起的中重度VMS的非激素疗法。这些里程碑式的进展源于四项III期临床研究（OASIS 1-4）均取得阳性结果。此外，针对绝经相关睡眠障碍女性开展的探索性II期NIRVANA研究的初步结果表明，Lynkuet™可能具有更广泛的应用潜力。细胞和基因疗法（CGT）：构建全面的产品组合拜耳旗下CGT产品组合中的多个项目获得了美国、欧洲和日本监管机构授予的多项优先审评资格，体现了这些项目在为患者带来变革性影响方面的潜力。拜耳与全资子公司BlueRock Therapeutics正在合作开发细胞疗法Bemdaneprocel，旨在替代帕金森病中丢失的多巴胺能神经元，目前已进入III期临床试验的关键性评估阶段。AskBio的在研基因疗法ametefgene parvec（AB-1005）正在一项针对中度帕金森病患者的II期临床试验中接受评估，首例受试者已在德国随机入组，同时在美国、英国和波兰招募患者。在眼科领域，BlueRock的OpCT-001，一种用于治疗原发性感光细胞疾病的iPSC衍生感光细胞疗法，已被美国FDA授予快速通道资格，目前正在进行I/IIa期临床试验。影像诊断：推进创新，拓展分子影像领域拜耳持续推进医学影像领域的创新，其在研低剂量磁共振成像（MRI）对比剂gadoquatrane旨在与其他大环状钆对比剂相比，将钆剂量减少60%。基于阳性的III期临床试验结果，拜耳已在全球主要市场（包括中国、欧盟、美国和日本）提交了其上市申请。为进一步拓展现有产品组合，拜耳宣布战略性收购两款用于诊断心脏淀粉样变性的在研放射性示踪剂，即处于III期临床开发阶段的正电子发射断层扫描（PET）示踪剂AT-01和处于I期临床开发阶段的单光子发射计算机断层扫描（SPECT）示踪剂AT-05。此举标志着拜耳正式进军诊断示踪剂领域，并彰显了其拓展分子影像业务的决心，旨在拓宽诊断选择，改善患者预后。关于拜耳拜耳作为一家跨国企业，在生命科学领域的医疗健康与农业方面具有核心竞争力。秉承“共享健康，消除饥饿”的使命，公司致力于通过产品和服务，帮助人们克服全球人口不断增长和老龄化带来的重大挑战，造福人类和地球繁荣发展。拜耳致力于推动可持续发展并对业务产生积极影响。同时，集团还通过科技创新和业务增长来提升盈利能力并创造价值。在全球，拜耳品牌代表着可信、可靠及优质。在2024财年，拜耳的员工人数约为93,000名，销售额为466亿欧元。不计特殊项目的研究开发投入为62亿欧元。更多信息请见www.bayer.com。前瞻性声明本新闻稿包括拜耳集团管理层基于当前设想和预测所作的前瞻性声明。各种已知和未知的风险、不确定性和其它因素均可能导致公司未来的实际运营结果、财务状况、发展或业绩与上述前瞻性表述中所作出的估计产生重大差异。这些因素包括在拜耳官方网站http://www.bayer.com/上公开的拜耳各项报告。本公司没有责任更新这些前瞻性声明或使其符合未来发生的事件或发展。

2026-01-14

·BioSpace

Bayer Accelerates Pharma Growth on High-Value Portfolio

Bayer is successfully executing on an ambitious growth strategy Five pivotal approvals worldwide in 2025 underscore a landmark year of strategic execution Bayer will drive significant global regulatory expansions and market penetration across its pharmaceutical portfolio, with multiple high-impact launches across oncology, cardiology, and women’s health Focus continues to accelerate a modality-rich pipeline across oncology, cardiology, neurology and immunology, complemented by existing high-value commercial products SAN FRANCISCO--(BUSINESS WIRE)--On the occasion of the 44th J.P. Morgan Healthcare Conference in San Francisco, Bayer AG today unveiled the strategic focus for its Pharmaceuticals Division in 2026. Capitalizing on new launch momentum, the company will drive significant global regulatory expansions and market penetration across its pharmaceutical portfolio. High-value commercial products and an accelerating modality-rich pipeline across oncology, cardiology, neurology, and immunology have firmly cemented the Pharmaceuticals Division’s growth for the coming years. Five pivotal worldwide approvals in 2025 underscore a landmark year of strategic execution, validating the successful advancement of Bayer’s ambitious pharmaceutical growth strategy. “We are now clearly seeing the success of our strategy. We have fundamentally accelerated Bayer Pharmaceutical’s growth runway with multiple high-impact launches across oncology, cardiology, and women’s health,” said Stefan Oelrich, Member of the Board of Management, Bayer AG, and President of Bayer’s Pharmaceuticals Division. “Our strategic focus remains on delivering transformative medicines to patients faster, powered by our cutting-edge R&D expertise, dynamic operating model, partnership-driven innovation, AI-enabled development, and commitment to commercial excellence. Our Pharmaceuticals Division is poised for sustainable growth over the coming years.” Innovating to capture additional market opportunity in cardiovascular and cerebrovascular medicine Bayer is advancing its global leadership in cardiovascular disease management through world-class science, strategic partnerships, and a high-value pipeline designed to deliver both patient and shareholder impact. Asundexian, an investigational, once daily, oral Factor XIa inhibitor, has been investigated as a potential treatment for secondary stroke prevention. Each year, approximately 12 million people worldwide will experience a stroke. Of these, 20-30% will be a recurrent stroke. 1,2 Despite available secondary stroke prevention options, the risk of secondary stroke remains high; one in five stroke survivors will have another stroke within five years. 3 Stroke is the second leading cause of death globally, and recurrent ischemic strokes tend to be more disabling and carry a higher mortality risk than the first stroke. 2,4,5 Topline data from the Phase III OCEANIC-STROKE study showed it met its primary safety and efficacy endpoints. OCEANIC-STROKE is the first successfully completed Phase III study of a Factor XIa inhibitor and these results underscore the blockbuster potential of asundexian in secondary stroke prevention. Asundexian has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke. Additionally, Bayer is driving forward its global leadership in cardiovascular and renal disease, leveraging integrated capabilities and robust partnerships to unlock new value streams. The FDA and Japan’s Ministry of Health, Labour and Welfare (MHLW), among other regulatory authorities, have approved finerenone (marketed as Kerendia ® ) for patients with heart failure with left ventricular ejection fraction (LVEF) of ≥40%, based on the positive results from the pivotal Phase III study FINEARTS-HF, further building on its established efficacy in chronic kidney disease (CKD) associated with type 2 diabetes. Applications in HF with LVEF ≥40% are under review in additional markets, including the EU and China. Ongoing, dedicated Phase III heart failure and chronic kidney disease programs (MOONRAKER and THUNDERBALL) continue to evaluate Kerendia’s potential across a broad spectrum of patients and clinical settings of Cardiovascular-Kidney-Metabolic (CKM) conditions. In November 2025, late-breaking, topline data from the Phase III study FINE-ONE presented at the American Society of Nephrology’s Kidney Week showed it met its primary safety and efficacy endpoints. For important risk and use information about KERENDIA, please see the full Prescribing Information . The European Commission granted marketing authorization for Beyonttra™ (acoramidis), marketed by Bridge Bio in the U.S., to treat wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Beyonttra slows the amyloidogenic process that results in ATTR-CM. Beyond current successes, Bayer is actively shaping the future of cardiology with a robust and diversified pipeline, strategically positioned to address critical unmet needs and drive significant long-term value. This includes AB-1002, an investigational single-dose gene therapy in development for congestive heart failure (CHF) developed together with AskBio Inc., a wholly owned subsidiary of Bayer. AB-1002 is progressing well in Phase II. Its Phase I results were published in Nature Medicine and it has been granted Pioneering Regenerative Medical Product designation (SAKIGAKE) by Japan’s MHLW. Additionally, Bayer has initiated the Phase II SIRIUS study of BAY-3018250, a first-in-class anti–alpha-2 antiplasmin (α2AP) antibody designed to enable targeted thrombolysis in deep vein thrombosis (DVT), and a Phase I clinical study of BAY-3670549, an investigational, highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor, with the potential to help control the electrical activity of heart cells in patients with atrial fibrillation. Bayer’s commitment to cutting-edge science is further underscored by the company’s licensed dilated cardiomyopathy program with Dewpoint Therapeutics, which leverages condensate biology to develop genotype-guided therapies for dilated cardiomyopathy patients with specific genetic mutations. Concurrently, securing exclusive rights in Japan to aficamten from Cytokinetics—a cardiac myosin inhibitor in development for hypertrophic cardiomyopathy—strengthens Bayer’s precision cardiology footprint and expands its strategic market access. Oncology growth engine: Leveraging blockbuster assets and precision pipeline for future leading position Bayer’s oncology portfolio is delivering significant patient benefit and commercial success, with blockbuster Nubeqa ® (darolutamide) continuing its exceptional global uptake, progressing towards a market-leading position. With over 200,000 patients treated worldwide and a third approval in prostate cancer in both the U.S. and Europe, Nubeqa continues its strong growth trajectory. Total global sales are on the rise in all markets. Third approval in China is anticipated in 2026. Its comprehensive clinical development program is exploring Nubeqa’s potential in earlier prostate cancer settings, with two additional Phase III readouts expected in 2027 and 2028. Darolutamide, under the brand name Nubeqa is approved for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with ADT, with or without chemotherapy, and with ADT alone in non-metastatic castration-resistant prostate cancer (nmCRPC) in patients who are at high risk of developing metastatic disease. For important risk and use information about Nubeqa, please see the full Prescribing Information . Adding to this momentum in oncology, the FDA granted accelerated approval for Bayer’s Hyrnuo ® (sevabertinib) for adult patients with locally advanced or metastatic non-squamous HER2 -mutant non-small cell lung cancer (NSCLC), who have received prior systemic therapy. Approval followed Breakthrough Therapy Designations from both the FDA and China’s CDE and was based on results from the SOHO-01 study. Bayer received Breakthrough Therapy Designation in the US and China for sevabertinib as a first-line treatment for patients with HER2 -mutant non-small cell lung cancer. The Breakthrough Therapy Designations are supported by preliminary clinical evidence from cohort F (patients who had not previously received treatment) of the ongoing Phase I/II SOHO-01 study. Sevabertinib addresses unmet needs for a patient population with limited treatment options. In addition to SOHO-01 the clinical program for sevabertinib includes ongoing trials evaluating its effectiveness as a first-line treatment for HER 2-mutant NSCLC and in patients with metastatic solid tumors harboring HER 2 activating mutations, excluding advanced NSCLC. For important risk and use information about Hyrnuo, please see the full Prescribing Information. As pioneers in Targeted Radionuclide Therapy (TRT), Bayer was instrumental in helping establish Targeted Alpha Therapies (TATs) as a standard of care for patients with metastatic castration resistant prostate cancer (mCRPC) with bone metastases. The EORTC PEACE III study evaluating radium-223 dichloride (marketed as Xofigo ® ) in combination with enzalutamide met its primary endpoint. An additional Phase III clinical study with radium-223 dichloride will be completed in 2026 and will guide decisions regarding future regulatory steps. Radium-223 dichloride is approved under the brand name Xofigo in over 50 countries for mCRPC patients with symptomatic bone metastases and no known visceral metastatic disease. For important risk and use information about Xofigo, please see the full Prescribing Information . Bayer’s oncology pipeline is advancing precision-driven therapies, making pivotal progress by targeting challenging tumor types and previously undruggable mechanisms, proteins or pathways resistant to current therapies. This includes multiple investigational agents for KRAS-mutant cancers (an internal SOS1 inhibitor, and a partnership with Kumquat for a KRAS G12D inhibitor), next-generation TATs (225Ac-GPC3 for advanced hepatocellular carcinoma), and a PRMT5 inhibitor (from Suzhou Puhe BioPharma) for MTAP-deleted tumors, all of which have entered Phase I. Further strengthening its discovery engine, Bayer secured worldwide rights to the clinical-stage Werner helicase inhibitor (VVD 214) via Vividion, whose R&D capabilities were expanded through new facilities and the acquisition of Tavros Therapeutics. These strategic investments underscore Bayer’s commitment to driving groundbreaking innovation and securing long-term growth in oncology. Menopause management: advancing care for women with diverse needs Bayer achieved a big step forward in women's health with the recent regulatory approvals of Lynkuet ® (elinzanetant) for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. It is the only hormone-free therapy approved in the EU for both moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy for breast cancer. These milestones follow consistent positive results across all four Phase III clinical studies (OASIS 1- 4). For important risk and use information about Lynkuet, please see the full Prescribing Information . Developing a comprehensive cell and gene therapy (CGT) portfolio Multiple regulatory priority designations granted by authorities in the U.S., Europe and Japan and across Bayer’s CGT portfolio reflect the potential of these programs to deliver transformative patient impact. Bemdaneprocel, an investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson’s disease, developed with Bayer’s wholly owned subsidiary BlueRock Therapeutics, entered pivotal evaluation in a Phase III study. AskBio’s ametefgene parvec (AB-1005), an investigational gene therapy, is being assessed in a Phase II study in moderate stage Parkinson’s disease. The first participant has been randomized in Germany while recruitments in the U.S., UK and Poland are ongoing. In ophthalmology, BlueRock’s OpCT-001, an iPSC-derived photoreceptor cell therapy for primary photoreceptor diseases, received FDA Fast Track designation and is progressing in its Phase I/IIa study. Radiology: Advancing innovation and expanding into Molecular Imaging Bayer continues to advance innovation in medical imaging with gadoquatrane, its investigational low-dose magnetic resonance imagining (MRI) contrast designed to reduce the gadolinium dose by up to 60% compared to other macrocyclic MRI contrast agents. Building on positive Phase III results, Bayer has submitted marketing authorization applications in key markets worldwide, including the U.S., EU, Japan, and China. Complementing progress in its existing portfolio, Bayer announced the strategic acquisition of two investigational radiotracers – AT-01 (a Positron Emission Tomography or PET tracer in Phase III of clinical development) and AT-05 (a tracer for Single Photon Emission Computed Tomography, or SPECT, currently in Phase I) – for the diagnosis of cardiac amyloidosis. This step marks Bayer’s entry into diagnostic tracers and underscores its ambition to expand in molecular imaging, aiming to broaden diagnostic options and enhance patient outcomes. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to . Find more information at Follow us on Facebook: Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 1 Feigin VL, et al. World Stroke Organization (WSO): global stroke fact sheet 2022. International Journal of Stroke. 2022 Jan;17(1):18-29. 2 Feigin VL, et al. Pragmatic Solutions to Reduce Global Burden of Stroke. Lancet Neurol. 2023;22:1160–1206. 3 Kolmos M, et al. Recurrent ischemic stroke–a systematic review and meta-analysis. Journal of Stroke and Cerebrovascular Diseases. 2021 Aug 1;30(8):105935. 4 Rochmah TN, et al. Economic burden of stroke disease: a systematic review. International journal of environmental research and public health. 2021 Jul 15;18(14):7552. 5 Skajaa N, et al. Risks of stroke recurrence and mortality after first and recurrent strokes in Denmark: a nationwide registry study. Neurology. 2022 Jan 25;98(4):e329-42. Contacts Contact for media inquiries : Elaine Colón Phone +1-732-236-1587 Email: elaine.colon@bayer.com Contact for investor inquiries: Bayer Investor Relations Team, phone +49 214 30-72704 Email: ir@bayer.com

临床3期临床结果上市批准临床1期临床2期

100 项与 Iodine (124I) evuzamitide 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
系统性淀粉样变性	临床3期	美国	Attralus, Inc.	2025-01-15
老年性心脏淀粉样变性	临床3期	美国	Attralus, Inc.	2025-01-14
转甲状腺素蛋白淀粉样变性心肌病	临床2期	美国	Attralus, Inc.	2022-07-08

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05235269 (AT01-001, CTgov)	临床2期	系统性淀粉样变性	33	124I-AT-01	構艱淵蓋夢鑰觸鹹壓壓 = 鬱艱壓製簾夢艱範範網繭鏇鑰餘衊糧糧觸醖廠 (繭淵壓簾蓋築憲蓋願醖, 遞壓簾築遞糧簾鹽簾衊 ~ 繭顧夢鑰鬱簾鏇選願築) 更多	-	2025-09-04
NCT05635045 (CTgov)	临床2期	转甲状腺素蛋白淀粉样变性心肌病 \| 老年性心脏淀粉样变性	10	I 124-Evuzamitide (Stabilizer Only)	範顧醖網積醖襯夢製衊(築製鏇鏇繭選遞襯窪製) = 壓積膚鏇獵餘繭壓鏇蓋鏇窪觸鹽醖糧遞簾構觸 (觸鹽糧糧鏇鏇積範網齋, 淵壓鹽醖鹽壓夢願壓網 ~ 遞鹹蓋艱鏇遞醖淵築鏇) 更多	-	2025-07-18
NCT05635045 (CTgov)	临床2期	转甲状腺素蛋白淀粉样变性心肌病 \| 老年性心脏淀粉样变性	10	I 124-Evuzamitide (Silencer Only)	範顧醖網積醖襯夢製衊(築製鏇鏇繭選遞襯窪製) = 齋壓製構襯顧網衊願淵鏇窪觸鹽醖糧遞簾構觸 (觸鹽糧糧鏇鏇積範網齋, 廠鑰壓製醖窪觸廠窪廠 ~ 齋艱糧鬱繭餘積觸鬱窪) 更多	-	2025-07-18
NCT03678259 (Literature) 人工标引	临床1/2期	系统性淀粉样变性	57	Iodine (124I) evuzamitide	範夢顧範築鑰憲選夢膚(壓齋積簾選構齋積鏇簾) = 築網夢蓋範遞觸範艱簾選鏇獵艱築膚鬱窪遞蓋 (觸齋鏇膚齋觸艱鑰繭襯, 82.8 ~ 97.8) 更多	积极	2023-11-07
NCT03678259 (ESC2020)	临床1期	老年性心脏淀粉样变性	22	124I-p5+14 peptide	餘蓋簾範鏇鑰築窪築鬱(鬱顧蓋鹹醖襯網廠鹹繭) = 鬱顧範獵艱廠廠糧淵糧膚製簾簾觸簾襯獵衊範 (憲壓獵鹹鹹蓋繭範鹹夢 )	-	2020-08-29
NCT03678259 (SNMMI2020)	临床1期	免疫球蛋白轻链淀粉样变性	3	124I-p5+14	艱鏇鏇膚鏇鹹夢構艱繭(獵廠鬱衊鹹選構衊願鬱) = fast and slow half-life estimates of ~ 15 min and ~700 min 齋壓糧鏇窪顧網遞醖顧 (衊顧淵網廠壓淵願鬱壓 )	积极	2020-05-15
NCT03678259 (Phase 1, SNMMI2020)	临床1期	系统性淀粉样变性	20	124I-p5+14 peptidee (124I-p5+14 peptide)	餘憲獵夢蓋鑰醖繭襯夢(範鏇選窪獵齋鏇襯淵獵) = 築願鹽範積構構淵衊窪餘網製齋壓艱鬱醖選衊 (壓鹽憲鹽憲觸遞艱餘餘 ) 更多	积极	2020-05-15