1. We expect to find that the silent cerebral infarct (SCI) rate is two fold higher in patients treated without caplacizumab. We also expect to find that the rate of mild and major cognitive impairment in patients treated with caplacizumab within 3 days of starting plasma exchange will be lower than patients treated without caplacizumab.
2. We expect that the differences in cognitive impairment in cases (caplacizumab) versus controls (no caplacizumab) will persist on serial evaluation 1 year later. We also expect that there will be differences in these groups even after adjusting for time since episode and severity of presentation.
3. We expect to find that SCI and cognitive impairment is associated with worse scores on the health related quality of life instrument (SF-36)
4. Based on studies in non-TTP populations, we expect to find that the rate of incident stroke over the period of follow up is at least 2 fold higher in patients that have SCI compared with patients who do not have SCI

开始日期2024-12-01

申办/合作机构-

NCT05876221

/ CompletedN/AIIT

Platelet Response to Caplacizumab in the Treatment of Acquired Thrombotic Thrombocytopenic Purpura

The interpretation of platelet counts has to be revaluated in the light of caplacizumab. By effectively blocking platelet binding sites on VWF-multimers, the nanobody leads to a rapid normalization of the platelet count within 3 to 4 days. Most importantly, caplacizumab uncouples platelet counts from ADAMTS13 activity and thereby launches unprecedented thrombocyte dynamics, with potential pitfalls for over- and undertreatment.
A relevant number of patients responds to caplacizumab with a brisk increase in platelet count, followed by a marked dip of platelets (patient on the left). This may mislead treating physicians into re-intensifying therapy, with a respective risk for adverse side-effects and complications. Taken together, these observations call for reliable descriptions and the identification of predictive parameters to predict the platelet response upon administration of caplacizumab in a large patient cohort. Here, PREDICT-2020 is designed as a retrospective study to specifically address the following aspects:
* Identifying and describing clusters of platelet responses to caplacizumab
* Identifying potential pitfalls for treating physicians
* Predicting the individual thrombocyte response
* Correlating platelet responses with individual patient outcome

开始日期2023-10-30

申办/合作机构

Universities of Cologne

NCT05468320

/ Completed临床3期

An Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura

This is a single group, treatment, Phase 3, open-label, single-arm study to evaluate the efficacy and safety of caplacizumab and immunosuppressive therapy (IST) without firstline therapeutic plasma exchange (TPE) with primary endpoint of remission in male and female participants aged 18 to 80 years with immune-mediated thrombotic thrombocytopenic purpura (iTTP).
The anticipated study duration per participant without a recurrence while on therapy is maximum 24 weeks (ie, approximately 1 day for screening + maximum 12 weeks of treatment for the presenting episode + 12 weeks of follow-up). Participants will have daily assessments during hospitalization and weekly visits for assessments during ongoing treatment with caplacizumab and IST. There will be 3 outpatient visits for assessments during the follow-up period. There will be two additional follow-up visits for participants who do not have ADAMTS13 activity levels of ≥50% at the time of caplacizumab discontinuation.

开始日期2022-11-21

申办/合作机构

Sanofi

100 项与卡普赛珠单抗相关的临床结果

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100 项与卡普赛珠单抗相关的专利（医药）

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324

项与卡普赛珠单抗相关的文献（医药）

2025-09-01·JOURNAL OF THROMBOSIS AND HAEMOSTASIS

Evaluation of different platelet-dependent von Willebrand factor activity assays to assess the in vivo inhibitory effect of caplacizumab on the von Willebrand factor-platelet interaction.

Article

作者: Cozzi, Giovanna ; Artoni, Andrea ; La Marca, Silvia ; Baronciani, Luciano ; Pagliari, Maria Teresa ; Novembrino, Cristina ; Lecchi, Anna ; Anzoletti, Massimo Boscolo ; Peyvandi, Flora ; Colpani, Paola ; Mancini, Ilaria ; Boscarino, Marco ; De Leo, Pasqualina

BACKGROUND:

Caplacizumab, a humanized anti-von Willebrand Factor (VWF) Nanobody®, is employed for immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP) treatment. Its binding to the VWF A1 domain sterically inhibits VWF interaction with platelet glycoprotein Ib (GPIb), counteracting microthrombosis and accelerating the normalization of the platelet count. In caplacizumab-treated iTTP patients with bleeding episodes, measuring platelet-dependent VWF activity (VWF activity) is crucial for monitoring treatment with VWF concentrates. This activity, traditionally assessed by the VWF ristocetin cofactor assay (VWF:RCo), nowadays could be evaluated with alternative methods as VWF:GPIbM, VWF:GPIbR, and VWF:Ab.

AIM:

To evaluate the capacity of five VWF activity assays to measure caplacizumab in vivo inhibitory effect on VWF-GPIb interaction.

METHODS:

17 iTTP patients treated effectively with caplacizumab, as demonstrated by normal platelet counts, were assessed by VWF activity using five commercially available assays. Three patients were further evaluated with the Total-Thrombus-Analysis-System (T-TAS).

RESULTS:

Patients treated with caplacizumab showed no VWF activity using VWF:GPIbM and VWF:RCo assays. The VWF:Ab assay produced the highest values, while both VWF:GPIbR assays showed reduced VWF activity levels, though not to the extent of VWF:GPIbM and VWF:RCo. In patients analyzed by T-TAS no capillary occlusion was observed, indicating complete inhibition of the VWF-GPIb interaction by caplacizumab.

CONCLUSION:

The VWF:GPIbM and VWF:RCo appear to be the most suitable assays for monitoring VWF activity in iTTP patients undergoing treatment with caplacizumab, as confirmed by T-TAS analysis. The VWF:GPIbR assays may be useful, but have a limited ability to detect caplacizumab's inhibition. The VWF:Ab assay is unsuitable for this purpose.

2025-08-12·JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Immune Thrombotic Thrombocytopenic Purpura

Review

作者: Li, Ang ; Cuker, Adam ; Pishko, Allyson M.

Importance:

Immune thrombotic thrombocytopenic purpura (iTTP) is a life-threatening thrombotic microangiopathy that presents with microangiopathic hemolytic anemia (MAHA) and thrombocytopenia. Worldwide annual incidence of iTTP is 2 cases per million to 6 cases per million.

Observations:

Immune TTP is caused by an autoantibody to a disintegrin and metallopeptidase with thrombospondin type 1 motif 13 (ADAMTS13), an enzyme that cleaves von Willebrand factor (vWF). With severely low ADAMTS13 activity (&lt;10%), large multimers of vWF accumulate and bind platelets, forming microvasculature thromboses that cause ischemic organ injury (eg, myocardial infarction and stroke). The incidence of iTTP is higher in adults than children (incident rate ratio [IRR], 31.62 per million person-years [95% CI, 14.68-68.10]), females than males (IRR, 3.19 [95% CI, 2.65-3.85]), and Black compared with non-Black individuals (IRR, 7.09 [95% CI, 6.05-8.31]). Common presenting symptoms are neurologic (eg, headache, confusion, or seizures [39%-80%]) and abdominal pain (35%-39%). For patients presenting with MAHA and thrombocytopenia, clinical prediction scores for iTTP using laboratory data, such as platelet count less than 30 × 109/L and creatinine level less than 2.0 mg/dL (176.8 μmol/L), can help guide empirical treatment initiation for iTTP before ADAMTS13 results are available. Prompt initiation of therapy with therapeutic plasma exchange, corticosteroids, and rituximab improves survival with iTTP from almost zero to approximately 93%. Caplacizumab, a synthetic small antibody (nanobody) that blocks platelet binding to vWF, administered concurrently with immunosuppression and therapeutic plasma exchange and continued until ADAMTS13 recovery, reduces the time to normalization of platelet count and decreases the risk of early recurrence (defined as within 30 days of completing therapeutic plasma exchange) compared with placebo (risk difference [RD], −29% [95% CI, −42 to −14%]) but increases bleeding risk (RD, 17% [95% CI, 4%-30%]). After obtaining clinical remission (defined as at least 30 days of sustained normalization of platelet count, decreased serum lactate dehydrogenase level, and absence of new or progressive ischemic organ injury without therapeutic plasma exchange or caplacizumab), 16% of patients have at least 1 relapse of iTTP. Regular monitoring of ADAMTS13 activity in remission and administration of rituximab when ADAMTS13 activity is less than 20% reduces risk of relapse (odds ratio, 0.09 [95% CI, 0.04-0.24]).

Conclusions and Relevance:

Immune TTP is a rare immune-mediated disorder that presents with thrombocytopenia and MAHA and may cause life-threatening thrombosis. Treatment with therapeutic plasma exchange, corticosteroids, and rituximab is associated with 30-day survival rates of more than 90%. Addition of caplacizumab shortens time to normalization of platelet count and reduces recurrences while receiving the drug but increases bleeding risk. Monitoring ADAMTS13 activity in survivors and initiation of rituximab for those with low ADAMTS13 activity reduces the risk of clinical relapse.

2025-08-01·TRANSFUSION AND APHERESIS SCIENCE

Relapse and beyond: Navigating the long-term clinical impacts of immune thrombotic thrombocytopenic purpura

Review

作者: Qiao, Jesse ; Jones, Jennifer ; Tran, Minh-Ha

Immune Thrombotic thrombocytopenic purpura (iTTP) is a rare but life-threatening thrombotic microangiopathy characterized by an autoantibody against ADAMTS13, leading to accumulation of ultra-large von Willebrand multimers, systemic platelet microthrombi, end-organ damage, and mortality if untreated. Therapeutic plasma exchange and corticosteroids have been the mainstay therapy for decades, but there exists significant relapse potential after the initial acute episode. While more recent advances in the use of immunotherapy (e.g. rituximab and caplacizumab) have significantly improved acute survival and short-term exacerbation/relapse prevention, long-term complications of the disease remain a concern for survivors. This narrative review discusses challenges of optimizing post-remission care after iTTP, highlighting disease impact on neurological, cardiovascular, and psychological health. Chronic cognitive impairment, increased risk of hypertension and ischemic events, and mental health challenges such as anxiety and depression are reported in iTTP survivors. Moreover, recurrence risk and persistent ADAMTS13 deficiency may define the need for long-term monitoring and individualized treatment of potential relapse. We emphasize the importance of multidisciplinary, patient-centered management, not only in the management and prevention of iTTP relapse episodes, but to improve quality of life and reduce morbidity in survivors of this rare disease. Providers should possess heightened awareness of long-term complications and atypical manifestations of relapse in survivors. We advocate for further research and observational cohort studies to formulate standardized guidelines for surveillance and intervention to mitigate the chronic burden of iTTP.

项与卡普赛珠单抗相关的新闻（医药）

2025-08-29

·EINPresswire

April - June 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Adcetris (brentuximab vedotin) Guillain-Barre syndrome FDA determined that no action is necessary at the time based on available information. Arzerra (ofatumumab) Gazyva (obinutuzumab) Riabni (rituximab-arrx) Rituxan (rituximab) Rituxan Hycela (rituximab and hyaluronidase human) Ruxience (rituximab-pvvr) Truxima (rituximab-abbs) Colitis FDA determined that no action is necessary at the time based on available information. Balversa (erdafitinib) Calciphylaxis The "Warnings and Precautions", "Patient Counseling Information", and the "Patient Information" sections of the labeling were updated in April 2022 to include information about soft tissue mineralization, including calciphylaxis. Balversa labeling Bavencio (avelumab) Keytruda (pembrolizumab) Opdivo (nivolumab) Yervoy (ipilimumab) Imfinzi (durvalumab) * Necrotizing fasciitis FDA determined that no action is necessary at this time based on available information. *An administrative error resulted in the omission of Imfinzi (durvalumab) from the list of product names. Imfinzi was added after the initial quarterly report was posted. Beta-blockers Betapace (sotalol hydrochloride) Brevibloc (esmolol hydrochloride) Bystolic (nebivolol) Byvalson (nebivolol and valsartan) Coreg (carvedilol) Coreg CR (carvedilol) Corgard (nadolol) Corzide (nadolol and bendroflumethiazide) Dutoprol (metoprolol succinate and hydrochlorothiazide) Kapspargo Sprinkle (metoprolol succinate) Lopressor HCT (metoprolol tartrate and hydrochlorothiazide) Sectral (acebutolol hydrochloride) Sotylize (sotalol hydrochloride) Tenoretic (atenolol and chlorthalidone) Toprol XL (metoprolol succinate) Trandate (labetalol hydrochloride) Ziac (bisoprolol fumarate and hydrochlorothiazide) Generic products containing beta-blockers Hemangeol (Propranolol Hydrochloride)* Inderal LA (Propranolol Hydrochloride)* Innopran XL (Propranolol hydrochloride)* Lopressor (metoprolol tartrate)* Tenormin (Atenolol)* Hypoglycemia in pediatric patients The "Warnings and Precautions" and "Patient Counseling Information" sections of the labeling were updated between March 2023 and June 2024 to add additional information regarding hypoglycemia. Example: Coreg labeling An administrative error resulted in the inclusion of Betapace AF, Levatol, and Zebeta in the list of product names at the time of the initial quarterly posting. *An administrative error resulted in the omission of Hemangeol, Inderal LA, Innopran XL, Lopressor, and Tenormin from the list of product names and was added after the initial quarterly report was posted. Bosulif (bosutinib monohydrate) Gleevec (imatinib mesylate) Iclusig (ponatinib) Sprycel (dasatinib) Tasigna (nilotinib) Osteonecrosis The "Adverse Reactions" section of the Tasigna labeling was updated in February 2024 to include information about osteonecrosis. Tasigna labeling FDA determined that Gleevec and Sprycel are adequately labeled for osteonecrosis, and that no further regulatory action is needed at this time. FDA determined no action is necessary at this time for Iclusig and Bosulif based on available information. Cablivi (caplacizumab-yhdp) Hemorrhage The "Warnings and Precautions", "Drug Interactions", and "Patient Counseling Information" sections of the labeling were updated in February 2022 to include information about life-threatening and fatal bleeding. Cablivi labeling Cyramza (ramucirumab) Cardiac failure The "Adverse Reactions" section of the labeling was updated in March 2022 to include information about heart failure. Cyramza labeling Doxil (doxorubicin hydrochloride) Acute interstitial pneumonitis FDA determined that no action is necessary at the time based on available information. Gleevec (imatinib mesylate) Tasigna (nilotinib) Myasthenia gravis FDA determined that no action is necessary at the time based on available information. Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (ribociclib; letrozole) Verzenio (abemaciclib) Radiation recall phenomenon FDA determined that no action is necessary at the time based on available information. Lokelma (sodium zirconium cyclosilicate) Gastrointestinal disorders FDA determined that no action is necessary at the time based on available information. Padcev (enfortumab vedotin-ejfv) Pancreatitis FDA determined that no action is necessary at the time based on available information. Padcev (enfortumab vedotin-ejfv) Pneumonitis The "Adverse Reactions", "Warnings and Precautions", and "Patient Counseling Information" sections of the labeling were updated in July 2021 to include information about pneumonitis. Padcev labeling Poteligeo (mogamulizumab-kpkc) Cytomegalovirus viraemia The "Adverse Reactions" section of the labeling was updated in March 2022 to include cytomegalovirus infection. Poteligeo labeling Procysbi (cysteamine bitartrate) Generic products containing cysteamine bitartrate Fibrosing colonopathy The "Warnings and Precautions", "Adverse Reactions", "Patient Information", and "Patient Counseling Information" sections of the labeling were updated in February 2022 to include information about fibrosing colonopathy. Example: Procysbi labeling Sarclisa (isatuximab-irfc) Herpes zoster The "Dosage and Administration", "Adverse Reactions", and "Patient Information" sections of the labeling were updated in July 2022 to include information about herpes zoster. Sarclisa labeling Sprycel (dasatinib) Drug-induced liver injury The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information” and “Patient Information” sections of the labeling were updated in February 2023 to include information about hepatotoxicity. Sprycel labeling Taxotere (docetaxel) Rhabdomyolysis FDA determined that no action is necessary at the time based on available information. Veklury (remdesivir) Bradycardia FDA determined that no action is necessary at the time based on available information. Zepzelca (lurbinectedin) Extravasation The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in April 2022 to include information about extravasation. Zepzelca labeling Zepzelca (lurbinectedin) Tumor lysis syndrome The “Adverse Reactions” section of the labeling was updated in April 2022 to include tumor lysis syndrome. Zepzelca labeling Zepzelca (lurbinectedin) Rhabdomyolysis The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of the labeling were updated in April 2022 to include rhabdomyolysis. Zepzelca labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

上市批准

2025-07-31

·药时代

度普利尤单抗大卖80亿美元！赛诺菲公布2025Q2财报

全文共1200字，共3图预计阅读时间：4分钟7月31日，赛诺菲公布2025Q2财报，Q2营收99.94亿欧元（约109.54亿美元），同步增长10.1%（按固定汇率CER计算，同下），研发投入19.09亿欧元（约20.92亿美元），同步增长17.7%。2025年上半年，总营收198.89亿欧元（约218亿美元），同比增长9.9%。研发投入37.17亿欧元（约40.74亿美元），占总营收的18.69%。按2025年上半年平均汇率换算，1欧元=1.0961美元，下同在制药业务中，新上市产品放量迅速，8款产品上半年销售额为17.44亿欧元（19.12亿美元），增长41.7%。其中，A型血友病药物ALTUVIIIO增速最快，上半年销售额为5.42亿欧元，增长95.4%。就业务板块来看，免疫学与疫苗无疑为赛诺菲收入核心，上半年分别营收75.57亿欧元（约82.83亿美元）和60.41亿欧元（约66.22亿美元）。其中，普利尤单抗（Dupixent）作为赛诺菲的核心产品，一款要撑起了一个板块，上半年销售额高达73.12亿欧元（约80.15亿美元），同比增长20.7%。Dupixent的大卖得益于适应症的不断扩增，包括特应性皮炎 (AD)、哮喘、慢性阻塞性肺病 (COPD) 等，上季度Dupixent再次斩获大疱性类天疱疮的适应症。值得一提的是，COPD适应症的获批并未给Dupixent带来明显的二次增长。此前，赛诺菲预计该适应症，有望为Dupixent单年至多增加50亿欧元左右的销售额，且上一季度受存货影响，Dupixent还环比出现负增长。除了Dupixent，销售额增速超过20%的产品还有：RSV中和抗体Beyfortus、1型糖尿病药物Tzield、慢性移植物抗宿主病药物Rezurock、多发性骨髓瘤药物Sarclisa、酸性鞘磷脂酶缺乏症药物Xenpozyme、血小板减少性紫癜药物Cablivi、A 型血友病药物ALTUVII1O以及风湿性多肌痛药物Kevzara。战略动作方面，今年以来赛诺菲已经进行了五项并购，希望通过外部合作能够找到新的增长点。基于增长动能，赛诺菲将2025年销售指引上调至高个位数增长区间上限，核心每股收益预计低双位数增长。同期荣登《时代》全球可持续发展企业榜首（制药行业第一）。参考资料：1.赛诺菲官网2.各公司官网3.其他公开资料图片来源：公司官网logo市值蒸发超600亿美元，诺和诺德如何度过“至暗时刻”？2025-07-30突发！CBER主任Vinay Prasad上任不足三个月离职2025-07-30出海！泽安生物医药&礼来达成合作，助力自免管线研发2025-07-30版权声明/免责声明本文为原创文章。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点击这里，查看更多精彩！

财报并购疫苗

2025-07-02

·Abiosciences

科研最前沿 | 气道壁的单细胞空间图谱揭示健康与哮喘状态下的促炎细胞生态系统及其相互作用

点击蓝字关注我们Abiosciences发表期刊：Nature Immunology影响因子：27.7发表时间：2025年5月21日研究疾病：哮喘样本类型：健康者、哮喘患者（轻至重度哮喘，均接受抗炎治疗）、接受Imatinib（酪氨酸激酶抑制剂）或安慰剂治疗6个月后的哮喘患者的支气管活检样本样本数量：8例健康者和20例哮喘患者的支气管活检样本10x Xenium：1张切片，包含4例健康者和4例哮喘患者的支气管活检样本；1张切片，包含4例接受安慰剂和4例接受Imatinib治疗的哮喘患者的支气管活检样本GEOMx DSP：1张切片（48个ROI），5例健康者和11例哮喘患者的支气管活检样本样本分组：健康vs哮喘；接受安慰剂vs接受Imatinib治疗应用技术：10x Xenium 、GEOMx DSP研究背景。确定组织内细胞的空间位置对理解驻留细胞与炎症细胞间的相互作用至关重要，是揭示疾病驱动机制的关键因素。尽管靶向2型炎症的单克隆抗体改善了哮喘治疗，但仍有许多患者对治疗无响应，因此需要进一步理解浸润性炎症细胞与构成支气管壁的驻留结构细胞之间的相互作用。传统研究缺乏空间分辨率，本研究应用单细胞空间转录组学技术，以揭示健康和哮喘状态下气道壁的景观，识别促炎细胞生态系统及其相互作用。研究思路研究结论这篇文章利用Xenium（339 基因 Panel）和 GeoMx（全转录组）单细胞空间转录组学平台，分析 8 例健康供体和 20 例轻至重度哮喘患者（接受吸入糖皮质激素或生物制剂治疗）的支气管内活检标本。研究发现，健康和哮喘样本中均存在促炎性细胞生态系统，这些系统聚焦于上皮 - 上皮下区和黏膜腺区，二者以平滑肌层为界，以高水平的趋化因子和警报素表达为特征，并富含基底细胞（BC1、BC2）、杯状细胞、内皮细胞（EnC1、EnC2）。机制上，EnC2高表达非典型趋化因子受体ACKR1，提示其通过滞留趋化因子调控免疫细胞迁移。肥大细胞密集分布于血管周围，通过分泌AREG参与上皮-基质作用，可能影响组织修复。尽管哮喘患者接受了抗炎治疗，整体趋化因子和警报素表达下调，但其气道黏膜仍表现出独特的重塑程序：BC1、EnC2与杯状细胞在上皮区形成更紧密的聚类，成纤维细胞和肥大细胞浸润其中。黏膜腺区同样发生重构，表现为杯状细胞MUC5B表达升高及LTF高表达的新型浆液细胞亚群出现，提示治疗未能完全逆转组织重塑。在药物干预实验中，Imatinib治疗抑制了多数警报素和趋化因子的表达，削弱肥大细胞特征（如CPA3和KIT减少）和内皮细胞的促炎能力（IL33, ACKR1表达显著下降），减少了细胞聚集，并恢复了细胞的正常空间排列。研究通过 Drug2Cell 工具结合 ChEMBL 数据库，分析了药物 - 靶点的空间互作模式。发现某些药物（如 tisotumab vedotin 和 caplacizumab）在特定细胞类型中具有较高的靶点表达，这为未来的个性化治疗提供了潜在的靶点。研究意义本研究通过单细胞空间转录组学技术，首次绘制了人类气道壁在健康与哮喘状态下的高分辨率空间图谱，揭示了由基底细胞、内皮细胞和肥大细胞等组成的促炎细胞生态系统及其在哮喘中的重塑机制。研究证实空间位置对细胞功能表型的决定性作用，发现哮喘中炎症枢纽的异常聚集与药物抵抗相关，并通过Imatinib（酪氨酸激酶抑制剂）治疗试验验证了靶向干预可重塑细胞空间组织与炎症微环境。此外，结合 Drug2Cell 工具的空间药物 - 靶点分析，为精准定位治疗靶点（如 ACKR1、肥大细胞蛋白酶）和个性化用药提供了全新范式，对理解慢性呼吸道疾病的病理机制及开发针对性疗法具有重要意义。百奥锐评1. 研究主要聚焦于重度难治性哮喘患者，且样本来源可能存在人群差异（如地域、治疗史），难以完全代表所有哮喘亚型的病理机制和和治疗反应的多样性。其次，部分细胞（如嗜酸性粒细胞）mRNA 转录本丰度低及现有细胞分割技术限制，未能捕获全部细胞类型，可能遗漏关键免疫细胞在哮喘中的作用。未来的研究需要扩大样本量，并结合多种技术手段，以更全面地解析气道壁的细胞生态系统。2. 研究主要集中在支气管壁的上皮和黏液腺区域，未来的研究可以进一步探索其他气道区域（如平滑肌层）的细胞生态系统及其在哮喘中的作用。同时，结合临床数据和多组学分析，将有助于更深入地理解哮喘的病理机制，并开发更有效的治疗策略。原文链接：https://doi.org/10.1038/s41590-025-02161-3END百奥智汇媒体矩阵

抗体药物偶联物

100 项与卡普赛珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	卡普赛珠单抗	B01AX07	DB06081

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
血栓性血小板减少性紫癜	加拿大	Sanofi-Aventis Canada, Inc.	2020-09-04
获得性血栓性血小板减少性紫癜	欧盟	Ablynx NV	2018-08-30
获得性血栓性血小板减少性紫癜	冰岛	Ablynx NV	2018-08-30
获得性血栓性血小板减少性紫癜	列支敦士登	Ablynx NV	2018-08-30
获得性血栓性血小板减少性紫癜	挪威	Ablynx NV	2018-08-30

未上市

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适应症	最高研发状态	国家/地区	公司	日期
稳定型心绞痛	临床2期	奥地利	Ablynx NV	2009-09-01
稳定型心绞痛	临床2期	比利时	Ablynx NV	2009-09-01
稳定型心绞痛	临床2期	捷克	Ablynx NV	2009-09-01
稳定型心绞痛	临床2期	德国	Ablynx NV	2009-09-01
稳定型心绞痛	临床2期	以色列	Ablynx NV	2009-09-01
稳定型心绞痛	临床2期	波兰	Ablynx NV	2009-09-01
稳定型心绞痛	临床2期	瑞士	Ablynx NV	2009-09-01
不稳定型心绞痛	临床2期	奥地利	Ablynx NV	2009-09-01
不稳定型心绞痛	临床2期	比利时	Ablynx NV	2009-09-01
不稳定型心绞痛	临床2期	捷克	Ablynx NV	2009-09-01

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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


ASH2024	N/A	血栓性血小板减少性紫癜	-	Caplacizumab	壓壓窪範廠糧願觸鏇憲(鏇選構襯憲顧憲簾範夢) = 獵壓鑰憲憲選構齋醖構憲繭鹽糧鑰齋鬱築餘鹽 (窪構膚鏇憲憲築築壓鬱 ) 更多	-	2024-12-08
				No Caplacizumab	淵觸鏇夢範壓夢構鬱製(選憲遞艱構齋觸鹹鏇鑰) = 餘蓋選襯壓鏇製構憲構餘夢衊製蓋衊獵鏇廠膚 (齋顧醖遞醖鏇夢蓋鬱築 ) 更多
NCT04985318 (REACT-2020, EHA2024)	N/A	血栓性血小板减少性紫癜	200	Caplacizumab-treated iTTP patients	窪顧鏇醖觸鏇製遞鹽觸(醖鬱範襯窪淵鹹蓋鹽蓋) = 窪醖顧壓願鹹齋膚鏇鹽餘憲鬱衊築醖築網淵糧 (艱築積鏇鏇淵顧餘製廠 ) 更多	积极	2024-05-14
ASH2023	N/A	获得性血栓性血小板减少性紫癜	33	Caplacizumab (Conventional treatment alone)	網製繭網積醖選壓積網(憲觸夢艱淵選網觸鹽願) = 鹹糧襯襯憲構築獵艱壓鹽鹽鑰簾鹹壓齋蓋製憲 (艱衊繭衊鑰壓範網糧願 ) 更多	积极	2023-12-10
				Conventional treatment + Caplacizumab	網製繭網積醖選壓積網(憲觸夢艱淵選網觸鹽願) = 鹽醖蓋壓鏇襯壓蓋網觸鹽鹽鑰簾鹹壓齋蓋製憲 (艱衊繭衊鑰壓範網糧願 )
ISTH2023	N/A	血栓性血小板减少性紫癜	505	Caplacizumab	築鏇簾襯齋艱窪鹽鏇鏇(積顧夢繭鬱鑰艱獵餘鏇) = Our study shows that bleeding is a common complication of Caplacizumab, which decreases the VWF levels and increases bleeding risk 構襯觸積製鹽蓋艱餘積 (鏇觸顧繭齋鏇範壓淵積 )	-	2023-06-24
EHA2023	N/A	获得性血栓性血小板减少性紫癜	60	CAPLACIZUMAB (Patients ≥60 years)	糧餘網窪選襯繭遞顧繭(鏇衊簾膚遞積製蓋艱鹹) = one patient ≥60 years died on day 12 after diagnosis due to multiorgan failure that was not considered caplacizumab-related, but progression of iTTP 鹹繭鹽襯鏇窪選夢鏇糧 (積壓齋構廠築鑰糧鬱築 ) 更多	-	2023-06-08
				CAPLACIZUMAB (Patients <60 years)
NCT04985318 (Pubmed \| J Thromb Haemost)	N/A	获得性血栓性血小板减少性紫癜一线	-	Caplacizumab	膚簾繭築壓淵夢鹽淵襯(簾廠製夢廠簾壓襯積獵) = 繭醖遞窪簾壓築醖獵廠鏇蓋鏇遞積糧範觸顧餘 (夢獵夢窪願壓積觸艱衊 ) 更多	-	2022-12-22
NCT04074187 (Pubmed)	临床2/3期	获得性血栓性血小板减少性紫癜	21	Caplacizumab 10mg	窪簾壓簾鏇鹽選願鏇簾(膚選構願築製鬱醖觸遞) = 網餘簾窪糧艱壓壓願簾鑰範蓋願衊構淵廠齋鏇 (夢齋窪願鹹遞餘餘憲鏇 )	积极	2022-11-24
NCT04985318 (REACT-2020, ASN2022)	N/A	获得性血栓性血小板减少性紫癜一线 ADAMTS13 activity below 10 percent \| relapsing thrombotic microangiopathy	-	Caplacizumab	廠範餘廠醖齋積鑰顧鹽(遞顧築選遞遞齋製衊鑰) = 網鬱遞餘願顧鏇鹹獵糧鹹選蓋顧鹽膚積顧憲淵 (醖獵醖窪築鹹艱鏇鹹鹽 )	积极	2022-11-03
				Standard of care without Caplacizumab	廠範餘廠醖齋積鑰顧鹽(遞顧築選遞遞齋製衊鑰) = 觸製選鏇選鏇艱構糧憲鹹選蓋顧鹽膚積顧憲淵 (醖獵醖窪築鹹艱鏇鹹鹽 )
NCT02878603 (HERCULES, Pubmed)	临床3期	获得性血栓性血小板减少性紫癜	104	Caplacizumab+TPE+IST	願築願遞餘糧簾網網夢(鏇鏇鏇膚餘憲醖襯觸鏇) = 餘齋顧鏇鏇糧膚鑰構鹽蓋壓鏇築積觸遞製襯鬱 (獵顧鏇繭鑰積蓋蓋繭糧 ) 更多	积极	2022-09-22
				Placebo+TPE+IST	願築願遞餘糧簾網網夢(鏇鏇鏇膚餘憲醖襯觸鏇) = 顧積憲遞鏇觸築鑰壓選蓋壓鏇築積觸遞製襯鬱 (獵顧鏇繭鑰積蓋蓋繭糧 )
Milan TTP Registry (ISTH2022)	N/A	获得性血栓性血小板减少性紫癜	26	Caplacizumab	繭獵醖選遞蓋網遞鹹憲(襯網夢糧簾衊鏇顧夢選) = 鏇遞鏇壓繭鑰範繭築鹹構鹹淵觸艱膚襯範鑰選 (範醖願鏇鏇糧鏇願範遞 )	积极	2022-07-09