更新于：2024-12-14
Aprocitentan
更新于：2024-12-14
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2024-03-19), |
最高研发阶段(中国)临床3期 |
特殊审评- |
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结构
分子式C16H14Br2N6O4S |
InChIKeyDKULOVKANLVDEA-UHFFFAOYSA-N |
CAS号1103522-45-7 |
关联
14
项与 Aprocitentan 相关的临床试验A Single-center, Open-label, Randomized, Two-way Crossover Phase 1 Study to Compare the Single-dose Pharmacokinetics of Different Tablet Formulations of Aprocitentan in Healthy Subjects
The main purpose is to study the pharmacokinetics of aprocitentan (ACT-132577) using 2 different tablet formulations. The clinical pharmacology data will be used to determine bioequivalence of 2 different tablet formulations.
开始日期2022-02-02 |
申办/合作机构 |
An Open-label Phase 1 Study to Investigate the Effect of Moderate Hepatic Impairment Due to Liver Cirrhosis on the Pharmacokinetics of a Single Dose of 25 mg Aprocitentan
This is a prospective, open-label, single-dose, Phase 1 study, to assess the effect of moderate hepatic impairment due to liver cirrhosis on the pharmacokinetics of aprocitentan (ACT-132577).
开始日期2020-06-26 |
申办/合作机构 |
Prospective, Single-center, Randomized, Double-blind, Placebo- and Moxifloxacin-controlled, 4-way Crossover Phase 1 Study to Assess the Effect of Multiple Therapeutic and Supratherapeutic Doses of Aprocitentan on the QT Interval Duration in Healthy Subjects
To demonstrate that multiple-dose administration of oral therapeutic and supratherapeutic doses of aprocitentan do not have a clinically relevant effect on the QT interval.
开始日期2020-01-14 |
申办/合作机构 |
100 项与 Aprocitentan 相关的临床结果
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100 项与 Aprocitentan 相关的转化医学
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100 项与 Aprocitentan 相关的专利（医药）
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58
项与 Aprocitentan 相关的文献（医药）2024-12-31·BLOOD PRESSURE
Aprocitentan: a new emerging prospect in the pharmacotherapy of hypertension
Review
作者: Naseralallah, Lina ; Koraysh, Somaya
BACKGROUND:
Resistant hypertension (RH) is linked to higher risks of cardiovascular events and there remains an unmet therapeutic need driven by pathophysiologic pathways unaddressed by guideline-recommended therapy. Whilst spironolactone is considered the preferred fourth-line therapy, its broad application is limited by its safety profile. Aprocitentan is a novel dual endothelin (ET) A and B receptors antagonist that has been recently approved by the FDA.
OBJECTIVE:
This review aims to summarise the available evidence on the discovery, pharmacokinetic, pharmacodynamic, efficacy, and safety of aprocitentan in the pharmacotherapy of RH.
METHODS:
We searched PubMed, Embase, and International Pharmaceutical Abstracts to identify relevant papers on aprocitentan use. Clinical trial registries were also searched.
RESULTS:
Aprocitentan targets the ET pathway which remains unopposed by contemporary alternative therapies for RH. It differs from other ET receptor antagonists in its pharmacological profile, as it is eliminated independently of CYP450 or BCRP, making it less likely to cause drug-drug interactions. Current evidence demonstrates that compared to placebo, aprocitentan significantly reduces blood pressure (BP) as measured via unattended automated office BP and 24-hour ambulatory BP. The most frequently reported adverse effects were fluid retention/edema and anaemia.
CONCLUSION:
Aprocitentan is a novel therapy for the management of RH that significantly reduces BP when compared to placebo. It delivers exciting prospects for future therapeutic options in the setting of RH and expands insights into its pathophysiology. However there is lack of data in relation to broader cardiovascular and renal protection, as well as its long-term safety profile.
2024-11-01·Heart (British Cardiac Society)
Diagnosis and management of resistant hypertension
Review
作者: Kreutz, Reinhold ; Cho, Myeong-Chan ; Camafort, Miguel
Resistant hypertension is a condition where blood pressure levels remain elevated above target despite changes in lifestyle and concurrent use of at least three antihypertensive agents, including a long-acting calcium channel blocker (CCB), a blocker of the renin-angiotensin system (ACE inhibitor or angiotensin receptor blocker) and a diuretic. To be diagnosed as resistant hypertension, maintaining adherence to therapy is required along with confirmation of blood pressure levels above target by out-of-office blood pressure measurements and exclusion of secondary causes of hypertension. The key management points of this condition include lifestyle changes such as reduced sodium and alcohol intake, regular physical activity, weight loss and discontinuation of substances that can interfere with blood pressure control. It is also recommended that current treatment be rationalised, including single pill combination treatment where antihypertensive drugs should be provided at the maximum tolerated dose. It is further recommended that current drugs be replaced with a more appropriate and less difficult treatment regimen based on the patient’s age, ethnicity, comorbidities and risk of drug–drug interactions. The fourth line of treatment for patients with resistant hypertension should include mineralocorticoid receptor antagonists such as spironolactone, as demonstrated in the PATHWAY-2 trial and meta-analyses. Alternatives to spironolactone include amiloride, doxazosin, eplerenone, clonidine and beta-blockers, as well as any other antihypertensive drugs not already in use. New approaches under research are selective non-steroidal mineralocorticoid receptor antagonists such as finerenone, esaxerenone and ocedurenone, selective aldosterone synthase inhibitors such as baxdrostat, and dual endothelin antagonist aprocitentan.
2024-09-01·Expert Review of Cardiovascular Therapy
Options for patients with out-of-control blood pressure: after all avenues have been exhausted
Review
作者: Tomlinson, Brian ; Zeng, Weiwei
INTRODUCTION:
Uncontrolled hypertension is the leading risk factor for global mortality. Most hypertensive patients can be controlled with standard medication combinations, but some may not respond adequately to ≥3 or even to ≥5 antihypertensive agents.
AREAS COVERED:
In this review, we summarize the recent literature on difficult-to-treat hypertension identified by a Medline search, and we discuss the options for fourth line and subsequent therapy.
EXPERT OPINION:
It is essential to confirm resistant hypertension with out-of-office blood pressure measurements and to consider lifestyle factors, adherence to medication and secondary causes of hypertension. When true resistant hypertension is confirmed and blood pressure is not controlled with an optimal triple combination, preferably as a fixed dose combination tablet, spironolactone is usually recommended as the fourth medication. Comorbid conditions should be treated as appropriate with sodium-glucose-cotransporter 2 inhibitors, glucagon-like peptide-1 receptor agonists, sacubitril-valsartan or finerenone. Renal denervation appears to be a useful addition to overcome some of the problems of medication adherence. The endothelin antagonist aprocitentan may be a final option in some countries. Of the drugs in development, the RNA based therapeutics that inhibit angiotensinogen synthesis appear to be some of the most promising.
96
项与 Aprocitentan 相关的新闻（医药）2024-11-29
Company enters into exclusive negotiations with an undisclosed party for global rights to aprocitentan
Company to streamline the business, resulting in cost containment – consequently, approximately 270 positions globally could become redundant
Company plans to restructure its outstanding debt
November 27, 2024 Idorsia Ltd (SIX: IDIA) today announced that it has entered into exclusive negotiations with an undisclosed party for the global rights to aprocitentan. Idorsia will receive an exclusivity fee of USD 35 million, which extends Idorsia’s cash runway into 2025. The potential agreement under discussion could include an upfront payment, additional milestone payments, and tiered royalties on sales in return for the transfer of global rights to aprocitentan and certain team members from Idorsia.
André C. Muller, CEO of Idorsia, commented: “I am pleased to announce that we made an important step to reaching a potential agreement for the global rights to aprocitentan. We are targeting signing before the end of 2024 and closing in early 2025, more details will be shared should a final agreement be signed. This is a first and crucial step in our plan to put Idorsia in a financially sustainable position and on the road towards profitability.”
André continued: “In addition, we are implementing initiatives which include cost-containment measures, and steps to restructure our outstanding debt. I am confident that our plan is achievable within the next few months, and that will allow us to shift our focus back to our products. Simply put, we must contain our ambition and restrict our investments until we are generating the revenues from both proprietary and partnered products that will sustain our activities.”
To reach sustainable profitability, the company must focus its efforts, reducing the number of active projects in research and development and preparing some for out-licensing. Consequently, a reduction of the number of employees is envisaged. Depending on the outcome of a consultation process initiated with employee representatives at headquarters, approximately 270 positions globally could become redundant, mainly in Research & Development and support functions at headquarters. Idorsia’s key global functions will continue to be headquartered in Allschwil, Switzerland. The company is committed to minimizing the number of potential redundancies through natural attrition, retirement, transfer along with aprocitentan, and other measures. As part of the ongoing aprocitentan discussions, the company is looking for ways to mitigate the social impact. The company expects some employees could potentially be offered the opportunity to continue to pursue their efforts to make aprocitentan a success should a final agreement be reached. Upon completion of the consultation process, Idorsia intends to conclude restructuring by the end of 2024, with the cost reduction becoming fully effective by Q2 2025.
Aprocitentan is Idorsia’s once-daily, orally active, dual endothelin receptor antagonist, which inhibits the binding of ET-1 to ETA and ETB receptors. On March 19, 2024, aprocitentan was approved as TRYVIO™ in the US. On June 27, 2024, aprocitentan was granted market authorization by the European Commission as JERAYGO™.
Idorsia Ltd is reaching out for more – we have more passion for science, we see more opportunities, and we want to help more patients.
The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize innovative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core.
Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has an experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients.
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上市批准引进/卖出
2024-11-27
Today, a brief rundown of news involving Kronos Bio, Idorsia and PTC Therapeutics, as well as updates from Alnylam Pharmaceuticals and Soleno Therapeutics that you may have missed.Kronos Bio will lay off 83% of its workforce by years end and its CEO, Norbert Bischofberger, will step down effective Dec. 3, the company said Wednesday. Deborah Knobelman, the companys chief operating officer and CFO appointed earlier this year, will become interim CEO. Kronos, which studies how to activate and deactivate genes to treat cancer and inflammatory disorders, had 97 employees as of Jan. 1, 2023, but layoffs reduced that number to 62 employees as of March 11 this year. A spokesperson didnt respond to a question about how many employees will remain after this round of layoffs. In November, Kronos halted work on its lead candidate in ovarian cancer because the benefit-risk profile [did]not warrant further clinical evaluation and announced it would begin a strategic review. Jonathan GardnerIdorsia is in discussions to sell global rights to its blood pressure drug aprocitentan sold in the U.S. as Tryvio to an undisclosed buyer. In return for agreeing to exclusive talks, Idorsia will receive a $35 million fee from the unnamed company, money that extends the biotechs runway into 2025. But to reach profitability, Idorsia has concluded it also needs to trim costs, and is considering cutting as many as 270 positions globally. The jobs potentially affected are mainly in R&D and support roles, Idorsia said, but some staff may be offered the opportunity to continue working on aprocitentan should a sale agreement be reached. Ned PagliaruloPTC Therapeutics is shelving a drug that just failed as a treatment for amyotrophic lateral sclerosis. According to the company, high-level results showed the drug didnt meet the main objective of the roughly 300-person trial, nor did it hit secondary goals focused on effectiveness. Analysts hadnt ascribed much, if any, value to this program, which may help explain why PTC shares were down only 2% in after-hours trading Tuesday. On Wednesday, the company announced plans to sell a priority review voucher, which it just won with U.S. approval of Kebilidi, to an unnamed buyer for $150 million. Jacob BellAcadia Pharmaceuticals has purchased exclusive worldwide rights to an experimental medicine from Saniona, a Denmark-based company. The medicine is meant to regulate a brain-calming chemical, and Acadia plans to start in 2026 a mid-stage study testing it in patients with essential tremor. Announced Tuesday, the deal is heavily backloaded, with Acadia shelling out $28 million upfront while offering as much as $582 million in potential milestone payments. Saniona may also receive tiered royalties on net sales of any resulting products. Jacob BellSoleno Therapeutics has to wait another three months before it learns whether the Food and Drug Administration will grant an approval of its drug for Prader-Wili syndrome, a rare disease characterized by feelings of intense hunger and developmental delays. The agency set a new decision deadline of March 27, 2025, extending its review to allow for assessment of new information provided by Soleno. Ned PagliaruloBy March 23, the FDA will decide whether to approve Alnylam Pharmaceuticals drug for a cardiac form of transthyretin amyloidosis known as ATTR-CM for short. If cleared, Alnylams drug would compete with Pfizers tafamidis and BridgeBio Pharmas recently OKd Attruby, and give physicians three treatment options for a deadly condition thought to affect tens of thousands of people in the U.S. and Europe. The FDA does not currently plan to hold an advisory committee to further vet Alnylams application, the company said Monday. Ned Pagliarulo '
高管变更加速审批
2024-11-13
关注并星标CPHI制药在线
减肥药开发是医药行业目前最大的热点之一，甚至有分析机构预测，减肥药市场未来的规模将发展到2000亿美元的水平，几乎可以和目前的肿瘤学产品比肩，因此众多生物医药和科技公司都渴望跻身这个拥有巨大开发潜力的市场之中。诺和诺德的减肥药Wegovy今年第三季度获得了25亿美元的销售业绩，预计明年将拿下130亿美元的全球销售额，并一举跻身重磅炸弹前十名的榜单。在这样一片大好的局面下，即便诺和的Wegovy和礼来的Zepbound把持了目前减肥药市场的绝大部分市场，但仍然有一干减肥药开发商抱着“野芳虽晚不须嗟”的信念在开发减肥药的道路上大干快上。而在另一块平行战场上，减肥药项目和企业的收购竞争也在经历激烈的明争暗斗。
最新的大热收购目标是12年前创立的总部位于加州圣迭戈的Viking Therapeutics。
Viking Therapeutics 的口服多肽减肥药 VK2735 在 1 期临床试验中表现出较高的有效性和安全性，吸引了行业的广泛关注。VK2735 是一种双重 GLP-1/GIP 受体激动剂。在其I期研究中，受试者的体重显著下降，并且VK2735表现出了良好的安全性和耐受性。在 100 mg 的最高剂量组中，VK2735 实现了安慰剂调整后28天6.8%的减重率，这个数据令行业侧目。众多分析师在看好VK2735未来的同时，也纷纷认为Viking Therapeutics将成为制药业巨头收购的下一个热点。
Viking没有稳定的资金注入，独自完成VK2735上市的目标稍显艰巨，尤其是考虑到口服版本的研究仍然处于I期，皮下注射的临床也只是II期，因此需要大量资金的注入才有可能实现产品的上市。之前Viking似乎一直处于“待价而沽”的状态，等待的似乎就是关键里程碑的实现。而如今I期口服制剂数据的出炉似乎就是最好的时机，因此Viking的收购成为了越来越接近现实的交易。
包括辉瑞和阿斯利康在内的多家大型公司在内，他们收购减肥药资产或公司的意愿早已不是秘密。阿斯利康从中国Eccogene Inc.（诚意生物）收购的GLP-1减肥药资产AZD5004恰好也是一款口服制剂，但不同于VK2735，AZD5004是一款小分子药物。阿斯利康也在近期的ObesityWeek 2024会议上公布了AZD5004的I期数据，显示出5.8%的四周减重率。因此阿斯利康继续收购口服减肥药资产的意愿可能没有那么强烈。而辉瑞在终止了其小分子GLP-1口服减肥药资产lotiglipron之后，又终止了另一款口服小分子减肥药danuglipron每日两剂的临床研究，目前只剩下danuglipron的每日一剂肥胖症项目，因此收购意图可能更为强烈。
除了Viking Therapeutics之外，作为“收购靶点”的公司还包括下列减肥候选药资产拥有者：
Structure Therapeutics
• 总部：美国加州南旧金山
• 成立时间：2021年
• 市值（2024年11月6日值，下同）：22亿美元
• 主要减肥药资产：Aleniglipron（又名GSBR-1290口服GLP-1受体激动剂），II期数据公布
• 收购看点：Aleniglipron的II期数据与礼来小分子口服GLP-1减肥候药orforglipron可比（12周安慰剂调整后减重率6.2%），但停药率可能较低。小分子口服药具有明显的成本优势，因此代表了减肥药开发的下一波热点。那些拥有口服减肥药资产，且已经产生了不错临床中后期数据的中小公司必然会成为收购重点。
• 收购阻碍：开发位置看上去至少落后orforglipron一年。在机制相同、疗效相近、模态一样的情况下，时间线决定了未来的市场地位和如今的收购价值。
Altimmune Inc.
• 总部：美国马里兰州Gaithersburg
• 成立时间：1997年
• 市值：5.1亿美元
• 主要减肥药资产：Pemvidutide（每周注射一次多肽GLP-1/胰高血糖素双受体共激动剂），III期研究中。
• 收购看点：长期减重率略优于Wegovy。2.4 mg pemvidutide 48周减重率15.6%。Pemvidutide同时对代谢障碍相关脂肪型肝炎（MASH）进行临床研究。
• 收购障碍：20% 的停药率可能是一个限制因素，但随着患者进入第 3 阶段，允许剂量减少，这应该会对耐受性所有帮助。
Zealand Pharma
• 总部：丹麦哥本哈根
• 成立时间：1999年
• 市值：87.6亿美元
• 主要减肥药资产：Survodutide（每周注射一次的多肽GLP-1/胰高血糖素双受体共激动剂），III期临床进行中，授权勃林格殷格翰开发；Dapiglutide（GLP-1/GLP-2共激动剂），II期进行中；Petrelintide（胰淀素类似物），II期进行中。
• 收购看点：Zealand Pharma将根据survodutide全球销售额获取10%左右的版税；项目已经进入III期，有望成为首批Wegovy和Zepbound的挑战者；46周19%减重率；针对MASH开发获得FDA突破性疗法头衔；同时拥有新颖机制的GLP-1/GLP-2双受体共激动剂中期资产，以及胰淀素激动剂中期资产petrelintide。Zealand Pharma在不久前的ObesityWeek 2024会议中公布了petrelintide的I期数据，引发了广泛关注。多次递增剂量 I 期试验数据显示，在16周每周注射一次（剂量分别为 2.4 mg, 4.8 mg 和 9.0 mg）后，平均体重减轻 4.8%、8.6% 和 8.3%，而合并安慰剂组减轻 1.7%。这显示了petrelintide不仅在机制上能够填补目前减肥药的空白，在实际疗效上可能也具备了未来与semaglutide和tirzepatide分庭抗礼的潜力。美国银行分析师表示，他们预计petrelintide将主要用于 GLP-1 不耐受或失败市场（约占 20% 的患者），并预计其年销售额将达到 80 亿美元的峰值。
• 收购障碍：自身被收购意愿可能较低，但Zealand Pharma已经表达出了正在寻找共同开发petrelintide的合作伙伴的动态。与授权survodutide的模式不同，Zealand Pharma将参与petrelintide的开发与商业化的整个过程。Zealand Pharma的CEO表示，目前已就petrelintide的潜在合作开发与前十大制药企业中的一家产生了关联，但不肯透露更多的消息。
Fractyl Health
• 总部：美国马萨诸塞州Burlington
• 成立时间：2010年
• 市值：1.1亿美元
• 主要减肥药资产：Revita（一种门诊内窥镜手术，通过热液消融持久改变十二指肠功能障碍，从而恢复代谢健康。有证据表明，Revita 可能为肥胖和 2 型糖尿病患者提供持久的体重维持和改善血糖控制。针对接受 GLP-1 药物治疗体重至少减轻 15% 并希望停止使用 GLA-1 药物而不反弹的患者进行临床研究）；Rejuva （一种新型局部给药 AAV 基因疗法，目前处于临床前开发阶段，可改善胰岛功能。通过改变患者的胰腺胰岛细胞中的代谢激素反应，实现持久的体重减轻和 2 型糖尿病的长期缓解。）
• 收购看点：提供长期体重管理的方案
• 收购障碍：特殊治疗后产生的不良反应
潜在肥胖症资产和公司买家
• 默沙东（收购意愿：高）：默沙东的药王Keytruda将在2028年专利到期，默沙东对代谢类疾病表现出了高度兴趣，但缺乏GLP-1管线资产。
• 诺和诺德（收购意愿：高）：诺和诺德一直在通过资产购买的方式巩固自己在代谢疾病领域的领先地位。
• 辉瑞（收购意愿：中/高）：辉瑞一直在努力开发口服减肥药，但屡遭挫折。目前几乎硕果仅存的GLP-1小分子减肥候选药daniglupron的前景并不被看好，因此在此路不通的情况下，辉瑞可能选择外部资产的引入。
• 强生（收购意愿：中/高）：近期代谢疾病领域的挫折（Xarelto, Invokana, aprocitentan）大大刺激了强生通过收购外部资产的渴望。
• 礼来（收购意愿：高）：与诺和诺德的减肥药“军备竞赛”。
• 阿斯利康（收购意愿：中/高）：从中国Eccogene Inc.（诚意生物）收购的GLP-1减肥药资产AZD5004令阿斯利康在减肥药竞赛中处于了一个有利的位置。阿斯利康透露出减肥药与Farxiga设计联合疗法的强烈愿望。
• 勃林格殷格翰（收购意愿：高）：BI对于代谢疾病疗法开发具有很高兴趣，其survodutide是从Zealand Pharma获取授权的资产，因此拥有一款独立的减肥药资产对于BI有着强大的吸引力。
• 罗氏（收购意愿：中/高）：最近从Carmot收购GLP-1资产显示了罗氏对开发减肥药的兴趣。罗氏并不算充盈的减肥药管线昭示着可能会有更多的收购项目到来。
• 第一三共（收购意愿：中）：尽管代谢类疾病曾经是第一三共的开发重点，但其目前的核心资产是肿瘤学产品。
• 赛诺菲（收购意愿：中）：赛诺菲的开发中心已经转移到了炎症和免疫产品，但历史上对于代谢疾病的开发可能重燃赛诺菲进军肥胖症的热情。
• 诺华（收购意愿：中）：虽然拥有不少代谢疾病资产，但诺华的核心竞争力在于肿瘤学、免疫学和罕见疾病。
Ref.
Malone, E. Top 10 Drugs Q2 2024: Mounjaro Comes Roaring In. Skyrizi Also Makes Its Debut. Scrip. 24. 10. 2024.
Structure Therapeutics Reports Positive Topline Data from its Phase 2a Obesity Study and Capsule to Tablet PK Study for its Oral Non-Peptide Small Molecule GLP-1 Receptor Agonist GSBR-1290. Structure Press Release. 03. 06. 2024.
Boehringer Ingelheim to advance survodutide into three global Phase III studies in obesity. BI Press Release. 17. 08. 2023.
Obesity Drugs: The Next Wave of GLP-1 Competition. New drugs from public and private companies will challenge Novo and Lilly's dominance. Morningstar & PitchBook. Sept. 2024.
END
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 难治性高血压 | 欧盟 | 2024-07-01 | |
| 难治性高血压 | 冰岛 | 2024-07-01 | |
| 难治性高血压 | 列支敦士登 | 2024-07-01 | |
| 难治性高血压 | 挪威 | 2024-07-01 | |
| 高血压 | 美国 | 2024-03-19 | |
| 高血压 | 美国 | 2024-03-19 |
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 慢性肾病 | 临床3期 | - | 2020-01-01 | |
| 慢性肾病 | 临床3期 | - | 2020-01-01 | |
| 原发性高血压 | 临床2期 | 美国 | 2015-12-14 | |
| 原发性高血压 | 临床2期 | 加拿大 | 2015-12-14 | |
| 原发性高血压 | 临床2期 | 以色列 | 2015-12-14 | |
| 原发性高血压 | 临床2期 | 波多黎各 | 2015-12-14 | |
| 肝硬化 | 临床1期 | 德国 | 2020-06-26 | |
| 肝硬化 | 临床1期 | 波兰 | 2020-06-26 | |
| 肝损伤 | 临床1期 | 德国 | 2020-06-26 | |
| 肝损伤 | 临床1期 | 波兰 | 2020-06-26 |
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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 |
|---|
临床3期 | - | Aprocitentan (12.5 mg) | 壓淵壓簾淵獵憲蓋觸膚(觸願壓鏇願夢廠醖網衊) = 顧積網憲積蓋製繭衊鏇 壓衊蓋觸淵艱餘壓觸蓋 (鬱淵繭夢鹽齋糧餘憲願, −17.5 ~ −13.3) 更多 | 优效 | 2024-03-19 | ||
Placebo | 壓淵壓簾淵獵憲蓋觸膚(觸願壓鏇願夢廠醖網衊) = 艱範廠糧鏇齋構餘蓋艱 壓衊蓋觸淵艱餘壓觸蓋 (鬱淵繭夢鹽齋糧餘憲願, −13.7 ~ −9.5) 更多 | ||||||
临床3期 | 730 | (Aprocitentan 12.5 mg in Part 1 (Double-blind)) | 構遞範夢製膚範願願膚(顧艱鑰鹽襯艱廠壓繭積) = 顧簾鹹製淵夢觸構鏇簾 夢網壓網鬱窪構鏇鹹窪 (繭窪膚構構簾選觸構淵, 選繭選蓋廠願鬱觸獵齋 ~ 築網網獵選積鏇鏇糧蓋) 更多 | - | 2023-03-21 | ||
(Aprocitentan 25 mg in Part 1 (Double-blind)) | 構遞範夢製膚範願願膚(顧艱鑰鹽襯艱廠壓繭積) = 觸製構艱窪廠齋遞積鹽 夢網壓網鬱窪構鏇鹹窪 (繭窪膚構構簾選觸構淵, 餘廠糧積蓋醖齋鏇膚鬱 ~ 網顧遞蓋觸網齋糧襯艱) 更多 | ||||||
临床2期 | 1,659 | Placebo (Placebo) | 膚遞糧簾廠窪廠願艱醖(遞醖網鹹齋壓製醖網鏇) = 蓋廠齋夢願積選蓋窪憲 糧夢選鹹蓋鑰鑰選鏇壓 (糧獵蓋選選願淵製鬱鑰, 餘簾餘淵艱鹹鬱夢鏇顧 ~ 範蓋蓋夢膚憲窪網構齋) 更多 | - | 2020-04-13 | ||
(Aprocitentan 5 mg) | 膚遞糧簾廠窪廠願艱醖(遞醖網鹹齋壓製醖網鏇) = 鑰窪遞網醖願壓窪觸鹽 糧夢選鹹蓋鑰鑰選鏇壓 (糧獵蓋選選願淵製鬱鑰, 廠積鬱廠淵鹽鹹獵齋鹹 ~ 襯壓積鏇選蓋廠網鑰鬱) 更多 |
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