A Single-center, Randomized, Placebo-controlled, Parallel-group, Double-blind Study to Investigate the Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of BAY 1817080 in Chinese Healthy Adult Male Participants.

Researchers are looking for a better way to treat chronic cough. Before patients with medical conditions can join clinical trials, researchers do trials in healthy participants first to understand how the body acts on the new treatment and learn how safe it is.
In this trial, the researchers will study how much of the trial drug, BAY1817080, gets into the blood in a small number of participants. The trial will include about 39 healthy Chinese male who are aged 18 to 45.
For this trial participants will be divided in 3 groups. Groups 1 and 2 will take either dose 1 or dose 2 of BAY1817080 or placebo 1 time. Participants of groups 3 will take dose 3 of BAY1817080 or placebo one time at the first day and continue to take dose 3 of BAY1817080 twice a day from day 7 to day 16 of the trial. On day 17 they will take only one dose 3 of BAY1817080.
All participants will take BAY1817080 or a placebo as a tablet by mouth. For this trial, the participants in Groups 1 and 2 will stay at the trial site for up to 10 days. The participants in Group 3 will stay at the trial site for up to 26 days. The trial will last up to 4 weeks for the participants in Groups 1 and 2, and 6 weeks for the participants in Group 3.
During the trial, the doctors will take blood and urine samples and check the participants blood pressure, pulse rate and electrocardiogram (ECG). The participants will answer questions about how they are feeling to check their general wellbeing.

开始日期2021-04-02

申办/合作机构

Bayer AG

CTR20210308 / Completed临床1期

一项在中国健康成年男性受试者中评估BAY 1817080单次和多次口服给药的药代动力学、安全性和耐受性的单中心、随机、安慰剂对照、平行组、双盲研究。

研究人员正在寻找治疗慢性咳嗽的更好方法。在患有疾病的患者可以参加临床试验之前，研究人员首先在少数健康志愿者中进行药代动力学、安全性和耐受性的研究，以支持BAY 1817080在慢性咳嗽患者中的进一步开发。

开始日期2021-04-02

申办/合作机构

拜耳医药保健有限公司

100 项与 Eliapixant 相关的临床结果

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100 项与 Eliapixant 相关的转化医学

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100 项与 Eliapixant 相关的专利（医药）

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项与 Eliapixant 相关的文献（医药）

2024-06-21·Clinical pharmacokinetics

P2X3 Receptor Antagonist Eliapixant in Phase I Clinical Trials: Safety and Inter-ethnic Comparison of Pharmacokinetics in Healthy Chinese and Japanese Participants.

Article

作者: Reif, Stefanie ; Klein, Stefan ; Li, Hui ; Okumura, Kazuhito ; Chen, Huijun ; Haranaka, Miwa ; Francke, Klaus ; Liu, Pei ; Friedrich, Christian ; Li, Xuening

BACKGROUNDAfferent neuronal hypersensitization via P2X3 receptor signaling has been implicated as a driver of several disorders, including refractory chronic cough, endometriosis, diabetic neuropathic pain, and overactive bladder. Eliapixant, a selective P2X3 receptor antagonist, has been in clinical development for all four disorders.OBJECTIVEThis paper describes pharmacokinetic (PK) and safety data from two phase I studies of eliapixant in healthy Japanese and Chinese participants and compares those data within the two populations and with previous multiple dose data from Caucasian participants.METHODSTwo separate phase I, single-center, randomized, placebo-controlled studies were conducted with healthy male participants. The Japanese study was single-blind and the Chinese study was double-blind. Eliapixant was administered as an oral amorphous solid dispersion immediate-release tablet in strengths of 25 mg, 75 mg, and 150 mg. PK characteristics after a single dose (SD) and at steady state (multiple dose [MD], twice daily), adverse events (AEs), and tolerability were evaluated. A post hoc comparison of PK characteristics after SD of eliapixant in Japanese and Chinese participants, and after MD of eliapixant in Japanese, Chinese, and Caucasian participants, was performed.RESULTSOverall, 36/39 participants enrolled in the Japanese/Chinese studies, respectively (mean [standard deviation] age 25.4 [6.5] and 26.7 [5.0] years, respectively). After SD administration, maximum plasma concentration (C_max) was higher among Japanese than Chinese participants in the 25 mg and 75 mg dose groups, but comparable in the 150 mg dose group. The area under the concentration-time curve (AUC) was comparable between Japanese and Chinese participants in the 25 mg and 75 mg dose groups, but lower among Japanese participants in the 150 mg group. Half-lives after SD and MD administration were also comparable in Japanese and Chinese participants. The post hoc analysis included 26 Japanese, 30 Chinese, and 50 Caucasian participants. Comparable exposure (C_max,md and AUC[0-12]_md) was observed after MD administration of eliapixant in Chinese and/or Japanese compared with Caucasian participants (geometric mean inter-ethnic ratios close to 1). The trough plasma concentration after eliapixant 150 mg MD, which was assumed to be relevant to eliapixant efficacy, was comparable across all ethnicity groups. Most AEs reported in the Japanese (eliapixant 75 mg SD, n = 2; eliapixant 150 mg MD, n = 2) and Chinese participants (eliapixant 25 mg SD, n = 7; eliapixant 75 mg SD, n = 6; eliapixant 150 mg SD, n = 7; eliapixant 150 mg MD, n = 9; placebo SD, n = 5; placebo MD, n = 1) were of mild intensity. Higher incidences of AEs in the Chinese population were likely due to differing standards of AE reporting between investigators.CONCLUSIONEliapixant was well tolerated by Japanese and Chinese participants. The inter-ethnic evaluation demonstrated similar PK characteristics across Japanese, Chinese, and Caucasian participants.REGISTRATIONClinicalTrials.gov identifier numbers: NCT04265781 and NCT04802343.

2024-06-19·BMC women's health

Efficacy and safety of eliapixant in endometriosis-associated pelvic pain: the randomized, placebo-controlled phase 2b SCHUMANN study.

Article

作者: Messina, Fabrizio ; Roth, Katrin ; Parke, Susanne ; Gude, Kerstin

BACKGROUNDThe SCHUMANN study evaluated the efficacy and safety of the selective P2 × 3 antagonist eliapixant in patients with endometriosis-associated pelvic pain (EAPP).METHODSSCHUMANN was a randomized, placebo- and active comparator-controlled, double-blind to placebo and open-label to comparator, parallel-group, multicenter, dose-finding phase 2b study. The participants were women with surgically diagnosed endometriosis who fulfilled defined EAPP criteria. Participants were randomized 1:1:1:1 to twice daily (BID) 25 mg, 75 mg, or 150 mg oral eliapixant or a placebo for 12 weeks. An exploratory once-daily elagolix 150 mg treatment group was also included. The primary endpoint was the absolute change in mean worst EAPP from baseline to the end of intervention (EOI).RESULTSOverall, 215 participants were randomized for treatment (44 to eliapixant 25 mg, 44 to eliapixant 75 mg, 43 to eliapixant 150 mg, 43 to a placebo, and 41 to elagolix 150 mg). For safety reasons, the study was terminated early; both treatment and enrollment stopped immediately, producing less than 50% of the planned number of completers. The study found no significant differences in EAPP reduction from baseline between groups and no significant dose-response model. The elagolix 150 mg group showed better pain reduction than any of the other groups. No new safety signals were observed, relative to the previously known safety profile of eliapixant, which was generally well tolerated. However, one case of moderate and probably drug-induced liver injury in a participant receiving eliapixant 150 mg BID supported the association between eliapixant and a potential increase in liver function values, defined before the start of the phase 2 program.CONCLUSIONSThis study did not meet its primary objective as no statistically significant or clinically relevant differences in changes of mean worst EAPP from baseline were observed between treatment groups. The single observed case of moderate, probably drug-induced liver injury was the second case in the eliapixant phase 2 program conducted in the following indications: refractory or unexplained chronic cough, diabetic neuropathic pain, overactive bladder, and EAPP. Due to this, the benefit-risk ratio for the study was no longer considered to be positive.CLINICAL TRIAL REGISTRATIONClinicalTrials.gov identifier NCT04614246; registered November 3, 2020.

2024-06-08·Chest

Benefit-risk profile of P2X3 receptor antagonists for treatment of chronic cough: Dose-response model-based network meta-analysis.

Article

作者: Yamamoto, Shota ; Horita, Nobuyuki ; Kaneko, Takeshi ; Mukae, Hiroshi ; Kanemitsu, Yoshihiro ; Hara, Johsuke ; Hara, Yu ; Obase, Yasushi ; Sasamoto, Mao ; Niimi, Akio

BACKGROUNDRefractory or unexplained chronic cough disrupts quality of life and burdens healthcare systems around the world. The P2X3 receptor antagonist gefapixant is approved in many countries for its antitussive effects, but taste disturbances are a common adverse effect. Four newer, more selective P2X3 receptor antagonists have been developed to address this problem.RESEARCH QUESTIONHow does the benefit-risk profile vary across the five available P2X3 receptor antagonists?STUDY DESIGN AND METHODSA systematic review and network meta-analyses were conducted to evaluate the efficacy of P2X3 receptor antagonists, including gefapixant, sivopixant, eliapixant, camlipixant, and filapixant. Primary outcomes were a reduction rate in 24-hour cough frequency and incidence of taste disturbance. Dose-response curves, and median effective dose (ED₅₀) were calculated. Effect size at ED₅₀ was ranked according to SUCRA. The confidence was evaluated by CINeMA.RESULTSSixteen randomized controlled trials involving 4,904 participants were analyzed. The gefapixant regimen demonstrated an ED50 of 90.7 mg/day for cough frequency reduction. Gefapixant showed the highest antitussive effectiveness at ED50 (reduction rate in 24-h cough frequency, median 28.1%; 95% Credible Interval 21.0 to 35.6%; ranked 1/5; moderate certainty) but the highest prevalence of taste disturbance (absolute risk difference per 100 patients, median 38; 95%CrI 27 to 51; ranked 5/5; high certainty) and the highest prevalence of discontinuation. Camlipixant had a well-balanced profile (reduction rate in 24-h cough frequency, median 14.7%; 95%CrI 5.4 to 26.0%; ranked 3/5; low certainty; and taste disturbance, absolute risk difference per 100 patients, median 2; 95%CrI 1 to 6; ranked 2/5; low certainty). Placebo had a mean of 33.1% reduction in 24-h cough frequency.INTERPRETATIONWhen used at safe doses, gefapixant had a favorable risk-benefit profile compared to the other four agents. Camlipixant showed initial promise, which may be further investigated by phase III trials currently underway.CLINICAL TRIAL REGISTRATIONUMIN000050622.

项与 Eliapixant 相关的新闻（医药）

2023-12-26

·药时代

FDA两次拒批默沙东同一款产品，只是因为试验设计问题吗？

默沙东的第二封CRL2023年11月，FDA为默沙东在研的口服选择性P2X3受体拮抗剂gefapixant召开了肺部过敏药物专家咨询委员会（PADAC），讨论gefapixant在治疗成人难治性慢性咳嗽（RCC）或不明原因慢性咳嗽（UCC）方面的风险获益及证据有效性问题。13位专家在经过7个多小时的讨论之后，以12：1的投票结果，不支持gefapixant的获益，这让gefapixant的获批显得愈发艰难。2023年12月20日，默沙东果然收到了一封来自FDA的完整回复函（CRL），这是默沙东在研的口服选择性P2X3受体拮抗剂gefapixant第二封CRL。（第一次被拒是2022年1月，默沙东没有选择重做临床试验，而是对原来的临床试验结果进行了全新的分析，并基于此，重新提交了NDA申请）在这封CRL中，FDA表示，gefapixant的数据结果并不能证明其在治疗RCC或UCC中的有效性。而事实上，gefapixant早于2022年1月就在日本获批上市，成为全球首款获批的P2X3受体拮抗剂；今年9月，gefapixant在欧洲获批上市。由此看来，gefapixant并不是毫无疗效的，但为何FDA会质疑其有效性？这一点则要从gefapixant针对的适应症有效性的特殊评估方式说起了……原始数据再统计，统计不是回春术因为默沙东没有进行新的临床试验，因此gefapixant的2项三期COUGH-1研究和COUGH-2研究披上了P027和P030的马甲，被重新讨论。试验的主要终点设置为12周（P027）和24周（P030）时，受试者24小时里的咳嗽频率，算法是用咳嗽次数÷统计时间。但该试验的的纳入标准为：在筛查和基线检查中，咳嗽严重程度视觉模拟量表（VAS）的 0 毫米至 100 毫米分值均≥40 毫米。也就是说，gefapixant临床研究的纳入标准与主要终点不匹配。不仅如此，VAS量表并不被FDA所认可，虽然最终重新计数的结果，45mg剂量组患者的咳嗽频率有小幅减少，但FDA难以买账。原因有二，（1）由于目前没有相关的慢性咳嗽疗法获批，FDA并没有监管先例，也就没有标准的统计方法，于是药企只能各显神通。（2）FDA不认可药企的分析方式。退一步讲，即使FDA认可gefapixant的分析方式，该试验结果依然存在问题：（1）试验数据并不具有统计学意义。在规模较大的P030试验中，45mg剂量组的P值勉强达到了0.030；在规模稍小的P02试验中，P值竟然达到了0.057。（2）疗效有限。在P030试验中，gefapixant 45mg剂量组相较于安慰剂组24小时咳嗽频率下降14.6%；P027试验中，gefapixant 45mg剂量组相较于安慰剂24小时咳嗽频率下降17%，均未达到30%的设定目标。（3）安全性一般。45mg剂量组有高达65%的受试者出现味觉障碍或丧失，14%的受试者因此终止试验……有人见势及时收手有人继续披荆斩棘默沙东研究实验室全球临床开发高级副总裁 Joerg Koglin表示对FDA的决定感到“失望”，因为在RCC和UCC领域，存在非常大的未被满足的临床需求。奥地利的一项流行病学研究发现，社区人群（18～80岁）慢性咳嗽的患病率大约为9%，无明显性别差异。发病率不低，但可用疗法却少之又少，P2X3受体拮抗剂就是其中一类“曾经”非常有前景的药物。目前，P2X3受体拮抗剂领域不只有默沙东一家在做，但是默沙东的gefapixant处在绝对的领先位置。可惜在连着两次被拒后，它的领先优势早就荡然无存。gefapixant被拒在P2X3受体拮抗剂领域引起了一场震荡。在gefapixant第一次被拒一周后，P2X3受体拮抗剂领域的另一位玩家——拜耳宣布，因为其在研的P2X3受体拮抗剂领域Eliapixant的效益风险状况令人失望，将终止Eliapixant的二期临床试验，并将Eliapixant的权益退还给了Evotec SE，火速逃离了P2X3受体拮抗剂领域。而gefapixant失去领先地位的时候，紧随其后的GSK隐隐有了赶超之势。今年年初，GSK以21.8亿美元收购加拿大生物技术公司Bellus Health，旨在获取其核心产品Camlipixant（BLU-5937）。Camlipixant也是一种P2X3受体拮抗剂，GSK称其具有同类最佳的潜力，但是Camlipixant又被临床试验设计扯了后腿。Camlipixant的2期临床BLU-5937没能做出剂量相关性，仅有的还算能看的数据是200mg亚组，有了较为明显的改善，和安慰剂组做出了统计学差异。于是后续试验重点放在了重症组，这次2b期临床试验，招募了249名≥25咳/小时的患者，在50mg与200mg两个剂量组中，患者病情有了30%以上的较大改善，该结果具有统计学意义。可是这个剂量阶梯试验的梯子恐怕是“天梯”，剂量跨度大到让人难以置信，12.5mg→50mg→200mg的剂量跨度……这恐怕是这次试验没有做出剂量相关性的一个主要原因。作为RCC和UCC领域最有希望的一个靶点，P2X3却始终在原地打转，未能前进一步。究其原因，药企和FDA各占一半。药企在主要终点设置上的“群魔乱舞”，FDA在审查上的“无例可询”，都是P2X3受体拮抗剂始终没能真正取得成功的原因。P2X3肯定是有一个未来的。但是它要走得路还长，或许在评估咳嗽的方法足够客观可信、在FDA在这方面的审查标准足够成熟时，P2X3会迎来一个天明。参考资料：1.https://www.biospace.com/article/merck-s-chronic-cough-drug-fails-to-secure-fda-approval-for-second-time/2.https://www.biospace.com/article/bayer-abandons-evotec-compound-for-4-indications-including-chronic-cough/3.https://www.fda.gov/media/173850/download4.中华结核和呼吸杂志, 2023,46(10) : 1022-1027.5.https://mp.weixin.qq.com/s/gIOK3TkGxAwY8yRfkCbyRQ6.其他公开资料图片来源：Pixabay未达主要终点？试验失败？这6款药仍获FDA批准上市裁员46%，为了一款没有进入1期的候选药物……点击阅读原文，查看更多精彩内容！

临床结果临床3期临床2期申请上市上市批准

2023-12-21

·BioSpace

Merck’s Chronic Cough Drug Fails to Secure FDA Approval for Second Time

Pictured: Merck Research Laboratories building in California/iStock, hapabapa For the second time in nearly two years, Merck has failed to secure regulatory approval for its chronic cough drug gefapixant. In a Complete Response Letter issued Wednesday, the FDA said that Merck’s data package for gefapixant “did not meet substantial evidence of effectiveness” for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. The regulator did not point to safety issues related to the drug candidate. Joerg Koglin, senior vice president of global clinical development at Merck Research Laboratories, said in a statement that the company is “disappointed” by the FDA’s decision, adding that there is currently a “significant unmet medical need” in the field of chronic cough and an “absence of any approved treatments for refractory or unexplained chronic cough.” The pharma giant will review the FDA’s letter and feedback to determine the next steps for gefapixant, according to Wednesday’s announcement. Gefapixant is an orally available P2X3 receptor antagonist that works by preventing the signaling cascade in the airways that culminates in a cough reflex. Merck first tried for an FDA approval in 2021 but was ultimately rejected in January 2022. Despite the regulatory speedbump, Merck said at the time that it remained “committed” to gefapixant’s development. However, Merck’s resubmission was similarly met with strong skepticism from the FDA. In a briefing document released ahead of a November 2023 advisory committee meeting, the regulator’s reviewers still found the efficacy data for gefapixant to be underwhelming. Treatment “showed a small reduction in cough frequency,” according to the reviewers, who were uncertain whether gefapixant’s effects were clinically meaningful or not. A few days later, the FDA’s Pulmonary-Allergy Drugs Advisory Committee shared the same concerns and voted 12-1 against gefapixant. Gefapixant’s regulatory stumble on Wednesday continues the industry’s losing streak in the chronic cough space. In February 2022, Bayer discontinued the Phase II development of eliapixant, which is also a P2X3 receptor antagonist, following its disappointing benefit-risk profile. Eliapixant was being developed for RFC, overactive bladder, endometriosis and diabetic neuropathic pain. Seeking to take advantage of this void in the marketplace, GSK in April 2023 signed a $2 billion contract to acquire Bellus Health, gaining access to its cough candidate camlipixant. In December 2021, the candidate aced the Phase IIb SOOTHE trial, eliciting strong reductions in cough frequency versus placebo. Like gefapixant and eliapixant, camlipixant is a P2X3 receptor agonist and has best-in-class potential, according to GSK. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

上市批准临床2期并购

2023-11-20

·药时代

12:1反对！默沙东first in class药物遭FDA专家咨询委员会质疑，这靶点……还有救吗？

正文共：2181字 2图预计阅读时间：7分钟作者 | 辰公子文章来源 | 药时代公众号2023年11月17日，FDA召开肺部过敏药物专家咨询委员会（PADAC），讨论默沙东口服P2X3受体拮抗剂gefapixant在治疗成人难治性慢性咳嗽（RCC）或不明原因慢性咳嗽（UCC）方面的风险获益及证据有效性问题。慢性咳嗽是巨大的未被满足的临床需求，美国成人慢性咳嗽的患病率约为5%，其中一部分患者对病因治疗无响应，称为RCC，另一部分经过彻底评估但咳嗽原因不明，称为UCC。目前美国市场尚无针对RCC或UCC的药物获批。经过7个小时的讨论后，13名专家就「考虑到咳嗽频率的小幅降低和患者报告的结果，现有证据是否支持成人UCC/RCC患者接受gefapixant治疗后的获益是有临床意义的？」的议题进行投票。最终，13名专家以12票反对，1票支持的结果不支持gefapixant的获益，获批前景不容乐观。First in class的优势逐渐丧失P2X3受体拮抗剂领域一度有4家公司battle，分别是默沙东、拜耳、Bellus Health 和 Shionogi，其中默沙东占据绝对领先的地位。2022年1月，gefapixant在日本获批用于治疗成人RCC/UCC，成为全球首款P2X3受体拮抗剂，彼时三款竞争产品都还没进入3期临床。但一周后，默沙东收到了FDA的完整回复函，gefapixant被拒，领先优势开始丧失。据默沙东表示，FDA拒绝gefapixant的原因是基于疗效担忧，要求默沙东提供更多药物疗效的资料，对安全性并无顾虑。但实际上gefapixant的耐受性是有问题的。在COUGH-1和COUGH-2 两项3期临床试验里，45mg高剂量组的不良事件退出率分别高达15%和20%，有58%和68.6%的受试者经历了味觉相关的不良事件，这可能与靶点相关。两周后，拜耳终止了同靶点产品eliapixant的开发工作，eliapixant此前已经达到2b期临床试验的主要终点。“二战”再受质疑，终点选择有问题？在收到CRL之后，默沙东并没有选择进行新的临床试验，而是对原有试验进行了额外分析，这也是其能快速重新递交NDA申请的原因。在PADAC会议上，COUGH-1和COUGH-2两个试验被套了P027和P030的马甲重新讨论。试验周期52周，主要终点是12周（P027）和24周（P030）时受试者24小时里的咳嗽频率，算法是用咳嗽次数÷统计时间。根据重新计数的结果，45mg剂量组患者的咳嗽频率有小幅减少，但其临床意义遭到了FDA的质疑。首先是统计分析，由于目前没有相关的慢性咳嗽疗法获批，FDA这边没有监管先例，没有标准的统计方法。而默沙东在数据统计方面做了非常复杂的计算，使得FDA难以评估临床结果。在专家咨询委员会的讨论上，默沙东的统计结果也没有获得专家的支持。然后FDA选择自己对试验结果进行时候分析。结果发现P值不行。规模较大的P030里，45mg剂量组的P值还勉强达到了0.030，规模稍小的P027里，P值直接干到了0.057。疗效数据方面，P030中，45mg gefapixant治疗相比于安慰剂24小时咳嗽频率下降14.6%；P027中，45mg gefapixant治疗相比于安慰剂24小时咳嗽频率下降17%，均小于目标设定的30%。另外，虽然药物总体上安全性良好，耐受性依然不行。45mg剂量组有高达65%的受试者出现味觉障碍或丧失，14%的受试者因此终止试验。靶点危机是否已经发生在P2X3靶点上参与竞争并试验失败的不止默沙东一家。就在今年年初，GSK以21.8亿美元收购加拿大生物技术公司Bellus Health，旨在获取其核心产品Camlipixant (BLU-5937)。尽管GSK看好BLU-5937，但客观而言，这款药的临床试验颇有波折。2期临床BLU-5937没做出剂量相关性，唯一能拉出来看的数据只有200mg亚组，有了较为明显的改善，和安慰剂组做出了统计学差异。于是后续Bellus调转方向，在重症组下功夫，2b期临床试验，招募了249名≥25咳/小时的患者，在50mg与200mg两个剂量组中，患者病情有了30%以上的较大改善，该结果具有统计学意义。但这个试验还是埋了个雷，50mg剂量组和200mg剂量没有做出剂量相关性，并且12.5mg→50mg→200mg的剂量梯度实在太大……👇详细分析请见此文👇临床失败后，适应症一再缩减，这药20亿美元买下亏不亏？BLU-5937的临床试验目前也存在较强的不确定性，整个赛道接连出现不尽如人意的安全性、疗效问题，似乎让整个P2X3靶点的前景都蒙上一层阴影。唯一的赞成票虽然专家们对gefapixant的临床试验结果不甚认可，但唯一患者代表Jennifer Schwartzott却还是在几经犹豫后投出了赞成票。Schwartzott表示，“对患者来说，药物无效可以停用，但如果有效就是惊喜，是否用药可以交由患者自行决定。确实，我们希望能有一款能彻底止住咳嗽的药物，但如果目前还没有的话，gefapixant也是一个不错的开始。对于慢性咳嗽患者而言，相比于疾病对生活的困扰，任何药物带来的改善都是有意义的。”参考资料：1.https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-17-2023-meeting-pulmonary-allergy-drugs-advisory-committee-11172023）2.https://www.fiercebiotech.com/biotech/fda-adcomm-shoots-down-mercks-chronic-cough-med-12-1-vote3.https://www.fiercebiotech.com/biotech/ahead-tomorrows-adcomm-fda-skeptical-mercks-gefapixant-even-after-pharma-recounted-coughs4.https://d18rn0p25nwr6d.cloudfront.net/CIK-0000064978/9c6dee39-9f0a-4a7f-85e6-13432ceb54e6.pdf5.clinicaltrials.gov6.其他公开资料图片来源：网络百亿美金蓝海市场，NASH药物进展如何？再花25亿美元建新厂！为保生产，礼来与诺和诺德今年已累计投资超过100亿美元…… 点击在看共济新药研发浪潮

临床3期临床结果

100 项与 Eliapixant 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
不明原因的慢性咳嗽	临床2期	捷克	Bayer AG	2020-10-02
膀胱过度活动症	临床2期	葡萄牙	Bayer AG	2020-09-16
膀胱过度活动症	临床2期	瑞典	Bayer AG	2020-09-16
膀胱过度活动症	临床2期	澳大利亚	Bayer AG	2020-09-16
膀胱过度活动症	临床2期	新加坡	Bayer AG	2020-09-16
膀胱过度活动症	临床2期	波兰	Bayer AG	2020-09-16
膀胱过度活动症	临床1期	德国	Bayer AG	2020-09-16
膀胱过度活动症	药物发现	奥地利	Bayer AG	2020-09-16
膀胱过度活动症	药物发现	捷克	Bayer AG	2020-09-16
膀胱过度活动症	药物发现	新西兰	Bayer AG	2020-09-16

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临床结果

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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


NCT04562155 (CTgov)	临床2期	不明原因的慢性咳嗽 \| 难治性慢性咳嗽	310	Placebo	鏇鹽網艱製鏇淵糧範廠(構願齋衊範遞製餘壓衊) = 範選鏇廠獵艱鏇憲鬱遞鹹製憲糧廠夢廠膚憲簾 (築餘鹽鹽鹽鏇鬱範廠齋, 鏇齋築鑰衊簾膚壓窪憲 ~ 繭窪膚鑰衊顧憲膚蓋鬱) 更多	-	2022-08-18
NCT03310645 (Pubmed) 人工标引	临床1/2期	难治性慢性咳嗽	47	Eliapixant	(廠壓簾鬱艱鹹醖繭糧蓋) = Eliapixant was well tolerated with a low incidence of taste-related adverse events. 積齋築獵醖襯襯齋鏇鹹 (鹹繭廠製鬱築選鹹醖膚 )	积极	2022-05-28
NCT03310645 (Pubmed) 人工标引	临床1/2期	难治性慢性咳嗽	47	Placebo		积极	2022-05-28