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）

2024-12-01·European Journal of Pharmacology

P2X3 and P2X2/3 receptors inhibition produces a consistent analgesic efficacy: A systematic review and meta-analysis of preclinical studies

Article

作者: Tejada, Miguel Ángel ; Marcos-Frutos, Daniel ; Huerta, Miguel Á ; Nava, Javier de la ; Huerta, Miguel Á. ; Roza, Carolina ; García-Ramos, Amador

BACKGROUNDP2X3 and P2X2/3 receptors are promising therapeutic targets for pain treatment and selective inhibitors are under evaluation in ongoing clinical trials. Here we aim to consolidate and quantitatively evaluate the preclinical evidence on P2X3 and P2X2/3 receptors inhibitors for pain treatment.METHODSA literature search was conducted in PubMed, Scopus and Web-of-Science on August 5, 2023. Data was extracted and meta-analyzed using a random-effects model to estimate the analgesic efficacy of the intervention; then several subgroup analyses were performed.RESULTS67 articles were included. The intervention induced a consistent pain reduction (66.5 [CI95% = 58.5, 74.5]; p < 0.0001), which was highest for visceral pain (114.3), followed by muscle (79.8) and neuropathic pain (71.1), but lower for cancer (64.1), joint (57.5) and inflammatory pain (49.0). Further analysis showed a greater effect for mechanical hypersensitivity (70.4) compared to heat hypersensitivity (64.5) and pain-related behavior (54.1). Sex (male or female) or interspecies (mice or rats) differences were not appreciated (p > 0.05). The most used molecule was A-317491, but other such as gefapixant or eliapixant were also effective (p < 0.0001 for all). The analgesic effect was higher for systemic or peripheral administration than for intrathecal administration. Conversely, intracerebroventricular administration was not analgesic, but potentiated pain.CONCLUSIONP2X3 and P2X2/3 receptor inhibitors showed a good analgesic efficacy in preclinical studies, which was dependent on the pain etiology, pain outcome measured, the drug used and its route of administration. Further research is needed to assess the clinical utility of these preclinical findings.PROTOCOL REGISTRATIONPROSPERO ID CRD42023450685.

2024-06-01·CHEST

Benefit-Risk Profile of P2X3 Receptor Antagonists for Treatment of Chronic Cough

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 health care 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-analysis was 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 the surface under the cumulative ranking curve. The confidence was evaluated by Confidence In Network Meta-Analysis.RESULTSSixteen randomized controlled trials involving 4,904 participants were analyzed. The gefapixant regimen demonstrated an ED₅₀ of 90.7 mg/d for cough frequency reduction. Gefapixant showed the highest antitussive effectiveness at ED₅₀ (reduction rate in 24-hour cough frequency: median, 28.1%; 95% credible interval [CrI], 21.0%-35.6%; ranked 1 of 5; moderate certainty) but the highest prevalence of taste disturbance (absolute risk difference per 100 patients: median, 38; 95% CrI, 27-51; ranked 5 of 5; high certainty) and the highest prevalence of discontinuation. Camlipixant had a well-balanced profile (reduction rate in 24-hour cough frequency: median, 14.7%; 95% CrI, 5.4%-26.0%; ranked 3 of 5; low certainty; and taste disturbance; absolute risk difference per 100 patients; median, 2; 95% CrI, 1-6; ranked 2 of 5; low certainty). Placebo had a mean of 33.1% reduction in 24-hour cough frequency.INTERPRETATIONWhen used at safe doses, gefapixant had a favorable risk-benefit profile compared with the other four agents. Camlipixant showed initial promise, which may be further investigated by phase III trials currently underway.CLINICAL TRIAL REGISTRATIONUniversity Hospital Medical Information Network Center (UMIN-CTR); No. UMIN000050622; URL: https://center6.umin.ac.jp.

2024-06-01·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 ; Chen, Huijun ; Okumura, Kazuhito ; Li, Hui ; 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.

项与 Eliapixant 相关的新闻（医药）

2024-10-17

·CPHI制药在线

浅谈子宫内膜异位症进展，和其瑞医药的HMI-115被纳入突破性治疗品种

关注并星标CPHI制药在线 10月15日，CDE官网显示，和其瑞医药（南京）有限公司1类新药「HMI-115」拟被纳入突破性治疗品种，用于治疗子宫内膜异位症相关的中重度疼痛。子宫内膜异位症是一种以内膜细胞种植在子宫内膜以外位置为特征的一种雌激素依赖的常见妇科疾病，通常表现为慢性炎症反应，常见症状包括下腹及盆腔痛、痛经、性交痛及不孕。子宫内膜异位症常见于育龄妇女，全球发病率在育龄妇女中约为10%。目前，子宫内膜异位症的病因尚不清楚，也无法治愈，常见治疗方式是止痛和治疗不孕症。 HMI-115是一款靶向泌乳素受体（PRLR）的单克隆抗体，被开发用于治疗子宫内膜异位症和雄激素性秃发，已在动物模型包括非人灵长类(NHP)模型和人体安全性方面展现出优异的特质。该药最初由拜耳作为治疗子宫内膜异位药物开发。2019年4月，和其瑞医药与拜耳签署一项全球独家许可协议，获得HMI-115在全球开展多个适应症的开发和产业化授权。 2014年1月，和其瑞医药宣布HMI-115治疗雄激素性脱发的临床1b期研究取得积极结果。该研究共入组16名雄激素性脱发（12名男性+4名女性）患者，HMI-115治疗24周时，12名男性患者的平均目标区域非毳毛数量与基线相比，每平方厘米增加了14根。同时，HMI-115展现出良好的安全性和耐受性。此次HMI-115被CDE纳入治疗子宫内膜异位症相关的中重度疼痛的突破性治疗品种，将加速HMI-115该适应症在国内的开发进程。国内在研子宫内膜异位症新药进展除了HMI-115，国内还有多款新药被开发用于治疗子宫内膜异位症相关的中重度疼痛，详见下表。在研药物靶点相对集中，主要为GnRH。研发进度上，大多处于1期临床。 Linzagolix进展较快，在国内处于3期临床。该药是Kissei Pharmaceutical开发的一款新型、口服、非肽类促性腺激素释放激素（GnRH）受体拮抗剂，2022年6月在欧盟及英国被批准用于治疗育龄妇女子宫肌瘤中度至重度症状。Linzagolix是第一个获批在非激素给药选择下的口服GnRH拮抗剂，2021年9月，葆正医药与Kissei Pharmaceutical达成授权协议，获得Linzagolix在中国的开发和商业化权利。2022年10月，Linzagolix在国内获批临床，用于治疗子宫内膜异位症相关的疼痛。 HS-10518等多款药物处于1期临床。其中HS-10518是一款靶向于GnRH的1类新药，拟用于治疗子宫内膜异位症相关中重度疼痛、子宫肌瘤相关月经过多等疾病。目前，HS-10518正处于Ⅰ期临床阶段，将在中国健康绝经前成年女性受试者中开展研究。 CMS-D002是康哲药业自主研发的一款小分子GnRH受体拮抗剂，通过与内源性GnRH竞争性结合垂体上的GnRH受体，在中枢神经水平阻断垂体性腺轴，减少内源性FSH和LH的释放，从而抑制下游雌激素、黄体酮和睾酮的分泌，缓解性激素相关疾病的进展。临床前研究表明：CMS-D002具有优异的有效性和安全性，有望开发用于治疗子宫内膜异位症、子宫肌瘤、前列腺癌等疾病。2024年2月，CMS-D002在国内获批临床。 G201-Na是以岭药业的一款小分子GnRH受体拮抗剂，临床前研究显示其药效确切、安全性良好。 BAY 1817080是一款在研P2X3拮抗剂，被开发用于治疗子宫内膜异位症、慢性咳嗽、膀胱过动症等多种疾病。P2X3受体是嘌呤类受体家族中的一员，是非选择性的配体门控离子通道，研究发现其表达在上皮细胞和感觉神经元上，而且P2X3受体的高表达和激活可以导致慢性疼痛模型动物的痛觉敏化。2021年1月，BAY 1817080在国内获批临床，用于治疗子宫内膜异位症。 SHR7280是恒瑞医药研发的一种新型口服小分子GnRH受体拮抗剂。药效学分析显示，SHR7280能够有效抑制雌二醇和黄体生成素浓度，并以剂量依赖的方式防止孕激素升高。已公布的SHR7280在子宫内膜异位症的绝经前期女性患者中开展的1/2期临床研究结果显示：该药在绝经前期女性患者中表现出良好的耐受性和药代动力学特性。此外，GnRH受体拮抗剂瑞卢戈利和艾拉戈克钠也在国内被开发用于治疗子宫内膜异位症相关的疼痛。其中瑞卢戈利是武田开发的一种可口服、非肽类小分子促性腺激素释放激素（GnRH）受体拮抗剂，2019年1月在日本获批，用于改善子宫肌瘤引起的下列症状：月经过多、下腹痛、腰痛、贫血和改善子宫内膜异位症引起的疼痛。目前，国内民生药业、齐鲁制药在开展瑞卢戈利改善子宫肌瘤引起的一些症状，如月经过多、下腹痛、腰痛、贫血等，以及改善子宫内膜异位症引起的疼痛的人体生物等效性试验。艾拉戈克钠是艾伯维与合作伙伴Neurocrine Bioscienc Chemicabookes共同研发的一种口服GnRH拮抗剂，2018年7月被FDA批准用于治疗与子宫内膜异位症相关的中度至重度疼痛，是十年来首个获FDA批准用于该适应症的口服疗法。据公开资料，艾拉戈克钠化合物专利2024年07月到期。目前，国内正大天晴、福安药业、齐鲁制药等企业在进行艾拉戈克钠人体生物等效性试验。总结作为一种常见妇科病，子宫内膜异位症摧残着不计其数的女性。目前，子宫内膜异位症治疗手段有限，治疗主要目的是缓解痛经。相对国外，我国子宫内膜异位症新药进展较慢，还未有任何一款GnRH拮抗剂被批准用于治疗子宫内膜异位症相关的疼痛，多款药物处于临床试验阶段，其中葆正医药引进的Linzagolix进展较快，已进入3期临床。值得一提是，在研子宫内膜异位症新药除了GnRH拮抗剂，还包括P2X3拮抗剂、PRLR靶向单抗。期待在药企的不懈努力下，我国子宫内膜异位症患者早日迎来新型治疗药物。 END 来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

突破性疗法临床1期临床2期申请上市ASH会议

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

100 项与 Eliapixant 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
不明原因的慢性咳嗽	临床2期	加拿大	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	奥地利	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2期	新加坡	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	新西兰	Bayer AG	2020-09-16
膀胱过度活动症	临床2期	捷克	Bayer AG	2020-09-16
膀胱过度活动症	临床2期	德国	Bayer AG	2020-09-16

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临床结果

适应症

分期

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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


NCT04614246 (SCHUMANN, Pubmed)	临床2期	盆腔疼痛 P2 × 3 antagonist	215	Eliapixant 150 mg BID	積襯遞鏇廠糧獵廠艱淵(廠壓窪鹹製窪構鏇鑰襯) = This 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 淵願鑰窪選膚繭膚製淵 (觸觸範蓋壓廠網築鹹觸 ) 更多	不佳	2024-06-19
NCT04562155 (PAGANINI, CTgov)	临床2期	不明原因的慢性咳嗽 \| 难治性慢性咳嗽	310	Placebo	選鑰夢淵衊獵選夢簾繭(鏇膚窪夢選糧構齋鑰鹽) = 襯鑰襯壓鹹艱選廠壓淵壓遞淵蓋齋繭糧製餘築 (選觸夢網製遞簾艱夢憲, 積鑰壓襯廠鏇選鬱鬱壓 ~ 窪醖鏇製膚齋鹽簾積衊) 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	(糧網遞築積蓋廠遞齋顧) = Eliapixant was well tolerated with a low incidence of taste-related adverse events. 選鬱夢膚製蓋築繭築夢 (膚遞蓋鏇鬱遞觸選鑰願 )	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