A Phase IIa, Multicenter, Randomized, Controlled, Open Label Study to Evaluate the Efficacy of SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease

This study is intended to evaluate the ability of SENS-401 to prevent the ototoxicity induced by cisplatin in subjects with a neoplastic disease. It is a multicenter, randomized, controlled, two-arm, open-label efficacy and safety study in adults with neoplastic disease requiring treatment with cisplatin as part of the chemotherapy protocol plan.

开始日期2022-12-30

申办/合作机构

Sensorion SA

NCT05258773 / Completed临床2期

A Phase IIa, Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Presence of SENS-401 in the Perilymph After 7 Days of Repeated Oral Administration in Adult Participants Scheduled for Cochlear Implantation

The aim of this study is to detect the presence of SENS-401 in the perilymph of participants undergoing cochlear implant surgery after 7 days of oral administration of SENS-401.

开始日期2022-08-10

申办/合作机构

Sensorion SA

100 项与 Azasetron besylate 相关的临床结果

登录后查看更多信息

100 项与 Azasetron besylate 相关的转化医学

登录后查看更多信息

100 项与 Azasetron besylate 相关的专利（医药）

登录后查看更多信息

项与 Azasetron besylate 相关的文献（医药）

2024-11-01·AMERICAN JOURNAL OF OTOLARYNGOLOGY

Efficacy and safety of SENS-401 in sudden sensorineural hearing loss: The AUDIBLE-S randomized placebo-controlled phase IIb trial

Article

作者: Cohen-Vaizer, Mauricio ; Honnet, Geraldine ; Glotin, Anne-Lise ; Doweck, Ilana ; Elziere, Maya ; Komazec, Zoran ; Esteve-Fraysse, Marie Jose ; Chrobok, Viktor ; Kazmer, Igor ; Hilly, Ohad ; Braverman, Itzhak ; Kalcioglu, Mahmut Tayyar ; Laredo, Judith ; Fitoussi, Serge

PURPOSE:

Safety and efficacy of SENS-401, a serotonin type 3 (5-HT₃) receptor antagonist and calcineurin inhibitor, in patients with acute sudden sensorineural hearing loss (SSNHL).

METHODS:

Multicentre randomized, double blind, placebo-controlled trial enrolled adult subjects with sudden sensorineural hearing loss (SSNHL) or unilateral/bilateral acute acoustic trauma leading to SSNHL within 96 h of disease onset. Subjects were randomly assigned to one of the three oral dose groups: 29 mg, 43.5 mg or placebo given twice daily for 28 days. The primary endpoint was the change from baseline in Pure Tone Average (PTA) in the affected ear to the end of treatment visit (day 28). Subjects were further followed up 8 weeks after the end of the treatment period (day 84).

RESULTS:

A total of 115 subjects were randomized. SENS-401 was well tolerated. Although the primary efficacy endpoint was not met at day 28, post-hoc analyses revealed clinically significant and meaningful efficacy outcomes with SENS-401 when compared to placebo in a substantial group of participants diagnosed with idiopathic SSNHL and who had received corticosteroid treatment. Notable improvements were observed in the PTA change from baseline, the complete hearing recovery rate, and the Word Recognition Score (WRS), particularly at day 84. The responder rate consistently favored treated subjects over those who received the placebo.

CONCLUSION:

While the primary endpoint was not achieved at the end of the treatment period, the study revealed consistently positive efficacy results of clinical relevance in patients with idiopathic SSNHL who received SENS-401, particularly in the 8-weeks follow-up phase after the completion of the treatment.

2021-06-26·International journal of analytical chemistry4区 · 化学

A Fast and Validated HPLC Method for the Simultaneous Analysis of Five 5-HT3 Receptor Antagonists via the Quantitative Analysis of Multicomponents by a Single Marker

4区 · 化学

ArticleOA

作者: Wang, Sicen ; Li, Peng ; Fang, Baoxia ; Chen, Fuchao

In this study, a new strategy for the simultaneous quantization of five serotonin 5-hydroxytryptamine receptor antagonists—ondansetron, azasetron, ramosetron, granisetron, and tropisetron—either in infusion samples or in injection dosage form was first established based on high-performance liquid chromatography combined with a quantitative analysis of multiple components by a single marker. The quantitative analysis of multicomponents by a single marker method was conducted with ondansetron as an internal reference substance and performed using relative retention time and ultraviolet spectral similarity as the double indicator. The quantitative analysis of the 5-HT3 receptor antagonists was calculated and investigated based on the relative correction factors. Chromatographic separation was achieved using a C18 column (150 mm × 4.6 mm, 5.0 μm), and the mobile phase was composed of acetonitrile-0.05 mol·L−1 potassium dihydrogen phosphate (pH 4.0) (25 : 75) at a flow rate of 1.0 mL·min−1 and detection wavelengths of 307 nm (ondansetron, azasetron, ramosetron), 302 nm (granisetron), and 285 nm (tropisetron). In addition, the accuracy of the quantitative analysis of multicomponents by a single marker method was compared with an external standard method, and no significant difference was observed between the two methods. The established method is rapid, is easy, and does not require many reference substances, and it can been successfully applied as part of the quality control of the five 5-HT3 receptor antagonists in their injection dosage form and infusion sample drugs in hospitals.

2019-08-01·Journal of pharmaceutical sciences3区 · 医学

Rat Kidney Slices for Evaluation of Apical Membrane Transporters in Proximal Tubular Cells

3区 · 医学

Article

作者: Washio, Ikumi ; Kubo, Hikaru ; Ishiguro, Naoki ; Nedachi, Shiho ; Arakawa, Hiroshi ; Staub, Angelina Yukiko ; Nakanishi, Takeo ; Tamai, Ikumi

Kidney slice has been often used as a tool reflecting basolateral transport in renal tubular epithelial cells. Recently, we reported that several important apical reabsorptive transporters such as Octn1/2, Sglt1/2, and Pept1/2 were functional in mouse kidney slices as well as transporter activities in basolateral side, which have been well accepted. Because rats are often used for preclinical pharmacodynamic and pharmacokinetic studies as well as mice, it is important to confirm applicability of rat kidney slices for evaluation of apically expressed transporters. The present study investigates usefulness of kidney slices from rats for evaluation of apical membrane transporters for efflux (multidrug resistance 1a, mdr1a) as well as influx (Octn1/2, Sglt1/2, Pept1/2). Na⁺-dependent uptake of ergothioneine (Octn1), carnitine (Octn2), and methyl-α-D-glucopyranoside (Sglt1/2) by rat kidney slices was observed, and the uptake was decreased by selective inhibitors. In addition, uptake of glycyl-sarcosine (Pept1/2) showed H⁺-dependence and was decreased by selective inhibitor. Furthermore, accumulation of mdr1a substrate azasetron was increased in the presence of zosuquidar, an mdr1a inhibitor, while strain differences existed. In conclusion, rat kidney slices should be useful for evaluation of renal drug disposition regulated by transporters in apical as well as basolateral membranes of rat renal proximal tubule cells.

项与 Azasetron besylate 相关的新闻（医药）

2024-12-03

·Business Wire

Sensorion to Present at the 43rd Annual J.P. Morgan Healthcare Conference

MONTPELLIER, France--( BUSINESS WIRE )--Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, announced today that it will present at the 43 rd Annual J.P. Morgan Healthcare Conference, San Francisco, USA, to be held on January 13-16, 2025. Nawal Ouzren, Chief Executive Officer of Sensorion, will make a presentation on January 16, 2025, at 9am PT (6pm CET). A Q&A session will follow the presentation. A live webcast of Sensorion’s presentation will be available on the Company’s website ( https://www.sensorion.com/en/ ). A replay of the webcast will be available on the Company’s website for approximately 30 days. About Sensorion Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat, and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates. It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT) currently being developed in a Phase 1/2 clinical trial, targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Sensorion’s portfolio also comprises clinical-stage small molecule programs for the treatment and prevention of hearing loss disorders. Sensorion’s clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) progressing in a planned Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) and, with partner Cochlear Limited, has completed in a study of SENS-401 in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022. www.sensorion.com Label: SENSORION ISIN: FR0012596468 Mnemonic: ALSEN Disclaimer This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2023 full year report published on March 14, 2024, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.

临床2期基因疗法

2024-11-06

·Business Wire

Sensorion Announces Its Participation in Upcoming Investor Conferences to be Held in November 2024

MONTPELLIER, France--( BUSINESS WIRE )--Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, today announced its participation in upcoming investor conferences to take place in November 2024. Sensorion will participate in the Stifel Healthcare Conference , which will be held in New York, USA, on November 18-19, 2024. Sensorion's management team will be present for one-to-one meetings on November 18, 2024. Sensorion will also participate in the LifeSci Capital and Sofinnova Partners Growth & Innovation Summit, to take place in London, UK, on November 18, 2024. Sensorion's management team will be present for one-to-one meetings throughout the conference. Sensorion will also be attending the Jefferies London Healthcare Conference, in London, UK, on November 19-21, 2024. Sensorion's management team will be present for one-to-one meetings throughout the conference. If you would like to meet Sensorion's management team, please contact us by email: ir.contact@sensorion-pharma.com About Sensorion Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat, and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates. It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT) currently being developed in a Phase 1/2 clinical trial, targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Sensorion’s portfolio also comprises clinical-stage small molecule programs for the treatment and prevention of hearing loss disorders. Sensorion’s clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) progressing in a planned Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) and, with partner Cochlear Limited, has completed in a study of SENS-401 in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022. www.sensorion.com Label: SENSORION ISIN: FR0012596468 Mnemonic: ALSEN Disclaimer This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2023 full year report published on March 14, 2024, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.

临床2期

2024-09-26

·Business Wire

Sensorion Announces Webconference for Retail Shareholders on October 10, 2024

MONTPELLIER, France--( BUSINESS WIRE )--Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, today announces it is hosting a webconference for its retail shareholders on October 10, 2024. The webconference will be held in French. Sensorion’s Chief Executive Officer, Nawal Ouzren, and management team, will host a webconference dedicated to its retail shareholders, in French, on October 10, 2024, at 6pm CET (12pm ET), to comment on the Company’s latest announcements and outlook. Click here to join the meeting Meeting ID: 312 282 544 045 Secret Code: bfjH3J You will also be able to join the webconference from Sensorion’s website . About Sensorion Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat, and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates. It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT) currently being developed in a Phase 1/2 clinical trial, targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT, in preclinical stage, targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Sensorion’s portfolio also comprises clinical-stage small molecule programs for the treatment and prevention of hearing loss disorders. Sensorion’s clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) progressing in a Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) and, with partner Cochlear Limited, has completed in a study of SENS-401 in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022. www.sensorion.com Label: SENSORION ISIN: FR0012596468 Mnemonic: ALSEN Disclaimer This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2023 full year report published on March 14, 2024, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.

临床2期基因疗法

100 项与 Azasetron besylate 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
突发性听力损失	临床3期	保加利亚	Sensorion SA	2019-02-15
突发性听力损失	临床3期	加拿大	Sensorion SA	2019-02-15
突发性听力损失	临床3期	捷克	Sensorion SA	2019-02-15
突发性听力损失	临床3期	法国	Sensorion SA	2019-02-15
突发性听力损失	临床3期	德国	Sensorion SA	2019-02-15
突发性听力损失	临床3期	以色列	Sensorion SA	2019-02-15
突发性听力损失	临床3期	塞尔维亚	Sensorion SA	2019-02-15
突发性听力损失	临床3期	斯洛伐克	Sensorion SA	2019-02-15
突发性听力损失	临床3期	土耳其	Sensorion SA	2019-02-15
突发性听力损失	临床3期	英国	Sensorion SA	2019-02-15

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


NCT05628233 (BusinessWire) 人工标引	临床2期	耳毒性	-	SENS-401	淵鹹餘製糧選築壓鏇襯(艱遞襯夢餘衊襯顧艱繭) = A good safety profile of SENS-401 is confirmed in the long term, with the drug being administered for the first time for an average duration of up to 23 weeks. 鑰齋壓繭餘鏇製繭餘壓 (艱築觸鬱鑰製鹽艱廠糧 )	积极	2024-09-20
NCT05258773 (Corporate Publications) 人工标引	临床2期	听力损失	24	SENS-401 (Arazasetron)	齋鬱襯膚憲襯鹹衊膚廠(鹽夢顧廠鹹齋齋獵壓網) = 範廠簾選窪願構襯艱蓋選餘築衊鏇鏇鑰淵膚襯 (醖廠製選簾製醖繭簾鏇 )	积极	2024-07-15
				Control group	齋鬱襯膚憲襯鹹衊膚廠(鹽夢顧廠鹹齋齋獵壓網) = 築範醖衊憲鹹襯淵鏇積選餘築衊鏇鏇鑰淵膚襯 (醖廠製選簾製醖繭簾鏇 )
NCT05258773 (Biospace) 人工标引	临床2期	听力损失	28	SENS-401	窪積膚衊窪鏇鬱夢築網(範獵廠鏇構餘艱鬱衊鹹) = Presence of SENS-401 in the perilymph is confirmed in 100% of the patients sampled following cochlear implantation at levels compatible with potential therapeutic efficacy 製鹽築壓襯鹹遞夢鬱膚 (積壓襯鬱簾鹽憲鏇遞選 ) 达到	积极	2024-03-11
				non-treated arm
NOTOXIS (Biospace) 人工标引	临床2期	耳毒性	-	SENS-401 43.5mg	艱鹽積顧鏇繭餘選齋窪(鏇選鏇醖糧獵齋餘選簾) = Preliminary data demonstrate that SENS-401 has a favorable safety profile when administered continuously for up to 11 weeks in adult patients undergoing cisplatin-based chemotherapy 網膚鏇遞簾願顧糧繭糧 (選壓艱積鹹觸遞壓憲鑰 )	积极	2023-12-18
				placebo
NCT03603314 (AUDIBLE-S, CTgov)	临床2/3期	突发性听力损失	115	SENS-401 (29 mg Dose Group)	鏇積艱積網鑰蓋淵蓋繭(鏇膚衊齋觸遞製遞淵鑰) = 蓋壓窪觸糧遞膚夢憲鹹繭遞簾遞襯製鹹窪觸鹹 (醖製選觸膚膚遞選簾蓋, 窪鑰願憲廠獵鬱餘網壓 ~ 積繭窪鬱憲繭遞製範選) 更多	-	2023-03-01
				SENS-401 (43.5 mg Dose Group)	鏇積艱積網鑰蓋淵蓋繭(鏇膚衊齋觸遞製遞淵鑰) = 廠積鏇夢觸糧選餘觸艱繭遞簾遞襯製鹹窪觸鹹 (醖製選觸膚膚遞選簾蓋, 獵壓範構顧艱願製獵顧 ~ 願網顧簾齋鏇觸壓鹹願) 更多
SFN2016	N/A	噪声性听力损失	-	SENS-401 5 mg/kg	觸構壓簾鑰簾膚壓醖壓(鑰糧壓廠鬱壓齋選衊獵) = 網蓋蓋窪艱鏇顧艱淵構構襯膚鑰鹹獵築壓願簾 (遞夢醖鏇膚積膚膚製選 ) 更多	-	2016-11-16
				SENS-401 10 mg/kg	觸構壓簾鑰簾膚壓醖壓(鑰糧壓廠鬱壓齋選衊獵) = 繭鹽夢鏇鬱襯鬱網積壓構襯膚鑰鹹獵築壓願簾 (遞夢醖鏇膚積膚膚製選 ) 更多