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.

Start Date30 Dec 2022

Sponsor / Collaborator

Sensorion SA

NCT05258773 / CompletedPhase 2

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.

Start Date10 Aug 2022

Sponsor / Collaborator

Sensorion SA

100 Clinical Results associated with Azasetron besylate

100 Translational Medicine associated with Azasetron besylate

100 Patents (Medical) associated with Azasetron besylate

Literatures (Medical) associated with Azasetron besylate

01 Nov 2024·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

Author: Glotin, Anne-Lise ; Cohen-Vaizer, Mauricio ; Honnet, Geraldine ; 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.

26 Jun 2021·International journal of analytical chemistryQ4 · CHEMISTRY

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

Q4 · CHEMISTRY

ArticleOA

Author: 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.

01 Aug 2019·Journal of pharmaceutical sciencesQ3 · MEDICINE

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

Q3 · MEDICINE

Article

Author: 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.

News (Medical) associated with Azasetron besylate

03 Dec 2024

·www.businesswire.com

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.

Phase 2Gene Therapy

06 Nov 2024

·www.businesswire.com

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.

Phase 2

26 Sep 2024

·www.businesswire.com

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.

Phase 2Gene Therapy

100 Deals associated with Azasetron besylate

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hearing Loss, Sudden	Phase 3	BG	Sensorion SA	15 Feb 2019
Hearing Loss, Sudden	Phase 3	CA	Sensorion SA	15 Feb 2019
Hearing Loss, Sudden	Phase 3	CZ	Sensorion SA	15 Feb 2019
Hearing Loss, Sudden	Phase 3	FR	Sensorion SA	15 Feb 2019
Hearing Loss, Sudden	Phase 3	DE	Sensorion SA	15 Feb 2019
Hearing Loss, Sudden	Phase 3	IL	Sensorion SA	15 Feb 2019
Hearing Loss, Sudden	Phase 3	RS	Sensorion SA	15 Feb 2019
Hearing Loss, Sudden	Phase 3	SK	Sensorion SA	15 Feb 2019
Hearing Loss, Sudden	Phase 3	TR	Sensorion SA	15 Feb 2019
Hearing Loss, Sudden	Phase 3	GB	Sensorion SA	15 Feb 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05628233 (BusinessWire) Manual	Phase 2	Ototoxicity	-	SENS-401	bvawwyxkwx(mqklyvgnxa) = 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. ybnjxzpahc (jxhpwduxpr )	Positive	20 Sep 2024
NCT05258773 (Corporate Publications) Manual	Phase 2	Hearing Loss	24	SENS-401 (Arazasetron)	zespjywfiw(pzbgvpjuad) = fzrrmfpyba jmudhlhmsz (fymzfemzsr )	Positive	15 Jul 2024
				Control group	zespjywfiw(pzbgvpjuad) = qunovactov jmudhlhmsz (fymzfemzsr )
NCT05258773 (Biospace) Manual	Phase 2	Hearing Loss	28	SENS-401	lvockdczwi(sjtahxxuvb) = 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 nnzecnogrk (hwgtzjpbzs ) Met	Positive	11 Mar 2024
				non-treated arm
NOTOXIS (Biospace) Manual	Phase 2	Ototoxicity	-	SENS-401 43.5mg	avglfkhzwr(sazgkkqkpw) = 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 xsuckssrsb (mymsveknnl )	Positive	18 Dec 2023
				placebo
NCT03603314 (AUDIBLE-S, CTgov)	Phase 2/3	Hearing Loss, Sudden	115	SENS-401 (29 mg Dose Group)	bxyqgcvpwa(pcthqznwzd) = adbcojoegc jnttykcpor (moqoueabow, lnfwzxenvc - jcdminogic) View more	-	01 Mar 2023
				SENS-401 (43.5 mg Dose Group)	bxyqgcvpwa(pcthqznwzd) = vygxowpfug jnttykcpor (moqoueabow, dqnhfxusxe - vpotqfvnoq) View more
SFN2016	Not Applicable	Hearing Loss, Noise-Induced	-	SENS-401 5 mg/kg	uahfgixfag(xkeekkftql) = sfuyhaxzei rmgwpnoqju (hdsihqgyrs ) View more	-	16 Nov 2016
				SENS-401 10 mg/kg	uahfgixfag(xkeekkftql) = lwwwwveecx rmgwpnoqju (hdsihqgyrs ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Azasetron besylate

Overview

Basic Info

Structure

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation