Printer Friendly

US FDA grants investigational new drug approval for Sensorion to proceed with SENS-401.

M2 PHARMA-July 16, 2019-US FDA grants investigational new drug approval for Sensorion to proceed with SENS-401


The US Food and Drug Administration (FDA) has granted investigational new drug approval (IND) to France-based Sensorion to proceed with SENS-401, based on preclinical data and clinical development plan, it was reported yesterday.

SENS-401 is under development for the treatment of Sudden Sensorineural Hearing Loss (or SSNHL). The product, arazasetron besylate, is a drug candidate that intends to protect and preserve inner ear tissue from damage that can cause progressive or sequelar hearing impairment.

The company started the Phase two clinical trial in this indication in 2019 in Europe, Canada, Israel and Turkey. The interim safety results are likely to be revealed at the end of 2019 and top line data will be announced mid-2020.

((Comments on this story may be sent to

COPYRIGHT 2019 Normans Media Ltd.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2019 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:M2 Pharma
Date:Jul 16, 2019
Previous Article:Sun Pharmaceutical's Ezallor Sprinkle capsules launched in US.
Next Article:Gilead Sciences signs 10-year global research and development collaboration with Galapagos.

Terms of use | Privacy policy | Copyright © 2020 Farlex, Inc. | Feedback | For webmasters