Targeted Therapeutics for Auditory Regeneration

About Us

Hearing ability serves an important role in the daily communications between families, friends, and colleagues and has a big impact on quality of life. There is the public interest in the threat of hearing loss caused by exposure to unsafe levels of sound from audio device and an aged society. Increasing evidences have shown that hearing loss diminishes a person’s mode of communication leading to social isolation and is associated with several diseases in the CNS. However, there is still no curable treatment for hearing loss at this point.

Astellas is taking the approach of regaining auditory functions by leveraging its core technology in the area of regenerative medicine. It believes doing so will not only help people regain auditory functions, but will also contribute to the well-being of society.

Astellas’ Auditory Regeneration has been working on the following leading programs.

  • FX-322 (Inner ear progenitor cell activator for sensorineural hearing loss, Phase 2)
  • ASP0598 (Recombinant heparin-binding epidermal growth factor-like growth factor (HB-EGF) for regeneration of tympanic membrane, Phase 1)

In addition, Astellas has the following capabilities:

  • Unique preclinical programs and optimal animal models for translational research
  • Our original local drug delivery system technology in the ear
  • Several pipelines in clinical stage and lots of expertise in development.
  • Top-notch researchers and clinicians through partnerships

Click on the banner below to see the summary.


Press Releases

Astellas and Frequency Therapeutics Enter into License Agreement for FX-322, a Regenerative Treatment Candidate for Hearing Loss

Astellas Executes License Agreement with Auration Biotech for the Development and Commercialization of AU-935



Assets and capabilities that Astellas expects from its partners

  • Drug/technology for regeneration of hair cell and repair of ribbon synapse formation, Strial vascular function improvement (preferably lead molecule identified)
  • Drug delivery system that targets the inner ear with small compound/protein/nucleic acid/gene therapy, in addition to hearable devices concurrently used with drug treatment/for diagnosis
  • Animal models to predict human effectiveness in sensorineural hearing loss