Summary: Cilcare entered an exclusive option agreement with Shionogi, granting the pharmaceutical company rights to license two promising drug candidates for hearing disorders.


  1. Exclusive Licensing Agreement: Shionogi has the option to license global rights to Cilcare’s drug candidates CIL001 and CIL003, with Cilcare receiving an upfront payment and potential milestone payments.
  2. Focus on Hearing Disorders: The drug candidates target hidden hearing loss and tinnitus, with CIL001 set for Phase 2a trials in 2025 and CIL003 in preclinical studies.
  3. Global Impact: The collaboration aims to address the significant global health challenge of hearing loss, affecting approximately 1.5 billion people worldwide.

Cilcare, a biotech company specializing in auditory sciences, announced an exclusive option agreement with Shionogi, an impact-driven pharmaceutical company, granting the pharma company the right to license global rights to CIL001 and/or CIL003, two promising drug candidates aimed at treating hearing disorders, with a particular focus on addressing the increasing prevalence of hidden hearing loss and tinnitus.

Under the terms of the agreement:

  • Shionogi will receive an exclusive option to license global rights to CIL001 and/or CIL003.
  • Cilcare will receive an upfront payment of €15 million (approximately $16 million USD).
  • Cilcare is eligible to receive up to €400 million (approximately $429 million USD) in milestone payments upon successful development and commercialization of the drug candidates.
  • Shionogi will decide whether to exercise the option right based on the results of the Phase 2a studies of CIL001 and preclinical study data of CIL003, both to be conducted by Cilcare.

Driven by its approaches from preclinical research to drug development, which harness AI-driven auditory markers known as digital auditory signatures, Cilcare is dedicated to advancing therapies for auditory-related diseases. The agreement with Shionogi underscores Cilcare’s commitment to external innovation and collaboration to address critical unmet needs in hearing disorders, the companies say.

Further reading: Cilcare Names New Chief Medical Officer

About CIL001 and CIL003

CIL001, a disease-modifying small molecule, holds promise for treating cochlear synaptopathy and associated disorders through a single and painless transtympanic administration. Supported by robust preclinical and clinical safety data, CIL001 is poised to enter Phase 2a trials in 2025 in Europe and United States of America. Additionally, preclinical studies for CIL003 are currently underway.

Global Impact of Hearing Loss

Hearing loss affects approximately 1.5 billion people worldwide, with hidden hearing loss, or cochlear synaptopathy, emerging as a significant challenge despite normal hearing tests. This condition, affecting about 15% of the population, underscores the urgent need for innovative therapies to address speech comprehension difficulties and other associated symptoms.

The collaboration between Cilcare and Shionogi represents a pivotal step in addressing the urgent global health crisis posed by hearing disorders, offering hope for millions of individuals worldwide, the companies say.

Photo: Cilcare