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GW-TT2 is an intranasal spray formulation of nimodipine, an FDA-approved L-type calcium channel blocker, being developed by Gateway Biotechnology for the treatment of recent-onset tinnitus (tinnitus developed within the last two years). By repurposing nimodipine through the 505(b)(2) regulatory pathway, GW-TT2 aims to modulate abnormal electrical activity and inflammatory pathways in the auditory system that result from increased calcium channel activity following noise-induced hearing loss. The nasal delivery route is specifically designed to enhance drug delivery to the brain and auditory tissues while minimizing systemic side effects typically associated with oral nimodipine administration. The program has received support from the U.S. Department of Defense via an SBIR Phase 2 grant and is currently in the preclinical and manufacturing phase, with plans to expand into indications such as Sudden Sensorineural Hearing Loss and Ménière's disease.
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