GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Ebselen overview

SPI-1005 (ebselen) is under development for the treatment of bipolar disorder, coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), mild to moderate noise-induced hearing loss (auditory threshold shift), Meniere's disease, and aminoglycoside-induced ototoxicity. The drug candidate is administered orally. It is a small molecule mimic of the enzyme glutathione peroxidase (Gpx). GPx is the dominant catalytic antioxidant enzyme that presents in the cochlea. it was also under development for chemotherapy in head and neck or non-small cell lung cancer induced hearing loss and tinnitus.

Sound Pharmaceuticals overview

Sound Pharmaceuticals (SPI) is a biopharmaceutical company that develops therapeutics for sensorineural otologic diseases. The company’s product pipeline includes SPI-1005, SPI-3005 and SPI-5557. Its SPI-1005 is a proprietary oral formulation of ebselen, a small molecule mimic and inducer of glutathione peroxidase used for treating acute noise-induced hearing loss (NIHL) and meniere’s disease; SPI-3005 is a chemoprotection for tinnitus; and SPI-5557 is used for regeneration of deaf. SPI develops drugs to regenerate cells within the cochlea and restore hearing, for individuals with severe to profound hearing loss. The company conducts clinical trials for the development of preclinical models of hearing loss and tinnitus. SPI is headquartered in Seattle, Washington, the US.

For a complete picture of Ebselen’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.