OSU-6162 is under clinical development by Saniona and currently in Phase II for Bipolar I Disorder. According to GlobalData, Phase II drugs for Bipolar I Disorder have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how OSU-6162’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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.

OSU-6162 overview

OSU-6162 (PNU-96391) is under development for the treatment of bipolar I, bipolar II disorder and SSRI/SNRI-resistant depression. The drug candidate is administered orally in the form of coated tablet. It has two enantiomers. Both enantiomers of OSU6162 has medium intrinsic activity and act as partial agonists at 5-HT2A receptors and low intrinsic activity partial agonists at D2 receptors. It was also under development for the treatment of Parkinson's disease, Huntington's disease, narcolepsy, multiple sclerosis, myalgic encephalomyelitis, chronic fatigue, alcohol dependence, dyskinesia in Parkinson's disease schizophrenia, residual symptoms after stroke.

Saniona overview

Saniona is a biopharmaceutical company that discovers, develops, and delivers treatments for rare diseases. It is investigating Tesomet, a combination of tesofensine and metoprolol against hypothalamic obesity and Prader-Willi syndrome. The company is also evaluating SAN711, a positive allosteric modulator of GABAA a3 receptors to treat rare neuropathic disorders; and SAN903, an inhibitor of calcium-activated potassium ion channel (KCa3.1) targeting rare inflammatory and fibrotic disorders. Saniona utilizes its proprietary ion channel drug discovery engine anchored by IONBASE to discover its products. It works in partnership with Productos Medix SA de CV, Novartis AG, Boehringer Ingelheim International GmbH, and other pharmaceutical companies. It has operational presence in Denmark and the US. Saniona is headquartered in Ballerup, Denmark.

For a complete picture of OSU-6162’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.