Pitolisant hydrochloride is under clinical development by Harmony Biosciences and currently in Phase II for Cognitive Impairment. According to GlobalData, Phase II drugs for Cognitive Impairment does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Pitolisant hydrochloride LoA Report. Buy the report here.
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Pitolisant hydrochloride overview
Pitolisant hydrochloride (Wakix, Ozawade) is a central nervous system drug. It is formulated as film-coated tablets for oral route of administration. Wakix is indicated in adults for the treatment of narcolepsy with or without cataplexy. Ozawade is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by, or who have not tolerated, OSA primary therapy, such as continuous positive airway pressure (CPAP).
It is under development for the treatment of obstructive sleep apnea, excessive diurnal sleepiness in patients with moderate to severe obstructive sleep apnoea (OSA) syndrome, obstructive sleep apnea and narcolepsy with or without cataplexy in adults and pediatrics, autism spectrum disorders and idiopathic hypersomnia. It is also under development for prader-willi syndrome (PWS), fatigue, cognitive impairment and myotonic dystrophy. It was also under development for the treatment of bipolar depression and cognitive-enhancing effects in schizophrenia or schizoaffective disorder and alcohol use disorder and Parkinson's disease.
Harmony Biosciences overview
Harmony Biosciences is a commercial-stage, pharmaceutical company that discovers, develops and commercializes therapies for patients with rare and other neurological diseases. The company offers WAKIX (pitolisant), a molecule with a novel mechanism of action for the treatment of excessive daytime sleepiness in adult patients with narcolepsy. It has an operational presence in Australia and the US. Harmony Biosciences is headquartered in Plymouth Meeting, Pennsylvania, the US.
For a complete picture of Pitolisant hydrochloride’s drug-specific PTSR and LoA scores, buy the report here.
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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.
