Advancing the Science

We see pitolisant as a portfolio in a product opportunity and are taking a mechanism-based approach to future clinical development. Our goal is to utilize pitolisant’s unique mechanism of action to address unmet medical needs for people living with rare, neurological disorders.

Jeffrey Dayno, M.D., Chief Medical Officer


Pitolisant was designed and developed by Bioprojet Societe Civile de Recherche (Bioprojet), which has marketed the product in Europe since its approval by the European Medicines Agency in 2016. Harmony has an exclusive license from Bioprojet to develop, manufacture and commercialize pitolisant in the United States.


The company is currently evaluating the novel mechanism of action of pitolisant for broader applications in neurological disorders that may be mediated by the H3 receptor. This mechanism-based approach for pitolisant offers the potential for future clinical development in a variety of conditions beyond disorders of wakefulness.

Harmony is actively evaluating the potential addition of new compounds to its portfolio with a focus on orphan/rare neurological disorders.


Harmony Biosciences product pipeline