Hetlioz is the trade name of Vanda Pharmaceuticals’ Tasimelteon, an oral compound in Phase III development for Non-24-Hour Disorder (Non-24).
Hetlioz is the trade name of Vanda Pharmaceuticals’ Tasimelteon, an oral compound in Phase III development for Non-24-Hour Disorder (Non-24), a circadian rhythm disorder with orphan designation in the USA and Europe. Tasimelteon is a circadian regulator that resets the master body clock in the suprachiasmatic nucleus (SCN) of the hypothalamus in the brain. Tasimelteon’s ability to reset the master body clock in the SCN has been shown to synchronize the body’s melatonin and cortisol circadian rhythms with the day/night cycle and to provide clinically meaningful benefits to patients with Non-24.
Tasimelteon is a circadian regulator in development for the treatment of Non-24. Tasimelteon is a dual melatonin receptor agonist (DMRA) with selective agonist activity at the MT1 and MT2 receptors. Tasimelteon aims to reset the master body clock in the suprachiasmatic nucleus (SCN), resulting in the entrainment of the body's melatonin and cortisol rhythms to align to the 24-hour day-night cycle. The patent claiming Tasimelteon as a new chemical entity extends through December 2022, assuming a five-year extension to be granted under the Hatch-Waxman Act.
Non-24 is a serious, rare, and chronic circadian rhythm disorder characterized by the inability to entrain (synchronize) the master body clock with the 24-hour day-night cycle. Non-24 affects a majority of totally blind individuals, or between 65,000 and 95,000 people in the US. Non-24 occurs almost entirely in individuals who lack the light sensitivity necessary to entrain the master body clock in the brain with the 24-hour day-night cycle. Most people have a master body clock that naturally runs longer than 24-hours and light is the primary environmental cue that resets it to 24 hours each day. Individuals with Non-24 have a master body clock that is not reset, and continually delays, resulting in prolonged periods of misalignment between their circadian rhythms and the 24-hour day-night cycle, including the timing of melatonin and cortisol secretion. As a result of this misalignment, Non-24 is associated with significant disruption of the sleep-wake cycle and impairments in social and occupational functioning, and marked subjective distress.