Tasimelteon is under clinical development by Vanda Pharmaceuticals and currently in Phase III for Autism Spectrum Disorder (ASD). According to GlobalData, Phase III drugs for Autism Spectrum Disorder (ASD) have a 13% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Tasimelteon’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.

Tasimelteon overview

Tasimelteon (Hetlioz) is a derivative of benzofuran acts as hypnotic agent, belongs to central nervous system class. It is formulated as hard gelatin capsules and suspension for oral route of administration. Hetlioz is indicated for the treatment of non-24-hour sleep-wake syndromes in adults. Hetlioz LQ capsules are indicated for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older. Hetlioz LQ oral suspension   is indicated for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in pediatric patients 3 to 15 years of age.

The drug candidate is under development for the treatment of non-24-hour sleep-wake syndrome (in pediatrics), autism spectrum disorder and jet lag disorder. The drug candidate was also under development for the treatment of major depressive disorder, chronic primary insomnia and transient insomnia.

Vanda Pharmaceuticals overview

Vanda Pharmaceuticals (Vanda) a biopharmaceutical company that develops and commercializes novel therapies for the treatment of central nervous system disorders. The company’s products include Hetlioz, a melatonin receptor agonist for the treatment of non-24-hour sleep-wake disorder; and Fanapt, a typical antipsychotic for the treatment of schizophrenia in adults. Its major pipeline products include Tradipitant (VLY-686), VTR-297, VQW-765, CFTR and portfolio of cystic fibrosis transmembrane conductance regulator inhibitors and activators. Vanda is headquartered in Washington, Washington DC, the US.

For a complete picture of Tasimelteon’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.