Tasimelteon is under clinical development by Vanda Pharmaceuticals and currently in Pre-Registration for Insomnia. According to GlobalData, Pre-Registration drugs for Insomnia have a 60% phase transition success rate (PTSR) indication benchmark for progressing into Marketed. 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.

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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 jet lag disorder, insomnia, delayed sleep-wake phase disorder (circadian rhythm sleep disorders), REM behavior disorder (parasomnia), non-24-hour sleep-wake syndrome in pediatrics, Smith-Magenis syndrome and autism spectrum disorder. It is administered through oral route in the form of capsule. 

The drug candidate was also under development for the treatment of major depressive disorder. 

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. The company’s 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.

This content was updated on 7 February 2024

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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 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.