Asset profile

tasimelteon · Hetlioz

Small molecule

Approved / Phase 4Mechanism not established
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Approvedregulatory verdict

Evidence outlook

Approved: Non-24-Hour Sleep-Wake Disorder

Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.

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Competitive landscape

No competitors sharing a mechanism or indication in the current universe.

Upcoming events

(1 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2027 (1)
November 2027 (1)
Phase 3Insomnia DisorderRecruiting
Est. primary completion 2027-11 · NCT06953869 · CT.gov ↗
What to watch
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All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (11)
Phase 2/3 (2)
Phase 2 (2)
Phase 1 (11)
Phase 4 (1)