VNDA

HETLIOZ® (tasimelteon)

Jet Lag Disorder

Report out on post-CRL FDA meeting

Exp Date

November 6, 2020 (Est)

Amp Volatility Score

Catalyst Info & Data Links

TITLE: HETLIOZ® (tasimelteon) for Jet Lag Disorder - Report out on post-CRL FDA meeting

  • ClinicalTrial.gov (NCT03291041) A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder

  • ClinicalTrial.gov (NCT03373201) Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia


WHAT IS THE NEXT CATALYST EVENT?

  • Report out on post-CRL FDA meeting


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?

  • November 6, 2020 (Est)


PRIOR DATA

PRESS RELEASES

MECHANISM OF ACTION / RATIONALE

  • The precise mechanism by which tasimelteon exerts its therapeutic effect in patients with Non- 24 is not known. Tasimelteon is an agonist at melatonin MT1 and MT2 receptors. These receptors are thought to be involved in the control of circadian rhythms (learn more pg 6).

Updated by HC

#VNDA, #HETLIOZ®, #tasimelteon, #Jet_Lag_Disorder

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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