The U.S. FDA has granted Vanda Pharmaceuticals a formal evidentiary public hearing for Hetlioz (tasimelteon), the first such drug approval hearing in more than 40 years.
In 2014, Vanda received FDA approval for Hetlioz, an oral melatonin receptor agonist, to treat non-24-hour sleep–wake disorder. Vanda was issued a CRL in 2019 for its sNDA in jet lag disorder. The FDA again declined to expand approval for jet lag disorder in January 2026. Vanda responded by requesting a hearing to review CDER's refusal of its sNDA.
In August 2025, Vanda won its case against the FDA before the U.S. Court of Appeals for the D.C. Circuit. The court determined that the FDA had inadequately engaged with evidence from Vanda, including statistically-significant results from clinical trials. This has ultimately led the FDA to grant Vanda a public hearing. If Hetlioz receives approval, it will become the first FDA-approved therapeutic for jet lag disorder.