TIK-301

TIK-301 (LY-156735) is an agonist for the melatonin receptors MT₁ and MT₂ that is under development for the treatment of insomnia and other sleep disorders. Its agonist action on MT₁ and MT₂ receptors in the suprachiasmatic nucleus in the brain enables its action as a chronobiotic. It is in the same class of melatonin receptor agonists as ramelteon and tasimelteon.

History and development

TIK-301 was first developed at Eli Lilly and Co in Indianapolis, IN as LY-156735. In 2002, it was licensed by Phase 2 Discovery for further commercialization and worldwide development as PD-6735. In July 2007, the open Investigational New Drug (IND) was transferred to Tikvah Therapeutics Inc. in Atlanta, GA by Phase II Discovery, where it was renamed to TIK-301. Currently, clinical trials are ongoing there. Because it has been traded and sublicensed by multiple companies, it can referred to by all three names. Mostly recently and commonly, it is referred to as TIK-301.

TIK-301 was in phase II clinical trials in 2002. In 2004, TIK-301 was designated an orphan drug by the FDA. In 2005, TIK-301 was expected to go into phase III trials.