Lasmiditan was discovered by Eli Lilly and Company and was then relicensed to CoLucid Pharmaceuticals in 2006, until CoLucid was bought by Eli Lilly in 2017 to allow Eli Lilly to reacquire the drug's intellectual property. The drug is protected by patents until 2031.
Phase II clinical trials for dose finding purposes were completed in 2007 for an intravenous form and in early 2010 for an oral form. Eli Lilly submitted a new drug application to the FDA in November 2018.
Three phase III clinical trials were completed. The SPARTAN trial compared placebo with 50, 100, and 200 mg of lasmiditan. SAMURAI compared placebo with 100 and 200 mg doses of lasmiditan. GLADIATOR is an open-label study that compared 100 and 200 mg doses of lasmiditan in patients that received the drug as part of a prior trial.
Topline results from the SPARTAN trial showed that the drug induced met its primary and secondary endpoints in the trial. The primary result showed a statistically significant improvement in pain relief relative to placebo 2 hours after the first dose. The secondary result showed a statistically significantly greater percentage of patients were free of their most bothersome symptom (MBS) compared with placebo at two hours following the first dose.
The FDA approved the drug on 11 October 2019. However, the drug is awaiting Drug Enforcement Administration (DEA) scheduling before it is made available in the United States.