First of the two phase I bioequivalence trials of once-daily extended release formulation of lorcaserin in healthy adults
Phase of Trial: Phase I
Latest Information Update: 27 Sep 2016
At a glance
- Drugs Lorcaserin (Primary) ; Lorcaserin
- Indications Obesity
- Focus Pharmacokinetics; Registrational
- Sponsors Arena Pharmaceuticals; Eisai Inc
- 27 Sep 2016 Results assessing pharmacokinetics published in the Clinical Therapeutics.
- 20 Jul 2016 According to Eisai media release, based on results of this and another phase I trial (CTP 700255712) trial the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for lorcaserin for chronic weight management.
- 30 Nov 2015 According to Eisai Inc media release, the US FDA has accepted for filling the New Drug Application (NDA) for extended release lorcaserin based on results of this and another phase I trial (CTP 700255707).