Alemany, one of the principal researches, who is also the holder of a 1998 U.S. patent () for fatty acid esters of estrone, including OE, in relation to fat loss. The group studied the effects of oral OE on Marià Alemany who was morbidly obese. It was shown for the first time to be effective at producing fat loss in a human and also a maintenance (and increase) of weight loss in two-month rest periods in between three-week dosing periods. This was achieved with no prescribed dietary restrictions. Clinical development OE was licensed to Manhattan Pharmaceuticals in 2002. An Investigational New Drug application was accepted by the U.S. Food and Drug Administration (FDA) in 2005 and a Phase I trial was conducted in Switzerland. The results showed OE to be safe and to lead to weight loss after just 7 days of dosing, and this weight loss was maintained for three further weeks after treatment had stopped. In June 2006, a Phase IIa trial of 100 patients began which included two 14-day dosing periods each followed by 28 days of no treatment which was designed to elucidate the best dosing methods and in particular the maintenance of weight loss that had been shown. This trial was originally a single-centre trial in Switzerland, but in November 2006 it was announced that the trial had been expanded to two additional clinical sites in the USA. An additional trial was commenced in October 2006 that is designed to investigate the efficacy of the drug in morbidly obese patients who had been designated as bariatric patient candidates. This trial which took place in the United States, recruited 24 patients and dosed OE for 30 days, without any break, followed by 30 days of evaluation after dosing completed. On July 10, 2007 Manhattan Pharmaceuticals announced that its phase 2a studies for oral oleoyl-estrone failed. The two studies demonstrated no clinically meaningful or statistically significant placebo adjusted weight loss. See also Lipoidal estradiol References Antiobesity drugs Estranes Estrogens