Taranabant— also known as MK-0364 or L-000899055— is showing impressive results in its phase III trial, reported by anecdotal from participants. And Merck has said it expects to file for approval to market the diet drug in the United States in spring 2008. But there have been no presentations of interim results of the trial to scientific meetings and Merck has had little to say about taranabant.

Some suggest Merck has drawn some important conclusions about how-not-to-gratuitously-alienate-the-FDA from recent experiences of Sanof, which trumpeted one exciting result after another from clinical trials of rimonabant only to find things moving slower and slower at the regulatory agency.

The FDA’s continually postponed action led Sanofi to finally withdraw its application in June. It has ended the hopes of early approval as millions of Americans eagerly anticipating approval of rimonabant. In this context, FDA advisory panel recommended the diet drug not be marketed until safety issues are resolved.

Meanwhile, taranabant— which started out several years behind rimonabant— moves quietly through the clinical trial process. The Phase III trial, which began enrolling participants in fall 2005, will be drawing to an end in the final quarter of this year, with contracts for researchers ending in early 2008.

Till spring, the final results from this trial are not expected, where participants were rerandomized for the second year in an effort to determine what dose is needed to keep off weight lost in the first, and there has been no hint Merck will bring interim news to the Obesity Society annual meeting in October.

The approach on taranabant has so far been very low in intensity as Merck may yet decide to provide some information on interim trial results.

Back to News