FDA has authorized a phase III Clinical Trial for Nolasiban

The pivotal US Clinical Trial (IMPLANT 3) will evaluate Nolasiban’s efficacy in women undergoing embryo transfer (ET) following in-vitro fertilization (IVF).

It should be considered that each year, more than 2 million Assisted Reproductive Technology (ART) treatments (IVF-ICSI) are performed all over the world. A successful embryo implantation and pregnancy is based upon numerous factors, particularly on endometrial receptivity: during the embryo transfer, this could be reduced by excessive uterine contractions and non-optimal blood flow to the uterus.

Nolasiban is an oral oxytocin receptor antagonist that is being analyzed for this use in a confirmatory Phase III European trial (IMPLANT 4); in a first European Phase III trial (IMPLANT 2), it was demonstrated that the drug is able to increase ongoing pregnancy rate and live birth rate in women undergoing single embryo transfer. There was no difference between Nolasiban and placebo.

Implant 3 will be the first study in the USA and it will consider the efficacy and safety in increasing the number of live births; about 1100 women undergoing a day 5 transfer of a single, fresh embryo will be enrolled.