FDA Clearance Given to Phase 3 Clinical Trial of Nolasiban in Women

FDA Clearance Given to Phase 3 Clinical Trial of Nolasiban for Women Undergoing Embryo Transfer

2019-10-31 14:00:00

Officials from the FDA have allowed ObsEva to begin enrolling patients in IMPLANT 3, the United States' Phase 3 clinical trial in nolasiban for women undergoing embryo transfer following in-vitro fertilization (IVF).

Nolasiban, an oral oxytocin receptor antagonist, is currently being studied in a confirmatory Phase 3 European trial known as IMPLANT 4. IMPLANT 3 will be the first study of nolasiban in the United States and will evaluate efficacy for an increasing the number of live births and safety, compared to placebo.

Assisted Reproductive Technology treatments are performed on more than 2 million reproductive-age couples each year. Nolasiban’s success could help reduce uterine contractions and suboptimal blood flow to the uterus at the time of embryo transfer.

REFERENCE

ObsEva announces clearance to initiate pivotal US phase 3 clinical trial (IMPLANT 3) of nolasiban in women undergoing embryo transfer following IVF [news release]. Geneva, Switzerland and Boston, MA; October 31, 2019: ObsEva Press Releases. https://www.obseva.com/pressrelease-detail-2/?pr=2665. Accessed October 31, 2019.