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Phase III study of nolasiban for in-vitro fertilisation

Trial Profile

Phase III study of nolasiban for in-vitro fertilisation

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 31 Oct 2019

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At a glance

  • Drugs Nolasiban (Primary)
  • Indications Female infertility
  • Focus Registrational; Therapeutic Use
  • Acronyms IMPLANT 3
  • Sponsors ObsEva
  • Most Recent Events

    • 31 Oct 2019 According to a ObsEva media release, the U.S. Food and Drug Administration (FDA) has allowed the Company to begin enrolling patients in this trial.
    • 19 Jun 2019 According to an ObsEva media release, the Company had an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), addressing a range of issues important to the trial design of nolasiban for increasing the rate of live births in women undergoing single blastocyst transfer (Day 5 SET) following in vitro fertilization (IVF). The company expects to submit the IMPLANT 3 trial protocol with an updated IND in the third quarter of 2019.
    • 19 Jun 2019 According to an ObsEva media release, the Company anticipates beginning this trial in the fourth quarter of this year or early 2020.
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