ReproNovo Doses First Participant in EU Phase 2 NORDIC Trial of Oral Oxytocin Receptor Antagonist RPN-002 for Embryo Implantation
核心洞察
ReproNovo (搜索) has dosed the first participant in its EU Phase 2 NORDIC trial evaluating RPN-002 (搜索) (nolasiban), an oral oxytocin receptor (搜索) antagonist designed to improve IVF/ICSI success rates.
The randomized, placebo-controlled, double-blind trial will enroll 120 participants across five European sites, testing higher doses and longer administration schedules than previously explored.
RPN-002 (搜索) aims to reduce uterine contractility during embryo transfer, a factor linked to lower pregnancy rates, potentially improving implantation and live birth outcomes in ART programs.
ReproNovo (搜索), a clinical-stage biopharmaceutical company headquartered in Lausanne, Switzerland, announced on July 6, 2026 that the first participant has been dosed in its EU Phase 2 clinical trial of RPN-002 (搜索) (nolasiban). The trial, entitled Nolasiban Optimized Regimen Dosing for Inhibition of Uterine Contractility (NORDIC), is designed to evaluate the oral oxytocin receptor (搜索) antagonist's ability to reduce uterine contractility and improve embryo implantation outcomes in women undergoing assisted reproductive technology (ART) programs.
The NORDIC study (EU CT Number: 2025-524896-22) is a randomized, placebo-controlled, double-blind, parallel-group, multicenter trial that will evaluate two dosing regimens of RPN-002 (搜索) on uterine contractility and endocrine parameters. Enrollment is planned to include 120 randomized participants across five sites in Europe. The study will investigate higher doses and a longer administration schedule than previously explored in this patient population, which the company believes may increase the likelihood of success.
"NORDIC is designed to generate the pharmacodynamic evidence needed to guide selection of an optimized dosing regimen for future clinical evaluation in improving implantation rates in IVF and ICSI," said Joan-Carles Arce, MD, PhD, Chief Scientific and Medical Officer of ReproNovo (搜索). "By assessing uterine contractility and other factors relevant for embryo implantation, the study will help us build on our unique understanding of the effects of RPN-002 (搜索) and its role in creating conditions conducive to embryo implantation."
The Implantation Challenge in ART
The implantation process after embryo transfer remains a key determinant of ART treatment success. Studies by different research groups have reported lower pregnancy rates in women with an increased frequency of uterine contractions during embryo transfer, indicating interference with the implantation process. For many women and couples undergoing ART, each embryo transfer represents a significant medical, emotional, and financial investment.
RPN-002 (搜索) is an orally administered oxytocin receptor (搜索) antagonist that aims to reduce uterine contractility and maintain uterine quiescence during the critical early implantation period. By targeting this mechanism, the therapy has the potential to increase pregnancy and live birth rates following embryo transfer.
"Dosing the first participant in NORDIC is an important milestone for a study designed to better understand how uterine contractility may be managed around embryo transfer," said Juan A. García Velasco, MD, PhD, Chief Scientific Officer of IVIRMA (搜索), representing the investigators of the NORDIC study. "Implantation remains one of the most critical and uncertain steps in ART, and data from this study may help inform future approaches to supporting patients undergoing fertility treatment."
Pipeline Context and Broader Development
The NORDIC milestone builds on ReproNovo (搜索)'s broader progress across multiple global Phase 2 clinical programs in male and female fertility as well as women's health. The company's pipeline includes RPN-001 (搜索) (leflutrozole), currently being evaluated in a U.S. Phase 2 trial in men with low sperm count and low testosterone (NCT06993155), and RPN-002 (搜索), which is also in development for the management of adenomyosis (搜索). In adenomyosis, RPN-002 may reduce abnormal uterine contractility, minimize local inflammation, alleviate menstrual pain, and potentially improve fertility rates in women affected by the disease.
ReproNovo (搜索) has acquired the exclusive rights, including all intellectual property and associated assets, related to nolasiban. The company is financed by Jeito Capital, BNP Paribas Asset Management Alts (formerly AXA IM Alts), founding investor M Ventures, Ysios Capital, and ALSA Ventures. With its primary development team in Copenhagen, Denmark, and an additional development site in Barcelona, Spain, ReproNovo has clinical and operational team members also based in the U.S.
The company has indicated four planned readouts over the next two years across its Phase 2 pipeline, positioning the NORDIC study as a key component of its strategy to address critical gaps in fertility and women's health.