Pipeline: Novel Approaches to Fertility and Women’s Health
ReproNovo is a clinical-stage biopharmaceutical company developing therapies for male and female fertility as well as women’s health. Our pipeline focuses on new scientific approaches designed to address critical gaps in current fertility treatments and improve the likelihood of successful conception. Programs prioritize mechanisms targeting biological drivers of infertility not adequately addressed by existing interventions. Our women’s health research aims to expand treatment options for conditions affecting women of reproductive age, with adenomyosis representing our first therapeutic focus.
ReproNovo Global Clinical Pipeline in Male and Female Fertility and Women’s Health
RPN-001 (leflutrozole)
What is RPN-001?
RPN-001 (leflutrozole) is ReproNovo’s orally administered aromatase inhibitor being developed for male infertility in men with low testosterone. RPN-001 has the potential to induce and increase sperm production and thereby enhance the availability of sperm for fertility treatment and natural conception. ReproNovo has an exclusive global license agreement for the development and commercialization of leflutrozole.
Who Is Being Evaluated for Treatment with RPN-001 for Male Fertility?
RPN-001 is being clinically evaluated in men with impaired sperm production and low testosterone, with the goal of improving the probability of pregnancy following intrauterine insemination (IUI) cycles and natural conception. It will also be explored in men with non-obstructive azoospermia (NOA), i.e., men with no sperm production, and low testosterone, with the aim of improving the probability of pregnancy following intracytoplasmic sperm injection (ICSI) cycles.
Why is RPN-001 important for fertility treatment?
Male-factor infertility is implicated in up to half of fertility cases worldwide, and no FDA-approved oral therapies currently exist for this population of men. Addressing this critical gap with RPN-001 has the potential to shift part of the fertility treatment burden away from the female partner by introducing a targeted therapeutic option for men.
How does RPN-001 work?
By inhibiting the aromatase enzyme, RPN-001 suppresses the conversion of testosterone to estradiol, thereby increasing testosterone levels and rebalancing the testosterone to estradiol ratio. RPN-001 also stimulates production of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) – hormones involved in male reproductive endocrine regulation. These effects lead to improved testicular function and increased sperm production.
RPN-002 (nolasiban)
What is RPN-002?
RPN-002 (nolasiban) is ReproNovo’s orally administered oxytocin receptor antagonist being developed to increase pregnancy rates and live birth rates in women undergoing embryo transfer after Assisted Reproductive Technology (ART) treatment. RPN-002 has the potential to enhance successful embryo implantation by reducing uterine contractility and maintaining uterine quiescence. ReproNovo has acquired the exclusive rights, including all intellectual property and associated assets, related to nolasiban.
Who Is Being Evaluated for Treatment with RPN-002 for Female Fertility?
RPN-002 is being developed for women undergoing embryo transfer as part of fertility treatment, with the goal of improving the likelihood of successful implantation and increase pregnancy and live birth rates.
Why is RPN-002 important for fertility treatment?
Despite advances in assisted reproductive technologies (ART), implantation failure remains a major limitation in fertility treatment. Understanding the reasons why embryos fail to implant is an area of research aimed at defining novel therapeutic options. Currently, no approved therapies specifically target embryo implantation at the time of embryo transfer by modulating uterine contractility.
How does RPN-002 work?
Oxytocin is a hormone that stimulates uterine contractility. By blocking oxytocin receptors, RPN-002 is expected to decrease uterine contractions around the time of embryo transfer and thereby lower the risk of the embryo moving away from the ideal implantation site, improving the chances of pregnancy.
RPN-002 (nolasiban)
What is RPN-002?
RPN-002 (nolasiban) is an orally administered oxytocin receptor antagonist being developed to treat the symptoms of adenomyosis, a common and often painful uterine condition that is also associated with difficulties conceiving. Adenomyosis occurs when tissue from the lining of the uterus grows into the muscular area of the uterus. Oxytocin receptors are overexpressed in adenomyosis patients, and RPN-002 may help alleviate the signs and symptoms of adenomyosis. ReproNovo has acquired the exclusive rights, including all intellectual property and associated assets, related to nolasiban.
Who Is Being Evaluated for Treatment with RPN-002 for Women’s Health?
RPN-002 is being developed for women diagnosed with adenomyosis and experiencing moderate to severe menstrual pain (dysmenorrhea). The goal is to provide a targeted, non-surgical therapeutic option for women living with adenomyosis.
Why is RPN-002 important for Women’s Health?
Despite its high prevalence and significant impact on women’s health, there are currently no approved treatment options, and to our knowledge no therapies in development specifically targeting adenomyosis.
How does RPN-002 work?
Oxytocin receptors are overexpressed in adenomyosis patients and increased activation of the oxytocin receptor and signaling could play a key role in the development and progression of adenomyosis. RPN-002 selectively blocks the oxytocin receptor, which may help normalize uterine dysperistalsis, reduce local tissue inflammation, relieve menstrual pain, and potentially improve fertility rates.
Pipeline Selection Criteria
ReproNovo applies a disciplined framework to select programs in male and female fertility as well as women’s health.
We prioritize assets that meet three core criteria:
Programs targeting male and female fertility or uterine conditions with significant unmet medical need, limited or no approved therapies and clear clinical demand, where innovation can fill critical gaps by meaningfully expanding the treatment landscape.