Repronovo announces enrollment in US phase 2 trial of RPN-001 to treat MALE INFERTILITY

Repronovo announces enrollment in US phase 2 trial of RPN-001 to treat MALE INFERTILITY

By, Admin 3 July 2025

ReproNovo, a company dedicated to developing innovative treatments for reproductive medicine and women’s health, announced that the first participant has been included in the company’s phase 2 clinical trial of its lead candidate RPN-001 (leflutrozole), an orally administered aromatase inhibitor in development for the treatment of male infertility.

Trial for evaluating safety profile

The randomized, placebo-controlled trial is evaluating the safety and efficacy of three dose levels of RPN-001 in men with low testosterone and impaired semen quality. The study plans to enroll approximately 200 men across multiple clinical sites in the US.

Words from Jean Duvall: CEO, ReproNovo

“Initiating this phase 2 study marks a significant milestone in our efforts to bring forward new solutions for the many couples affected by male-factor infertility,” said Jean Duvall, chief executive officer of ReproNovo. “Low testosterone levels are becoming more prevalent, even in younger men, highlighting the urgent demand for new treatments. Our goal is to develop a targeted, well-tolerated therapy that expands options for men and reduce the burden on female partners.”

RPN-001: First-in-Class Oral Therapy for Male-Factor Infertility

  • Male-factor infertility is implicated in up to half of infertility cases worldwide. Currently, no FDA-approved oral therapies exist for men with this diagnosis. 
  • RPN-001 is the first candidate in its class developed specifically for this indication and has demonstrated a promising profile in early clinical studies. 
  • RPN-001 is being studied to show improvements in testicular function and promotion of sperm production (spermatogenesis).

Words from Joan-Carles Arce: ReproNovo

“RPN-001 has the potential to offer clinicians a new way to increase the amount of functional sperm available for fertility treatments based on a well-understood biological pathway,” said Joan-Carles Arce, MD, PhD, chief scientific and medical officer of ReproNovo. “With this phase 2 study now underway, we are taking the next step toward addressing a clear and growing unmet need in reproductive medicine.”

This milestone builds on momentum from ReproNovo’s recent $65 million Series A financing to advance its multiple phase 2 clinical programmes in reproductive medicine and women’s health.

The novel compound: RPN-001

  • RPN-001 is a novel orally administered compound being developed for the treatment of infertility in men with low serum testosterone. 
  • The small molecule inhibits the enzyme aromatase, suppressing testosterone conversion to estradiol, thereby normalizing testosterone levels. 
  • Low testosterone levels are becoming more prevalent, even in younger men, highlighting the urgent demand for new treatments.
  • ReproNovo has an exclusive global license agreement with Mereo BioPharma for the development and commercialization of leflutrozole.

About the company: ReproNovo

  • ReproNovo is a cutting-edge biopharmaceutical company developing innovative solutions to address critical gaps in reproductive medicine and women’s health. 
  • Its team is composed of proven experts with deep experience in reproductive medicine, drug development, regulatory affairs and business development who have throughout their careers successfully brought multiple therapies to market.

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