The approval enables initiation of RPN-001 Phase 1 trial in China.Key regulatory milestone in the global development of RPN‑001.
Lausanne, Switzerland and Copenhagen, Denmark, September 30, 2025 ReproNovo, a company dedicated to developing innovative treatments for reproductive medicine and women’s health, today announced that China’s National Medical Products Administration (NMPA) has issued a clinical trial approval notice for RPN-001 (leflutrozole). This approval enables the initiation of a Phase 1 trial in China, marking a key regulatory milestone in the global development of RPN‑001 as a potential treatment for male infertility associated with low serum testosterone.
Entering China with our first approved clinical study marks a meaningful geographic expansion for ReproNovo. With this approval, we will soon have active clinical programs in the U.S. and China, two of the world’s largest healthcare markets, which reinforces our commitment to global development in reproductive medicine.
RPN-001 is being studied to show improvements in testicular function and promotion of sperm production (spermatogenesis). The latest approval in China aligns with ReproNovo’s global development strategy and follows recent progress in the U.S., where a Phase 2 trial is underway.
We are committed to expanding access to innovative therapies where few treatment options currently exist. With clinical activities now advancing in both the U.S. and China, we are building the foundation for a truly global approach to reproductive medicine and women’s health innovation.
ABOUT REPRONOVO:
ReproNovo is a cutting-edge biopharmaceutical company developing innovative solutions to address critical gaps in reproductive medicine and women’s health. Our 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. Lead clinical compound, RPN-001 (leflutrozole), is being developed to treat male infertility. RPN-002 (nolasiban) is a first-in-disease and first-in-class molecular entity being developed to manage adenomyosis and increase the probability of embryo implantation in women undergoing assisted reproductive technology (ART) treatments. Both assets are Phase 2 ready. ReproNovo is financed by Jeito Capital, AXA IM Alts, founding investor M Ventures, Ysios Capital and ALSA Ventures. Headquartered in Lausanne, Switzerland, the company has its primary development team in Copenhagen, Denmark and an additional development site in Barcelona, Spain. For more information, visit the Company’s website at www.repronovo.com or follow us on LinkedIn.
ABOUT RPN-001 (leflutrozole):
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. RPN-001 is currently being evaluated in a U.S. Phase 2 trial (https://clinicaltrials.gov/study/NCT06993155?term=Leflutrozole&rank=1). ReproNovo has an exclusive global license agreement with Mereo BioPharma for the development and commercialization of leflutrozole.
CONTACT INFORMATION:
ReproNovo
Rue de Langallerie 11
1003 Lausanne, Switzerland
info@repronovo.com
MEDIA CONTACT:
MC Services AG
Brittney Sojeva
repronovo@mc-services.eu
+49 211 529 252 14
