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Finerenone Restores Fertility in POI: A Breakthrough in Antifibrotic Treatment for Infertility
In February 2026, a research team led by Professor Liu Kui from The University of Hong Kong and Dr. Wang Tianren from the Hong Kong University Shenzhen Hospital published a groundbreaking study in Science. The paper, titled " Antifibrotic drug finerenone restores fertility in premature ovarian insufficiency," ( click to read more) reveals that the antifibrotic drug finerenone can restore fertility in patients with Premature Ovarian Insufficiency (POI). The study also confirms that targeting ovarian stromal fibrosis is an effective strategy for treating POI-related infertility. Furthermore, the research uncovers new potential indications for several FDA-approved antifibrotic drugs, providing a novel clinical approach to treating POI, a disease currently lacking effective therapeutic options.
Drug Screening
Using Kitl gene (a key gene regulating the activation of primordial follicles) mRNA upregulation as a marker, the team performed a multi-stage screening of 1,297 FDA-approved drugs. This included an initial cell-based screening, mouse ovarian organ culture validation, renal capsule transplantation experiments, and in vivo administration (intravenous injection/oral gavage) confirmation. Ultimately, finerenone was identified as the core candidate drug for treating POI-associated infertility.
Animal Model Validation
In mouse experiments, the research team found that finerenone, administered orally twice a week for three weeks, significantly increased ovarian weight and enhanced follicular development and vitality in aging mice. Furthermore, the total number of offspring in long-term treated mice was significantly higher than in the control group, with no observed embryotoxicity or developmental abnormalities.
The study also revealed that the expression levels of finerenone’s target in the ovaries were much higher than in its classic target organs, such as the heart and kidneys, confirming that the ovaries are a direct target of the drug.
Fig.1 Ovaries are a direct target of the drug
Pilot Clinical Trial
After comprehensive animal studies, the research team conducted a small-scale pilot clinical trial involving 14 POI patients who met international diagnostic criteria. These patients were treated with a low-dose regimen of finerenone (20 mg orally, twice a week, far below the dose used for kidney disease treatment) and followed up for 3 to 7 months. Clinical results showed that all 14 patients experienced follicular development, with excellent oocyte retrieval rates. Notably, 8 patients successfully obtained oocytes with no adverse effects.
Fig.2 Finerenone has no negative impact on pregnancy outcomes, offspring growth, or cognitive function in mice.
Antifibrotic Treatment as a New Direction
The research team further validated that several FDA-approved antifibrotic drugs with different mechanisms of action, such as nintedanib (used in the treatment of pulmonary fibrosis) and ruxolitinib (used in the treatment of myelofibrosis), significantly promoted ovarian follicle development in mice.
These findings confirm that ovarian stromal fibrosis is a core pathological issue in POI. The excessive deposition of collagen in ovarian tissues acts like a “lock” that inhibits follicular development. Antifibrotic drugs, by targeting and disrupting this fibrotic “lock,” create a more permissive microenvironment for follicle growth. This also suggests that future POI patients may have access to a variety of oral antifibrotic drug options.
Significance of the Study
This study marks a significant breakthrough in POI-related infertility treatment, transforming it from an "irreversible" condition to one that can be intervened with oral medication. By shifting the focus from the follicles themselves to targeting ovarian stromal fibrosis, the research opens up a new and effective therapeutic avenue. It also provides a fresh perspective for future research and clinical applications in the treatment of POI-related infertility.
Reference:
Francesca E. Duncan,Elnur Babayev,The ovarian stroma as a therapeutic target, Science, 391, 6785, (552-553), (2026)./doi/10.1126/science.aee7270
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