Freya Pharma launches phase 2 study of therapy for female sexual dysfunction
Ella Day | August 5, 2025 | News story | Research and Development | Female Sexual Interest/Arousal Disorder (FSIAD), Freya Pharma Solutions, Genito-Urinary system, sexual health
Freya Pharma Solutions has announced the initiation of a phase 2 study evaluating its Lybrido to treat female sexual interest/arousal disorder (FSIAD). Conducted at Chaim Sheba Medical Center, Israel, the study will test two dose combinations of sublingual testosterone and oral sildenafil to assess their physiological effects on genital blood flow.
Led by principal investigator Cobi Reisman and co-investigator Anna Padoa, the trial will use a new imaging technique – clitoral doppler duplex ultrasound – to objectively quantify changes in clitoral blood flow, a biomarker of female genital arousal.
“Combination therapy of testosterone and sildenafil shows promise in treating FSIAD, and our goal is to better understand the underlying mechanisms using measurable physiological endpoints,” said Reisman.
The study mirrors the mechanism of Freya’s investigational therapy Lybrido, which is designed to enhance both central sexual motivation and genital arousal. It combines fast-acting testosterone with delayed-release sildenafil in a fixed-dose tablet.
“This research supports our scientific strategy and informs the design of our upcoming trial scheduled to launch across Europe in late 2025,” said Jan van der Mooren, Freya’s chief medical officer.
Female sexual dysfunction is an under-addressed condition, with low sexual desire being the most frequently reported issue. FSIAD, as defined in DSM-5, affects emotional well-being and intimate relationships, underlining the need for targeted therapies like Lybrido.
Ella Day
5/8/25
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