Freya Pharma Phase 2 Study for Female Sexual Dysfunction
Freya Pharma Solutions Initiates Phase 2 Trial of Lybrido for Female Sexual Interest/Arousal Disorder (FSIAD)
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August 5, 2025 – Freya Pharma Solutions has begun a Phase 2 clinical study to evaluate Lybrido, its investigational therapy for Female Sexual Interest/Arousal Disorder (FSIAD).The trial, conducted at Chaim Sheba Medical Center in Israel, represents a meaningful step forward in addressing a frequently under-recognized and impactful condition affecting women’s health and well-being.
Understanding FSIAD and the Need for New Treatments
Female sexual dysfunction is a prevalent issue, with hypoactive sexual desire disorder (HSDD) – often overlapping with FSIAD – being the most commonly reported concern.FSIAD, formally recognized in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), is characterized by persistent or recurrent deficiencies in sexual fantasies and desire, or arousal, causing clinically significant distress or interpersonal difficulty. This disorder extends beyond simple lack of desire, impacting emotional health, self-esteem, and intimate relationships.
Currently, treatment options for FSIAD are limited, highlighting the urgent need for targeted therapies. Lybrido aims to fill this gap by addressing both the psychological and physiological components of the disorder.
Lybrido’s Mechanism and the Phase 2 Trial Design
Lybrido is a novel fixed-dose tablet combining sublingual testosterone and oral sildenafil. This combination is designed to together enhance central sexual motivation – through testosterone’s effects on the brain – and improve genital arousal by increasing blood flow, facilitated by sildenafil.The Phase 2 trial will investigate the physiological effects of two different dose combinations of this dual-action therapy.Researchers, led by Principal Investigator Cobi Reisman and co-investigator Anna Padoa, will utilize a cutting-edge imaging technique: clitoral Doppler duplex ultrasound. This non-invasive method allows for objective quantification of changes in clitoral blood flow, a validated biomarker directly correlated with 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,” explained Reisman.This focus on objective physiological data distinguishes this study and promises to provide valuable insights into Lybrido’s efficacy.
Looking Ahead: European Trials and the Future of FSIAD Treatment
Freya Pharma Solutions is strategically leveraging the findings from this Phase 2 trial. According to Jan van der Mooren, Freya’s Chief Medical Officer, “This research supports our scientific strategy and informs the design of our upcoming trial scheduled to launch across Europe in late 2025.” This planned expansion indicates the company’s commitment to bringing Lybrido to a wider patient population.
The growth of Lybrido,and the rigorous research supporting it,signals a growing awareness and investment in addressing female sexual health concerns. As research continues to refine our understanding of FSIAD and its underlying causes, and as innovative therapies like Lybrido progress through clinical trials, the outlook for effective treatment options is increasingly optimistic. The future promises a more nuanced and thorough approach to supporting women’s sexual well-being, moving beyond historical stigmas and towards evidence-based solutions.