Freya Pharma Solutions Rebrands as Arletta Pharma Solutions, Marking New Phase in Women’s Healthcare Innovation
- New name reflects company’s transformation as it advances toward the final phase of Lybrido™’s clinical development
- The Arletta butterfly symbolism underscores commitment to women’s health and lifecycle transitions
- CDU Phase II study ongoing with preliminary data expected near-term; ALETTA pivotal study positioned for launch pending financing completion
- Company leverages fifteen years of research in Female Sexual Disorders
Amsterdam, the Netherlands, 27 November 2025 – Freya Pharma Solutions, Freya Pharma Solutions, a pharmaceutical company specializing in innovative therapies for women diagnosed with Female Sexual Disorders (FSD), today announced it will rebrand as Arletta Pharma Solutions, effective December 1, 2025. The new name, derived from a rare butterfly species, symbolizes the company’s transformation as it progresses toward pivotal clinical milestones and its strategic objectives of securing regulatory approval.
“Like a caterpillar emerging as a butterfly, this name change marks the beginning of our company’s final phase,” said CEO Nicole Hijnen, Chief Executive Officer of Arletta Pharma Solutions. “This rebranding comes at the optimal moment in our evolution—as we advance our clinical programs and prepare to deliver on our founding mission to address a significant unmet medical need affecting millions of women worldwide.”
The Butterfly: A Universal Symbol in Women’s Healthcare
The name Arletta, inspired by a rare butterfly species, carries profound significance for women’s medical care. The butterfly symbolizes transformation, change, beauty, and freedom—concepts that resonate deeply throughout women’s healthcare. Internationally, the term “butterfly” appears frequently in medical contexts related to women’s health, from anatomical structures to diagnostic indicators, reflecting the transformative nature of women’s life stages.
Throughout their lives, women undergo remarkable transformations—puberty, reproductive years, perimenopause, and postmenopause—each representing a metamorphosis that requires specialized medical attention and understanding. Arletta Pharma’s focus on developing innovative therapies for Female Sexual Interest/Arousal Disorder (FSIAD) acknowledges these unique transitions and the need for targeted therapeutic solutions that respect the complexity of female sexual health.
Clinical Programs Advancing
Arletta Pharma’s Clitoral Doppler Duplex Ultrasonography (CDU) Phase II study is currently ongoing at Chaim Sheba Medical Center, evaluating two testosterone-sildenafil dose-combinations in 16 premenopausal women with acquired generalized FSIAD. Led by Prof. Cobi Reisman and Dr. Anna Padoa, the study utilizes clitoral doppler duplex ultrasound imaging to quantify clitoral blood flow parameters, with preliminary data expected in the near term. Additionally, the company is finalizing preparations for the ALETTA pivotal study across 20 European research sites in five countries, with enrollment positioned to commence in the foreseeable future pending completion of financing arrangements—a critical milestone toward regulatory approval in Europe.
Building on Fifteen Years of Scientific Foundation
Arletta Pharma Solutions (formerly Freya Pharma Solutions) is developing Lybrido™, an innovative on-demand dual-action therapy for FSIAD and Hypoactive Sexual Desire Disorder (HSDD), building upon fifteen years of research. Lybrido™ features a novel dual-route, dual-release tablet with a testosterone coating for sublingual administration and a sildenafil (PDE-5 inhibitor) inner core. The delayed-immediate-release matrix synchronizes peak plasma concentration of sildenafil with the testosterone-induced window of increased sexual motivation, enhancing genital arousal through increased responsivity to sexual stimuli. Effects last 3 to 6 hours after intake. To date, Lybrido™ has been investigated in 20 Phase I and Phase IIa trials, plus large-scale Phase IIb trials across 17 US research sites.
About Female Sexual Disorders
Low sexual desire is the most common female sexual disorder (FSD), often causing clinically significant distress, dissatisfaction in intimate relationships, and profoundly impacting emotional well-being. Female Sexual Interest/Arousal Disorder (FSIAD), as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), combines persistent reductions in sexual interest and/or arousal lasting six months while causing clinically significant distress. FSIAD represents the clustering of Hypoactive Sexual Desire Disorder and Female Sexual Arousal Disorder, listed in the World Health Organization’s International Classification of Diseases, 11th Revision (ICD-11) under Code HA00/HA01.0.
About Arletta Pharma Solutions
Arletta Pharma Solutions (formerly Freya Pharma Solutions) is a pharmaceutical company focused on developing effective pharmaceutical therapies for FSIAD/HSDD, building upon fifteen years of solid research. The company’s core asset under development is Lybrido™, designed to address FSIAD/HSDD through an innovative on-demand dual-action mechanism. Based in Amsterdam, The Netherlands, Arletta Pharma Solutions aims to offer patients a convenient, personalized on-demand solution for this recognized unmet medical need.
For further information please contact:
Arletta Pharma Solutions, Amsterdam
Marcel Wijma, Chief Business Officer
marcel@arlettapharmasolutions.com
For media
LifeSpring Life Sciences Communication, Amsterdam
Leon Melens
T: +31 6 538 16 427
E: lmelens@lifespring.nl
Freya Pharma Solutions Announces Launch of Phase II Clinical Dose-Response Study testing its LybridoTM Concept Targeting Female Sexual Dysfunction
Freya Pharma Solutions Announces Launch of Phase II Clinical Dose-Response Study testing its LybridoTM Concept Targeting Female Sexual Dysfunction
- Study evaluates Lybrido™’s Dual-Action therapy for Female Sexual Dysfunction
- Innovative clitoral blood flow measurement technique aims to objectively quantify treatment efficacy of two dose-combinations
- ALETTA Pivotal Study prepared for Late 2025 launch in Europe amid significant unmet medical need
Amsterdam, the Netherlands, 4 August 2025 - Freya Pharma Solutions, a pharmaceutical company specializing in innovative therapies for women diagnosed with Female Sexual Disorders (FSD), today announced the initation of a Phase II clinical study evaluating its LybridoTM concept. The study will investigate two dose-combinations of testosterone and sildenafil, assessing their effects on female sexual response through physiological measurements of genital blood flow parameters.
This investigator-initiated clinical study, designed and led by Princial Investigator Prof. Cobi Reisman, (urologist, sexologist), and Co-Investigator Dr. Anna Padoa (gynecologist), will be conducted at the Chaim Sheba Medical Center. The study aims to assess objective physiological measurements of arousal response in premenopausal women diagnosed with acquired generalized Female Sexual Interest/Arousal Disorder (FSIAD) following treatment with combined sublingual testosterone and oral sildenafil therapy. Clitoral blood flow parameters – a key biomarker of genital arousal - will be quantified using standardized Clitoral Doppler Duplex Ultrasound imaging.
Prof. Cobi Reisman, MD, PhD, FCESM,ECPS said:
“Combination therapy of sublingual testosterone and oral sildenafil is reported as a potentially effective and safe treatment option for premenopausal women with FSIAD. We are very interested in this promising treatment modality, and aim to better understand the mechanisms behind the clinical observations reported sofar. Sexual function is frequently measured with validated and standardized questionnaires to determine the subjective sexual response, whereas objective measures warrant physical measurement. In this regard, clitoral vascularization is reported as a relevant physiological indicator of the female genital arousal response. In our study we will use Clitoral Doppler Duplex Ultrasound which is a promising technique to assess clitoral blood flow in women.”
Dr. Jan van der Mooren, Chief Medical Officer at Freya Pharma Solutions commented:
"The combination of sublingual testosterone and oral sildenafil being studied by Prof. Reisman and Dr. Padoa closely mirrors the mechanism of action of LybridoTM, our investigational product for women diagnosed with FSIAD. This research aligns with Freya Pharma’s commitment to advancing science in this field, and we’re proud to support a study that could deepen our understanding of LybridoTM’s therapeutic potential. Concurrently, Freya Pharma Solutions is finalizing preparations for the ALETTA clinical study - a pivotal clinical study as part of Lybrido™’s European clinical development program. Enrollment is slated to begin in late 2025 across 20 European research sites in five countries.”
About Female Sexual Disorders
Among female sexual disorders (FSD), representing a significant health concern, low sexual desire consistently is reported as the most common issue affecting women. This widespread challenge often leads to clinically significant distress, dissatisfaction in intimate relationships, profoundly impacting emotional well-being and social connections.
In the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), Female Sexual Interest/Arousal Disorder (FSIAD) combines persistent reductions in both sexual interest and/or arousal, requiring symptoms to persist for six months, while causing clinically significant distress. Clinicians diagnose FSIAD through specific symptom thresholds and further categorize it by severity (mild, moderate, or severe) and subtype: lifelong versus acquired, and generalized versus situational presentations. FSIAD is the clustering of Hypoactive Sexual Desire Disorder and Female Sexual Arousal Disorder; listed in the World Health Organization’s International Classification of Diseases, 11th Revision (ICD-11) under Code 17 HA00/HA01.0 Hypoactive Sexual Desire Dysfunction and Female Sexual Arousal Dysfunction (https://icd.who.int/).
About LybridoTM
A total of 20 phase I and phase IIa trials, and large-scale phase IIb trials in 17 research sites in the US have been conducted to date. These trials have investigated the efficacy and safety of two novel on-demand pharmacological treatments that have been designed to treat FSIAD, LybridoTM and LybridosTM. LybridoTM increases central sexual motivation and physiological sexual responses, such as swelling of genitals and lubrication. The therapy can be taken ‘on-demand’ and helps to increase central sexual motivation from 3 to 6 hours after intake. This treatment consists of a novel (dual-route, dual-release, fixed-dose) combination tablet, consisting of a testosterone coating for sublingual administration and an inner-core component containing the phosphodiesterase type 5 (PDE 5) inhibitor, sildenafil. The inner-core component is coated with a delayed-immediate-release matrix to ensure that the peak plasma concentration of the PDE 5 inhibitor coincides with the window of increased sexual motivation induced by the sublingually administered testosterone. Thus, this combination enables an increase in genital arousal through an increase in responsivity to sexual stimuli.
About Freya Pharma Solutions
Freya Pharma Solutions is a pharmaceutical company, focused on developing effective pharmaceutical therapies for FSIAD/HSDD, building upon fifteen years of solid research. The company’s core asset under development is LybridoTM, designed to address FSIAD/HSDD. Based in Amsterdam, The Netherlands, Freya Pharma Solutions aims to offer patients a convenient, personalized ‘on-demand’ solution for this recognized unmet medical need.
For further information please contact:
Freya Pharma Solutions, Amsterdam
Marcel Wijma, Chief Business Officer
marcel@freyapharmasolutions.com
For media
LifeSpring Life Sciences Communication, Amsterdam
Leon Melens
T: +31 6 538 16 427
E: lmelens@lifespring.nl