Arletta Pharma Solutions

What Arletta Pharma Solutions does

Arletta Pharma Solutions is a privately held, late clinical-stage pharmaceutical company headquartered in Amsterdam, the Netherlands (Arletta Pharma Solutions B.V.), that develops on-demand, dual-action drug therapies for Female Sexual Interest/Arousal Disorder (FSIAD) and Hypoactive Sexual Desire Disorder (HSDD). The company was established in December 2021 when it acquired all intellectual property — including know-how and prior clinical trial results — for two investigational therapies, Lybrido and Lybridos, from Dutch company Emotional Brain BV, and rebranded from Freya Pharma Solutions to Arletta Pharma Solutions effective December 1, 2025.

The company's core asset is Lybrido, a novel dual-route, dual-release fixed-dose combination tablet that pairs a testosterone coating for sublingual absorption with an inner-core of sildenafil (a PDE5 inhibitor) in a delayed-immediate-release matrix; this architecture synchronizes the pharmacokinetics of central sexual motivation (testosterone) and physiological arousal (sildenafil), with effects lasting 3-6 hours per dose. A second compound, Lybridos, combines sublingual testosterone with buspirone and targets the FSIAD sub-population with overactive sexual inhibition. The clinical package is built on 15+ years of prior research encompassing 20+ Phase I/IIa trials, large-scale Phase IIb trials across 17 US research sites, and a recent Phase II Clitoral Doppler Duplex Ultrasound study showing more than 60% improvement in clitoral blood flow with statistical significance (p=0.008) at the high-dose combination; the pivotal ALETTA Phase 3 trial is planned for 516 patients across approximately 20 European sites in 5 countries.

Arletta is pre-revenue. Its planned business model is a one-time prescription pharmaceutical sale distributed through pharmacies and healthcare providers upon regulatory approval in Europe and the United States, supported by an enterprise field-sales motion targeting sexual-medicine specialists and scientific engagement through key opinion leaders. The company has secured US$8.5 million in funding (March 2022), has received scientific advice from both the EMA and FDA on its clinical program, and is led by CEO Nicole Hijnen, CBO/Founder Marcel Wijma, and CMO Steve van Os (appointed June 2026).

Name

Arletta Pharma Solutions

Legal name

Arletta Pharma Solutions B.V.

Website

https://arlettapharmasolutions.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

1–10 employees

Short description

Arletta Pharma Solutions is a private Amsterdam-based clinical-stage pharmaceutical company developing Lybrido and Lybridos, investigational on-demand dual-action therapies for women with Female Sexual Interest/Arousal Disorder (FSIAD) and Hypoactive Sexual Desire Disorder (HSDD).

Ownership category

akta.pro rank

Product category

Women's Health Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Scientific Research and Development Services (5417)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Endocrinology & Reproductive Health Pharmaceuticals (incl. Women’s Health) (HLAIAAAJ)

akta.pro secondary industry

Clinical Pharmacology & Pharmacometrics (Modeling & Simulation) (HLAIALAG)

Keywords

• Female sexual health
• HSDD treatment
• FSIAD therapy
• Women's health pharmaceuticals
• Sexual dysfunction therapeutics

Headquarters

HQ city

Amsterdam

HQ country

Netherlands

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales, Others

Revenue model

1. Pharmaceutical Product Revenue: Once regulatory approval is obtained, Arletta plans to generate revenue through the sale of prescription pharmaceutical products (Lybrido) distributed through pharmacies and healthcare providers in Europe and the United States.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Arletta Pharma Solutions is a clinical-stage biopharmaceutical company developing investigational on-demand, dual-action pharmaceutical therapies for Female Sexual Interest/Arousal Disorder (FSIAD) and Hypoactive Sexual Desire Disorder (HSDD). Its flagship product Lybrido™ is a novel dual-route, dual-release fixed-dose combination tablet containing sublingual testosterone and a delayed-release sildenafil inner-core, designed to be taken on-demand with effects lasting 3-6 hours. A second compound, Lybridos™, combines testosterone with buspirone for a different FSIAD subtype.

Product overview

Arletta Pharma Solutions is a biopharmaceutical company developing pharmaceutical therapies for Female Sexual Interest/Arousal Disorder (FSIAD) and Hypoactive Sexual Desire Disorder (HSDD). The company's core product portfolio consists of two investigational compounds: Lybrido™ and Lybridos™, both designed as on-demand dual-action therapies. Lybrido™ combines testosterone (sublingual) with sildenafil (oral, delayed-release) targeting women with low sensitivity to sexual cues. Lybridos™ combines testosterone with buspirone targeting women with overactive sexual inhibition. Both products employ a novel dual-route, dual-release tablet formulation to synchronize the effects of their combined active ingredients.

Differentiator

Problem solved

Functional benefit

Brands

• Lybrido: An investigational on-demand, dual-action therapy designed to address both psychological and physiological components of Female Sexual Interest/Arousal Disorder (FSIAD) and Hypoactive Sexual Desire Disorder (HSDD). The treatment consists of a novel dual-route, dual-release fixed-dose combination with testosterone for sublingual administration and sildenafil in a delayed-immediate-release core.
• Lybridos

Products and services

• Lybrido™
• Lybridos™

Quantifiable outcome

• More than 60% average improvement in clitoral blood flow (Peak Systolic Velocity) with both dose combinations in Phase II CDU study
• +3 more outcomes

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Three partnerships are on record, tiered core.

• Emotional Brain BVcoreStrategic or Co-development Partner · 17 December 2022In December 2021, Arletta acquired all intellectual property, including know-how and prior clinical trial results, for two therapies (Lybrido and Lybridos) from Dutch Emotional Brain BV. This acquisition provided the foundational IP and clinical data for Arletta's FSIAD drug development program.
• CR2O BVcoreImplementation/ SI/ Consulting PartnerCR2O BV is a full-service clinical contract research organization leading the preparation, execution, and reporting of Arletta's Lybrido Phase 3 clinical trial (ALETTA). The CRO is specialized in developing innovative treatments for unmet medical needs.
• Chaim Sheba Medical CentercoreStrategic or Co-development PartnerInvestigator-initiated clinical studies are conducted at Chaim Sheba Medical Center in Israel, led by Prof. Cobi Reisman (urologist, sexologist) and Dr. Anna Padoa (gynecologist). The center conducted the Phase II Clitoral Doppler Duplex Ultrasound study evaluating Lybrido dose combinations.

Scale indicators7 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Sprout Pharmaceuticals: Sprout developed and markets Addyi (flibanserin), the first FDA-approved oral treatment for HSDD in premenopausal women. It is the most direct comparator to Arletta's Lybrido as both target female sexual dysfunction with an oral, on-demand therapy.
• Ovoca Bio (formerly Ivix): Ovoca Bio developed BP-101, a non-hormonal therapy for HSDD. It is a direct peer as another small-cap, late-stage women's sexual health company with a single-asset pipeline pursuing regulatory approval in female sexual dysfunction.
• Palatin Technologies: Palatin developed Vyleesi (bremelanotide), an FDA-approved on-demand treatment for HSDD in premenopausal women. Palatin is led by a Supervisory Board member of Arletta (James Hattersley) and directly competes in the same HSDD/FSIAD space with a differentiated mechanism (melanocortin agonist).

Broad incumbents

• TherapeuticsMD: TherapeuticsMD commercializes several FDA-approved women's health products including hormone therapies targeting menopausal symptoms. Comparable as a women's-health specialty pharma overlapping in endocrinological mechanisms relevant to female sexual function.
• Endoceutics: Endoceutics developed Intrarosa (prasterone/DHEA) for menopausal dyspareunia, addressing female sexual pain. Comparable as a women's sexual medicine developer using hormone-based mechanisms.
• Evofem Biosciences: Evofem commercializes Phexxi for women's sexual and reproductive health. Comparable as a women's sexual/reproductive health specialty pharma targeting underserved female indications.

Others

• Emotional Brain BV: Emotional Brain BV is the Dutch company from which Arletta acquired all Lybrido and Lybridos IP and clinical data in December 2021. Highly relevant as the originator of the asset Arletta is developing.

Emerging players

• Dare Bioscience: Dare Bioscience is a clinical-stage biopharmaceutical company focused exclusively on women's health with multiple programs in hormone therapy and reproductive health. Comparable as a small women's-health-focused developer pursuing regulatory approvals in underserved indications.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/freyapharmasolutions

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Arletta Pharma Solutions