Acrux Details Female Testosterone Push With $6.6Bn US Market in Sights by FY28
Acrux pivots to Female Testosterone for HSDD in strategic overhaul
In its April 2026 Strategic Update presentation, Acrux Limited (ASX: ACR) outlined a material strategic shift from its Topical Generics focus to bringing Female Testosterone to market for the treatment of Hypoactive Sexual Desire Disorder (HSDD). The pivot follows a comprehensive business review conducted by new CEO John Warmbrunn and the Executive Team.
The review evaluated six critical areas before arriving at the new strategy:
- Existing Topical Generics performance and potential for geographic expansion
- Development pipeline potential for Topical Generic drugs currently under development
- Changes in the clinical and regulatory environment for Hormone Replacement Therapy in Women’s Health
- Opportunities to leverage existing Acrux R&D know-how and capabilities
- FDA feedback on completed Phase I and Phase II trials for Female Testosterone
- Co-development commercialisation strategies for bringing the product to market
The product is Phase III ready following completed Phase I and Phase II clinical trials, which demonstrated a strong efficacy and safety profile with no material adverse events recorded. This positions Acrux to pursue an expedited regulatory pathway in an underserved therapeutic area with substantial commercial potential.
John Warmbrunn, CEO and Managing Director
“Female Testosterone is a great opportunity that Acrux is incredibly well positioned to exploit. The core revenue we are generating from our Topical Generics portfolio underpins and supports our capacity to bring this product to market.”
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Understanding HSDD and the Female Testosterone opportunity
Hypoactive Sexual Desire Disorder (HSDD) is characterised by low or absent sexual desire and/or response to stimulation that causes personal distress. The condition affects approximately 4.9 million menopausal women in the US, with a total addressable US population of approximately 12 million sufferers across all age groups. HSDD impacts approximately 10% of all adult women.
Beyond reduced sexual function, HSDD manifests through low self-esteem, reduced energy, depression, anxiety, and interpersonal conflict. The therapeutic efficacy of testosterone therapy has been demonstrated in 36 randomised clinical trials, with approximately 52% of patients reporting improved sexual function within 6-8 weeks of treatment initiation. Anecdotal benefits include improved mood, energy levels, and cognitive function.
The scientific foundation for testosterone therapy in women is well established. Professor Susan R Davis, Head of the Monash Women’s Health Research programme and author of the 2019 Global Consensus Position Statement on the Use of Testosterone Therapy for Women, notes that testosterone “is not simply a male hormone but is also an important hormone in women,” and that “there is irrefutable evidence that testosterone therapy in doses that result in blood levels within the physiological range for premenopausal women improves sexual desire, arousal, orgasm and sexual self-image and reduces personal distress in postmenopausal women with HSDD.”
The unmet need creating Acrux’s opportunity
The commercial opportunity stems from a critical market gap: there is currently no Female Testosterone treatment approved for HSDD in the US. Despite this regulatory void, approximately 2 million US women already use off-label testosterone products to treat HSDD, signalling substantial pent-up demand for an approved formulation.
Acrux estimates the US menopausal HSDD market alone could deliver commercial value of approximately US$2.88 billion per annum. The total US HSDD market potential across all age groups is estimated at US$6.6 billion annually. The demographic tailwinds are significant: by 2030, approximately 130,000 women will enter menopause globally each day, with approximately 120 million women estimated to have HSDD globally by that date.
| Age Segment | Market Value (US$Bn) |
|---|---|
| 18-44 years | 1.44 |
| 45-65 years (menopausal) | 2.88 |
| >65 years | 2.24 |
The market estimates assume 12.3% of women aged 45-65 years, 8.9% of women aged 18-44 years, and 7.4% of women over 65 years have HSDD. Acrux’s calculations factor in an annual treatment cost of US$300 per month, with 40% of women responding to treatment with clinically meaningful improvements, 75% willing to speak to a doctor, and 82% of those initiating discussion with a healthcare provider.
Clinical progress and FDA regulatory pathway
Acrux has maintained positive engagement with the US FDA regarding the clinical pathway required to register Female Testosterone for HSDD treatment. The regulatory timeline demonstrates both the company’s early development efforts and recent momentum:
- 2002: Pre-IND meeting held with FDA to discuss potential populations and Phase II protocol design; IND application lodged
- 2005: Pre-IND meeting held with FDA to discuss safety requirements; end of Phase II meeting planned to discuss Phase III programme; programme subsequently ceased
- October 2025: Acrux submitted a Pre-IND package to the FDA
- November 2025: US Department of Health & Human Services removed FDA Black Box warnings from female hormone replacement therapy products
- January 2026: Acrux’s registration pathway clarified by the FDA
The removal of Black Box warnings in November 2025 marks a watershed moment for the women’s health sector. The warnings stemmed from early 2000s findings by the World Health Initiative that overall risks exceeded benefits from certain hormone products (not including testosterone), creating a broader misconception that hindered development in this therapeutic area.
In July 2025, the FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women identified HSDD in post-menopausal women as a key unmet clinical need. This was followed by regulatory approvals in 2025 in the UK, Australia, New Zealand, and South Africa for products treating HSDD in post-menopausal women, signalling a global shift in regulatory attitudes.
Acrux is pursuing the 505(b)(2) regulatory pathway, which offers an exclusivity period and enables the company to leverage existing safety and efficacy data alongside its own clinical trials.
MDTS technology and product positioning
Acrux’s Metered Dose Transdermal System (MDTS) technology provides the delivery mechanism for Female Testosterone. The MDTS functions as a “patchless patch”—a spray formulation applied to the abdomen that creates an invisible drug reservoir within the skin. This application site reduces the risk of incidental contact and transfer compared to products applied to the arms or other exposed areas.
The technology platform has been proven through Lenzetto and Evamist, both FDA-registered hormone products, ensuring high scalability once the Female Testosterone product reaches market. The MDTS comprises three components: an applicator used for simple, accurate, and flexible dosing; ACROSS enhancers that allow drugs to pass through the skin more rapidly; and the Patchless Patch reservoir that forms within the skin.
Product positioning strategy centres on four pillars:
- First-line and first-choice dosage form: Once-a-day administration applied to the abdomen
- Enhancement of sexual desire: Reducing sexual distress whilst improving overall mood and energy
- Complement to existing hormone therapy: Positioning testosterone’s role in comprehensive hormone optimisation alongside estrogen-progesterone approaches
- Patient preference: The spray delivery system offers discretion and ease of use compared to patches or gels
Co-development strategy targets FY28 market launch
Acrux will pursue co-development with a major global partner to de-risk and expedite the regulatory and market entry process. The presentation emphasised that Acrux has “significant, long-term existing relationships with potential co-developers”—a material advantage given the company’s history commercialising Axiron, Evamist, and Lenzetto through licensing partnerships.
The partnering criteria target organisations with clinical trial expertise, established sales force access to relevant prescriber networks, experience with hormone products, and market education and advocacy capabilities. This approach leverages external resources for the capital-intensive Phase III trial process whilst preserving Acrux’s economic interest in the asset.
John Warmbrunn, CEO and Managing Director
“The direction provided by the FDA, and our long-term existing relationships with potential partners, means that a co-development pathway is clearly the best option to commercialise the product. With a huge unmet need for women with Hypoactive Sexual Desire Dysfunction (HSDD), Acrux is looking forward to making a significant contribution to women’s health globally.”
The development roadmap targets multiple near-term and medium-term milestones to maintain investor engagement through to US market launch:
| Milestone | Target Timing |
|---|---|
| Co-development Partnering | Mid CY26 |
| CRO Contract | Early FY27 |
| Manufacturing | Early FY27 to launch |
| Phase III Trials | Early FY27 to submissions |
| Dossier to US FDA | Early FY28 |
| Submission and Product Launch | Late FY28 to Early FY29 |
The mid CY26 partnering milestone provides a near-term catalyst, whilst the late FY28 to early FY29 launch window positions the product to capture first-mover advantage before competitors can navigate their own regulatory pathways.
Existing portfolio supports development runway
Acrux stands apart from clinical-stage biotechnology peers through its existing portfolio of in-market, FDA-registered products generating revenue to subsidise R&D activities. Quarterly revenues from product licensing are growing, driven by the launch of Nitroglycerin 0.4% Ointment at the end of Q2 FY25.
FY26 Product Licensing Income is on track to be more than double the prior year, represented by +305% growth. The commercialised portfolio comprises:
- Nitroglycerin 0.4% ointment (launched)
- Dapsone 5.0% gel (launched)
- Dapsone 7.5% gel (launched)
- Evamist royalties (ongoing)
The company continues to pursue geographic expansion of its FDA-registered products to broaden the revenue base. Proceeds from the divestment of Prilocaine 2.5% and Lidocaine 2.5% cream were received in 1H FY26, demonstrating active portfolio management to optimise asset mix.
This self-funding capability differentiates Acrux from cash-burning development-stage biotechnology companies and reduces dilution risk during the capital-intensive Phase III development period.
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Lifecycle management and exclusivity strategy
Acrux is pursuing the 505(b)(2) exclusivity period to establish competitive protection following regulatory approval. Beyond the initial exclusivity window, the company has identified multiple differentiation considerations to extend the product lifecycle:
- New improved MDTS applicator with patent protection: Enhancing the delivery system to maintain technological advantage
- Combination therapies with patent protection: Developing formulations that combine testosterone with other hormones for comprehensive hormone replacement therapy
Indication expansion opportunities provide growth optionality beyond the initial HSDD in post-menopausal women label. The presentation outlined three near-term expansion pathways:
- Surgically post-menopausal women: Patients who have undergone surgical menopause often experience more severe hormonal deficiency
- Women with premature menopause: Addressing patients who enter menopause before the typical age range
- Post-chemotherapy/radiotherapy patients: Treating hormone deficiency resulting from cancer treatments
The broader global population potential extends across multiple indications. Whilst no published market report segments the testosterone market exclusively for women by indication, Acrux’s derived estimates suggest 45% of potential users are post-menopausal women with HSDD (natural and surgical), 9% are pre-menopausal women with HSDD, 6% have premature menopause or premature ovarian insufficiency, 4% represent IVF/ovarian priming applications, and 28% represent potential cognitive decline applications including Alzheimer’s disease.
These expansion pathways provide long-term revenue protection and growth optionality, positioning Female Testosterone as a platform asset rather than a single-indication product.
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