- Acrux says FDA feedback confirms its Phase I and II data give it a clear pathway to Phase III and US registration for Female Testosterone.
- Combined US and EU addressable market for HSDD, is estimated at US$21.3 billion a year.
- FY26 customer receipts increased 860% to $5 million.
- The FDA is holding a public meeting on testosterone use in menopausal women on 17 September 2026.
Acrux has spent 25 years perfecting a spray-based hormone delivery platform. With FDA feedback in hand and a co-development search underway, it is now aiming that platform at a therapy no one has ever gotten approved in the United States
Figure 1: Patchless Patch underpins the dose control (Source: Acrux)
No testosterone product has ever won FDA approval for women. Acrux (ASX:ACR) wants to be first.
The company has designed a spray-based hormone delivery platform, using it to get one testosterone product to market for men and a menopause therapy into 40-plus countries. It has now taken that platform through Phase I and II trials for a Female Testosterone MDTSspray, and says FDA feedback tells it the data is good enough to move to the final stage.
Two attempts before it never got that far.
The therapy nobody has been able to land
Hypoactive Sexual Desire Disorder, or HSDD, is characterised by persistent, distressing loss of sexual desire not explained by another cause. It affects roughly 10% of adult women worldwide, an estimated 4.9 million of them in the US alone. Researchers project the number could reach 120 million globally by 2030.
Testosterone is one of the few treatments with clinical evidence behind it. The Menopause Society’s 2019 global consensus statement backs testosterone therapy for HSDD in postmenopausal women, citing consistent benefit across multiple randomised trials.
But nobody has gotten a testosterone product approved for women in the US.
Procter & Gamble’s Intrinsa patch was rejected by the FDA in 2004 over long-term safety data, despite winning approval in Europe. BioSante’s LibiGel failed Phase III in 2011 when its effect couldn’t clear a large placebo response.
The TRT Catalog website argues dosing precision sits behind both outcomes. Hand-applied gels and creams make it hard to hold women in a narrow physiological dose range, which can impact safety and the efficacy signal. Since Intrinsa and LibiGel, the field has gone quiet on new drug development. Male testosterone products used off-label by women have continued to increase.
A study published in JACC: Advances shows US testosterone prescribing for women rose 31.8% a year from 2022 to 2025, then jumped 58.7% in 2025 over 2024. The fastest-growing and largest group was women aged 45 to 64.
Built on a platform 25 years in the making
Acrux’s answer is its Patchless Patch™, a metered-dose spray technology developed at Monash University and refined in-house. It delivers a precise, controlled dose through the skin without gels, patches or needles.
The company has already proven the model works commercially. Its male testosterone spray was licensed to Eli Lilly and reached the US market. Its menopause hormone therapy spray is sold in more than 40 countries and generated roughly €50 million in global sales last year.
Felicia Colagrande, Acrux’s Product Development and Technical Affairs Director and the researcher credited with developing the original Patchless Patch, has spent 25 years on the platform. On the Female Testosterone MDTSprogram, she said:
‘I am so delighted that Acrux is working to get our Patchless Patch™ with Female Testosterone MDTSavailable for HSDD. It means women will have a precise, consistent, discreet and easy to use option for their Menopause Hormone Therapy.’
Felicia Colagrande, Product Development & Technical Affairs Director, Acrux
From Phase II data to a stated FDA pathway
On 28 April 2026, Acrux announced it had completed Phase I and Phase II trials for its Female Testosterone MDTSproduct. The company said FDA feedback — addressing preclinical safety data, toxicology and manufacturing plans alongside the clinical results — confirmed the data provide a valid base to move into Phase III, and described a clear pathway to registration in the US.
CEO and Managing Director John Warmbrunn called it the point where planning turns into action.
▶ WATCH · CEO and Managing Director John Warmbrunn on the FDA pathway and the search for a co-development partner.
‘Getting something from [the FDA] means a lot to us. But also means that when we’re talking about co-development, we can get really specific now about what we’re doing — we can move from theory to reality, and get on with planning the specifics of the trial, selecting clinical research partners, and looking at the exact finances of how it’s going to work.’
John Warmbrunn, CEO & Managing Director, Acrux
Why this is a live moment
Acrux has already created a short list of potential co-development partners, and talks can now move onto more tangible aspects of a deal, such as upfront payments and co-development terms.
‘I think the key thing is obviously going to be getting a
co-development partner. That’s the big one. We have a short list already
— we’re talking to big pharma, we’re talking to women’s health specialists in the US and Europe. They’ve been active in our data room in August. And now we’ve got the FDA guidance, that’s the last piece of
the puzzle, so we can actually get into real meaningful, co-development discussions.’
John Warmbrunn, CEO & Managing Director, Acrux
The FDA itself is also acting. Its Office of Women’s Health and Center for Drug Evaluation and Research will hold a public workshop on testosterone use in menopausal women. That’s the same patient population Acrux’s program targets.
The FDA’s own notice cites growing off-label use and gaps in the evidence and has opened a public comment docket running to 19 October 2026.
Acrux funded the next stage of work with a $1.6 million placement to support Phase III preparation and the co-development search.
In May the cash runway received another boost. Acrux amended its agreement with Gedeon Richter to bring its menopause hormone therapy spray to Australia. The deal is worth up to $5.4 million in milestone payments over two years, including a $1.35 million upfront payment. The remaining $4.05 million is tied to Australian regulatory approval and sales targets.
▶ WATCH · CEO John Warmbrunn on the Gedeon Richter Lenzetto Australia deal.
‘In conjunction with our recent placement, this means we have a clear runway for our Phase III trials for Female Testosterone MDTSand a co-development deal. But perhaps just as importantly, it demonstrates the depth of Acrux’s heritage in hormone replacement therapy and our long-standing relationship with key players in the space such as Gedeon Richter.’
John Warmbrunn, CEO & Managing Director, Acrux
What the company expects next
Acrux reported FY26 customer receipts of $5 million, up from $0.5 million the year before, including $1.780 million in the June quarter alone, largely on the back of the Gedeon Richter payment.
Cash on hand stood at $1.705 million at 30 June 2026.
Warmbrunn has highlighted a sequence of milestones the company has on its radar: choosing a co-development partner and agreeing commercial terms, finalising trial design, selecting a clinical research organisation, and building out manufacturing.
The company’s guidance points to a US launch in the FY28–FY29 window, contingent on a partner being signed and the trial completing on schedule.