• Massive unmet need for Hypoactive Sexual Desire Disorder treatments addressed by new Female Testosterone product
• Phase I and II clinical trials completed. Phase III to be done in co-development with global partners.
• Unique, Australian developed unique Patchless Patch™ delivery technology

MELBOURNE, Australia, April 28, 2026 /PRNewswire/ -- Acrux is a successful Australian pharmaceutical company that develops innovative drugs for the global market. It recently announced its new strategy to enter the final, phase III clinical trial, stage of development for a Female Testosterone product. This continues the company's heritage in designing and developing patient-preferred drug delivery systems and it address a large unmet patient need. The unmet need is Hypoactive Sexual Desire Disorder (HSDD) or, in common English low libido or low sex drive in women.

HSDD is common in peri and post-menopausal women who make up 10% of the population. Of these around 10% suffer from HSDD. In July, a US Food and Drug Administration (FDA) advisory panel emphasised the importance of finding treatments for women's health challenges, such as HSDD. Testosterone occurs naturally in both men and women but in lower levels in women. One of the leading global experts in HSDD, Dr Susan R Davis AO, MBBS FRACP PhD FAHMS, of Monash University, commented that:

"Testosterone is not simply a male hormone but is also an important hormone in women. Low sexual desire is the most prevalent sexual concern amongst women. When sufficient to cause personal distress women are considered as having hypoactive sexual desire dysfunction or HSDD.

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 Acrux' Testosterone MDTS has the advantages of acting as a "patchless" patch with good pharmacokinetic evidence of absorption".

Acrux was a pioneer in making patient preferred solutions for treatment of low testosterone in males available. The company has also invested in the same technology for women; successfully completing phase I and II clinical trials. This means the company is extremely well positioned to be one of the early players to bring a product for women with HSDD to market globally. The superiority of Acrux drug delivery systems also means that women will have an option to avoid having to use their hands to apply gels or creams when using testosterone; part of the company's vision of owning patient-preferred solutions.

Acrux's estrogen products (Evamist® and Lenzetto®) are also delivered by the company's unique Patchless Patch™ delivery technology. This technology was invented at Monash University and, over 25 years, has helped change the lives of women all over the world. One of the original researchers who developed the product still works at Acrux. Felicia Colagrande said:

"I am so delighted that Acrux is working to get our Patchless Patch™ with Female Testosterone available for HSSD. It means women will have a precise, consistent, discreet and easy to use option for their Menopause Hormone Therapy."

The company is confident about its pathway to market because it has recently received feedback from the Food and Drug Administration (FDA). The feedback confirmed the results from the phase I and II clinical trials provide a valid base to move into the final stages of bringing this important solution to market and a clear pathway to registration in the US.

Acrux's previous experience in successfully commercialising products in male and female replacement hormone therapy (Lenzetto® and Evamist®) markets opens global opportunities for partnerships. The company is exploring co-development partnerships with partners who have strong, commercial experience in global women's health markets. By engaging early with partners, Acrux intends to optimise the Phase III clinical trial design for maximum impact and bring Female Testosterone to market at the earliest possible date.

Acrux CEO and Managing Director, John Warmbrunn commented,

"Having Female Testosterone in such and advanced stage of development allows Acrux to, again, demonstrate its excellence in innovation and to help change the lives of millions of women globally. Receiving the feedback from the FDA has cemented female testosterone as a core strategy for Acrux and means that we can have a real impact in women's health."

Further detail available in the company Stategic Update available on the ASX
https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-03083082-3A692076&v=undefined

About Acrux
Acrux is a dynamic Australian drug delivery company developing and commercialising patient preferred healthcare products for global markets. Economic value at Acrux is created by talented people who effectively develop and commercialise healthcare products using invented or acquired technologies. Acrux's products are patient-preferred, protected by patent or other means, using innovative drug delivery.

For further information on Acrux, visit: www.acrux.com.au

Source: ACRUX LIMITED