Acrux (ASX:ACR) Receives Clear FDA Regulatory Pathway for Female Testosterone MDTS

Aditi Sarkar

12 October 2026 05:07 PM AEDT

Acrux (ASX:ACR) Receives Clear FDA Regulatory Pathway for Female Testosterone MDTS

Image Source: Shutterstock

You are reading a free article with opinions that may differ from the recommendation given by Kalkine in its paid research reports. Become a Kalkine member today to get access to our research reports, in-depth technical and fundamental research. Learn more

Start Your Free Trial Now!

Highlights

The FDA has confirmed a Phase III regulatory pathway for Acrux's Female Testosterone MDTS.
Two 24-week Phase III trials are expected to support approval.
Acrux will be eligible to apply for three years of data exclusivity.
A recent FDA workshop highlighted unmet need in this treatment area.

Acrux Limited (ASX:ACR) has announced that the US Food and Drug Administration (FDA) has provided a clear regulatory pathway for its Female Testosterone metered-dose transdermal spray (MDTS). The product is being developed for postmenopausal women with hypoactive sexual desire disorder (HSDD).

Outcomes of the FDA Meeting

The update follows the formal minutes from Acrux's end-of-Phase II meeting with the FDA. Two adequate and well-controlled 24-week Phase III trials are expected to demonstrate efficacy and support approval, with a further 28 weeks of data to inform long-term safety.

The FDA indicated that the two trials do not need to be identical in design, giving Acrux flexibility. The agency also provided alternative approaches to patient-reported outcome endpoints and recommended a chronic dermal and systemic safety study, the protocol for which Acrux is finalising.

Three-Year Exclusivity Eligibility

The FDA confirmed that Acrux's Phase III trials and new formulation meet the requirements for three years of data exclusivity, which is available for the first approval of an established active ingredient in a new indication supported by new clinical studies.

If granted, this exclusivity would prevent competing products from launching for the first three years after registration.

Market Need and Partnering

A public FDA workshop held in September 2026 highlighted a significant unmet need for an FDA-approved testosterone product for women and the importance of controlled dosing within the physiological range.

CEO and Managing Director John Warmbrunn said, "It is an important time to be receiving feedback from the FDA on Female Testosterone MDTS." He added that regulatory and market signals support discussions with potential co-development partners.

Key Takeaways

Acrux now has a defined Phase III pathway for Female Testosterone MDTS.
Two 24-week Phase III trials are expected to support approval.
The product is eligible for three years of data exclusivity if approved.
Acrux is pursuing discussions with potential co-development partners.

FAQs

Q: What has the FDA confirmed for Acrux?

A: A Phase III regulatory pathway for its Female Testosterone MDTS.

Q: What condition is the product targeting?

A: Hypoactive sexual desire disorder (HSDD) in postmenopausal women.

Q: What trials are required?

A: Two adequate and well-controlled 24-week Phase III trials, with extended safety data.

Q: What exclusivity is available?

A: Acrux will be eligible to apply for three years of data exclusivity.

Q: What are Acrux's next steps?

A: Finalising the safety study protocol and progressing discussions with potential co-development partners.

Download Free Report – Explore 3 Stock Ideas & Industry Insights

Unlock 3 stock ideas and key industry insights in our free report. This information is general in nature and does not consider your personal objectives, financial situation, or needs. It is not financial advice.

All investments involve risk—consider independent advice before making any investment decisions.

View 3 Research Reports

Disclaimer:

This article (“Article”) has been prepared by Kalkine Pty Limited (ABN 34 154 808 312) (Australian financial services licence number 425376) (“Kalkine”) and its related bodies corporate who are authorised to provide general financial product advice. Kalkine.com.au and its associated pages are published by Kalkine.

Any information/advice provided in this article is general in nature and does not take into account your objectives, financial situation or needs. You should therefore consider whether the information is appropriate for your objectives, financial situation and needs before acting upon it.

There may be a Product Disclosure Statement, Information Memorandum or other offer document (“Offer Document”) for the securities or other financial products referred to in Kalkine articles. You should obtain a copy of the Offer Document and consider it before making any decision about whether to acquire the security or financial product.

Kalkine strongly recommends that you seek advice from a financial adviser, stockbroker or other professional (including taxation and legal advice) before acting on any advice/information in this Article or on the Kalkine website. Not all investments are appropriate for all people.

The information in this Article and on Kalkine website has been prepared from a wide variety of sources, which Kalkine, to the best of its knowledge and belief, considers accurate. Kalkine has made every effort to ensure the reliability of the information contained in its articles (including this Article), newsletters and websites. All information represents our views at the date of publication and may change without notice.

The information in this Article does not constitute an offer to sell securities or other financial products or a solicitation of an offer to buy securities or other financial products.

Kalkine does not issue, sell or deal in any financial products.

This Article may contain information on past performance of particular investments. Please note past performance is neither an indicator nor a guarantee of future performance.

To the extent permitted by law, and excluding any dishonesty or gross negligence by Kalkine, Kalkine disclaims and excludes all liability for any direct, indirect, implied, punitive, special, incidental or other consequential loss or damage arising from the use of or reliance on this Article, the Kalkine website and any information published on the Kalkine website without any warranties or representations by Kalkine to you. To the extent the law prohibits or limits this exclusion, Kalkine limits its liability to the resupply of services.

Please also read our Terms & Conditions and Financial Services Guide for further information.

Employees and/or associates of Kalkine and its related entities may hold interests in the securities or other financial products covered in this Article or on the Kalkine website. Any such employees and associates are required to comply with certain safeguards, procedures and disclosures as required by law.

Some of the images/music that may be used in the Article are copyright to their respective owner(s). Kalkine does not claim ownership of any of the pictures displayed/music used in the Article unless stated otherwise. The images/music that may be used in the Article are taken from various sources on the internet, including paid subscriptions or are believed to be in public domain. We have used reasonable efforts to accredit the source wherever it was indicated or was found to be necessary.

Kalkine Media Pty Ltd, an affiliate of Kalkine Pty Ltd, may have received, or be entitled to receive, financial consideration in connection with providing information about certain entity(s) covered on its website.