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Acrux

A legacy of pharmaceutical innovation. A new focus on women's health.

Founded in 1998, Acrux Limited (ASX: ACR) is an Australian specialty pharmaceutical company with more than 25 years of experience developing and commercialising innovative topical and transdermal medicines.

Building on drug delivery technology originating at Monash University, Acrux has developed pharmaceutical products that have achieved regulatory approval and been commercialised in international markets through global partnerships.

Today, Acrux is leveraging this expertise to advance its next chapter of innovation, with a strategic focus on Female Testosterone MDTS, a novel transdermal treatment being developed for postmenopausal women with hypoactive sexual desire disorder (HSDD).

Our Journey

More than 25 years of innovation and commercialisation

  1. The Acrux team in the laboratory
    1998

    Acrux Established

    Acrux was incorporated to commercialise innovative drug delivery technology developed at Monash University.

  2. 2001

    First US Patent Granted

    Acrux secured its first US patent, establishing a foundation for its proprietary drug delivery technology.

  3. 2004

    ASX Listing

    Acrux listed on the Australian Securities Exchange (ASX: ACR), supporting the continued development and commercialisation of its pharmaceutical technologies.

  4. Evamist estradiol transdermal spray
    2007–2008

    First Commercial Hormone Therapy Product

    Acrux's estradiol transdermal spray received US FDA approval in 2007 and was subsequently launched in the United States as Evamist®.

  5. 2010–2011

    Testosterone Product Commercialisation

    Acrux's testosterone solution received US FDA approval in 2010 and was launched as Axiron® by Eli Lilly in 2011, demonstrating the Company's experience in developing and commercialising testosterone treatments.

  6. Lenzetto estradiol spray
    2016

    International Expansion

    Lenzetto®, Acrux's estradiol spray, was launched in Europe through its commercial partner, Gedeon Richter.

  7. Dapsone gel packaging
    2024–2025

    Expansion of Commercialised Portfolio

    Acrux expanded its commercial portfolio with the launch of topical generic pharmaceutical products in the United States, including Dapsone gels and Nitroglycerine Ointment.

  8. The Acrux metered dose transdermal spray applicator
    2026

    New Strategic Direction

    Acrux announced a strategic shift towards innovative, high-value transdermal pharmaceuticals, with Female Testosterone MDTS becoming its lead development priority.

  9. Acrux leaders discussing the FDA feedback
    October 2026

    FDA Clarifies Phase III Development Pathway

    Following an End-of-Phase II meeting, the US FDA provided greater clarity on the Phase III clinical development pathway for Female Testosterone MDTS and confirmed Acrux's eligibility to apply for three-year data exclusivity upon submission for approval.

Looking Ahead

Advancing the next chapter in women's health

Acrux is building on its established pharmaceutical development and commercialisation capabilities to advance Female Testosterone MDTS towards Phase III clinical development.

With no FDA-approved testosterone treatment specifically for women in the United States, the program represents an opportunity to address a significant unmet medical need through a female-specific, controlled-dose transdermal treatment.

Explore Female Testosterone MDTS