Acrux secures FDA Phase 3 pathway approval

• Acrux has received formalised meeting minutes from the U.S. Food and Drug Administration confirmed its Phase 3 clinical trial pathway for a female testosterone spray.
• Following the regulatory update, shares in the pharmaceutical company rose 4.55% during trading.
• The decision allows the company to pursue a 3-year market exclusivity period upon submission of its product application.

Acrux (ASX:ACR) has secured a confirmed Phase 3 regulatory pathway from the U.S. Food and Drug Administration for its female testosterone metered-dose transdermal spray targeting hypoactive sexual desire disorder.

The agreement follows an end-of-Phase 2 meeting with the regulator and provides the drug developer with formal guidelines for final clinical testing.

"The guidance provides greater clarity on our regulatory pathway and aligns closely with key themes from the FDA’s public workshop, including the unmet need for an FDA-approved testosterone product for women, the importance of controlled dosing, and the need to maintain testosterone exposure within the physiological range," said Acrux CEO John Warmbrunn.

Under the regulator's framework, two 24-week trials with 52 weeks of total safety data will be required, alongside eligibility for a 3-year exclusivity period upon submission.

The company stated that these regulatory signals are supporting ongoing co-development partner discussions as it prepares to commence Phase 3 trials.

Following the announcement, the Acrux share price was up at $0.011.

Acrux develops and commercialises speciality transdermal pharmaceutical products delivered through the skin using proprietary technology platforms.

The Melbourne-based company recently received a $2 million research and development tax incentive rebate for the 2026 financial year to support its pipeline.