On October 12, 2026 (Australian time), ASX-listed Acrux Limited (ASX:ACR) said the U.S. Food and Drug Administration has confirmed a Phase III regulatory pathway for its Female Testosterone MDTS, a metered-dose transdermal spray for postmenopausal women with hypoactive sexual desire disorder (HSDD). The confirmation comes from the FDA's formal minutes of Acrux's end-of-Phase II meeting. The company held an investor webinar the same afternoon.

Why It Matters

U.S. women who use testosterone today get it off-label, usually as compounded creams or fractions of male products. Recent prescribing data in our workshop coverage show that use is climbing quickly. A sponsor with a written FDA roadmap and a possible three-year exclusivity window turns that grey market into a regulated product opportunity. It also gives telehealth and menopause platforms a future branded option to stock alongside, or instead of, compounded supply. The cost is the hard part. Two 24-week pivotal trials plus a year of safety follow-up is an expensive program for a small-cap company, which is why the partner question matters. The timeline is years, not quarters, and nothing here shows efficacy. What it does is remove regulatory uncertainty. Watch for a co-development deal, final Phase III protocols, and whether rival sponsors move now that the FDA has publicly signalled interest. The FDA workshop's public docket closes **October 19**.

The minutes set out what approval will require. Per the company filing as summarised by Kalkine, the FDA wants two adequate and well-controlled 24-week Phase III efficacy trials, plus another 28 weeks of data (52 weeks in total) to establish safety for chronic use. The agency told Acrux the two trials do not need to be identical, which leaves room to vary things like timing intervals. It also offered alternative approaches to the patient-reported-outcome co-primary endpoints, in line with its 2016 draft guidance on drugs for low sexual interest, desire and/or arousal in women. The FDA treated the spray as a new formulation and asked only for a minimal preclinical package covering chronic dermal and systemic safety. Acrux says it is finalising that protocol.

The commercial headline is exclusivity. The FDA confirmed that Acrux will be eligible to apply for three years of data exclusivity when it submits. That protection is available for the first approval of an established active ingredient in a new indication backed by new clinical studies. TipRanks' summary of the announcement says the guidance supports Acrux's talks with potential co-development partners, and that the company is aiming to become the first approved female testosterone product in the U.S. CEO John Warmbrunn and product development and technical affairs director Felicia Colagrande are quoted in the filing.

The filing ties the news directly to the FDA's September public workshop on testosterone in menopausal women (our coverage: fda-testosterone-women-workshop). Acrux lists the themes it took from that meeting: a significant unmet need for an FDA-approved testosterone treatment developed specifically for women, the importance of female-appropriate dosing that keeps levels within the physiological range, and FDA openness to working with sponsors.

Sources

Update — 2026-10-12

Initial entry — story first created.