Actinogen is developing a revolutionary oral therapeutic, Xanamem®, which controls levels of the “stress hormone” cortisol in the brain, with the goal of improving the lives of patients and their families. Topline results from our first pivotal Alzheimer’s trial, evaluating its potential to slow disease progression, are expected in November 2026.
Our Fundamentals
In conjunction with the US FDA and other regulatory authorities, we strive for excellence in science and clinical data within our programs. As a result, we’ve conducted multiple high-quality clinical trials to bring our molecule, Xanamem, to this late clinical stage of development.
We are valued and respected by patients, physicians, and industry peers to bring Xanamem’s development forward. Science, data and transparency guide us to bring hope and potentially change the world of cognitive impairment forever.
Building on the solid scientific rationale for Xanamem’s action, we are rapidly developing programs in multiple disease areas, with a priority on Alzheimer’s disease and depression.
Xanamem is a cutting-edge therapy and world-class product that reduces cortisol (the “stress hormone”) levels in the brain. As a result, it is a catalyst for new approaches in managing neurodegenerative and other illnesses.
About Us
Actinogen Medical (ACW) is an ASX-listed, biotechnology company developing a novel therapy for neurological diseases associated with dysregulated brain cortisol. There is a strong association between cortisol and detrimental changes in the brain, affecting cognitive function, harm to brain cells and long term cognitive health.
Cognitive function means how a person understands, remembers and thinks clearly. Important cognitive functions include episodic and working memory, attention, problem solving, and language.
We are currently developing our lead compound, Xanamem®, as a revolutionary new therapy for Alzheimer’s Disease, Major Depressive Disorder, and other neurological diseases where reducing cortisol inside brain cells could have a positive impact. The cognitive dysfunction, behavioral abnormalities, and neuropsychological burden associated with these conditions is significantly debilitating for patients, and there is a substantial unmet medical need for new and improved treatments.
About Xanamem® (emestedastat)
inhibition of the cortisol synthesis enzyme, 11β-HSD1, without affecting production of cortisol by the adrenal glands which
is essential for the body’s normal functioning. Xanamem is a first-in-class, once-a-day pill designed to deliver high levels
of cortisol control in key areas of the brain related to Alzheimer’s and other diseases such as the hippocampus and frontal
cortex.
Chronically elevated cortisol is associated with progression in Alzheimer’s Disease and excess cortisol is known to be
toxic to brain cells. Cortisol itself is also associated with depressive symptoms and when targeted via other mechanisms
has shown some promise in prior clinical trials. The recent XanaCIDD trial demonstrated clinically and sometimes
statistically significant benefits on depressive symptoms, further validating the cortisol control mechanism for the
Xanamem 10 mg oral daily dose.
The Company has studied 11β-HSD1 inhibition by Xanamem in more than 500 volunteers and patients in eight clinical
trials. Xanamem has a promising safety profile and has demonstrated clinical activity in patients with depression, patients
Xanamem is an investigational product and is not approved for use outside of a clinical trial by the FDA or by any global
regulatory authority. Xanamem® is a trademark of Actinogen Medical.
® Xanamem is a registered trademark of Actinogen Medical Limited. Xanamem is an investigational product and is not approved for use outside of a clinical trial by the FDA or by any global regulatory authority.
The Xanamem® Pipeline
Our Team
Annual Reports
Our Strategic Priorities
development of Xanamem
in Alzheimer’s disease
to prepare the market
for Xanamem and
support future partnerships
and related patent protection
prospective development
and commercial partners
- Meet with FDA and EMA to define the most efficient path to approval
- Enrol 220 participants with mild to moderate disease in the pivotal XanaMIA trial
- Perform an interim safety and efficacy futility analysis in January CY2026
- Efficient pre-screening in XanaMIA to identify people with progressive disease using elevated blood pTau 181
- Implement an extension trial in which all XanaMIA participants can receive active Xanamem
- Ensure high quality rating training and standarization to minimize noise in key efficacy endpoints
- Leverage ‘hands on’ clinical operations and management model in Australia and the US to optimize quality and reduce cost
- Strengthen advisory board and elicit updated program guidance
- Engage with a broad range of key opinion leaders and principal investigators in AD
- Communicate Xanamem’s novel mechanism of action and its differentiated therapeutic profile via multiple channels
- Refine Xanamem target product profile in AD based on feedback from market research and AD experts
- Production of large batch of Xanamem tablets by Catalent, US
- Manufacture of an additional 15kg of API by Asymchem, China
- National phase entry for three manufacturing patents
- Identify and partner with one or more synergistic regional biopharma companies
- Continue to develop relationships with potential, future large-cap partners
- Review detailed Xanamem data with selected parties under confidentiality agreements
- Attend key international and national scientific and business meetings
- Form collaborative relationships with all major global regulatory authorities.