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