StreetInsider.com News Articles

Xanamem proof-of-concept trial demonstrating anti-depressant activity published in the British Journal of Psychiatry

Mon, 20 Jul 2026 08:51:00 -0400

SYDNEY, July 20, 2026 (GLOBE NEWSWIRE) -- Actinogen Medical Limited (ASX: ACW) today announces that results from its proof-of-concept trial, entitled “A phase 2 randomised, double-blind, placebo-controlled trial of emestedastat in patients with major depressive disorder (MDD) and cognitive impairment (CI)” have been published as a peer-reviewed article in the British Journal of Psychiatry, a leading international journal in behavioural and psychiatric medicine.

The article is available here.

A key conclusion from the article is that Xanamem® showed clinically, and at times, statistically significant antidepressant activity and is worthy of

Xanamem proof-of-concept trial demonstrating anti-depressant activity published in the British Journal of Psychiatry

Mon, 20 Jul 2026 08:51:00 -0400

The article is available here.

A key conclusion from the article is that Xanamem® showed clinically, and at times, statistically significant antidepressant activity and is worthy of

Xanamem proof-of-concept trial demonstrating anti-depressant activity published in the British Journal of Psychiatry

Mon, 20 Jul 2026 08:51:00 -0400

The article is available here.

A key conclusion from the article is that Xanamem® showed clinically, and at times, statistically significant antidepressant activity and is worthy of

Xanamem proof-of-concept trial demonstrating anti-depressant activity published in the British Journal of Psychiatry

Mon, 20 Jul 2026 08:51:00 -0400

The article is available here.

A key conclusion from the article is that Xanamem® showed clinically, and at times, statistically significant antidepressant activity and is worthy of

Xanamem proof-of-concept trial demonstrating anti-depressant activity published in the British Journal of Psychiatry

Mon, 20 Jul 2026 08:51:00 -0400

The article is available here.

A key conclusion from the article is that Xanamem® showed clinically, and at times, statistically significant antidepressant activity and is worthy of

Xanamem proof-of-concept trial demonstrating anti-depressant activity published in the British Journal of Psychiatry

Mon, 20 Jul 2026 08:51:00 -0400

The article is available here.

A key conclusion from the article is that Xanamem® showed clinically, and at times, statistically significant antidepressant activity and is worthy of

Xanamem proof-of-concept trial demonstrating anti-depressant activity published in the British Journal of Psychiatry

Mon, 20 Jul 2026 08:51:00 -0400

The article is available here.

A key conclusion from the article is that Xanamem® showed clinically, and at times, statistically significant antidepressant activity and is worthy of

Xanamem proof-of-concept trial demonstrating anti-depressant activity published in the British Journal of Psychiatry

Mon, 20 Jul 2026 08:51:00 -0400

The article is available here.

A key conclusion from the article is that Xanamem® showed clinically, and at times, statistically significant antidepressant activity and is worthy of

Actinogen trial using intended commercial Xanamem tablet formulation confirms target exposures in fed and fasted states

Wed, 27 Aug 2025 08:00:00 -0400

Phase 2b/3 Alzheimer's trial enrolment passes 50% - twenty US trial sites continuing to recruit participants

SYDNEY, Aug. 27, 2025 /PRNewswire/ -- Actinogen Medical Limited (ASX: ACW) announces that a recent trial designed to confirm therapeutic blood levels of the intended commercial tablet formulation of Xanamem®, given both with and without food, demonstrated the expected blood levels or "exposure", comparable with prior studies of a capsule formulation. This indicates that 10 mg once daily remains the target therapeutic dose for the clinical program.

Actinogen trial using intended commercial Xanamem tablet formulation confirms target exposures in fed and fasted states

Wed, 27 Aug 2025 08:00:00 -0400

Phase 2b/3 Alzheimer's trial enrolment passes 50% - twenty US trial sites continuing to recruit participants

Actinogen trial using intended commercial Xanamem tablet formulation confirms target exposures in fed and fasted states

Wed, 27 Aug 2025 08:00:00 -0400

Phase 2b/3 Alzheimer's trial enrolment passes 50% - twenty US trial sites continuing to recruit participants

Actinogen trial using intended commercial Xanamem tablet formulation confirms target exposures in fed and fasted states

Wed, 27 Aug 2025 08:00:00 -0400

Phase 2b/3 Alzheimer's trial enrolment passes 50% - twenty US trial sites continuing to recruit participants

A novel oral treatment for Alzheimer's: Actinogen's pivotal trial currently recruiting participants in the US

Tue, 22 Jul 2025 08:00:00 -0400

All 20 US trial sites are now open in the XanaMIA phase 2b/3 trial that is studying oral Xanamem® vs. placebo for 36 weeks, followed by an open label extension of active Xanamem for up to 24 months

SYDNEY, July 22, 2025 /PRNewswire/ -- Actinogen Medical Limited (ASX: ACW) is encouraging individuals and their loved ones affected by Alzheimer's disease to take part in a groundbreaking clinical trial that could transform the way we treat this devastating condition.

A novel oral treatment for Alzheimer's: Actinogen's pivotal trial currently recruiting participants in the US

Tue, 22 Jul 2025 08:00:00 -0400

A novel oral treatment for Alzheimer's: Actinogen's pivotal trial currently recruiting participants in the US

Tue, 22 Jul 2025 08:00:00 -0400

A novel oral treatment for Alzheimer's: Actinogen's pivotal trial currently recruiting participants in the US

Tue, 22 Jul 2025 08:00:00 -0400

Actinogen confirms 100th participant in XanaMIA phase 2b/3 Alzheimer's disease trial and interim analysis timeline

Mon, 30 Jun 2025 08:30:00 -0400

Interim analysis planned for January 2026 with final trial results in late 2026

Highlights:

With the 100^th participant enrolled in the XanaMIA trial, the timeline for the planned interim analysis is confirmed for January 2026 and the timeline for final results reconfirmed for late 2026
An independent Data Monitoring Committee will review all available patient data in January 2026 after which the results of the review will be announced
A Type C meeting will be held with the FDA in the second half of 2025 regarding the company's AD program and pathways to regulatory approval.

SYDNEY, June 30,

Actinogen confirms 100th participant in XanaMIA phase 2b/3 Alzheimer's disease trial and interim analysis timeline

Mon, 30 Jun 2025 08:30:00 -0400

Interim analysis planned for January 2026 with final trial results in late 2026

Highlights:

With the 100^th participant enrolled in the XanaMIA trial, the timeline for the planned interim analysis is confirmed for January 2026 and the timeline for final results reconfirmed for late 2026
An independent Data Monitoring Committee will review all available patient data in January 2026 after which the results of the review will be announced
A Type C meeting will be held with the FDA in the second half of 2025 regarding the company's AD program and pathways to regulatory approval.

SYDNEY, June 30,

Actinogen confirms 100th participant in XanaMIA phase 2b/3 Alzheimer's disease trial and interim analysis timeline

Mon, 30 Jun 2025 08:30:00 -0400

Interim analysis planned for January 2026 with final trial results in late 2026

Highlights:

With the 100^th participant enrolled in the XanaMIA trial, the timeline for the planned interim analysis is confirmed for January 2026 and the timeline for final results reconfirmed for late 2026
An independent Data Monitoring Committee will review all available patient data in January 2026 after which the results of the review will be announced
A Type C meeting will be held with the FDA in the second half of 2025 regarding the company's AD program and pathways to regulatory approval.

SYDNEY, June 30,

Actinogen confirms 100th participant in XanaMIA phase 2b/3 Alzheimer's disease trial and interim analysis timeline

Mon, 30 Jun 2025 08:30:00 -0400

Interim analysis planned for January 2026 with final trial results in late 2026

Highlights:

With the 100^th participant enrolled in the XanaMIA trial, the timeline for the planned interim analysis is confirmed for January 2026 and the timeline for final results reconfirmed for late 2026
An independent Data Monitoring Committee will review all available patient data in January 2026 after which the results of the review will be announced
A Type C meeting will be held with the FDA in the second half of 2025 regarding the company's AD program and pathways to regulatory approval.

SYDNEY, June 30,

Actinogen confirms 100th participant in XanaMIA phase 2b/3 Alzheimer's disease trial and interim analysis timeline

Mon, 30 Jun 2025 08:30:00 -0400

Interim analysis planned for January 2026 with final trial results in late 2026

Highlights:

With the 100^th participant enrolled in the XanaMIA trial, the timeline for the planned interim analysis is confirmed for January 2026 and the timeline for final results reconfirmed for late 2026
An independent Data Monitoring Committee will review all available patient data in January 2026 after which the results of the review will be announced
A Type C meeting will be held with the FDA in the second half of 2025 regarding the company's AD program and pathways to regulatory approval.

SYDNEY, June 30,

Actinogen confirms 100th participant in XanaMIA phase 2b/3 Alzheimer's disease trial and interim analysis timeline

Mon, 30 Jun 2025 08:30:00 -0400

Interim analysis planned for January 2026 with final trial results in late 2026

Highlights:

With the 100^th participant enrolled in the XanaMIA trial, the timeline for the planned interim analysis is confirmed for January 2026 and the timeline for final results reconfirmed for late 2026
An independent Data Monitoring Committee will review all available patient data in January 2026 after which the results of the review will be announced
A Type C meeting will be held with the FDA in the second half of 2025 regarding the company's AD program and pathways to regulatory approval.

SYDNEY, June 30,

Actinogen confirms 100th participant in XanaMIA phase 2b/3 Alzheimer's disease trial and interim analysis timeline

Mon, 30 Jun 2025 08:30:00 -0400

Interim analysis planned for January 2026 with final trial results in late 2026

Highlights:

With the 100^th participant enrolled in the XanaMIA trial, the timeline for the planned interim analysis is confirmed for January 2026 and the timeline for final results reconfirmed for late 2026
An independent Data Monitoring Committee will review all available patient data in January 2026 after which the results of the review will be announced
A Type C meeting will be held with the FDA in the second half of 2025 regarding the company's AD program and pathways to regulatory approval.

SYDNEY, June 30,

Actinogen confirms 100th participant in XanaMIA phase 2b/3 Alzheimer's disease trial and interim analysis timeline

Mon, 30 Jun 2025 08:30:00 -0400

Interim analysis planned for January 2026 with final trial results in late 2026

Highlights:

With the 100^th participant enrolled in the XanaMIA trial, the timeline for the planned interim analysis is confirmed for January 2026 and the timeline for final results reconfirmed for late 2026
An independent Data Monitoring Committee will review all available patient data in January 2026 after which the results of the review will be announced
A Type C meeting will be held with the FDA in the second half of 2025 regarding the company's AD program and pathways to regulatory approval.

SYDNEY, June 30,

Actinogen announces peer-reviewed clinical pharmacology manuscript for Xanamem (emestedastat) published in Clinical Pharmacology in Drug Development journal

Wed, 12 Feb 2025 08:00:00 -0400

Confirms the utility of the 10 mg daily oral dose of Xanamem being studied in late-stage clinical trials in Alzheimer's disease and major depressive disorder

SYDNEY, Feb. 12, 2025 /PRNewswire/ -- Actinogen Medical Limited (ASX: ACW) announces that the publication of its most recent peer-reviewed journal article entitled Clinical Pharmacology and Approach to Dose Selection of Emestedastat, a Novel Tissue Cortisol Synthesis Inhibitor for the Treatment of Central Nervous System Disease in Clinical Pharmacology in Drug Development, the journal associated with the American College of Clinical Pharmacology.