A Randomized, Open-label, Single Dose, Crossover Trial to Assess the Effects of Food on the Pharmacokinetics of 10 mg Emestedastat Tablet in Healthy Adult Participants

Start Date16 Jun 2025

Sponsor / Collaborator

Actinogen Medical Ltd.

NCT06125951

/ Active, not recruitingPhase 2/3

A Phase 2b/3, Double-Blind, Placebo-Controlled, Parallel-Group, 36-Week, 2-Arm Trial With an Open-Label Extension Phase to Assess the Safety, Tolerability, and Efficacy of Xanamem® 10 mg Daily in Patients With Mild or Moderate Dementia Due to Alzheimer's Disease

Xanamem® is being developed as a potential treatment for symptomatic, early stages of Alzheimer's Disease (AD) and Major Depressive Disorder (MDD).
This XanaMIA Phase 2b/3 study is to investigate the safety, tolerability, and efficacy of Xanamem in in mild or moderate dementia due to AD. Trial participants will be randomized to either receive 10mg of Xanamem once daily or a placebo for 36 weeks at a 1:1 ratio in a double-blinded fashion. Participants who have completed the main trial will be eligible to participate in an open-label phase, which involves treatment with 10mg Xanamem once daily for a treatment period of up to a maximum of 108 weeks. The OLE is intended to finish when all participants have completed at least 60 weeks of treatment and a follow-up visit 4 weeks later.

Start Date12 Apr 2024

Sponsor / Collaborator

Actinogen Medical Ltd.

NCT05657691

/ CompletedPhase 2

XanaCIDD: A Double-Blind, Randomized, Placebo Controlled, Parallel-Group Trial to Assess the Safety, Tolerability, and Efficacy of Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition

Xanamem is being developed as a potential treatment for symptomatic, early stages of Alzheimer's Disease (AD) and Major Depressive Disorder (MDD).
This XanaCIDD Phase II study in MDD is to investigate the safety and efficacy of Xanamem™ in treating patients with cognitive and depressive symptoms. Trial participants will be randomized to either receive 10mg of Xanamem™ once daily or a Placebo at a 1:1 ratio in a double-blinded fashion.

Start Date28 Nov 2022

Sponsor / Collaborator

Actinogen Medical Ltd.

[+1]

100 Clinical Results associated with Emestedastat

100 Translational Medicine associated with Emestedastat

100 Patents (Medical) associated with Emestedastat

Literatures (Medical) associated with Emestedastat

01 Dec 2025·Alzheimers & Dementia

Validating the cortisol hypothesis: Xanamem demonstrates positive clinical effects by lowering CNS cortisol

Article

Author: Jaros, Mark ; Rolan, Paul ; Hilt, Dana ; Taylor, Jack ; Harrison, John E

Abstract:

Background:

Xanamem TM (Emestedastat) is an oral, selective 11β‐HSD1 inhibitor designed to reduce cortisol production in the brain under development for the treatment of AD. Clinical trials have demonstrated adequate target engagement by PET, improvements in cognitive performance in healthy older adults, and attenuation of decline in pTau181‐elevated clinically diagnosed AD patients at doses of 10mg daily. The recent positive results from the XanaCIDD trial in Major Depressive Disorder (MDD) validate the target as well as the 10mg daily dose of Xanamem.

Method:

XanaCIDD was a Phase 2, proof‐of‐concept trial of 10 mg Xanamem daily in MDD patients with a current depressive episode (HamD >17) and a cognitive deficit (DSST at least 0.5 SD below age and educational norms). Participants were randomized in a double‐blind design 1:1 to Xanamem 10mg or placebo for 6 weeks (Week 6), with 4 weeks follow‐up (Week 10). The primary endpoint was a customized Cogstate test battery (CTB) comprising three tests of attention and working memory at Week 6. Secondary endpoints included assessment of depression with the MADRS and Participant Global Impression of Severity scores (PGI‐S). Clinical effect sizes were described by the Cohen’s d statistic (Cd) with ≥0.2 considered to be clinically meaningful.

Result:

Both active and placebo groups improved substantially on the Cogstate CTB slightly favoring placebo (p=0.17). In the mITT population (n=165), a clinically and statistically significant benefit on MADRS was seen at Week 10 (2.7 points, Cd=0.43, p<0.05). In 76 patients taking SSRI medication, Xanamem benefit on MADRS was greater at the same timepoint (4.5 points, Cd=0.63, p=0.03). Xanamem showed a trend towards higher response rates at Week 10 (50% MADRS reduction, 34% Xanamem vs. 22% placebo, p=0.08). Trends towards improvement in PGI‐S scores favored the Xanamem group from Week 2 and were clinically significant at Weeks 4, 6 and 10 (p<0.2). There was a low incidence of treatment‐related adverse events which were generally mild or moderate and similar between treatment groups.

Conclusion:

These data suggest validation of the hypothesis that controlling CNS tissue cortisol production may be beneficial for the treatment of AD as well as MDD.

01 Feb 2025·Clinical Pharmacology in Drug Development

Clinical Pharmacology and Approach to Dose Selection of Emestedastat, a Novel Tissue Cortisol Synthesis Inhibitor for the Treatment of Central Nervous System Disease

Review

Author: Woodward, Michael ; Harrison, John ; Mills, Richard ; Rolan, Paul ; Seckl, Jonathan ; Jaros, Mark ; Taylor, Jack ; Maruff, Paul ; Hilt, Dana

Abstract:

This review demonstrates the value of central pharmacodynamics (PD), including positron emission tomography (PET) and computerized cognitive testing, to supplement pharmacokinetic (PK) and peripheral PD for determining the target dose range for clinical efficacy testing of emestedastat, an 11β‐hydroxysteroid dehydrogenase 1 (11β‐HSD1) inhibitor. Combined data from 6 clinical trials in cognitively normal volunteers and patients with Alzheimer disease included a population PK model, endocrine PD, a human PET trial (11β‐HSD1 brain imaging), and computerized cognitive testing. PK and PET findings were similar in volunteers and patients with Alzheimer disease. PK modeling suggested that 20 mg daily would be optimal to maintain cerebrospinal fluid concentrations above the brain half maximal inhibitory concentration. However, subsequent PET scanning suggested that emestedastat doses of 10 or even 5 mg daily may be sufficient to adequately inhibit 11β‐HSD1. With once‐daily doses of 5‐20 mg in cognitively normal, older volunteers, a consistent pattern of pro‐cognitive benefit, without dose‐response, was seen as improvement in attention and working memory but not episodic memory. Thus, emestedastat therapeutic activity might be attained at doses lower than those predicted from cerebrospinal fluid drug levels. Doses as low as 5 mg daily may be efficacious and were studied in subsequent trials.

25 Jun 2024·JOURNAL OF ALZHEIMERS DISEASE

Plasma pTau181 Predicts Clinical Progression in a Phase 2 Randomized Controlled Trial of the 11β-HSD1 Inhibitor Xanamem® for Mild Alzheimer’s Disease

Article

Author: Chen, Christopher ; Harrison, John ; Jaros, Mark ; Hilt, Dana ; Taylor, Jack

Background: Blood biomarkers are proposed as a diagnostic alternative to amyloid PET or cerebrospinal fluid (CSF) analyses for the diagnosis of Alzheimer’s disease (AD). Relatively little is known of the natural history of patients identified by different blood biomarkers. Objective: To identify patients with elevated plasma phosphorylated tau (pTau)181 from a prior Phase 2a trial, and explore the natural histories of their clinical progression, and potential efficacy of Xanamem, a selective inhibitor of 11beta-hydroxysteroid dehydrogenase type 1 (11β-HSD1) in these patients. Methods: A prespecified, double-blind analysis was conducted in 72 participants with clinically diagnosed AD and available plasma samples from baseline and Week 12 of the “XanADu” Phase 2a trial of Xanamem versus placebo. The analysis prespecified plasma pTau181 > median to identify patients more likely to have AD (“H”, > 6.74 pg/mL, n = 34). Cohen’s d (d) of≥0.2 defined potential clinical significance. Results: In the placebo group, H patients showed greater clinical progression compared to L patients (pTau181≤median) on ADCOMS (d = 0.55, p < 0.001), CDR-SB (d = 0.63, p < 0.001), MMSE (d = 0.52, p = 0.12), and ADAS-Cog14 (d = 0.53, p = 0.19). In H patients, a potentially clinically meaningful Xanamem treatment effect compared to placebo was seen in the CDR-SB (LS mean difference 0.6 units, d = 0.41, p = 0.09) and Neuropsychological Test Battery (NTB; LS mean difference 1.8 units, d = 0.26, p = 0.48) but not ADCOMS or ADAS-Cog14. Conclusions: This trial demonstrates that elevated plasma pTau181 identifies participants more likely to have progressive AD and is a suitable method for enrichment in AD clinical trials. Xanamem treatment showed evidence of potential clinically meaningful benefits.

News (Medical) associated with Emestedastat

20 Jul 2026

·www.globenewswire.com

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

Ongoing Xanamem (emestedastat) Alzheimer’s disease pivotal trial progresses toward final results in November this yearSYDNEY, 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 further investigation as a novel anti-depressant. Secondly, in contrast to the widely held belief that cognitive impairment improves along with depressive symptoms, improvements in cognition and depression were not correlated. In contrast to effects on depression, there was no demonstrable benefit of Xanamem on cognition. The phase 2a trial was randomized and double-blind, evaluating Xanamem 10mg once daily versus placebo over six weeks in 165 participants, followed by four weeks of blinded follow-up. A distinctive feature of the trial was the enrolment of participants with measurable CI in addition to a current MDD episode. Approximately 80% of participants were receiving background anti-depressant therapy, and the mean number of prior depressive episodes was ten. Anti-depressant benefit compared with placebo in the overall population commenced at the end of six weeks of therapy and was maximal four weeks later during the blinded follow up phase (2.7 MADRS1 points, p < 0.05). A similar benefit was seen in key subgroups, including in the 46% of patients receiving background SSRI2 therapy, who also achieved maximal benefit at the end of four weeks of blinded follow up (4.2 MADRS points, p < 0.05). The timecourse of Xanamem benefit on depression is consistent with the known timeframe of onset and reversal of chronic cortisol-related adverse effects (e.g. when starting or stopping chronic prednisone treatment). Professor Michael Berk AO, academic psychiatrist and co-author, said: “These results are highly encouraging for the Xanamem 10 mg daily dose that is also being used in the Alzheimer’s disease program. The trial demonstrates that the drug penetrates the brain and there is a signal of clinically meaningful activity to improve depressive symptoms in a difficult-to-treat MDD patient population. There remains a significant unmet medical need for therapies such as Xanamem that have a novel mechanism of action and can be safely combined with existing depression treatments.” Alzheimer’s disease program progress towards first pivotal readout in November Actinogen continues to advance its Alzheimer’s disease program supported by a recent positive recommendation from the XanaMIA pivotal trial’s independent Data Monitoring Committee (DMC) on June 17. The DMC reviewed available safety data from all 247 XanaMIA trial participants and concluded that the trial should continue without amendment. Earlier this year the DMC also recommended continuation following a formal interim analysis of unblinded safety and efficacy futility. Topline results from the fully enrolled, randomized phase of the XanaMIA trial of Xanamem 10 mg versus placebo are expected in November this year. The trial enrolled a population with mild to moderate, progressive Alzheimer’s disease. Participants were pre-screened for elevated plasma pTau181 levels and were required to have a Mini-Mental State Examination score between 18 to 26 points. Dr Dana Hilt, the Company’s CMO said: “Depressive symptoms also occur frequently in patients with Alzheimer’s disease. Anti-depressant activity may be a useful feature of Xanamem treatment for Alzheimer’s disease and help to improve well-being and quality of life in these patients. Topline results in November 2026 will include initial evaluation of Xanamem effects on psychiatric symptoms. Xanamem has the potential to be a game-changer for Alzheimer’s disease, given its potential product profile as a safe and effective oral therapy that can significantly slow disease course progression beyond currently approved treatments.” ® Xanamem is a registered trademark of Actinogen Medical Limited1 MADRS: Montgomery-Asberg Depression Rating Scale2 SSRI: Selective Serotonin Reuptake Inhibitors are the commonest class of anti-depressant in use About Actinogen Medical Actinogen Medical (ACW) is an ASX-listed, biotechnology company in the late clinical stages of development for Xanamem® (emestedastat), its novel oral therapy for Alzheimer’s disease and depression. The Company is based in Sydney, Australia with operations and clinical trials in Australia and the US. Xanamem has been studied in eight clinical trials with more than 500 people treated to date and has a promising safety and efficacy profile. ACW’s ongoing clinical trial, XanaMIA, is a phase 2b/3 pivotal trial of 247 participants with mild to moderate Alzheimer’s disease, treated for 36 weeks with Xanamem 10 mg or placebo, followed by an open-label extension phase with active Xanamem 10 mg for completing participants. In January 2026 an Independent DMC conducted an interim analysis of safety and efficacy futility and recommended the trial proceed to completion. The trial is now fully enrolled and will report topline, final results from the randomized phase in November this year. About Xanamem (emestedastat) Xanamem’s novel mechanism of action is to control the level of cortisol in the important areas of the brain through the inhibition of the cortisol synthesis enzyme, 11β-HSD1, without blocking normal production of cortisol by the adrenal glands. Xanamem is a first-in-class, once-a-day pill designed to deliver high levels of brain cortisol control in regions where 11β-HSD1 is highly expressed such as the hippocampus. Chronically elevated cortisol is associated with progression in Alzheimer’s Disease and excess cortisol is known to be toxic to brain cells. Elevated cortisol is also associated with depressive symptoms. Xanamem has demonstrated excellent brain target engagement and in human trials has shown potential to slow progression of Alzheimer’s disease and improve depressive symptoms in patients with moderately severe depression. To view Xanamem’s two-minute Mechanism of Action animation, click here. 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. Disclaimer This announcement and attachments may contain certain “forward-looking statements” that are not historical facts; are based on subjective estimates, assumptions and qualifications; and relate to circumstances and events that have not taken place and may not take place. Such forward looking statements should be considered “at-risk statements” - not to be relied upon as they are subject to known and unknown risks, uncertainties and other factors (such as significant business, economic and competitive uncertainties / contingencies and regulatory and clinical development risks, future outcomes and uncertainties) that may lead to actual results being materially different from any forward looking statement or the performance expressed or implied by such forward looking statements. You are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Actinogen Medical does not undertake any obligation to revise such statements to reflect events or any change in circumstances arising after the date hereof, or to reflect the occurrence of or non-occurrence of any future events. Past performance is not a reliable indicator of future performance. Actinogen Medical does not make any guarantee, representation or warranty as to the likelihood of achievement or reasonableness of any forward-looking statements and there can be no assurance or guarantee that any forward-looking statements will be realized. Dr. Steven Gourlay CEO & Managing Director E: steven.gourlay@actinogen.com.au Investors Will Souter Investor Relations E: will.souter@actinogen.com.au Media George Hazim Media & Public Affairs Australia E: georgehazim@mediaaffairs.com.au

Phase 2Clinical Result

28 May 2026

·www.biospace.com

Actinogen receives positive EMA scientific advice aligned with prior FDA guidance for its Alzheimer’s disease program

XanaMIA randomized, pivotal trial of oral Xanamem 10 mg fully enrolled and remains on track for topline final results in November 2026 SYDNEY, May 28, 2026 (GLOBE NEWSWIRE) -- Actinogen Medical Limited (ASX: ACW) today announces the successful outcome of its scheduled scientific advice meeting (written response) on Alzheimer’s disease (AD) with the European Medicines Agency (EMA). Actinogen and the EMA reached a common understanding of the pathway to marketing approval for AD in the European Union (EU). This includes agreements related to regulatory starting materials used in drug substance synthesis, design considerations for one additional pivotal clinical trial and the limited number of ancillary clinical pharmacology trials and nonclinical studies required. Key understandings include: Agreement on the suitability of the ‘Regulatory starting materials’ for the commercial manufacturing of Xanamem ® (emestedastat) drug substance Design of one additional, well-controlled, pivotal (phase 3) trial to follow a positive XanaMIA pivotal trial – both use a 10 mg dose vs. placebo Standard total number of people to be treated with Xanamem to be described in the Marketing Authorization Application – that is, the proposed makeup of the planned safety database consistent with EMA and FDA guidelines Small number of ancillary clinical pharmacology trials to be conducted parallel with the next pivotal trial Small number of nonclinical studies required to further characterize safety, metabolism and excretion pathways to be conducted parallel with the next pivotal trial The outcome reached at this meeting aligns closely with the guidance received at an earlier meeting with the FDA’s Neurology-I Division in September 2025. With the new EMA advice, Actinogen now has a clear pathway and guidance towards marketing approvals in two key pharmaceutical markets. Approvals in the US and EU also contribute to approvals in many other countries and regions. The advice from both the FDA and EMA provides regulatory clarity for ongoing discussions with potential development and marketing partners. Dr Steven Gourlay, the Company’s CEO said: “We are pleased with the clear guidance from the EMA that closely conforms with our plans for streamlined development of Xanamem in Alzheimer’s disease, as agreed previously with the FDA. Importantly, the EMA agreed with our approach for only one additional, pivotal trial using a single 10 mg Xanamem dose vs. placebo to support a marketing application for Alzheimer’s in the EU. ” Topline results from the randomized phase of the XanaMIA pivotal Alzheimer’s disease trial of Xanamem 10 mg vs. placebo are expected in November this year. The trial enrolled 247 participants in the US and Australia with mild to moderate Alzheimer’s disease and elevated levels of plasma pTau181. Earlier this year the Independent Data Monitoring Committee (DMC) recommended the trial continue unchanged after a confidential assessment of unblinded safety and efficacy futility data. Dr Dana Hilt, the Company’s CMO said: “With positive feedback from both the FDA and EMA on our Xanamem program and a positive DMC interim analysis, we look forward to potentially groundbreaking XanaMIA trial results in November. Such results would provide important evidence that control of brain cortisol can safely slow the progression of Alzheimer’s disease. Our second pivotal trial in patients with mild to moderate Alzheimer’s disease would then commence mid next year in multiple regions.” All XanaMIA participants are now potentially eligible to extend their treatment by participation in the Open Label Extension (OLE) phase. The OLE will provide valuable data on longer-term safety and efficacy trajectories. The XanaMIA trial is intended to serve as one of two pivotal trials supporting the earliest possible marketing approvals for Xanamem in multiple regions. If the trial results are strongly positive in November, the Company will also explore expedited approval pathways with relevant regulators while commencing the new pivotal phase 3 trial. The FDA recently announced a new policy supporting approval based on a single pivotal trial with adequate supporting evidence. ® Xanamem is a registered trademark of Actinogen Medical Limited About Actinogen Medical Actinogen Medical (ACW) is an ASX-listed, biotechnology company in the late clinical stages of development for Xanamem ® (emestedastat), its novel oral therapy for Alzheimer’s disease and depression. The Company is based in Sydney, Australia with operations and clinical trials in Australia and the US. Xanamem has been studied in eight clinical trials with more than 500 people treated to date and has a promising safety and efficacy profile. ACW’s ongoing clinical trial, XanaMIA, is a phase 2b/3 pivotal trial of 247 participants with mild to moderate Alzheimer’s disease, treated for 36 weeks with Xanamem 10 mg or placebo, followed by an open-label extension phase with active Xanamem 10 mg for completing participants. In January 2026 an Independent DMC conducted an interim analysis of safety and efficacy futility and recommended the trial proceed to completion. The trial is now fully enrolled and will report topline, final results from the randomized phase in November this year. About Xanamem (emestedastat) Xanamem’s novel mechanism of action is to control the level of cortisol in the important areas of the brain through the inhibition of the cortisol synthesis enzyme, 11β-HSD1, without blocking normal production of cortisol by the adrenal glands. Xanamem is a first-in-class, once-a-day pill designed to deliver high levels of brain cortisol control in regions where 11β-HSD1 is highly expressed such as the hippocampus. Chronically elevated cortisol is associated with progression in Alzheimer’s Disease and excess cortisol is known to be toxic to brain cells. Elevated cortisol is also associated with depressive symptoms. Xanamem has demonstrated excellent brain target engagement and in human trials has shown potential to slow progression of Alzheimer’s disease and improve depressive symptoms in patients with moderately severe depression. To view Xanamem’s two-minute Mechanism of Action animation, click here . 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. Disclaimer This announcement and attachments may contain certain "forward-looking statements" that are not historical facts; are based on subjective estimates, assumptions and qualifications; and relate to circumstances and events that have not taken place and may not take place. Such forward looking statements should be considered “at-risk statements” - not to be relied upon as they are subject to known and unknown risks, uncertainties and other factors (such as significant business, economic and competitive uncertainties / contingencies and regulatory and clinical development risks, future outcomes and uncertainties) that may lead to actual results being materially different from any forward looking statement or the performance expressed or implied by such forward looking statements. You are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Actinogen Medical does not undertake any obligation to revise such statements to reflect events or any change in circumstances arising after the date hereof, or to reflect the occurrence of or non-occurrence of any future events. Past performance is not a reliable indicator of future performance. Actinogen Medical does not make any guarantee, representation or warranty as to the likelihood of achievement or reasonableness of any forward-looking statements and there can be no assurance or guarantee that any forward-looking statements will be realized. CONTACT: Dr. Steven Gourlay CEO & Managing Director E: steven.gourlay@actinogen.com.au Investors Michael Roberts Investor Relations E: michael.roberts@actinogen.com.au Media George Hazim Media & Public Affairs Australia E: georgehazim@mediaaffairs.com.au

02 Apr 2026

·www.globenewswire.com

Actinogen commences open-label phase of XanaMIA Alzheimer’s trial and provides business update

April 01, 2026 -- Actinogen Medical Limited (ASX: ACW) announces that the first participant has been treated in the open-label extension (OLE) phase of the XanaMIA trial following completion of 36 weeks of treatment in the randomized phase. Open-label phase of up to 25 months duration, during which all participants will receive active Xanamem® 10 mg once daily, with no placebo control group Open to all former and current participants who have completed the randomized phase of the XanaMIA pivotal Alzheimer’s disease trial in Australia and the United States Generates longer term safety data and observational data on key efficacy endpoints including CDR- SB1, cognition and activities of daily living Data will be analyzed and reported progressively and compared with relevant historical control cohorts of patients with mild to moderate Alzheimer’s disease, as well as with data from the randomized phase of the trial. Dr Dana Hilt, the Company’s CMO said: “The commencement of the open-label extension phase of the XanaMIA trial enables us to offer current and past participants access to active Xanamem therapy for up to 25 months. This is an important opportunity for our trial participants, particularly the half who initially received placebo, and allows all participants to contribute valuable data on the potential durability of Xanamem benefit and its long-term safety.” “Xanamem has the potential to be a game-changer for patients with Alzheimer’s as a potentially safe and effective oral therapy to slow or halt disease progression. Unlike anti-amyloid antibody therapies, Xanamem does not require serial MRI monitoring for safety as there is no suggestion it causes brain swelling also known as ARIA.” The randomized phase of the XanaMIA pivotal Alzheimer’s disease trial continues in parallel with the OLE, following a positive Independent Data Monitoring Committee safety and efficacy futility recommendation in January this year. Final topline safety and efficacy results for the full 36-week treatment period are expected in November 2026. The XanaMIA trial is intended to serve as one of two pivotal trials supporting the earliest potential marketing approvals for Xanamem in Alzheimer’s disease. If the trial is positive, the Company will also explore accelerated approval pathways with relevant regulators, including discussions with the FDA regarding its recently announced policy supporting approval based on a single pivotal trial with adequate supporting evidence. During the current quarter, the Company plans to meet with the European Medicines Agency to discuss opportunities to streamline the pathway to Xanamem approval in the European Union. This meeting will be similar in nature to the successful engagement held with the US FDA in 2025. In addition, publication of results from the XanaCIDD Phase 2a depression trial in a peer-reviewed journal is anticipated in the near term. Future depression trials will be considered once results from the pivotal XanaMIA trial are available. Dr Steven Gourlay, the Company’s CEO said: “Actinogen is proud to be advancing Xanamem toward pivotal trial results later this year while simultaneously offering active Xanamem to all eligible participants through the new open-label extension phase. A safe and effective oral therapy capable of slowing disease progression in Alzheimer’s disease is arguably the ‘holy grail’ in the field and we hope that Xanamem’s ability to control brain tissue cortisol levels will lead to clinically significant disease modulation.” Actinogen Medical (ACW) is an ASX-listed, biotechnology company in the late clinical stages of development for Xanamem® (emestedastat), its novel oral therapy for Alzheimer’s disease and depression. The Company is based in Sydney, Australia with operations and clinical trials in Australia and the US. Xanamem, has been studied in eight clinical trials with more than 500 people treated to date and has a promising safety and efficacy profile. ACW’s ongoing clinical trial, XanaMIA, is a phase 2b/3 pivotal trial of 247 participants with mild to moderate Alzheimer’s disease, treated for 36 weeks with Xanamem 10 mg or placebo, followed by an open-label extension phase with active Xanamem for completing participants. The trial is now closed for recruitment and will report topline final results from the randomized phase in November this year. Xanamem’s novel mechanism of action is to control the level of cortisol in the important areas of the brain through the inhibition of the cortisol synthesis enzyme, 11β-HSD1, without blocking normal production of cortisol by the adrenal glands. Xanamem is a first-in-class, once-a-day pill designed to deliver high levels of brain cortisol control in regions where 11β-HSD1 is highly expressed such as the hippocampus. Chronically elevated cortisol is associated with progression in Alzheimer’s Disease and excess cortisol is known to be toxic to brain cells. Elevated cortisol is also associated with depressive symptoms. Xanamem has demonstrated excellent brain target engagement and in human trials has shown potential to slow progression of Alzheimer’s disease and improve depressive symptoms in patients with moderately severe depression. 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. The content above comes from the network.if any infringement, please contact us to modify.

Clinical Study

100 Deals associated with Emestedastat

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 3	United States	Actinogen Medical Ltd.	12 Apr 2024
Alzheimer Disease	Phase 3	Australia	Actinogen Medical Ltd.	12 Apr 2024
Cognitive Dysfunction	Phase 2	Australia	Actinogen Medical Ltd.	28 Nov 2022
Cognitive Dysfunction	Phase 2	United Kingdom	Actinogen Medical Ltd.	28 Nov 2022
Depressive Disorder, Major	Phase 2	Australia	Actinogen Medical Ltd.	28 Nov 2022
Depressive Disorder, Major	Phase 2	United Kingdom	Actinogen Medical Ltd.	28 Nov 2022
Mild cognitive disorder	Phase 2	Australia	Actinogen Medical Ltd.	30 Jun 2021
Cognition	Phase 1	Australia	Actinogen Medical Ltd.	21 Jan 2019
Small Fiber Neuropathy	Phase 1	Australia	Actinogen Medical Ltd.	21 Jan 2019
Fragile X Syndrome	Preclinical	Australia	Actinogen Medical Ltd.	16 Jul 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05657691 (XanaCIDD, PRNewswire) Manual	Phase 2	Depressive Disorder	165	Xanamem	japxowqmim(aerjnqrmki) = Benefits on a newly analysed secondary endpoint called PGI-S showed consistent and clinically significant benefits for Xanamem (Cd = 0.3 at Week 10), corroborating the observations from the MADRS depression endpoint. csfajqjxyg (derapaouvm ) View more	Positive	26 Aug 2024
				Placebo
NCT05657691 (XanaCIDD, PRNewswire) Manual	Phase 2	Depressive Disorder	167	Xanamem	emmzzrmhtf(ospbayvqme) = ymioqdfdbj nclhlrrslw (sclkmruzuo ) Not Met View more	Positive	12 Aug 2024
				Xanamem (less severe depression)	qoipxxdgto(pppgsjmcxr) = nhngutqjuf ybvbsjhdrw (vkgrihodzw ) View more
NCT02727699 (XanADu, PRNewswire) Manual	Phase 2	Alzheimer Disease	72	Xanamem	gduzirdnmw(nchrtxrplu): Difference = 0.6, P-Value = 0.09 View more	Positive	26 Jun 2024
				Placebo
NCT06125951 (XanaMIA, CTAD2022)	Phase 1	-	-	5 mg Xanamem	nxobrkemfx(vdvduvphnd) = zfgwthvvul rzeyjrdxaz (uvghwidoyg )	-	03 Dec 2022
				10 mg Xanamem	nxobrkemfx(vdvduvphnd) = oomjjzxqkz rzeyjrdxaz (uvghwidoyg )
NCT02727699 (XanADu, NEWS) Manual	Phase 2	Alzheimer Disease	72	Xanamem	bxiclohifv(suoqmmyhos) = gjsnnomuhb fybxftnmbf (rszpsgxykk )	Positive	10 Oct 2022
				Placebo	-
NCT02727699 (XanADu, CTgov)	Phase 2	Alzheimer Disease	185	Xanamem™ (Xanamem™)	aicpijwnqt(mjkdrmskxy) = ryuoyxhvop qgjpozmpts (cvijfvtvrx, 6.47) View more	-	06 May 2021
				Placebo (for Xanamem™) (Placebo)	aicpijwnqt(mjkdrmskxy) = cfjvfprqfs qgjpozmpts (cvijfvtvrx, 6.65) View more
NCT02727699 (XanADu, AAIC2016)	Phase 2	Alzheimer Disease	200	Xanamem 35mg bd	enhdnjmkft(pnubxeoaam) = activated at doses of 10mg and above fqsrarvfjh (dijubbujlc )	-	01 Jul 2016
				Placebo

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Emestedastat

Overview

Basic Info

Structure/Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation