This section highlights FDA-related milestones and regulatory updates for drugs developed by Anavex Life Sciences (AVXL).
Over the past two years, Anavex Life Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ANAVEX, ANAVEX®2-73, and ANAVEX®3-71. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ANAVEX 2-73 (blarcamesine) FDA Regulatory Timeline and Events
ANAVEX 2-73 (blarcamesine) is a drug developed by Anavex Life Sciences for the following indication: Alzheimer's Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ANAVEX 2-73 (blarcamesine)
- Announced Date:
- January 27, 2025
- Indication:
- Alzheimer's Disease
Announcement
Anavex Life Sciences Corp. announced today it was issued a new U.S. Patent No. 12,180,174 entitled "A2-73 CRYSTALLINE POLYMORPH COMPOSITIONS OF MATTER AND METHODS OF USE THEREOF" from the United States Patent and Trademark Office (USPTO) for its U.S. Patent Application Serial Number USSN: 17/978,818.
AI Summary
Anavex Life Sciences Corp. announced that it has been granted a new U.S. Patent No. 12,180,174 for “A2-73 CRYSTALLINE POLYMORPH COMPOSITIONS OF MATTER AND METHODS OF USE THEREOF.” The patent covers new crystalline forms of the dihydrogen phosphate salt of ANAVEX®2-73 (blarcamesine), including various formulations such as freebase forms, transdermal patches, and enteric-coated oral dosage forms. These innovations are designed to support effective neuroprotection and treatment of conditions like Alzheimer’s and Parkinson’s disease.
The new patent, which complements Anavex’s existing portfolio for ANAVEX®2-73, is expected to remain in force until at least July 2039, not including any patent extensions. This milestone highlights the company’s commitment to developing novel drug delivery systems that aim to improve patient convenience and compliance, potentially benefiting a large number of patients with neurodegenerative disorders.
Read Announcement- Drug:
- ANAVEX 2-73 (blarcamesine)
- Announced Date:
- January 15, 2025
- Indication:
- Alzheimer's Disease
Announcement
Anavex Life Sciences Corp. announced that The Journal of Prevention of Alzheimer's Disease (JPAD) has published peer-reviewed detailed results from the Phase IIb/III study evaluating oral blarcamesine (ANAVEX®2-73) for the treatment of early Alzheimer's Disease (AD).
AI Summary
Anavex Life Sciences Corp. announced that the peer-reviewed results from its Phase IIb/III trial of oral blarcamesine (ANAVEX®2-73) for early Alzheimer’s disease have been published in The Journal of Prevention of Alzheimer’s Disease. The study showed that once-daily blarcamesine significantly slowed clinical progression—by 36.3% overall and 49.8% in patients with the SIGMAR1 wild-type gene—over 48 weeks. The drug demonstrated a solid safety profile with no neuroimaging adverse events and has the advantage of being an oral treatment, potentially providing an alternative or complement to injectable therapies. Blarcamesine targets autophagy through SIGMAR1 activation, a mechanism that may restore cellular balance and counter the neurodegenerative process observed in early Alzheimer’s disease, bringing hope to patients and their caregivers.
Read Announcement- Drug:
- ANAVEX 2-73 (blarcamesine)
- Announced Date:
- January 13, 2025
- Indication:
- Alzheimer's Disease
Announcement
Anavex Life Sciences Corp. announced that over three years of continuous treatment with blarcamesine (ANAVEX®2-73) demonstrated significantly reduced clinical decline showing continued clinically and meaningful benefit for early Alzheimer's disease patients.
AI Summary
Anavex Life Sciences Corp. announced promising long-term results from a three-year continuous treatment program using blarcamesine (ANAVEX®2-73) for early Alzheimer’s disease patients. The study demonstrated a significant reduction in clinical decline, with patients who started treatment earlier showing notably better preservation of cognitive function and daily living activities. Results from the delayed-start analysis support the idea that early intervention can lead to clinically and meaningfully improved outcomes, as measured by standard Alzheimer's scales. These findings indicate that continuous blarcamesine treatment may slow disease progression, offering hope for enhanced quality of life for patients. In addition, the treatment maintained a favorable safety profile over the three-year period, further strengthening its potential as a scalable, long-term therapeutic option for early Alzheimer’s care.
Read Announcement - Drug:
- ANAVEX 2-73 (blarcamesine)
- Announced Date:
- December 23, 2024
- Indication:
- Alzheimer's Disease
Announcement
Anavex Life Sciences Corp. announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for blarcamesine (ANAVEX®2-73), an investigational drug for the treatment of Alzheimer's disease.
AI Summary
Anavex Life Sciences Corp. announced that the European Medicines Agency (EMA) has accepted for review its Marketing Authorization Application (MAA) for blarcamesine (ANAVEX®2-73), an investigational oral drug designed to treat Alzheimer’s disease. This acceptance follows positive results from a Phase IIb/III clinical trial in patients with early Alzheimer’s. Blarcamesine works by activating the SIGMAR1 receptor, which enhances autophagy—a process that helps restore cellular balance and may slow the progression of Alzheimer’s. The EMA review is a major step forward, potentially expanding access to this novel treatment option across Europe. Anavex is looking forward to collaborating with the EMA as it continues to develop and refine this promising therapeutic candidate aimed at addressing the underlying pathology of Alzheimer’s disease.
Read Announcement- Drug:
- ANAVEX 2-73 (blarcamesine)
- Announced Date:
- November 26, 2024
- Indication:
- Alzheimer's Disease
Announcement
Anavex Life Sciences Corp. announced the submission of the blarcamesine (ANAVEX®2-73) MAA (Marketing Authorization Application) to the European Medicines Agency (EMA). The MAA submission is for the treatment of Alzheimer's Disease.
AI Summary
Anavex Life Sciences Corp. recently submitted its Marketing Authorization Application (MAA) for blarcamesine (ANAVEX®2-73) to the European Medicines Agency (EMA). The application is for a new oral treatment aimed at helping patients with Alzheimer’s disease. In clinical trials, the once-daily medication showed promising results by improving cognitive scores and potentially slowing down neurodegeneration compared to current therapies. The ease of oral administration and a favorable safety profile, which avoids the need for constant MRI monitoring, could make it a valuable alternative or complement to existing treatments based on anti-beta amyloid monoclonal antibodies.
This important regulatory step marks a milestone for Anavex as it seeks to bring an innovative therapy to millions affected by Alzheimer’s disease, addressing a significant need in Europe where cases are expected to rise dramatically in the coming years.
Read Announcement- Drug:
- ANAVEX 2-73 (blarcamesine)
- Announced Date:
- November 25, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- Alzheimer's Disease
Announcement
Anavex Life Sciences Corp. announced that Results from the ANAVEX2-73-AD-004 Phase IIB/III trial," in a medical journal with focus on Alzheimer's disease. The publication date is expected around Q4 2024
AI Summary
Anavex Life Sciences Corp. recently announced an important step in its Alzheimer's research. The company shared that its manuscript titled "Blarcamesine for the treatment of Early Alzheimer’s Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial" has been accepted for publication in a peer-reviewed medical journal focused on Alzheimer’s disease. This milestone highlights the promising findings from the trial, which could provide valuable insights into the potential of oral blarcamesine for treating Alzheimer’s. The publication is expected to be released around Q4 2024, making it a significant milestone for both the scientific community and the millions of people affected by this debilitating disease. The study reinforces the company's commitment to advancing treatment options and educating medical professionals about new potential therapies for Alzheimer’s disease.
Read Announcement- Drug:
- ANAVEX 2-73 (blarcamesine)
- Announced Date:
- November 25, 2024
- Indication:
- Alzheimer's Disease
Announcement
Anavex Life Sciences Corp. announced the acceptance of a peer-reviewed manuscript titled, "Blarcamesine for the treatment of Early Alzheimer's Disease
AI Summary
Anavex Life Sciences Corp. announced that a key manuscript titled "Blarcamesine for the treatment of Early Alzheimer's Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial" has been accepted for publication in a peer-reviewed medical journal. The study focuses on the potential of oral blarcamesine as a treatment for early Alzheimer’s disease and is expected to be published around Q4 2024 or Q1 2025.
The acceptance of this manuscript marks an important achievement for the company and its research team. Senior leaders expressed their excitement in sharing these findings, believing the work will help educate the scientific and Alzheimer’s communities about the possible benefits of oral blarcamesine. This milestone further highlights the ongoing efforts to develop promising therapies to address the urgent healthcare burdens posed by Alzheimer’s disease.
Read Announcement- Drug:
- ANAVEX 2-73 (blarcamesine)
- Announced Date:
- November 25, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 2025
- Indication:
- Alzheimer's Disease
Announcement
Anavex Life Sciences Corp. announced that Results from the ANAVEX2-73-AD-004 Phase IIB/III trial," in a medical journal with focus on Alzheimer's disease. The publication date is expected around Q1 2025.
AI Summary
Anavex Life Sciences Corp. announced that a key manuscript detailing results from its ANAVEX2-73-AD-004 Phase IIB/III trial has been accepted for publication in a peer-reviewed Alzheimer's disease journal. The article, titled “Blarcamesine for the Treatment of Early Alzheimer’s Disease,” focuses on the trial results for the drug candidate intended to treat early-stage Alzheimer’s. Its publication is expected around the first quarter of 2025, marking an important milestone in the company’s efforts to share scientific findings with the medical community. The peer review and forthcoming publication underscore the significance of the trial data and aim to inform professionals about the potential benefits of oral blarcamesine. This development is part of Anavex’s broader initiative to advance its clinical trials and regulatory submissions for new Alzheimer's therapies.
Read Announcement- Drug:
- ANAVEX 2-73 (blarcamesine)
- Announced Date:
- July 30, 2024
- Indication:
- Alzheimer's Disease
Announcement
Anavex Life Sciences Corp. reported positive preclinical results in directly to humans' translatable biomarkers for individuals with FXS for ANAVEX®2-73 (blarcamesine), in a disease model of Fragile X syndrome (FXS).
AI Summary
Anavex Life Sciences Corp. reported promising preclinical results for its drug ANAVEX®2-73 (blarcamesine) in a Fragile X syndrome (FXS) mouse model. In the study, the drug corrected EEG biomarkers that are directly translatable to humans, particularly improving brain activity measured by the auditory steady state response (ASSR) test. This test, important for central nervous system disorders, revealed that ANAVEX®2-73 enhanced neural synchrony in the frontal and auditory cortices in a dose-dependent manner. These findings suggest that the drug may help restore the balance of excitatory and inhibitory signaling in the brain, potentially alleviating behavioral, sensory, and cognitive challenges associated with FXS. Based on these positive results, Anavex plans to soon begin a clinical trial to assess the safety and efficacy of ANAVEX®2-73 in individuals with FXS.
Read Announcement- Drug:
- ANAVEX 2-73 (blarcamesine)
- Announced Date:
- July 28, 2024
- Indication:
- Alzheimer's Disease
Announcement
Anavex Life Sciences Corp today presented comprehensive results from the Phase IIb/III study showing that blarcamesine (ANAVEX®2-73), once daily orally, significantly slowed clinical decline in people with early Alzheimer's disease (AD).
AI Summary
Anavex Life Sciences Corp. presented strong results from its Phase IIb/III study on blarcamesine (ANAVEX®2-73), an oral treatment taken once daily. The study showed that the drug significantly slowed clinical decline in people with early Alzheimer’s disease. Specifically, patients receiving the treatment experienced a reduction in cognitive decline by about 38.5% with a 50 mg dose and 34.6% with a 30 mg dose compared to those on placebo, as measured by the ADAS-Cog13 test at 48 weeks.
The data also suggest that blarcamesine positively affected biomarkers linked to Alzheimer’s pathology, including amyloid-beta levels and brain volume. Researchers highlighted the drug’s good safety profile, with no neuroimaging adverse events, which could make it a convenient alternative with minimal monitoring needs. These promising results indicate that blarcamesine might offer a new, accessible treatment option for early Alzheimer’s patients.
Read Announcement- Drug:
- ANAVEX 2-73 (blarcamesine)
- Announced Date:
- July 28, 2024
- Indication:
- Alzheimer's Disease
Announcement
Anavex Life Sciences Corp. announced that EMA submission expected in Q4
AI Summary
Anavex Life Sciences has announced promising Phase IIb/III study results for its oral drug blarcamesine, a treatment for early Alzheimer’s disease. In the trial, both 30 mg and 50 mg doses significantly slowed clinical decline and reduced brain atrophy, while demonstrating a good safety profile without any observed neuroimaging adverse events. The study showed improvements in key cognitive assessments and reductions in biomarkers linked to Alzheimer’s pathology, such as amyloid-beta accumulation and decreased brain volume loss.
In a key update, Anavex revealed that a full regulatory submission for blarcamesine to the European Medicines Agency (EMA) is expected in the fourth quarter of 2024. This submission is an important step towards providing a novel, convenient, and potentially complementary treatment option for patients with early Alzheimer’s disease.
Read Announcement
ANAVEX®2-73 FDA Regulatory Events
ANAVEX®2-73 is a drug developed by Anavex Life Sciences for the following indication: For early Alzheimer's disease patients.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ANAVEX®2-73
- Announced Date:
- April 21, 2025
- Indication:
- For early Alzheimer's disease patients.
Announcement
Anavex Life Sciences Corp. announced that Marwan Noel Sabbagh, MD, Professor of Neurology at Barrow Neurological Institute and Chairman of Anavex's Scientific Advisory Board gave an oral presentation titled, "Oral Blarcamesine Novel Mechanism for Alzheimer Disease: Autophagy Restoration through Upstream SIGMAR1 Activation Clinical Efficacy Phase IIb/III Trial" at the 9th International Conference on Alzheimer's Disease and Related Disorders in the Middle East.
AI Summary
Anavex Life Sciences Corp. reported that Dr. Marwan Noel Sabbagh, Professor of Neurology at Barrow Neurological Institute and Chairman of the company’s Scientific Advisory Board, delivered an important presentation at the 9th International Conference on Alzheimer’s Disease and Related Disorders in the Middle East. The event, held in Abu Dhabi from April 18-20, 2025, brought together clinicians and researchers from across the MENA region, the USA, Europe, and beyond, all focused on advancing Alzheimer’s research and clinical care.
Dr. Sabbagh’s talk, titled “Oral Blarcamesine Novel Mechanism for Alzheimer Disease: Autophagy Restoration through Upstream SIGMAR1 Activation Clinical Efficacy Phase IIb/III Trial,” highlighted a novel therapeutic approach. The presentation detailed how the investigational drug candidate, blarcamesine, aims to restore cellular balance by activating SIGMAR1, potentially offering a new way to treat Alzheimer’s disease and related neurodegenerative conditions.
Read Announcement- Drug:
- ANAVEX®2-73
- Announced Date:
- April 5, 2025
- Indication:
- For early Alzheimer's disease patients.
Announcement
Anavex Life Sciences Corp. announced that over three years of continuous treatment with blarcamesine (ANAVEX®2-73) demonstrated significantly amelioration on clinical decline showing continued clinically and meaningful benefit for early Alzheimer's disease patients.
AI Summary
Anavex Life Sciences Corp. recently reported that three years of continuous treatment with its investigational drug blarcamesine (ANAVEX®2-73) significantly reduced clinical decline in patients with early Alzheimer's disease. The study data showed that early and ongoing treatment led to meaningful improvements in cognitive function and daily living activities, suggesting that blarcamesine may have a disease‐modifying effect. Using a delayed-start analysis, researchers found that patients who began treatment sooner maintained better clinical stability over time compared to those who started treatment approximately one year later.
In addition, the long-term data supports the importance of uninterrupted therapy, reinforcing that a continuous treatment regimen could provide greater benefits. The study also emphasized that blarcamesine has a favorable safety profile, with no reports of treatment-related severe adverse events, highlighting its potential as an effective option for early Alzheimer's disease patients.
Read Announcement
ANAVEX®3-71 FDA Regulatory Events
ANAVEX®3-71 is a drug developed by Anavex Life Sciences for the following indication: For the treatment of neurodegenerative and neurodevelopmental disorders.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ANAVEX®3-71
- Announced Date:
- May 1, 2025
- Indication:
- For the treatment of neurodegenerative and neurodevelopmental disorders
Announcement
Anavex Life Sciences Corp announced the successful completion of enrollment in its Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia (ANAVEX3-71-SZ-001, NCT06245213).
AI Summary
Anavex Life Sciences Corp. announced that its Phase 2 clinical study (ANAVEX®3-71-SZ-001, NCT06245213) for schizophrenia has fully enrolled 71 participants. The study is divided into two parts, with 16 participants in Part A and 55 in Part B. In Part A, which focused on testing multiple ascending doses, promising safety and EEG biomarker results have already been reported. Part B, with more participants and a longer treatment period, will collect additional clinical and biomarker data to better understand the drug’s effectiveness and safety in treating schizophrenia.
The company is optimistic that ANAVEX®3-71, a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator, could offer a new treatment option that addresses all symptom areas of schizophrenia without the common side effects of current medications. Top-line results are expected in the second half of 2025.
Read Announcement- Drug:
- ANAVEX®3-71
- Announced Date:
- May 1, 2025
- Estimated Event Date Range:
- July 1, 2025 - December 31, 2025
- Target Action Date:
- H2 2025
- Indication:
- For the treatment of neurodegenerative and neurodevelopmental disorders
Announcement
Anavex Life Sciences Corp Top line data expected in the second half of 2025
AI Summary
Anavex Life Sciences Corp has completed enrollment for its Phase 2 study testing ANAVEX®3-71 as a treatment for schizophrenia. The study enrolled 71 participants, with 16 in Part A and 55 in Part B. Part A involved multiple ascending doses and showed promising safety and biomarker results, while Part B will provide more detailed information on the drug’s effectiveness and safety over a longer treatment period.
The company has announced that it expects to report the top-line data from the study in the second half of 2025. This upcoming data is seen as an important step in further assessing the potential of ANAVEX®3-71, which works by targeting both the SIGMAR1 and M1 muscarinic receptors. Anavex hopes that this treatment will offer new benefits for managing the diverse symptoms of schizophrenia.
Read Announcement
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