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Details:
ANAVEX 2-73 (blarcamesine) is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. It is under phase 3 clinical development for the treatment of patients with Rett syndrome (RTT).
Lead Product(s): Blarcamesine
Therapeutic Area: Genetic Disease Product Name: Anavex 2-73
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 02, 2024
Details:
ANAVEX 2-73 (blarcamesine) is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. It is under phase 3 clinical development for the treatment of patients with Rett syndrome (RTT).
Lead Product(s): Blarcamesine
Therapeutic Area: Genetic Disease Product Name: Anavex 2-73
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2023
Details:
ANAVEX 2-73 (blarcamesine) is M1 & σ1 receptor agonist, which is being evaluated in phase 2/3 clinical trials for the treatment of Alzheimer’s Disease.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: ANAVEX 2-73
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2023
Details:
ANAVEX2-73 (blarcamesine) is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. It is under phase 2/3 clinical development for the treatment of Alzheimer's disease.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: ANAVEX2-73
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 20, 2023
Details:
ANAVEX®2-73 (blarcamesine) is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. It is being investigated for alzheimer’s disease.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Anavex 2-73
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2023
Details:
ANAVEX®2-73 (blarcamesine) is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. It is being investigated for rett syndrome.
Lead Product(s): Blarcamesine
Therapeutic Area: Genetic Disease Product Name: Anavex 2-73
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2023
Details:
ANAVEX®2-73 (blarcamesine) is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. It is being investigated for rett syndrome.
Lead Product(s): Blarcamesine
Therapeutic Area: Genetic Disease Product Name: Anavex 2-73
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2023
Details:
ANAVEX®2-73 (blarcamesine) is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. It is being investigated for rett syndrome.
Lead Product(s): Blarcamesine
Therapeutic Area: Genetic Disease Product Name: Anavex 2-73
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2023
Details:
ANAVEX®2-73 (blarcamesine) is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. It is being investigated for systolic hypertension, or lowering systolic blood pressure.
Lead Product(s): Blarcamesine
Therapeutic Area: Cardiology/Vascular Diseases Product Name: ANAVEX 2-73
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 01, 2023
Details:
ANAVEX®2-73 (blarcamesine) is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. It is being investigated for parkinson’s disease.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Anavex 2-73
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2023
Details:
ANAVEX®2-73 (blarcamesine) is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. It is being investigated for rett syndrome.
Lead Product(s): Blarcamesine
Therapeutic Area: Genetic Disease Product Name: Anavex 2-73
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 02, 2023
Details:
ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Anavex 2-73
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2022
Details:
ANAVEX®2-73 (blarcamesine) is an orally available, small-molecule activator of the sigma-1 receptor (SIGMAR1), which, data suggest, is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Anavex 2-73
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2022
Details:
ANAVEX®2-73 (blarcamesine) is an orally available, small-molecule activator of the sigma-1 receptor, which, data suggest, is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Anavex 2-73
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2022
Details:
ANAVEX®2-73 transcriptomics analysis (RNAseq) identified a gene network that is differentially expressed in Parkinson’s disease dementia (PDD) patients treated with ANAVEX®2-73 compared to placebo after 14 weeks of treatment.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Anavex 2-73
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 31, 2022
Details:
Findings demonstrate that treatment effect of ANAVEX2-73 (blarcamesine), resulting in reversal of hyperactivity, restoration of associative learning and reduction of anxiety in mouse model of Fragile X Syndrome.
Lead Product(s): Blarcamesine
Therapeutic Area: Genetic Disease Product Name: Anavex2-73
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: FRAXA Research Foundation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2022
Details:
ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease.
Lead Product(s): Blarcamesine
Therapeutic Area: Rare Diseases and Disorders Product Name: Anavex 2-73
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Details:
SIGMAR1 mRNA expression significantly increased in ANAVEX®2-73-treated patients vs placebo (p=0.035) and was significantly associated with improvements of MDS-UPDRS scores and cognitive efficacy endpoints CDR system.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Anavex 2-73
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 15, 2022
Details:
Based on the results of the AVATAR Phase 3 study (ANAVEX®2-73-RS-002) and the prior successful U.S. Phase 2 (ANAVEX®2-73-RS-001) study in adult patients with Rett syndrome, Anavex is planning to meet with the FDA to discuss the approval pathway.
Lead Product(s): Blarcamesine
Therapeutic Area: Genetic Disease Product Name: Anavex2-73
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 04, 2022
Details:
Primary and secondary efficacy safety endpoints for ANAVEX®2-73 (blarcamesine), activates the sigma-1 receptor met for the treatment of adult patients with Rett syndrome, with consistent improvements in RSBQ AUC, ADAMS, and CGI-I, response.
Lead Product(s): Blarcamesine
Therapeutic Area: Genetic Disease Product Name: Anavex2-73
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2022
Details:
ANAVEX®2-73 activates the sigma-1 receptor (SIGMAR1). Data suggests that activation of SIGMAR1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Anavex 2-73
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2021
Details:
Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine), successfully completed a Phase 2a clinical trial for Alzheimer’s disease and recently a Phase 2 proof-of-concept study in Parkinson’s disease dementia and a Phase 2 study in adult patients with Rett syndrome.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: ANAVEX 2-73
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 22, 2021
Details:
Studies with ANAVEX®2-73 show that SIGMAR1 activation is also involved in autophagy, an intricate phenomenon that clears damaged cellular organelles & misfolded proteins. SIGMAR1 agonists, ANAVEX®2-73 & ANAVEX®3-71 have been reported to block toxic Aβ, tau & neuroinflammation.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Anavex 2-73
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 14, 2021
Details:
The DSMB has recommended to continue the studies without modification, upon review of the interim safety data for the randomized, double-blind, placebo-controlled AVATAR (ANAVEX®2-73-RS-002) study in adult patients with Rett syndrome.
Lead Product(s): Blarcamesine
Therapeutic Area: Genetic Disease Product Name: ANAVEX2-73
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 12, 2021
Details:
As specified in the protocol, the DSMB reviewed the interim safety data for the ANAVEX®2-73 Phase 2b/3 Alzheimer’s disease clinical study ANAVEX®2-73-AD-004 and its Open Label Extension (OLE) ANAVEX®2-73-AD-EP-004 ATTENTION-AD study.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: ANAVEX2-73
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2021
Details:
ANAVEX®2-73 activates the sigma-1 receptor (SIGMAR1). Data suggests that activation of the sigma-1 receptor (SIGMAR1) is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Anavex 2-73
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: The Michael J. Fox Foundation for Parkinson’s Research
Deal Size: $1.0 million Upfront Cash: Undisclosed
Deal Type: Funding January 11, 2021
Details:
The study validated the precision medicine approach of targeting SIGMAR1 as a genetic biomarker of response to ANAVEX®2-73 (blarcamesine), confirming that ANAVEX®2-73 (blarcamesine) acts through SIGMAR1 activation.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Anavex 2-73
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 06, 2020
Details:
The study confirmed the precision medicine approach of targeting SIGMAR1 as a genetic biomarker of response to ANAVEX®2-73 (blarcamesine).
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Anavex 2-73
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 15, 2020
Details:
The multi-center, double-blind clinical study at 8 sites across U.S. measured safety, tolerability, and efficacy of daily oral ANAVEX®2-73 (blarcamesine) doses or placebo.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Anavex 2-73
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 10, 2020
Details:
The TGA approved the Special Access Scheme Category B applications based on the safety profile of ANAVEX®2-73 (blarcamesine), as well as clinical evidence that ANAVEX®2-73 (blarcamesine) may benefit patients.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Anavex 2-73
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2020
Details:
The Phase 2/3 study will use a convenient once-daily oral liquid ANAVEX®2-73 formulation to treat Rett syndrome. Safety and efficacy will be investigated in at least 69 patients over a 12-week treatment period including ANAVEX®2-73-specific precision medicine biomarkers.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Anavex 2-73
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2020
Details:
Anavex Life Sciences has surpassed by 50% the company’s original enrollment target for the ANAVEX®2-73 U.S. Phase 2 study in Rett syndrome. ANAVEX®2-73 (blarcamesine) is an orally available, small-molecule activator of the sigma-1 receptor.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Anavex 2-73
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 16, 2020
Details:
The 48-week Phase 2b/3 study ANAVEX®2-73-AD-004 of ANAVEX®2-73 (blarcamesine) using biomarker and precision medicine in 450 patients with early Alzheimer’s disease is ongoing and currently over 50% enrolled.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 04, 2020
Details:
Clinically meaningful biomarkers identified in ANAVEX®2-73 (Blarcamesine) studies demonstrate a significant impact on clinical outcomes at one year (57 weeks) and beyond three years (148 weeks)
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 23, 2020
Details:
Clinical sites continue to screen and recruit patients for the two Phase 2 Rett syndrome trials and the Phase 2b/3 Alzheimer's disease trial in ongoing trials.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2020
Details:
Published in Journal of Neuroimmunology, results highlight ANAVEX®2-73 (blarcamesine) shown to protect and repair myelin forming cells.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2020
Details:
Fast Track designation is backed by the Phase 2 Rett syndrome study demonstrating ANAVEX®2-73 significantly improves the two global efficacy endpoints.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 03, 2020
Details:
The ANAVEX®2-73 Phase 2 PDD study design incorporates genomic precision medicine biomarkers. Primary and secondary endpoints will assess cognition and Parkinsonian motor symptoms and sleep function.
Lead Product(s): Blarcamesine
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 27, 2020
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