Zunveyl (benzgalantamine) / Alpha Cognition - LARVOL DELTA

Comparison table: Drugs for Alzheimer's disease dementia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Drugs for dementia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Alzheimer's Disease • CNS Disorders • Dementia • Movement Disorders • Parkinson's Disease

Alpha Cognition to Present New Clinical on ZUNVEYL (Benzgalantamine) at Multiple Upcoming Alzheimer’s Association International Conferences (Businesswire)

Clinical data • Alzheimer's Disease

MIXED METHODS OF DATA CAPTURE ARE AN ADVANCEMENT IN DETERMINING REAL-WORLD DEMENTIA TREATMENT EFFECTIVENESS, RETROSPECTIVELY-THE BEACON STUDY (ISPOR 2026) - "OBJECTIVES: Real-world effectiveness data for Zunveyl®(Benzgalantamine) as treatment for dementia in the long-term care (LTC) setting are sparse... Real-world outcome data for patients with dementia in long-term care is not easily available, but this novel approach allows for valuable data to be compiled for large numbers of patients efficiently and provides opportunities for unique clinical insights into real-world drug effectiveness in the LTC setting."

Real-world • Real-world evidence • Retrospective data • Alzheimer's Disease • CNS Disorders • Dementia

Alpha Cognition…announced the enrollment of the first patient in BEACON, a Phase 4 real world effectiveness study, to assess the impact of ZUNVEYL in the Long-Term Care (LTC) setting (Businesswire) - "The BEACON study is designed to assess the real-world impact of ZUNVEYL on cognition, neuropsychiatric symptoms, safety, and tolerability in patients with Alzheimer’s disease residing in nursing homes....BEACON is a post-approval study expected to enroll approximately 200 patients across multiple clinical sites....Alpha Cognition expects to report topline results in the fourth quarter of 2026, following completion of enrollment and patient follow-up."

P4 data • Real-world • Trial status • Alzheimer's Disease

Alpha Cognition Inc...has been granted a new U.S. patent covering specific oral dosing methods for benzgalantamine in treating mild to moderate Alzheimer’s disease, the company announced Wednesday. (Investing.com) - "The United States Patent and Trademark Office issued Patent Application No. 12,551,491...which is expected to provide protection through July 2045...The patent includes method-of-use claims for orally administering the company’s FDA-approved Alzheimer’s therapy ZUNVEYL, adding to Alpha Cognition’s existing intellectual property portfolio."

Patent • Alzheimer's Disease

Drug Development. (PubMed, Alzheimers Dement) - "ZUNVEYL was well-tolerated with no serious adverse event noted. The steady state study established a scientific bridge to the LD, galantamine hydrobromide ER capsules. Although the extent of absorption measured by the AUC[0-24]ss was comparable between ZUNVEYL and the LD, the Cmaxss was slightly higher than the LD. The safety of the higher Cmax of galantamine derived from ZUNVEYL compared to galantamine hydrobromide ER capsules is supported by the lower Cmax of galantamine derived from ZUNVEYL compared to the galantamine hydrobromide immediate release tablets [see abstract # 107030]."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Dementia

Drug Development. (PubMed, Alzheimers Dement) - "ZUNVEYL was well-tolerated with no serious adverse events noted. Bioequivalence assessment demonstrated that ZUNVEYL was bioequivalent to galantamine hydrobromide IR for AUC0-t and AUC0-∞, under fed and fasting conditions, and for Cmax under fed conditions. These results combined with those of a steady state study [abstract # 107147], established a scientific bridge to the LDs and the approval of ZUNVEYL, relying on FDA's previous finding of safety and efficacy of the LDs."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Dementia

Drug Development. (PubMed, Alzheimers Dement) - "ZUNVEYL was well-tolerated, no serious adverse events were observed. Statistical analysis confirmed the dose proportionality for Cmax, AUC0-t, & AUC0-∞ over the entire 5 mg to 15 mg dose range for ZUNVEYL. The studies demonstrating bioequivalence, under fed and fasted (abstract #107030), and steady state (abstract #107147) conditions, and dose proportionality studies, lead to the conclusion that one ZUNVEYL 5 mg DR tablet is equivalent to one galantamine hydrobromide 4 mg immediate release tablet."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Dementia

Evaluation of the Benefits of Benzgalantamine (ZUNVEYL®) Therapy on Sleep Quality and Behavioral and Psychological Symptoms of Dementia in Alzheimer's Disease Patients, and on Reduction of Care-Partner Burden: A Proposed Study Design. (CTAD 2025) - No abstract available

Clinical • Alzheimer's Disease • CNS Disorders • Dementia

Benzgalantamine (Zunveyl) for the Treatment of Mild to Moderate Alzheimer Disease. (PubMed, Am Fam Physician) - No abstract available

Journal • Alzheimer's Disease • CNS Disorders

China Medical System (867.HK, 8A8.SG) NDA for the Improved New Drug ZUNVEYL for Alzheimer’s Disease Accepted in China (GlobeNewswire) - "China Medical System Holdings Limited...is pleased to announce that on 28 July 2025, the New Drug Application (NDA) for improved new drug ZUNVEYL (Benzgalantamine Gluconate Enteric-coated Tablets) ('ZUNVEYL' or the 'Product') has been accepted by the National Medical Products Administration of China (NMPA). The Product is indicated for the treatment of mild-to-moderate dementia of the Alzheimer’s type in adults."

China filing • Alzheimer's Disease

Alpha Cognition to Present ZUNVEYL (Benzgalantamine) Study Data at Alzheimer’s Association International Conference (Businesswire) - "Alpha Cognition...announced it will present new clinical data on ZUNVEYL at the Alzheimer’s Association International Conference (AAIC)....The Company will share the following poster presentations: (i) Bioequivalence of ZUNVEYL, a Galantamine Prodrug to Galantamine Hydrobromide Extended-Release Demonstrated Under Steady State Conditions (Poster #107147) - July 27; (ii) Bioequivalence of ZUNVEYL, a Galantamine Prodrug to Galantamine Hydrobromide Immediate-Release Demonstrated Under Fed and Fasting Conditions (Poster#107030) - July 28; (iii) Dose Proportionality of ZUNVEYL, a Galantamine Prodrug, Over a Dosage Range of Five to Fifteen Milligrams Demonstrated Under Fasting Conditions (Poster #107255) -July 30."

Clinical data • Alzheimer's Disease

Alpha Cognition to Present ZUNVEYL (Benzgalantamine) Clinical Data at 2025 Alzheimer’s Association International Conference (Businesswire) - "Alpha Cognition Inc...announced three upcoming presentations at the 2025 Alzheimer’s Association International Conference (the 'AAIC'), taking place July 27–31, 2025 in Toronto, Canada...The presentations will highlight clinical studies supporting ZUNVEYL (benzgalantamine), the Company’s lead product and a novel galantamine prodrug approved by the FDA in July 2024 and commercially launched in March 2025. The studies demonstrated bioequivalence to galantamine IR and ER and were integral to the NDA submission and approval."

Clinical data • Alzheimer's Disease

Benzgalantamine (Zunveyl) for Alzheimer's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Alzheimer's Disease • CNS Disorders

Alpha Cognition Announces the Commercial Launch of ZUNVEYL (Benzgalantamine) for the Treatment of Mild to Moderate Alzheimer’s Disease (Businesswire) - "Alpha Cognition Inc...announced the official commercial launch of ZUNVEYL, a new treatment for mild to moderate Alzheimer’s disease....ZUNVEYL is designed to provide a differentiated treatment option for patients with mild to moderate Alzheimer’s disease, offering an alternative for those who may have limited options. With the commercial launch now underway, Alpha Cognition is engaging with healthcare providers, payers, and caregivers to support patient access and education. Patients can now access ZUNVEYL in three doses (5 mg, 10 mg, and 15 mg) through a prescription that can be filled at pharmacies nationwide."

Launch US • Alzheimer's Disease

Alpha Cognition Secures Additional U.S. Patent for ZUNVEYL (benzgalantamine) in the Treatment of Mild to Moderate Alzheimer’s disease (Businesswire) - "Alpha Cognition Inc...today announced that the United States Patent and Trademark Office (USPTO) has granted a new patent titled 'Coated Tablets for pH-Dependent Release of Benzgalantamine.'....With this approval, ZUNVEYL has patent protection in the United States through 2044, supporting the Company’s long-term growth strategy as it prepares for commercialization....ZUNVEYL will be available by prescription in pharmacies nationwide in Q1 2025."

Launch US • Patent • Alzheimer's Disease

Alpha Cognition Announces a $44 Million Exclusive Licensing Agreement for the Development and Commercialization of ZUNVEYL (benzgalantamine), an FDA-Approved Treatment for Mild-to-Moderate Alzheimer’s Disease, in China (Businesswire) - "Alpha Cognition, Inc...and China Medical System Holdings Limited...today announced an exclusive licensing agreement for the development, manufacturing and commercialization of ZUNVEYL (benzgalantamine) in Asia (excluding Japan), Australia and New Zealand. ZUNVEYL is a next generation acetylcholinesterase inhibitor approved in the US for the treatment of mild-to-moderate Alzheimer’s disease. Terms of the agreement total $44 million, which includes $6 million in total upfront payments split into tranches and development and commercial milestone payments. Additionally, ACI is eligible to receive royalties on net sales of ZUNVEYL in Asia (excluding Japan), Australia and New Zealand."

Commercial • Alzheimer's Disease • CNS Disorders

Alpha Cognition to Present Q1 2025 ZUNVEYL (benzgalantamine) Launch Strategy Targeting the $2 Billion U.S. Alzheimer’s Long-Term Care Market During Investor Update Call (Businesswire) - "Alpha Cognition Inc...today announced it will host an investor update call on Tuesday, January 28th, 2025 at 4pm EST to present its commercial launch strategy for ZUNVEYL (benzgalantamine), an FDA-approved treatment for mild-to-moderate Alzheimer’s disease (AD). The call will focus on the company’s plans to address the needs of a growing patient population within the $2 billion long-term care market in the U.S...Alpha Cognition’s leadership team will provide key updates on the Q1 2025 commercial launch strategy, including market positioning, launch strategy, and long-term growth objectives."

Commercial • Launch US • Alzheimer's Disease • CNS Disorders

Alpha Cognition Announces Partial Exercise of Over-allotment Option (Businesswire) - "Alpha Cognition Inc...today announced that the underwriters of its underwritten U.S. public offering (the 'Offering') have partially exercised their over-allotment option to purchase an additional 488,506 common shares at the public offering price of US$5.75 per share for an additional US$2.8 million in gross proceeds....The Company intends to use the proceeds towards the commercialization and launch of ZUNVEYL in Alzheimer’s Disease, further research and development of its pipeline product candidates, continued commercial CMC activities (chemistry, manufacturing, and controls), and for working capital and general corporate purposes."

Financing • Alzheimer's Disease • CNS Disorders

Alpha Cognition Receives Notice of Allowance for Composition-of-Matter Patent for ZUNVEYL for Mild to Moderate Alzheimer’s Disease (Businesswire) - "Alpha Cognition Inc...is pleased to announce that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for patent application No. 18/434,155, entitled 'Coated Tablets for pH-Dependent Release of benzgalantamine,' which includes claims covering tablet forms of benzgalantamine (ZUNVEYL). This composition of matter patent, once issued, provides protection for the current formulation of ZUNVEYL and complements other patents that the company holds for benzgalantamine and provides protection in the United States through 2044."

Patent • Alzheimer's Disease • CNS Disorders

Alpha Cognition Receives Notice of Allowance for Composition-of-Matter Patent for ZUNVEYL for Mild to Moderate Alzheimer’s Disease (Businesswire) - "Alpha Cognition Inc...is pleased to announced the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for patent application No. 18/463,157, entitled 'Solid Forms of ALPHA-1062 Gluconate,' which includes claims covering an additional novel crystalline solid form of ZUNVEYL and complements existing patents that the Company holds for ZUNVEYL. The patent provides protection for a second commercially viable form of the drug. A Notice of Allowance is issued after the USPTO makes the determination that the claimed invention is patentable, and a patent should be granted from an application."

Patent • Alzheimer's Disease • CNS Disorders • Tauopathies And Synucleinopathies

Alpha Cognition Announces Financial Results for the Second Quarter and Six Months Ended June 2024 and Provides Corporate Update (Businesswire) - "Research and development (R&D) expenses were $0.9 million for the three months ended June 30, 2024, and $1.9 million for the six months ended June 30, 2024, compared to $1.3 million and $2.4 million in the same periods in 2023, respectively. R&D expenses decreased from the prior year primarily due to the completion of the main clinical trails for ZUNVEYL in AD and the majority of the NDA filing expenditures having been incurred during 2023."

Commercial • Alzheimer's Disease • CNS Disorders

Alpha Cognition’s Oral Therapy ZUNVEYL Receives FDA Approval to Treat Alzheimer's Disease (Businesswire) - "Alpha Cognition...announces that the U.S. Food and Drug Administration (FDA) has granted approval for ZUNVEYL (benzgalantamine) previously known as ALPHA-1062, for the treatment of mild-to-moderate Alzheimer's disease. Alzheimer’s disease (AD) is a progressive brain disorder that slowly destroys memory, thinking skills, and eventually the ability to do simple tasks, like carry on a conversation. AD is the most common form of dementia affecting nearly 7 million people, and is the leading cause of nursing home admissions and deaths, with 70% of all nursing home residents suffering with AD."

FDA approval • Alzheimer's Disease • CNS Disorders

Alpha Cognition Files U.S. Patent Application Covering an ALPHA-1062 Oral Formulation to Treat Mild to Moderate Alzheimer’s Disease (Businesswire) - "Alpha Cognition...is pleased to announce that it has filed a new composition-of-matter patent that secures broad protection for its lead asset, ALPHA-1062, currently under review by the FDA for mild-to-moderate Alzheimer’s Disease. The present composition-of-matter patent application is filed for approval with the USPTO and may be extended to pursue protection throughout the world and, if approved, will secure composition-of-matter protection for an oral formulation of ALPHA-1062....If approved, the patent will provide protection for ALPHA-1062 into 2044, adding to other patent protection that currently protect ALPHA-1062 through 2042."

Patent • Alzheimer's Disease