Zunveyl (benzgalantamine) / Alpha Cognition - LARVOL DELTA

The Effects of Benzgalantamine (ZUNVEYL ®) on Safety, Tolerability, Neuropsychiatric Symptoms, and Caregiver Distress in the Treatment of Mild to Moderate Alzheimer's Dementia. RESOLVE: a Phase IV Open-label Study (CTAD 2026) - No abstract available

Clinical • P4 data • Alzheimer's Disease • CNS Disorders • Dementia • Psychiatry

Alpha Cognition…announced that the European Patent Office (EPO) has granted a patent covering a crystalline solid form of benzgalantamine, the active ingredient in ZUNVEYL, for use in the treatment of mild-to-moderate Alzheimer’s disease (Businesswire) - "The patent includes claims directed to the specific crystalline solid form, related pharmaceutical compositions, preparations, methods of manufacture and medical-use claims. The grant further strengthens Alpha Cognition’s global intellectual property portfolio and may provide additional patent protection for benzgalantamine’s pharmaceutical development and potential commercialization into 2042, subject to applicable patent requirements."

Patent • Alzheimer's Disease

Alpha Cognition Announces First Patient Enrolled in RESOLVE Phase 4 Study Evaluating ZUNVEYL in Patients with Mild to Moderate Alzheimer’s Disease (Businesswire) - "RESOLVE is a multicenter, post-approval Phase 4 study designed to further evaluate the tolerability profile of ZUNVEYL in clinical practice, in patients with Alzheimer's disease....The RESOLVE study is expected to enroll approximately 150 patients across multiple clinical sites and will monitor adverse events, treatment persistence, and discontinuation rates throughout the study....Alpha Cognition expects patient enrollment to continue through the second quarter of 2027, with topline results anticipated following completion of enrollment and study follow-up."

P4 data • Trial status • Alzheimer's Disease

Alpha Cognition Reports Positive Top-Line Results from BEACON Real-World Study of ZUNVEYL in Alzheimer’s Disease (Businesswire) - "98% of providers reported a favorable overall treatment experience among patients receiving ZUNVEYL....Providers reported cognitive improvement in 92% of patients following ZUNVEYL treatment. Providers reported improvement in activities of daily living (ADLs) in 71% of patients following treatment with ZUNVEYL....Providers reported improvement in neuropsychiatric symptoms in 93% of patients following ZUNVEYL administration."

P4 data • Retrospective data • Alzheimer's Disease

A Study of Zunveyl on Safety, Tolerability, Neuropsychiatric Symptoms, and Caregiver Distress in Alzheimer's Disease (RESOLVE) (clinicaltrials.gov) - P4 | N=150 | Recruiting | Sponsor: Alpha Cognition, Inc

New P4 trial • Alzheimer's Disease • CNS Disorders • Psychiatry • Aβ42

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

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

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