galantamine extended release / Generic mfg. - LARVOL DELTA

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

Effect of Galantamine on Inflammation and Cognition (clinicaltrials.gov) - P2 | N=63 | Completed | Sponsor: University of Pennsylvania | N=114 ➔ 63

Enrollment change • Cognitive Disorders • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CD14 • CD163 • CD4 • NDUFA2

Effect of Galantamine on Inflammation and Cognition (clinicaltrials.gov) - P2 | N=114 | Completed | Sponsor: University of Pennsylvania | Active, not recruiting ➔ Completed

Trial completion • Cognitive Disorders • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • CD4

Effect of Galantamine on Inflammation and Cognition (clinicaltrials.gov) - P2; N=114; Active, not recruiting; Sponsor: University of Pennsylvania; Recruiting ➔ Active, not recruiting; Trial primary completion date: Jan 2022 ➔ May 2022

Enrollment closed • Trial primary completion date • Cognitive Disorders • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • CD4

Quintuple Hypotheses Targeted in Schizophrenia: Fight Fire With Fire (SIRS 2019) - "The galantamine-memantine combination was significantly better for cognition than the 1 donepezil-memantine combination in patients with Alzheimer’s disease...Participants received galantamine ER 24 mg and memantine XR 21 mg for four weeks...This combination targets the quintuple hypotheses (dopamine, nicotinic-cholinergic, glutamatergic/NMDA, GABA, and KYNA) concurrently and has the potential to treat positive, cognitive, and primary negative symptoms. The galantamine-memantine combination has the potential to become the first antischizophrenia treatment."

CNS Disorders • Schizophrenia

Effect of Galantamine on Inflammation and Cognition (clinicaltrials.gov) - P2; N=150; Recruiting; Sponsor: University of Pennsylvania; Active, not recruiting ➔ Recruiting; N=85 ➔ 150

Enrollment change • Enrollment open • Gene Therapies • Human Immunodeficiency Virus • Immunology • Infectious Disease

Drug approval reports (FDA) - Razadyne ER label revised on 09th Feb, 2015.

FDA event • Alzheimer's Disease

Drug approval reports (FDA) - Razadyne and Razadyne ER label revised on 15th Dec, 2015.

FDA event • Alzheimer's Disease

Galantamine Effects in Patients With Metabolic Syndrome (clinicaltrials.gov) - P4; N=60; Active, not recruiting; Sponsor: University of Sao Paulo; Recruiting -> Active, not recruiting

Enrollment closed • Biosimilar • Diabetes • Immunology • Inflammation • Obesity

Effect of Galantamine on Inflammation and Cognition (clinicaltrials.gov) - P2; N=85; Active, not recruiting; Sponsor: University of Pennsylvania; Recruiting ➔ Active, not recruiting; N=150 ➔ 85

Enrollment change • Enrollment closed

France removes state funding for dementia drugs (BMJ Open) - "The first country in Europe to act on concerns over limited effectiveness...drugs for dementia would no longer be supported in France but would be further promoted in England and Wales. France is the only European country to take this …"

Financing