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Razadyne (GALANTAMINE)
Razadyne works by blocking the enzyme that breaks down acetylcholine, allowing more of this neurotransmitter to be available in the brain.
Razadyne (GALANTAMINE) is a small molecule cholinesterase inhibitor developed by Janssen Pharmaceutica, targeting acetylcholinesterase to treat Alzheimer's disease. It was FDA-approved in 2001 and is now off-patent with 16 generic manufacturers. Razadyne works by inhibiting the breakdown of acetylcholine, a neurotransmitter involved in memory and learning, thereby improving cognitive function in patients with Alzheimer's disease. The drug has a bioavailability of 99% and a half-life of 5.3 hours. As an off-patent medication, it is widely available in the market.
At a glance
| Generic name | GALANTAMINE |
|---|---|
| Sponsor | Johnson & Johnson |
| Drug class | Cholinesterase Inhibitor |
| Target | Acetylcholinesterase |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2001 |
Mechanism of action
Mechanism of Action. Although the etiology of cognitive impairment in Alzheimers disease (AD) is not fully understood, it has been reported that acetylcholine-producing neurons degenerate in the brains of patients with Alzheimers disease. The degree of this cholinergic loss has been correlated with degree of cognitive impairment and density of amyloid plaques (a neuropathological hallmark of Alzheimers disease).Galantamine, tertiary alkaloid, is competitive and reversible inhibitor of acetylcholinesterase. While the precise mechanism of galantamines action is unknown, it is postulated to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by cholinesterase. If this mechanism is correct, galantamines effect may lessen as the disease process advances and fewer cholinergic neurons remain functionally intact. There is no evidence that galantamine alters the cour
Approved indications
- Mild to moderate dementia of the Alzheimer's type
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Anorexia
- Weight decrease
- Fatigue
- Dizziness
- Syncope
- Bradycardia
- Anemia
- Hematuria
- Rhinitis
Drug interactions
- anticholinergic medications
- succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents, or cholinergic agonists
Key clinical trials
- Cognitive Rehabilitation and Galantamine for Post Stroke Cognitive Impairment (PHASE2)
- Enhancing Parasympathetic Activity to Improve Endothelial Dysfunction, Vascular Oxidative Stress in African Americans (PHASE1,PHASE2)
- Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia (PHASE4)
- Intravenous Infusion of Umbilical Cord Blood as an Adjunctive Treatment for Alzheimer's Disease (EARLY_PHASE1)
- Masitinib in Patients With Mild Alzheimer's Disease (PHASE3)
- Exploration of the Efficacy and Mechanism of Galantamine (an Extract From Lycoris Aurea) in Treating Ischemic Stroke (PHASE2,PHASE3)
- Vagal Stimulation in POTS (PHASE1)
- Effect of Galantamine on Inflammation and Cognition (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Razadyne CI brief — competitive landscape report
- Razadyne updates RSS · CI watch RSS
- Johnson & Johnson portfolio CI