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GALANTAMINE HYDROBROMIDE
Galantamine Hydrobromide is a marketed drug primarily indicated for the treatment of mild to moderate dementia of the Alzheimer's type. Its key strength lies in its established market presence, supported by a key composition patent that remains in effect until 2028. The primary risk is the eventual patent expiry in 2028, which could lead to increased competition from generic versions.
At a glance
| Generic name | GALANTAMINE HYDROBROMIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2001 |
Approved indications
- Mild to moderate dementia of the Alzheimer's type
Common side effects
- nausea
- vomiting
- diarrhea
- decreased appetite
- headache
- dizziness
- depression
- fatigue
- fall
- abdominal pain
- asthenia
- tremor
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:
- GALANTAMINE HYDROBROMIDE CI brief — competitive landscape report
- GALANTAMINE HYDROBROMIDE updates RSS · CI watch RSS