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Extended-release galantamine hydrobromide
Extended-release galantamine hydrobromide is a Cholinesterase inhibitor Small molecule drug developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. It is currently in Phase 3 development for Mild to moderate Alzheimer's disease.
Galantamine is a cholinesterase inhibitor that increases acetylcholine levels in the brain by blocking its breakdown, and also acts as an allosteric modulator of nicotinic receptors.
Galantamine is a cholinesterase inhibitor that increases acetylcholine levels in the brain by blocking its breakdown, and also acts as an allosteric modulator of nicotinic receptors. Used for Mild to moderate Alzheimer's disease.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression). -
Big-pharma sponsor
+3.0pp
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Extended-release galantamine hydrobromide |
|---|---|
| Sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| Drug class | Cholinesterase inhibitor |
| Target | Acetylcholinesterase; nicotinic acetylcholine receptors |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting acetylcholinesterase, galantamine increases the concentration of acetylcholine at synapses, enhancing cholinergic neurotransmission. Additionally, galantamine allosterically modulates nicotinic acetylcholine receptors, potentiating their response to acetylcholine. This dual mechanism is intended to improve cognitive function and slow cognitive decline in neurodegenerative conditions.
Approved indications
- Mild to moderate Alzheimer's disease
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Headache
- Syncope
- Bradycardia
Key clinical trials
- Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia (PHASE4)
- Effect of Galantamine on Inflammation and Cognition (PHASE2)
- A Study to Help People Quit Smoking. (NA)
- Effect of Galantamine on Short-term Abstinence (PHASE2)
- Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse (PHASE2)
- Effect of Galantamine on Smoking Abstinence (PHASE2)
- Efficacy and Safety of Galantamine for Improving Dysfunction in People With Bipolar Disorder (PHASE4)
- A Study of the Effectiveness and Safety of Galantamine Hydrobromide on Cognitive Impairment in Patients With Schizophrenia. (PHASE3)
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 |
|---|---|
| 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:
- Extended-release galantamine hydrobromide CI brief — competitive landscape report
- Extended-release galantamine hydrobromide updates RSS · CI watch RSS
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. portfolio CI
Frequently asked questions about Extended-release galantamine hydrobromide
What is Extended-release galantamine hydrobromide?
How does Extended-release galantamine hydrobromide work?
What is Extended-release galantamine hydrobromide used for?
Who makes Extended-release galantamine hydrobromide?
What drug class is Extended-release galantamine hydrobromide in?
What development phase is Extended-release galantamine hydrobromide in?
What are the side effects of Extended-release galantamine hydrobromide?
What does Extended-release galantamine hydrobromide target?
Related
- Drug class: All Cholinesterase inhibitor drugs
- Target: All drugs targeting Acetylcholinesterase; nicotinic acetylcholine receptors
- Manufacturer: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Mild to moderate Alzheimer's disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing