Galantamine
Galantamine (galantamine) is a small molecule pharmaceutical. Galantamine was first approved as Razadyne on 2001-02-28. It is used to treat alzheimer disease in the USA. It is known to target acetylcholinesterase.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
Galantamine (discontinued: Galantamine, Razadyne)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Galantamine hydrobromide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| RAZADYNE | Johnson & Johnson | N-021169 DISCN | 2001-02-28 | 3 products, RLD |
| RAZADYNE | Johnson & Johnson | N-021224 DISCN | 2001-06-22 | 1 products |
| RAZADYNE ER | Johnson & Johnson | N-021615 DISCN | 2005-04-01 | 3 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| galantamine | ANDA | 2026-01-19 |
| galantamine galantamine hydrobromide | ANDA | 2018-03-15 |
| galantamine hydrobromide | ANDA | 2025-09-12 |
| galantamine hydrobromide oral solution | ANDA | 2009-08-19 |
| razadyne | New Drug Application | 2010-11-11 |
| zunveyl | New Drug Application | 2026-03-17 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| alzheimer disease | EFO_0000249 | D000544 | F03 |
Agency Specific
FDA
EMA
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Patent Expiration
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Clinical
Clinical Trials
116 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | — | 13 | 3 | 2 | 18 |
| Dementia | D003704 | EFO_0003862 | F03 | — | 1 | 11 | 1 | 2 | 15 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | — | 3 | 1 | 1 | 5 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | 1 | 1 | — | 2 |
| Psychotic disorders | D011618 | — | F20.81 | — | — | 1 | 1 | — | 2 |
| Tic disorders | D013981 | — | F95 | — | — | — | 1 | — | 1 |
| Tourette syndrome | D005879 | EFO_0004895 | F95.2 | — | — | — | 1 | — | 1 |
| Tics | D020323 | — | — | — | — | — | 1 | — | 1 |
| Craniocerebral trauma | D006259 | — | S00 | — | — | — | 1 | — | 1 |
| Headache | D006261 | — | R51 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain diseases | D001927 | — | G93.40 | — | — | 1 | — | 1 | 2 |
| Nervous system diseases | D009422 | — | G00-G99 | — | — | 1 | — | 1 | 2 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | — | 1 | — | 1 | 2 |
| Vascular dementia | D015140 | — | F01 | — | — | 2 | — | — | 2 |
| Depression | D003863 | — | F33.9 | — | — | 1 | — | — | 1 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | 1 | — | — | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | 1 | — | — | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | 1 | — | — | 1 |
| Mixed dementias | D000093902 | — | — | — | — | 1 | — | — | 1 |
| Cognition disorders | D003072 | — | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Frontotemporal dementia | D057180 | — | G31.0 | — | 1 | — | — | — | 1 |
| Frontotemporal lobar degeneration | D057174 | — | — | — | 1 | — | — | — | 1 |
| Primary progressive aphasia | D018888 | EFO_0009053 | G31.01 | — | 1 | — | — | — | 1 |
| Pick disease of the brain | D020774 | EFO_0003096 | G31.01 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 1 | 1 |
| Aphasia | D001037 | — | R47.01 | — | — | — | — | 1 | 1 |
| Broca aphasia | D001039 | — | — | — | — | — | — | 1 | 1 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Galantamine |
| INN | galantamine |
| Description | Galanthamine is a benzazepine alkaloid isolated from certain species of daffodils. It has a role as an antidote to curare poisoning, an EC 3.1.1.7 (acetylcholinesterase) inhibitor, a cholinergic drug, an EC 3.1.1.8 (cholinesterase) inhibitor and a plant metabolite. It is an organic heterotetracyclic compound, a tertiary amino compound, a benzazepine alkaloid and a benzazepine alkaloid fundamental parent. It is a conjugate base of a galanthamine(1+). |
| Classification | Small molecule |
| Drug class | Acetylcholinesterase inhibitor |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1ccc2c3c1O[C@H]1C[C@@H](O)C=C[C@@]31CCN(C)C2 |
Identifiers
| PDB | — |
| CAS-ID | 357-70-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL659 |
| ChEBI ID | 42944 |
| PubChem CID | 9651 |
| DrugBank | DB00674 |
| UNII ID | 0D3Q044KCA (ChemIDplus, GSRS) |
Target
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Estimated US medical usage
Galantamine
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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5,487 adverse events reported
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