Overview
Galantamine is a tertiary alkaloid and reversible, competitive inhibitor of the acetylcholinesterase (AChE) enzyme, which is a widely studied therapeutic target used in the treatment of Alzheimer's disease. First characterized in the early 1950s, galantamine is a tertiary alkaloid that was extracted from botanical sources, such as Galanthus nivalis. Galantamine was first studied in paralytic and neuropathic conditions, such as myopathies and postpolio paralytic conditions, and for reversal of neuromuscular blockade. Following the discovery of its AChE-inhibiting properties, the cognitive effects of galantamine were studied in a wide variety of psychiatric disorders such as mild cognitive impairment, cognitive impairment in schizophrenia and bipolar disorder, and autism; however, re-development of the drug for Alzheimer’s disease did not commence until the early 1990s due to difficulties in extraction and synthesis. Galantamine blocks the breakdown of acetylcholine in the synaptic cleft, thereby increasing acetylcholine neurotransmission. It also acts as an allosteric modulator of the nicotinic receptor, giving its dual mechanism of action clinical significance. The drug was approved by the FDA in 2001 for the treatment of mild to moderate dementia of the Alzheimer's type. As Alzheimer's disease is a progressive neurodegenerative disorder, galantamine is not known to alter the course of the underlying dementing process. Galantamine works to block the enzyme responsible for the breakdown of acetylcholine in the synaptic cleft, thereby enhancing cholinergic neuron function and signalling. Under this hypothesized mechanism of action, the therapeutic effects of galantamine may decrease as the disease progression advances and fewer cholinergic neurons remain functionally intact. It is therefore not considered to be a disease-modifying drug. Galantamine is marketed under the brand name Razadyne, and is available as oral immediate- and extended-release tablets and solution.
Background
Galantamine is a tertiary alkaloid and reversible, competitive inhibitor of the acetylcholinesterase (AChE) enzyme, which is a widely studied therapeutic target used in the treatment of Alzheimer's disease. First characterized in the early 1950s, galantamine is a tertiary alkaloid that was extracted from botanical sources, such as Galanthus nivalis. Galantamine was first studied in paralytic and neuropathic conditions, such as myopathies and postpolio paralytic conditions, and for reversal of neuromuscular blockade. Following the discovery of its AChE-inhibiting properties, the cognitive effects of galantamine were studied in a wide variety of psychiatric disorders such as mild cognitive impairment, cognitive impairment in schizophrenia and bipolar disorder, and autism; however, re-development of the drug for Alzheimer’s disease did not commence until the early 1990s due to difficulties in extraction and synthesis. Galantamine blocks the breakdown of acetylcholine in the synaptic cleft, thereby increasing acetylcholine neurotransmission. It also acts as an allosteric modulator of the nicotinic receptor, giving its dual mechanism of action clinical significance. The drug was approved by the FDA in 2001 for the treatment of mild to moderate dementia of the Alzheimer's type. As Alzheimer's disease is a progressive neurodegenerative disorder, galantamine is not known to alter the course of the underlying dementing process. Galantamine works to block the enzyme responsible for the breakdown of acetylcholine in the synaptic cleft, thereby enhancing cholinergic neuron function and signalling. Under this hypothesized mechanism of action, the therapeutic effects of galantamine may decrease as the disease progression advances and fewer cholinergic neurons remain functionally intact. It is therefore not considered to be a disease-modifying drug. Galantamine is marketed under the brand name Razadyne, and is available as oral immediate- and extended-release tablets and solution.
Indication
Galantamine is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.
Associated Conditions
- Mild to Moderate Dementia Due to Alzheimer's Disease
- Mild Dementia of the Alzheimer's Type
- Moderate Alzheimer's Type Dementia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/04 | Phase 2 | Not yet recruiting | Shanghai Yueyang Integrated Medicine Hospital | ||
2021/02/24 | Phase 1 | Recruiting | |||
2017/12/27 | Phase 2 | Completed | |||
2017/04/21 | Phase 1 | Active, not recruiting | |||
2017/01/09 | Phase 1 | Withdrawn | |||
2015/03/02 | Phase 3 | Terminated | |||
2015/02/18 | Phase 1 | Completed | |||
2014/11/05 | Phase 4 | Completed | |||
2014/09/09 | Phase 2 | Terminated | Sheppard Pratt Health System | ||
2014/03/28 | Phase 2 | UNKNOWN | Amsterdam UMC, location VUmc |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sun Pharmaceutical Industries, Inc. | 47335-835 | ORAL | 8 mg in 1 1 | 10/26/2023 | |
| Rising Pharma Holdings, Inc. | 57237-051 | ORAL | 12 mg in 1 1 | 2/8/2024 | |
| Yabao Pharmaceutical Co., Ltd. Beijing | 51990-111 | ORAL | 4 mg in 1 1 | 5/28/2015 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-984 | ORAL | 16 mg in 1 1 | 11/15/2014 | |
| TWi Pharmaceuticals USA, Inc. | 24979-724 | ORAL | 12 mg in 1 1 | 2/21/2024 | |
| American Health Packaging | 68084-729 | ORAL | 4 mg in 1 1 | 5/13/2022 | |
| Aurobindo Pharma Limited | 65862-460 | ORAL | 12 mg in 1 1 | 2/8/2024 | |
| Zydus Pharmaceuticals USA Inc. | 68382-177 | ORAL | 4 mg in 1 1 | 11/9/2022 | |
| Yabao Pharmaceutical Co., Ltd. Beijing | 51990-113 | ORAL | 12 mg in 1 1 | 5/28/2015 | |
| Sun Pharmaceutical Industries, Inc. | 47335-836 | ORAL | 16 mg in 1 1 | 10/26/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| REMINYL PROLONGED RELEASE CAPSULE 8 MG | SIN13019P | CAPSULE, COATED, EXTENDED RELEASE | 8 MG | 8/10/2004 | |
| REMINYL PROLONGED RELEASE CAPSULE 16 MG | SIN13020P | CAPSULE, COATED, EXTENDED RELEASE | 16 MG | 8/10/2004 | |
| REMINYL PROLONGED RELEASE CAPSULE 24 MG | SIN13021P | CAPSULE, COATED, EXTENDED RELEASE | 24 MG | 8/10/2004 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Galanthamine Hydrobromide Capsules | 国药准字H20053126 | 化学药品 | 胶囊剂 | 9/2/2020 | |
| Galantamine Hydrobromide Dispersible Tablets | 国药准字H20051958 | 化学药品 | 片剂 | 11/16/2020 | |
| Galantamine Hydrobromide Dispersible Tablets | 国药准字H20051349 | 化学药品 | 片剂 | 6/15/2020 | |
| Galantamine Hydrobromide Dispersible Tablets | 国药准字H20070266 | 化学药品 | 片剂 | 7/12/2022 | |
| Galantamine Hydrobromide Sustained-release Tablets | 国药准字H20110108 | 化学药品 | 片剂 | 8/26/2021 | |
| Galanthamine Hydrobromide Tablets | 国药准字H20030957 | 化学药品 | 片剂 | 7/3/2020 | |
| Galanthamine Hydrobromide Tablets | 国药准字H20040590 | 化学药品 | 片剂 | 5/26/2020 | |
| Galanthamine Hydrobromide Orally Disintegrating Tablets | 国药准字H20244022 | 化学药品 | 片剂 | 6/18/2024 | |
| Galanthamine Hydrobromide Orally Disintegrating Tablets | 国药准字H20244021 | 化学药品 | 片剂 | 6/18/2024 | |
| Galanthamine Hydrobromide Orally Disintegrating Tablets | 国药准字H20140015 | 化学药品 | 片剂 | 5/9/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||