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.
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
Research Report
Galantamine (DB00674): A Comprehensive Pharmacological and Clinical Monograph
Executive Summary & Introduction
Galantamine is a tertiary alkaloid originally isolated from botanical sources, most notably the bulbs and flowers of the common snowdrop, Galanthus nivalis, and other plants belonging to the Amaryllidaceae family.[1] As a parasympathomimetic agent, it is classified pharmacologically as a cholinesterase inhibitor. First characterized in the 1950s by the Bulgarian chemist Dimitar Paskov, galantamine was initially investigated for its effects in paralytic and neuropathic conditions before its therapeutic potential in neurodegenerative disease was fully realized.[1]
The United States Food and Drug Administration (FDA) approved galantamine in 2001, and it is currently indicated for the symptomatic treatment of mild to moderate dementia of the Alzheimer's type.[1] It is available globally as a prescription-only (℞-only) medication under brand names such as Razadyne and Reminyl.[1]
Galantamine is distinguished from other agents in its class by a unique dual mechanism of action. It functions as a reversible, competitive inhibitor of the acetylcholinesterase (AChE) enzyme and, concurrently, as a positive allosteric modulator (PAM) of nicotinic acetylcholine receptors (nAChRs).[1] This dual activity is hypothesized to provide a more robust enhancement of cholinergic neurotransmission, which is known to be deficient in the brains of patients with Alzheimer's disease.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/04 | Phase 2 | 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 |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
REMINYL PROLONGED RELEASE CAP 8MG | N/A | N/A | N/A | 3/5/2007 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
Help Us Improve
Your feedback helps us provide better drug information and insights.