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Galantamine

Generic Name
Galantamine
Brand Names
Razadyne
Drug Type
Small Molecule
Chemical Formula
C17H21NO3
CAS Number
357-70-0
Unique Ingredient Identifier
0D3Q044KCA

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

Published: Aug 2, 2025

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.

Continue reading the full research report

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

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.

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