Amantadine

Overview

An antiviral that is used in the prophylactic or symptomatic treatment of influenza A. It is also used as an antiparkinsonian agent, to treat extrapyramidal reactions, and for postherpetic neuralgia. The mechanisms of its effects in movement disorders are not well understood but probably reflect an increase in synthesis and release of dopamine, with perhaps some inhibition of dopamine uptake.

Background

Indication

For the chemoprophylaxis, prophylaxis, and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Also for the treatment of parkinsonism and drug-induced extrapyramidal reactions.

Associated Conditions

Dyskinesia
Extrapyramidal disorder caused by neuroleptic drugs without Tardive dyskinesia
Influenza A Virus Infection
Parkinson's Disease (PD)
Parkinson's Disease With Wearing-off Motor Fluctuations
Parkinsonism

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The Effect of Amantadine As Add-on Therapy for Motor Fluctuations in Advanced Parkinson's Disease: a Randomized Double-blinded Placebo-controlled Trial	2025/02/10	NCT06817200	Phase 2	Not yet recruiting	University Hospital, Toulouse
Effect of Intravenous Amantadine Sulphate on Disorders of Consciousness	2024/06/05	NCT06443827	Phase 2	Active, not recruiting	Azienda Sanitaria dell'Alto Adige
Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301) in Patients With Severe Traumatic Brain Injury (TBI).	2024/02/12	NCT06253923	Phase 2	Recruiting	SHINKEI Therapeutics, Inc
A Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid	2024/01/31	NCT06234462	Phase 2	Recruiting	University of Texas Southwestern Medical Center
Amantadine Therapy for Cognitive Impairment in Long COVID	2023/09/26	NCT06055244	Phase 2	Recruiting	Ohio State University
Combined Cerebrolysin and Amantadine Sulfate Administration for Patients With Traumatic Brain Injury in the ICU	2023/09/25	NCT06052787	Phase 3	Recruiting	Ain Shams University
Amantadine and Transcranial Magnetic Stimulation for Treating Fatigue in Multiple Sclerosis	2023/04/12	NCT05809414	Phase 3	Recruiting	Hospital San Carlos, Madrid
The Effect of Amantadine on Post-COVD-19 Fatigue	2022/12/28	NCT05667077	Phase 2	Not yet recruiting	Shahid Beheshti University of Medical Sciences
Antihistamines, Amantadine and Evolution of the SARS-CoV-2 Infection	2022/08/17	NCT05504057	N/A	Recruiting	Consorci Sanitari de Terrassa
Amantadine for Neuroenhancement in Acute Patients Study	2022/07/28	NCT05479032	Phase 2	Recruiting	University Hospital Tuebingen

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
OSMOLEX ER	Adamas Pharma, LLC	70482-075	ORAL	129 mg in 1 1	2/8/2024
AMANTADINE HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	17856-0646	ORAL	50 mg in 5 mL	3/1/2022
Amantadine Hydrochloride	A-S Medication Solutions	50090-0020	ORAL	100 mg in 1 1	12/15/2016
Amantadine Hydrochloride	Bryant Ranch Prepack	71335-9618	ORAL	100 mg in 1 1	11/19/2019
Amantadine HCl	Rebel Distributors Corp.	21695-564	ORAL	100 mg in 1 1	1/6/2010
Amantadine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	0615-8263	ORAL	100 mg in 1 1	10/8/2020
Amantadine Hydrochloride	REMEDYREPACK INC.	70518-3381	ORAL	100 mg in 1 1	1/9/2024
Amantadine Hydrochloride	Chartwell RX, LLC	62135-609	ORAL	100 mg in 1 1	6/26/2023
Amantadine	Alembic Pharmaceuticals Inc.	62332-586	ORAL	100 mg in 1 1	4/24/2023
amantadine hydrochloride	Graviti Pharmaceuticals Private Limited	69844-027	ORAL	100 mg in 1 1	1/11/2019

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
SYMMETREL 100 CAPSULE 100 mg	Catalent Germany Eberbach GmbH, Lek Pharmaceuticals d.d (Pri & sec packaging)	SIN01481P	CAPSULE	100 mg	5/23/1988

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Amantadine Hydrochloride Syrup	甘肃成纪生物药业有限公司	国药准字H62020965	化学药品	糖浆剂	9/11/2020
Amantadine Hydrochloride Syrup	福州海王金象中药制药有限公司	国药准字H35021227	化学药品	糖浆剂	8/21/2020
Amantadine Hydrochloride Syrup	河南同源制药有限公司	国药准字H41024775	化学药品	糖浆剂	8/29/2023
Amantadine Hydrochloride Syrup	石药集团江西金芙蓉药业有限公司	国药准字H36022364	化学药品	糖浆剂	7/24/2020
Amantadine Hydrochloride Syrup	沈阳康芝制药有限公司	国药准字H21024465	化学药品	糖浆剂	5/29/2020
Amantadine Hydrochloride Syrup	成都迪康药业股份有限公司	国药准字H50021648	化学药品	糖浆剂	11/18/2020
Amantadine Hydrochloride Syrup	江苏亚邦生缘药业有限公司	国药准字H32026150	化学药品	糖浆剂	6/23/2020
Amantadine Hydrochloride Syrup	四川省通园制药集团有限公司	国药准字H20057281	化学药品	糖浆剂	8/12/2020
Amantadine Hydrochloride Syrup	浙江康恩贝制药股份有限公司	国药准字H33021832	化学药品	糖浆剂	4/24/2020
Amantadine Hydrochloride Syrup	福建南少林药业有限公司	国药准字H35021239	化学药品	糖浆剂	4/30/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
ENZIL TAB 100MG	N/A	PT. YUNG SHIN PHARMACEUTICAL INDONESIA	N/A	N/A	5/29/1991
PK-MERZ TAB 100MG	N/A	JACOBSON MEDICAL (HONG KONG) LIMITED	N/A	N/A	8/20/1986

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
AMANTAMED amantadine hydrochloride 100 mg capsule blister pack	398492	Medsurge Pharma Pty Ltd	Medicine	A	9/18/2023
SYMMETREL 100 amantadine hydrochloride 100mg capsule bottle	11057	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	8/2/1991
AMANTADINE MEDSURGE amantadine hydrochloride 100 mg capsule blister pack	398491	Medsurge Pharma Pty Ltd	Medicine	A	9/18/2023
AMANTADINE MEDICIANZ amantadine hydrochloride 100 mg capsule blister pack	398490	Medsurge Pharma Pty Ltd	Medicine	A	9/18/2023

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