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Safinamide

Generic Name: Safinamide

Brand Names: Xadago

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₁₉FN_₂O_₂

CAS Number: 133865-89-1

Unique Ingredient Identifier: 90ENL74SIG

Overview

Safinamide is for the treatment of parkinson's disease. It was approved in Europe in February 2015, and in the United States on March 21, 2017.

Background

Safinamide is for the treatment of parkinson's disease. It was approved in Europe in February 2015, and in the United States on March 21, 2017.

Indication

用于治疗帕金森病

Associated Conditions

Parkinson's Disease (PD)

Clinical Trials

A Study to Evaluate the Efficacy and Safety of Safinamide Mesilate as Add-on Therapy to Levodopa in Parkinson's Disease Participants With Motor Fluctuation in South Korea

Phase 4

Completed

Posted: 2022/04/05

Sponsor:Eisai Korea Inc.

ID:NCT05312632

Safinamide for Levodopa-induced Dyskinesia (PD-LID)

Phase 3

Withdrawn

Posted: 2019/06/17

Sponsor:Zambon SpA

ID:NCT03987750

Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease

Phase 4

Recruiting

Posted: 2019/05/30

Sponsor:Alain Kaelin

ID:NCT03968744

Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)

Completed

Posted: 2019/05/10

Sponsor:Supernus Pharmaceuti...

ID:NCT03944785

A Single and Multiple Dose Study to Assess How the Drug Enters, Moves Through and Exits the Body, Safety and Tolerability of Safinamide in Healthy Adult Chinese Volunteers

Phase 1

Completed

Posted: 2019/03/22

Sponsor:Zambon SpA

ID:NCT03887221

FDA Approved Products

Xadago

Manufacturer:MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.

Route:ORAL

Strength:100 mg in 1 1

Approved: 2023/12/20

NDC:27505-111

Xadago

Manufacturer:MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.

Route:ORAL

Strength:50 mg in 1 1

Approved: 2023/12/20

NDC:27505-110

Singapore Approved Products

EQUFINA FILM-COATED TABLET 50MG

Manufacturer:Meiji Seika Pharma Co., Ltd., Odawara Plant, Bora Pharmaceuticals Co., Ltd. (Primary packager and secondary packager)

Form:TABLET, FILM COATED

Strength:50mg

Online:Yes

Approved: 2022/09/28

Approval:SIN16615P

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