Darifenacin

Overview

Darifenacin (Enablex®, Novartis) is a medication used to treat urinary incontinence. Darifenacin blocks M3 muscarinic acetylcholine receptors, which mediate bladder muscle contractions. This block reduces the urgency to urinate and so it should not be used in people with urinary retention. It is unknown if M3 receptor selectivity is clinically advantageous in overactive bladder syndrome treatments.

Indication

For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

Associated Conditions

Overactive Bladder Syndrome (OABS)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Darifenacin x Parasacral Transcutaneous Electric Nerve Stimulation for OAB in Patients Infected With Human T-Lymphotropic Virus 1	2024/09/27	NCT06616675	Phase 4	Completed	Hospital Universitário Professor Edgard Santos
A Study to Assess the Safety, Tolerability, and Pharmacology of Darifenacin in Patients With ALS	2024/02/08	NCT06249867	Phase 2	Recruiting	McGill University
Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania	2018/07/27	NCT03602508	N/A	Completed	Astellas Pharma Singapore Pte. Ltd.
A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China	2018/06/28	NCT03572231	N/A	Completed	Astellas Pharma Singapore Pte. Ltd.
Efficacy of Darifenacin and Physiotherapy for the Treatment of Overactive Bladder in Women	2014/05/21	NCT02143570	Phase 3	Completed	Universidad de Valparaiso
Single Dose Bioequivalence Study of Darifenacin Tablets 7.5 mg in Fed Healthy Volunteers.	2010/10/27	NCT01229280	Phase 1	UNKNOWN	Center for Clinical Pharmacology Research Bdbeq S.A.
Single Dose Two-periods Crossover Bioequivalence Study of Darifenacin Tablets in Healthy Volunteers.	2010/10/25	NCT01227811	Phase 1	UNKNOWN	Center for Clinical Pharmacology Research Bdbeq S.A.
Preoperative Use of Darifenacin (Enablex) to Alleviate Postoperative Ureteral Stent Pain	2010/08/26	NCT01189071	Not Applicable	Terminated	University of Missouri-Columbia
Exploratory Study Evaluating the Effects of Darifenacin on Nocturia, Sleep and Daytime Wakefulness	2009/11/23	NCT01018225	Phase 4	Withdrawn	Cognitive Research Corporation
FREEDOM - First Real-Life Evaluation of Enablex Done in ZA Overactive Bladder Patients During a 3 Months Period	2009/06/16	NCT00921245	N/A	Completed	Bayer

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Darifenacin 7.5 mg	Xiromed, LLC	70700-182	ORAL	7.5 mg in 1 1	4/30/2021
Enablex	Physicians Total Care, Inc.	54868-5363	ORAL	15 mg in 1 1	7/29/2010
DARIFENACIN	Alembic Pharmaceuticals Inc.	62332-223	ORAL	7.5 mg in 1 1	12/14/2021
Darifenacin	Cipla USA Inc.	69097-431	ORAL	7.5 mg in 1 1	8/16/2021
Enablex	Physicians Total Care, Inc.	54868-5704	ORAL	7.5 mg in 1 1	7/29/2010
Darifenacin	Cipla USA Inc.	69097-432	ORAL	15 mg in 1 1	8/16/2021
DARIFENACIN	Alembic Pharmaceuticals Limited	46708-224	ORAL	15 mg in 1 1	1/30/2023
Darifenacin	Torrent Pharmaceuticals Limited	13668-202	ORAL	7.5 mg in 1 1	4/11/2022
Darifenacin	Rising Pharma Holdings, Inc.	16571-767	ORAL	7.5 mg in 1 1	4/14/2021
Darifenacin	Macleods Pharmaceuticals Limited	33342-277	ORAL	15 mg in 1 1	1/25/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Emselex	pharmaand GmbH,Taborstrasse 1,1020 Vienna,Austria	Authorised	10/22/2004

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ENABLEX darifenacin 15mg (as hydrobromide) modified release tablet blister pack	99439	Aspen Pharmacare Australia Pty Ltd	Medicine	A	3/16/2005
ENABLEX darifenacin 7.5mg (as hydrobromide) modified release tablet blister pack	99418	Aspen Pharmacare Australia Pty Ltd	Medicine	A	3/16/2005

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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