Fesoterodine

Generic Name: Fesoterodine

Brand Names: Toviaz

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₃₇NO_₃

CAS Number: 286930-02-7

Unique Ingredient Identifier: 621G617227

Overview

Fesoterodine is an antimuscarinic prodrug for the treatment of overactive bladder syndrome.

Indication

适用于治疗急迫性尿失禁和膀胱过度活动综合征患者的尿频、尿急、尿失禁或所有这些症状组合。

Associated Conditions

Neurogenic Detrusor Overactivity
Overactive Bladder Syndrome (OABS)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study To Assess The Bioequivalence Under Fed And Fasted Conditions Of The Fesoterodine Beads-In-Capsule SR4 And SR7 Formulations And To Estimate The Bioavailability of SR7 Beads Sprinkled On Apple Sauce Relative To The Beads-In-Capsule SR7 Formulation Administer	2020/07/01	NCT04452838	Phase 1	Completed	Pfizer
Fall Prevention in Older Adults With OAB	2019/05/10	NCT03946124	Phase 4	Completed	University of Pennsylvania
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.
Fesoterodine for Amelioration of Autonomic Dysreflexia (AD) Following Spinal Cord Injury (SCI)	2016/02/08	NCT02676154	Phase 2	Completed	University of British Columbia
Extension Study of Fesoterodine for Overactive Bladder Syndrome in Children.	2015/11/25	NCT02614482	Phase 3	Completed	Stéphane Bolduc
Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.	2015/07/17	NCT02501928	Phase 3	Completed	Pfizer
Fesoterodine on Urgency Episodes in Parkinson's Disease Population	2015/03/11	NCT02385500	Phase 4	Terminated	Sir Mortimer B. Davis - Jewish General Hospital
Fesoterodine and Oxybutynin XL for Overactive Bladder Syndrome in Children	2014/12/31	NCT02327936	Phase 3	Completed	Stéphane Bolduc
Comparison Between Desmopressin and Fesoterodine for Treatment of Night Time Voiding in Women Aged 65 and Older	2014/10/13	NCT02262936	Phase 2	Terminated	Mount Sinai Hospital, Canada

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
fesoterodine fumarate	Zydus Pharmaceuticals USA Inc.	68382-479	ORAL	4 mg in 1 1	4/2/2024
Fesoterodine Fumarate	ANI Pharmaceuticals, Inc.	62559-376	ORAL	8 mg in 1 1	1/4/2023
fesoterodine fumarate	Lupin Pharmaceuticals, Inc.	68180-618	ORAL	4 mg in 1 1	1/31/2023
Fesoterodine Fumarate	Ascend Laboratories, LLC	67877-068	ORAL	8 mg in 1 1	4/11/2022
Fesoterodine Fumarate	AvKARE	42291-053	ORAL	4 mg in 1 1	11/7/2023
FESOTERODINE FUMARATE	Camber Pharmaceuticals, Inc.	31722-033	ORAL	4 mg in 1 1	3/26/2024
FESOTERODINE FUMARATE	Aurobindo Pharma Limited	65862-767	ORAL	8 mg in 1 1	8/30/2023
fesoterodine fumarate	Zydus Pharmaceuticals USA Inc.	68382-480	ORAL	8 mg in 1 1	4/2/2024
Toviaz	Physicians Total Care, Inc.	54868-6175	ORAL	8 mg in 1 1	4/6/2012
Toviaz	Pfizer Laboratories Div Pfizer Inc	0069-0244	ORAL	8 mg in 1 1	11/30/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Toviaz	Pfizer Europe MA EEIG,Boulevard de la Plaine 17,1050 Bruxelles,Belgium	Authorised	4/20/2007

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
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
APO-FESOTERODINE	Apotex Inc	02493462	Tablet (Extended-Release) - Oral	4 MG	N/A
ACH-FESOTERODINE	Accord Healthcare Inc	02536005	Tablet (Extended-Release) - Oral	8 MG	N/A
TOVIAZ	Pfizer Canada Ulc	02380048	Tablet (Extended-Release) - Oral	8 MG	4/19/2012
APO-FESOTERODINE	Apotex Inc	02493470	Tablet (Extended-Release) - Oral	8 MG	N/A
ACH-FESOTERODINE	Accord Healthcare Inc	02535998	Tablet (Extended-Release) - Oral	4 MG	N/A
TOVIAZ	Pfizer Canada Ulc	02380021	Tablet (Extended-Release) - Oral	4 MG	4/19/2012
SANDOZ FESOTERODINE FUMARATE	Sandoz Canada, Inc.	02521768	Tablet (Extended-Release) - Oral	4 MG	5/2/2022
SANDOZ FESOTERODINE FUMARATE	Sandoz Canada, Inc.	02521776	Tablet (Extended-Release) - Oral	8 MG	5/2/2022

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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