Data updated: May 26, 2026
FESOTERODINE FUMARATE
Urology
Approved 2015-12-10
7
Indications
--
Phase 3 Trials
10
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2015-12-10
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
Companies
Teva ALEMBIC Dr. Reddy's Aurobindo Pharma Sun Pharma ANI PHARMS Novartis ALKEM LABS LTD HETERO LABS LTD V ACCORD HLTHCARE ZYDUS PHARMS CHARTWELL RX AMNEAL PHARMS NY
Active Ingredient: FESOTERODINE FUMARATE
Website: ↗
FESOTERODINE FUMARATE Approval History
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
54 FDA actions from 2015 to 2025
Sep 2025 SUPPL
Label · Labeling
Apr 2025 SUPPL
Label · Labeling
Dec 2024 SUPPL
Label · Labeling
Nov 2024 SUPPL
Label
Nov 2024 SUPPL
Label
Aug 2024 SUPPL
Label
Jul 2024 SUPPL
Label
Jan 2024 ORIGINAL
Update
Feb 2023 SUPPL
Label
Jan 2023 ORIGINAL
Update
Jan 2023 ORIGINAL
Update
Aug 2019 ORIGINAL
Update
Oct 2017 ORIGINAL
Update
Feb 2017 ORIGINAL
Update
Dec 2015 ORIGINAL
Update
What FESOTERODINE FUMARATE Treats
7 FDA approvalsOriginally approved for its first indication in 2015 . Covers 7 distinct patient populations.
- Other (7)
Other
(7 approvals)- • Approved indication (Dec 2015)
- • Approved indication (Feb 2017)
- • Approved indication (Oct 2017)
- • Approved indication (Aug 2019)
- • Approved indication (Jan 2023)
- • Approved indication (Jan 2023)
- • Approved indication (Jan 2024)
📋
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01786967 URGE results posted | 13-2066 1R03AG042335-01, Pro00036147 | Ph 3 | completed | Understanding the Response to Fesoterodine Through Genetic Evaluation in the Elderly (URGE) |
| NCT01566760 | A0221069 | Ph 1 | completed | A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers |
| NCT01605617 results posted | 11-004589 | Ph 4 | terminated | Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate |
| NCT00798434 SOFIA results posted | A0221045 | Ph 4 | completed | A Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder. |
| NCT00832650 results posted | A0221057 | Ph 1 | terminated | Multiple Dose Study To Investigate The Effects Of Fesoterodine And Solifenacin On Gastrointestinal Transit |
| NCT00658684 results posted | A0221006 A0221006 | Ph 3 | completed | Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder. |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FESOTERODINE FUMARATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.