TheraRadar
Data updated: May 26, 2026

DETROL LA (tolterodine tartrate)

Trial Activity: Declining
Urology Approved 2000-12-22

Detrol LA helps patients with an overactive bladder. It is used to manage symptoms like the sudden, strong need to urinate and the frequent need to go throughout the day. It also treats urge urinary incontinence, which is the accidental loss of urine associated with a strong urge.

Source: FDA Label • UPJOHN

How DETROL LA Works

This medication works by competing with acetylcholine to bind with muscarinic receptors, which are the primary triggers for bladder contractions. After it is processed by the liver, it forms an active metabolite that also targets these receptors with high specificity. By blocking these signals, the drug helps control the muscle activity responsible for bladder emptying.

Development Insights

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. conducting 5 trials (71%)
4 indications explored (Focused)
urinary bladder, overactive (5 trials)
urge incontinence (1 trials)
urinary incontinence, urge (1 trials)
3
Indications
--
Phase 3 Trials
1
Priority Reviews
25
Years on Market

Details

Status
Prescription
First Approved
2000-12-22
Routes
ORAL
Dosage Forms
CAPSULE, EXTENDED RELEASE

Companies

Active Ingredient: TOLTERODINE TARTRATE

DETROL LA Approval History

2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
32 FDA actions from 2000 to 2018 · 2 indication expansions
Jul 2018 SUPPL
Label · Labeling
Jul 2014 SUPPL
Mfg · Manufacturing (CMC)
Aug 2012 SUPPL
Label · Labeling

What DETROL LA Treats

2 indications

DETROL LA is approved for 2 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Overactive Bladder
  • Urge Urinary Incontinence
Source: FDA Label

DETROL LA Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to DETROL LA

3 of 12

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

DARIFENACIN
DARIFENACIN HYDROBROMIDE
2 shared
MACLEODS PHARMS LTD
Shared indications:
Overactive BladderUrge Urinary Incontinence
DARIFENACIN HYDROBROMIDE
DARIFENACIN HYDROBROMIDE
2 shared
TORRENT
Shared indications:
Overactive BladderUrge Urinary Incontinence
MIRABEGRON
MIRABEGRON
2 shared
SAWAI USA
Shared indications:
Overactive BladderUrge Urinary Incontinence
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Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT01521767 A6121196 Ph 1 completed Pharmacokinetics and Relative Bioavailability Study
NCT02436889 TRIUMPH results posted 14-15553 Ph 4 completed Treatment of Incontinence Without Memory Problems
NCT00768521 results posted 0000-107 2008_560 Ph 1 completed A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

DETROL LA FDA Label Details

Indications & Usage

FDA Label (PDF)

DETROL LA is indicated for the treatment of Overactive Bladder; Urge Urinary Incontinence.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment