Detrol La

(tolterodine)

ApprovedSmall molecule

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Detrol La is a small molecule that works as a Muscarinic Acetylcholine Receptor M2 Antagonist; Muscarinic Acetylcholine Receptor M3 Antagonist.[2] It is being used across 7 indications, with its most advanced program in Approved.[1]

Detrol La is one of 122 small molecule programs targeting Polyuria. It is currently in Approved.

Indications

Total Trials

Active Trials

121

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

PolyuriaActive, not recruiting

Neuropathic PainApproved

NephrolithiasisApproved

Lower Urinary Tract SymptomApproved

Chronic ProstatitisActive, not recruiting

DrugCompleted

Overactive BladderCompleted

PolyuriaApproved

Active, not recruiting

Neuropathic PainApproved

Approved

NephrolithiasisApproved

Approved

Lower Urinary Tract SymptomApproved

Approved

Chronic ProstatitisPreclinical

Active, not recruiting

DrugPreclinical

Completed

Overactive BladderApproved

Completed

Competition

Competitive Landscape

52 competitors in Neuropathic Pain

#DrugCompanyPhaseTrials

Detrol La

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

46 2

Lyrica

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

44 3

Cymbalta

Jazz Pharmaceuticals

Approved

10 4

Trileptal

Novartis

Approved

2 5

Neurontin

VViatris Specialty LLC

Approved

10 6

Ketalar

AAultman Health Foundation

Approved

9 7

Aricept

Eisai

Approved

1 8

Calciferol

Marinol

Zofran

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2028

Phase 3Not yet recruiting

Overactive Bladder

NCT07114640

Clinical

Trials by Indication[1]

Overactive Bladder21 trials

Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

Completed· Astellas logo

Astellas·Phase 3·NCT00688688·2,792 enrolled

ELB245 for 12 Weeks Versus 4mg Tolterodine in Patients With Incontinent Overactive Bladder (OAB)

Terminated·Eelbion AG·Phase 2·NCT00439192·275 enrolled

Study to Test the Efficacy and Safety of YM178 in Subjects With Symptoms of Overactive Bladder

Completed· Astellas logo

Astellas·Phase 2·NCT01604928·260 enrolled

Show 18 more trials

Comparisons of the Impact of Monotherapy With Mirabegron or Tolterodine Versus Combined Treatment With Mirabegron and Tolterodine on Autonomic Function and Bladder Blow Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study

Unknown status·FFar Eastern Memorial Hospital·Phase 4·NCT05946902·150 enrolled

A Confirmatory Study of KUC-7483 in Patients With Overactive Bladder

Completed·KKissei Pharmaceutical Co., Ltd.·Phase 3·NCT01004315·750 enrolled

Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder

Completed· Pfizer logo

Pfizer·Phase 2·NCT00746681·188 enrolled

A Study to Evaluate Safety and Efficacy of YM178 in Patients With Overactive Bladder

Completed· Astellas logo

Astellas·Phase 3·NCT00966004·1,139 enrolled

A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China

Completed· Astellas logo

Astellas··NCT03572231·805 enrolled

Study of ONO-8539 in Patients With Overactive Bladder

Completed· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 2·NCT00876421·435 enrolled

Overactive Bladder Innovative Therapy Trial (OrBIT)

Completed·UUroplasty, Inc·Phase 4·NCT00448175·100 enrolled

Exploring Predictors of Symptoms Relapse After Discontinuation of Treatment in Overactive Bladder (OAB) Patients

Completed·KKYU-SUNG LEE·Phase 4·NCT00730535·173 enrolled

Treatment of Overactive Bladder With Anticholinergic Agents

Active, not recruiting·SSehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital··NCT07046156·120 enrolled

Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder

Completed·LLee's Pharmaceutical Limited·Phase 3·NCT01512004·324 enrolled

Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder

Completed·SSamsung Medical Center·Phase 4·NCT00836381·56 enrolled

Postmarketing Study to Evaluate add-on Therapy With Anticholinergics in Patients With Overactive Bladder (OAB) on Mirabegron.

Completed· Astellas logo

Astellas·Phase 4·NCT02294396·649 enrolled

A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00645281·896 enrolled

The Effect of Nighttime Mirabegron, Solifenacin, Tolterodine, or Oxybutynin on Nocturia, Sexual Function, Autonomic Function, and Lower Urinary Tract Blood Flow Perfusion in Women With Overactive Bladder Syndrome: Randomized Controlled Trial

Not yet recruiting·FFar Eastern Memorial Hospital·Phase 3·NCT07114640·220 enrolled

SSR240600C Treatment in Women With Overactive Bladder

Completed· Sanofi logo

Sanofi·Phase 2·NCT00564226·345 enrolled

Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

Completed· Astellas logo

Astellas·Phase 3·NCT00689104·2,336 enrolled

A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients

Completed· Astellas logo

Astellas·Phase 3·NCT00368706·246 enrolled

Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania

Completed· Astellas logo

Astellas··NCT03602508·5,589 enrolled

Treatment4 trials

Genetic Determinants of Amitriptyline Efficiency for Pain Treatment

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT02256943·48 enrolled

Genetic Determinants of Amitriptyline Efficiency for Pain Treatment - Part II

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT02256956·48 enrolled

Low Dose Tadalafil for Treatment of Female OAB Syndrome: Short Term Follow up.

Completed·KKasr El Aini Hospital·Phase 1·NCT04500860·90 enrolled

Show 1 more trial

Pharmacological vs Surgical Treatment for Mixed Incontinence

Withdrawn·IImperial College London·Phase 4·NCT00523068

Cardiovascular2 trials

Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects

Completed· Novartis logo

Novartis·Phase 1·NCT00703703·117 enrolled

Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects

Completed· Novartis logo

Novartis·Phase 4·NCT00413790·162 enrolled

Tics1 trial

Effects of Novel Combinations of Tolterodine/Pilocarpine on Pharmacokinetics (PK) and Pharmacodynamics (PD) of Tolterodine in Healthy Subjects

Completed·TTheraVida, Inc.·Phase 1·NCT01036035·18 enrolled

Low back pain1 trial

Linking Altered Central Pain Processing and Genetic Polymorphism to Drug Efficacy in Chronic Low Back Pain (Predictio)

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 3·NCT01179828·150 enrolled

16 more indications

Central Sensitisation1 trial

GABAergic Modulation in Pain Transmission in Human: Effect of the GABAA Agonist Clobazam on Peripheral and Central Sensitisation

Completed·UUniversity Hospital, Geneva·Phase 1/2·NCT01291316·25 enrolled

Experimental1 trial

Effects of GABA-a-Agonists on Pain Mechanisms: An Experimental Study in Healthy Volunteers

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 3·NCT01011036·17 enrolled

Gastrointestinal1 trial

Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects

Completed·MMayo Clinic·Phase 2·NCT00332137·36 enrolled

NAC1 trial

Solifenacin Succinate Versus Tolterodine 4mg Once Daily

Completed· Astellas logo

Astellas·Phase 3·NCT00802373·1,355 enrolled

Chronic Prostatitis1 trial

Efficacy Study of Tamsulosin and Tolterodine Treatment for Chronic Prostatitis

Unknown status·—·N/A·NCT00913315·30 enrolled

Heart1 trial

Evaluation of the Link Between Bladder Sensation and Changes in Skin Electrical Conductance and Heart Rate.

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT00481728·28 enrolled

Menopause1 trial

A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause.

Terminated·—·Phase 4·NCT00323635·19 enrolled

Drug1 trial

Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

Completed·CCarelon Research·N/A·NCT00090584·307 enrolled

Pelvic Organ Prolapse1 trial

the Indications and Clinical Efficacy of Pelvic Organ Prolapse Surgery

Unknown status·PPeking University People's Hospital·Phase 3·NCT02599311·1,000 enrolled

Urinary incontinence1 trial

MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.

Completed· Sanofi logo

Sanofi·Phase 2·NCT00174798·118 enrolled

Completed· Astellas logo

Astellas·Phase 4·NCT01964183·24 enrolled

TED1 trial

The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms

Completed·UUrmia University of Medical Sciences·Phase 2/3·NCT01530243·104 enrolled

Overactive Bladder (OAB)1 trial

Evaluation of the Effects of Antimuscarinic Drugs on Ejaculation Duration and Refractory Period in Male Patients Treated for Overactive Bladder: An Observational Study

Completed·BBaşakşehir Çam & Sakura City Hospital··NCT07736560·40 enrolled

Unspecified2 trials

Study of Herbmed Plus in Ureteral Stent Discomfort

Completed·DDr .S.B.PATANKAR·Phase 2·NCT01356355·140 enrolled

STUDY The Effect of HNF-4A G60D Variant on the In VIVO CYP2D6 Activity By Tolterodine Pharmacokinetic Study

Completed·IInje University·Phase 1·NCT01181505·31 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 25, 1998

DETROL

NDA NDA020771

Dec 22, 2000

DETROL LA

NDA NDA021228

Sources

References

[1]
ClinicalTrials.gov — 46 trial records for tolterodine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — tolterodine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for tolterodine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021228). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Pfizer's Upjohn has merged with Mylan to form Viatris Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Muscarinic Acetylcholine Receptor M2 Antagonist; Muscarinic Acetylcholine Receptor M3 Antagonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Detrol La

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2028

Trials by Indication[1]

Overactive Bladder21 trials

Treatment4 trials

Cardiovascular2 trials

Tics1 trial

Low back pain1 trial

Central Sensitisation1 trial

Experimental1 trial

Gastrointestinal1 trial

NAC1 trial

Chronic Prostatitis1 trial

Heart1 trial

Menopause1 trial

Drug1 trial

Pelvic Organ Prolapse1 trial

Urinary incontinence1 trial

Detrusor Overactivity1 trial

Efficacy and Safety1 trial

Concentration1 trial

TED1 trial

Overactive Bladder (OAB)1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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