Fesoterodine

Summary

Fesoterodine (CHEMBL1201764) is an approved small molecule (ATC G04BD11); indicated across 6 conditions including overactive bladder and autonomic dysreflexia.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: G04BD11
• Indications: 6 conditions
• Clinical trials: 48
• Chemistry: 411.6 Da · C26H37NO3

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1201764
Name	Fesoterodine
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	6918558
ATC	G04BD11
Molecular formula	C26H37NO3
Molecular weight	411.6
InChIKey	DCCSDBARQIPTGU-HSZRJFAPSA-N

SMILES: CC(C)C(=O)OC1=C(C=C(C=C1)CO)[C@H](CCN(C(C)C)C(C)C)C2=CC=CC=C2

IUPAC name: [2-[(1R)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl] 2-methylpropanoate

Also known as: Fesoterodina, Fesoterodine, SID174006830, FESOTERODINE, Fesoterodine fumarateÊ, Fesoterodine fumarateÂ, Fesoterodine Fumarate, fesoterodine

Parent form; salt/anhydrous children: CHEMBL1201765

Patent coverage: 2,240 distinct patent families (4,036 SureChEMBL compound mentions), from 2 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 2 (assay-derived). Sample: Muscarinic acetylcholine receptor M2, Muscarinic acetylcholine receptor M1.

Bioactivity

ChEMBL activities: 2 potent at pChembl ≥ 5 of 2 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
CHRM1	6.45	AC50	354.2	nM	CHEMBL_ACT_25210227
CHRM2	6.38	AC50	414.1	nM	CHEMBL_ACT_25195753

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

6 indications (2 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
overactive bladder	3	MONDO:0006624	EFO:1000781
autonomic dysreflexia	2	MONDO:0043975	EFO:1001762

4 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 48.

Phase distribution

Phase	Trials
PHASE4	13
PHASE1	10
PHASE3	9
Not specified	9
PHASE2	5
PHASE2/PHASE3	1
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00798434	PHASE4	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.
NCT00806494	PHASE4	COMPLETED	UK Study Assessing Flexible Dose Fesoterodine in Adults
NCT00862745	PHASE4	COMPLETED	Bringing Simple Urge Incontinence Diagnosis & Treatment to Providers (BRIDGES)
NCT00911937	PHASE4	COMPLETED	A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency
NCT00928070	PHASE4	COMPLETED	A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder
NCT01054222	PHASE4	COMPLETED	Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder
NCT01302054	PHASE4	COMPLETED	A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.
NCT01302067	PHASE4	COMPLETED	A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine
NCT01578304	PHASE4	COMPLETED	Comparison of Efficacy and Safety Between Imidafenacin and Fesoterodine in Patients With Overactive Bladder
NCT01605617	PHASE4	TERMINATED	Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate
NCT01661166	PHASE4	COMPLETED	A Study of Effects of Fesoterodine in Men at High Risk for Overactive Bladder/Detrusor Overactivity Post Robotic-Assisted Lap. Prostatectomy
NCT02385500	PHASE4	TERMINATED	Fesoterodine on Urgency Episodes in Parkinson’s Disease Population
NCT03946124	PHASE4	COMPLETED	Fall Prevention in Older Adults With OAB
NCT00425100	PHASE3	COMPLETED	A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients
NCT00444925	PHASE3	COMPLETED	Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)
NCT00536484	PHASE3	COMPLETED	Fesoterodine Flexible Dose Study
NCT00546637	PHASE3	COMPLETED	Fesoterodine add-on Male Overactive Bladder Study
NCT00611026	PHASE3	COMPLETED	Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.
NCT00658684	PHASE3	COMPLETED	Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.
NCT01786967	PHASE3	COMPLETED	Understanding the Response to Fesoterodine Through Genetic Evaluation in the Elderly (URGE)
NCT02262936	PHASE2/PHASE3	TERMINATED	Comparison Between Desmopressin and Fesoterodine for Treatment of Night Time Voiding in Women Aged 65 and Older
NCT02327936	PHASE3	COMPLETED	Fesoterodine and Oxybutynin XL for Overactive Bladder Syndrome in Children
NCT02614482	PHASE3	COMPLETED	Extension Study of Fesoterodine for Overactive Bladder Syndrome in Children.
NCT00561951	PHASE2	COMPLETED	Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.
NCT00857896	PHASE2	COMPLETED	Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years
NCT01042236	PHASE2	COMPLETED	Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients
NCT02240459	PHASE2	COMPLETED	A Study of Fesoterodine and Oxybutynin on Cognitive Function in Mild Cognitive Impairment
NCT02676154	PHASE2	COMPLETED	Fesoterodine for Amelioration of Autonomic Dysreflexia (AD) Following Spinal Cord Injury (SCI)
NCT00786240	PHASE1	COMPLETED	Phase1, Single Dose, Crossover Study to Determine Bioequivalence
NCT00807118	PHASE1	COMPLETED	Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect
NCT00832650	PHASE1	TERMINATED	Multiple Dose Study To Investigate The Effects Of Fesoterodine And Solifenacin On Gastrointestinal Transit
NCT00902187	PHASE1	COMPLETED	A Bioequivalence Study Of 4 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects
NCT00902681	PHASE1	COMPLETED	A Bioequivalence Study Of 8 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects
NCT00911235	PHASE1	COMPLETED	The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects
NCT01161472	PHASE1	COMPLETED	A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects
NCT01286454	PHASE1	COMPLETED	This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
NCT01566760	PHASE1	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
NCT02160158	PHASE1	COMPLETED	Study to Estimate the Relative Bioavailability Compared to Commercial Extended-release Tablet Formulation and the Effects of Food Or Sprinkling on Applesauce for Fesoterodine Sustained-release Beads-in-capsule Formulations in Healthy Adult Volunteers
NCT00713921	EARLY_PHASE1	WITHDRAWN	Neuropathic Investigation and Anticholinergic Treatment of Bladder Dysfunction in Diabetes and Stroke Patients
NCT00691093	Not specified	COMPLETED	Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline, but PharmGKB curates 1 clinical and 7 variant annotation(s) for this drug (gene-keyed; see PharmGKB).

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).