Enablex

(Darifenacin)

ApprovedSmall molecule

Darifenacin is used to treat overactive bladder, helping to reduce urinary urgency, frequency, and incontinence by relaxing the bladder muscles.[2] Enablex is currently approved and in use across 5 indications[4].[1]

Enablex is one of 79 small molecule programs targeting Polyuria. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

PolyuriaActive, not recruiting

Urinary IncontinenceActive, not recruiting

Amyotrophic Lateral SclerosisApproved

Overactive BladderCompleted

ALSRecruiting

PolyuriaApproved

Active, not recruiting

Urinary IncontinenceApproved

Active, not recruiting

Amyotrophic Lateral SclerosisApproved

Approved

Overactive BladderApproved

Completed

ALSPhase 2

Recruiting

Competition

Competitive Landscape

55 competitors in Amyotrophic Lateral Sclerosis

#DrugCompanyPhaseTrials

Enablex

AbbVie

Approved

21 2

Nourianz

Kyowa Kirin Co., Ltd.

Vimpat

Bosulif

PPrism Pharmaceuticals

Approved

1 5

Qalsody

Biogen

Approved

3 6

Avodart

Akero Therapeutics

Approved

—7

Rocephin

CConrado Roberto Hoffmann Filho

Mirapex

Rapamune

PPrism Pharmaceuticals

Approved

—10

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Approved

—

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

Timeline

Expected Milestones

Q3 2027

Phase 2Recruiting

ALS

NCT06249867

Clinical

Trials by Indication[1]

Overactive Bladder8 trials

Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder

Completed· Novartis logo

Novartis·Phase 4·NCT00171184·400 enrolled

Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder

Completed· Novartis logo

Novartis·Phase 4·NCT00366002·500 enrolled

A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.

Completed· Novartis logo

Novartis·Phase 3·NCT00171145·445 enrolled

Show 5 more trials

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

Completed· Astellas logo

Astellas··NCT03602508·5,589 enrolled

Efficacy of Darifenacin and Physiotherapy for the Treatment of Overactive Bladder in Women

Completed·UUniversidad de Valparaiso·Phase 3·NCT02143570·80 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

Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder

Completed· Novartis logo

Novartis·Phase 4·NCT00127270·395 enrolled

A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder

Completed· Novartis logo

Novartis·Phase 3·NCT00170755·718 enrolled

Cardiovascular2 trials

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

Completed· Novartis logo

Novartis·Phase 4·NCT00413790·162 enrolled

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

Completed· Novartis logo

Novartis·Phase 1·NCT00703703·117 enrolled

Single Dose2 trials

Single Dose Two-periods Crossover Bioequivalence Study of Darifenacin Tablets in Healthy Volunteers.

Unknown status·CCenter for Clinical Pharmacology Research Bdbeq S.A.·Phase 1·NCT01227811·24 enrolled

Single Dose Bioequivalence Study of Darifenacin Tablets 7.5 mg in Fed Healthy Volunteers.

Unknown status·CCenter for Clinical Pharmacology Research Bdbeq S.A.·Phase 1·NCT01229280·24 enrolled

Neurogenic Detrusor Overactivity1 trial

A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Years) With Neurogenic Detrusor Overactivity

Terminated·WWarner Chilcott·Phase 2·NCT00712322·35 enrolled

Virus1 trial

Darifenacin x Parasacral Transcutaneous Electric Nerve Stimulation for OAB in Patients Infected With Human T-Lymphotropic Virus 1

Completed·HHospital Universitário Professor Edgard Santos·Phase 4·NCT06616675·42 enrolled

7 more indications

Preoperative1 trial

Preoperative Use of Darifenacin (Enablex) to Alleviate Postoperative Ureteral Stent Pain

Terminated·UUniversity of Missouri-Columbia·N/A·NCT01189071·3 enrolled

ALS1 trial

A Study to Assess the Safety, Tolerability, and Pharmacology of Darifenacin in Patients With ALS

Recruiting·OOliver Blanchard·Phase 2·NCT06249867·30 enrolled

Multiple Sclerosis1 trial

Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity

Terminated· Bayer logo

Bayer·Phase 2·NCT00845338·7 enrolled

Efficacy1 trial

Efficacy and Tolerability of Tadalafil Versus Darifenacin in Management of Ureteric Stent-Related LUTS

Completed·—·Phase 1/2·NCT07206706·150 enrolled

NAC1 trial

Study to Compare How the Body Changes the Blood Level of Darifenacin Tablet Form vs. the Modified Release Liquid Form in Healthy Subjects

Completed· Novartis logo

Novartis·Phase 1·NCT00413426·28 enrolled

Aged1 trial

Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over

Completed· Novartis logo

Novartis·Phase 2·NCT00170768·150 enrolled

Nocturia1 trial

Exploratory Study Evaluating the Effects of Darifenacin on Nocturia, Sleep and Daytime Wakefulness

Withdrawn·CCognitive Research Corporation·Phase 4·NCT01018225

Regulatory

FDA Approval Timeline[5]

Dec 22, 2004

ENABLEX

NDA NDA021513

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for Darifenacin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Enablex drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Darifenacin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Darifenacin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021513). U.S. Food & Drug Administration.
[6]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Muscarinic Acetylcholine Receptor M3 Antagonist; Muscarinic Acetylcholine Receptor M2 Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AbbVie

Enablex

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2027

Trials by Indication[1]

Overactive Bladder8 trials

Cardiovascular2 trials

Single Dose2 trials

Neurogenic Detrusor Overactivity1 trial

Virus1 trial

Preoperative1 trial

ALS1 trial

Multiple Sclerosis1 trial

Efficacy1 trial

NAC1 trial

Aged1 trial

Nocturia1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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