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Enablex (DARIFENACIN)
Enablex works by blocking the action of a chemical called acetylcholine on the bladder muscle, which helps to relax the muscle and improve bladder control.
Enablex (DARIFENACIN) is a small molecule cholinergic muscarinic antagonist developed by WARNER CHILCOTT LLC and currently owned by Abbvie. It targets the muscarinic acetylcholine receptor M3 to treat bladder muscle dysfunction, including overactive bladder, increased urinary frequency, urge incontinence of urine, and urgent desire to urinate. Enablex was FDA approved in 2004 and is now off-patent with multiple generic manufacturers. The drug has a half-life of 3.6 hours and bioavailability of 17%. It is used to relax the bladder muscle and improve bladder control.
At a glance
| Generic name | DARIFENACIN |
|---|---|
| Sponsor | AbbVie |
| Drug class | Cholinergic Muscarinic Antagonist |
| Target | Muscarinic acetylcholine receptor M3 |
| Modality | Small molecule |
| Therapeutic area | Urology |
| Phase | FDA-approved |
| First approval | 2004 |
Mechanism of action
Darifenacin is competitive muscarinic receptor antagonist. Muscarinic receptors play role in cholinergically mediated functions, including contractions of the urinary bladder smooth muscle. In vitro studies using human recombinant muscarinic receptor subtypes show that darifenacin has greater affinity for the M3 receptor than for the other known muscarinic receptors (9- and 12-fold greater affinity for M3 compared to M1 and M5, respectively, and 59-fold greater affinity for M3 compared to both M2 and M4). M3 receptors are involved in contraction of human bladder.
Approved indications
- Bladder muscle dysfunction - overactive
- Increased Urinary Frequency
- Urge incontinence of urine
- Urgent desire to urinate
Common side effects
- Dry Mouth
- Constipation
- Dyspepsia
- Abdominal Pain
- Nausea
- Diarrhea
- Urinary Tract Infection
- Dizziness
- Asthenia
- Dry Eyes
- Accidental Injury
- Flu Syndrome
Drug interactions
- atazanavir
- boceprevir
- conivaptan
- desipramine
- flecainide
- imipramine
- indinavir
- itraconazole
- ketoconazole
- mibefradil
- nefazodone
- nelfinavir
Key clinical trials
- Efficacy and Tolerability of Tadalafil Versus Darifenacin in Management of Ureteric Stent-Related LUTS (PHASE1,PHASE2)
- A Study to Assess the Safety, Tolerability, and Pharmacology of Darifenacin in Patients With ALS (PHASE2)
- Efficacy of Low-Intensity Shockwave Therapy in Treating Radiation Cystitis (EARLY_PHASE1)
- Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania
- A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)
- Darifenacin x Parasacral Transcutaneous Electric Nerve Stimulation for OAB in Patients Infected With Human T-Lymphotropic Virus 1 (PHASE4)
- 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 (PHASE2)
- A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Enablex CI brief — competitive landscape report
- Enablex updates RSS · CI watch RSS
- AbbVie portfolio CI