Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Darifenacin · 5 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Darifenacin |
| 2 | PLACEBO_COMPARATOR | Placebo |
| 3 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Darifenacin | DRUG | Darifenacin 15 mg tablets once daily |
| Placebo | DRUG | Placebo tablets once daily |
| Oxybutynin | DRUG | Oxybutynin extended release 10 mg tablet once daily titrated to 15 mg, then to 20 mg once daily |
| Tolterodine | DRUG | Tolterodine extended release (ER) 4 mg once daily |
| Darifenacin (DAR328) | DRUG | - |
Inclusion Criteria: * Three symptoms of OAB (urge incontinence, frequency and urgency) for at least six months prior to Visit 2. * Patients capable of independent toileting and able of independently completing the patient diary. Exclusion Criteria: * Patients in whom the use of anticholinergic dr...
Darifenacin is a small molecule drug studied for overactive bladder syndrome and in healthy volunteers. Clinical trials have evaluated its long-term safety, tolerability, and efficacy in adult patients with overactive bladder, as well as its effects on warning time in patients with this condition. It has also been studied in healthy subjects for cognitive effects and pharmacokinetic comparisons.
Darifenacin is developed by Novartis AG, a company traded on the New York Stock Exchange under the ticker NVS. The company has sponsored clinical trials of the drug in the United States and India.
Darifenacin has completed Phase 1, Phase 2, and Phase 3 clinical trials. The completed trials include a Phase 3 long-term safety and efficacy study, a Phase 2 cognitive effects study, and a Phase 1 pharmacokinetic study. The drug is not approved and remains investigational.
Darifenacin has been studied in four completed clinical trials. NCT00170755 was a Phase 3 long-term safety and efficacy study in overactive bladder. NCT00170768 was a Phase 2 cognitive effects study in healthy volunteers aged 60 and over. NCT00171145 was a Phase 3 warning time study, and NCT00413426 was a Phase 1 pharmacokinetic study in healthy subjects.
Darifenacin is not the same as oxybutynin. A clinical trial compared the cognitive effects of darifenacin and oxybutynin extended release in volunteers aged 60 and over, indicating they are distinct drugs studied for similar conditions.