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Darifenacin

Phase 4FDA approved 2004

Overactive Bladder Syndrome | Small molecule | Urology |Novartis AG|Trials Updated: Jan 23, 2008

Darifenacin development status

FDA approval Dec 22, 2004 as Enablex
Approval holderAbbvie
ApplicationNDA021513
Highest phase Phase 4 (NCT00127270)
Phase scored for NVSPhase 3
Registered trials 10 across 3 sponsors since Aug 2005

Darifenacin target and mechanism

Molecular targetCHRM3, CHRM2
Target classAntagonist
ModalitySmall molecule

Also known as Darifenacin (DAR328), Enablex

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment1,163

FDA Designations

No designations recorded

Darifenacin clinical trials

Darifenacin · 2 trials · 1 indication

Phase 3 2
NCT00171145A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.Overactive Bladder Syndrome
COMPLETED445 Analytics
NCT00170755A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive BladderOveractive Bladder Syndrome
COMPLETED718 Analytics
PHASE3COMPLETED
A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.
Overactive Bladder SyndromeUnlock trial analytics
PHASE3COMPLETED
A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder
Overactive Bladder SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in warning time at week 12.
Long term safety and tolerability. Safety assessments consisted of monitoring and recording all adverse events (AEs), serious adverse events (SAEs), hematology, blood chemistry, and urinalysis, vital signs, physical condition and body weight.

Secondary Endpoints

Change in warning time at weeks 2 & 6.
Change in frequency of urge incontinence episodes.
Change in frequency of micturitions.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALDarifenacin
2PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
DarifenacinDRUGDarifenacin 15 mg tablets once daily
PlaceboDRUGPlacebo tablets once daily
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:United States
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Frequently asked questions about Darifenacin

What is Darifenacin used for?

Darifenacin is used for overactive bladder syndrome, a urology condition. It is a small molecule developed by Novartis AG under the ticker NVS. The clinical program includes two completed Phase 3 trials in adults with overactive bladder, one evaluating warning time and one assessing long-term safety, tolerability and efficacy.

What does Darifenacin target?

Darifenacin targets CHRM3 and CHRM2, which are muscarinic acetylcholine receptors. It acts as an antagonist at these receptors. By blocking these targets, darifenacin is designed to reduce bladder contractions associated with overactive bladder syndrome. The compound is a small molecule and is identified in ChEMBL as CHEMBL1346.

Who makes Darifenacin?

Darifenacin is developed by Novartis AG, which trades under the ticker NVS. Novartis is the company behind the clinical development program for darifenacin in overactive bladder syndrome. The asset is also referred to as darifenacin (DAR328) in development records.

What phase is Darifenacin in?

Darifenacin is in Phase 3 development for overactive bladder syndrome. Two Phase 3 trials have been completed, and no trials are currently active. The program has enrolled 1,163 patients in total across randomized, double-blind, placebo-controlled studies in adults aged 18 years and older.

What clinical trials is Darifenacin in?

Darifenacin has been studied in two completed Phase 3 trials. NCT00171145 was a 12-week study evaluating darifenacin to increase warning time in patients with overactive bladder, enrolling 445 participants. NCT00170755 was a long-term safety, tolerability and efficacy study in adult patients with overactive bladder, enrolling 718 participants. Both were conducted in the United States.

Is Darifenacin the same as DAR328?

Yes, DAR328 is an alternative name for darifenacin. The two names refer to the same small molecule developed by Novartis AG for overactive bladder syndrome. Readers searching for DAR328 will find the same Phase 3 asset, which targets CHRM3 and CHRM2 as an antagonist.