TheraRadar
Data updated: Jun 28, 2026

ENABLEX (darifenacin hydrobromide) · AbbVie

Trial Activity: Declining
Urology Approved 2004-12-22

ENABLEX is FDA-approved to treat 2 conditions (same as DARIFENACIN HYDROBROMIDE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Hospital Universitário Professor Edgard Santos conducting 1 trials (20%)
6 indications explored (Moderate)
→ htlv-1 (1 trials)
→ overactive bladder syndrome (1 trials)
→ neurogenic detrusor overactivity (1 trials)
1
Indication
--
Phase 3 Trials
21
Years on Market

Details

Status
Discontinued
First Approved
2004-12-22
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

AbbVie
Active Ingredient: DARIFENACIN HYDROBROMIDE

ENABLEX Approval History

2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
30 FDA actions from 2004 to 2021
Jul 2021 SUPPL
Label · Labeling
FDA Letter Label
Jan 2016 SUPPL
Mfg · Manufacturing (CMC)
Dec 2015 SUPPL
Mfg · Manufacturing (CMC)

What ENABLEX Treats

2 indications

ENABLEX is approved for 2 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as DARIFENACIN HYDROBROMIDE (same active ingredient).

Source: FDA Label
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ENABLEX FDA Label Details

Indications & Usage

FDA Label (PDF)

ENABLEX is FDA-approved to treat 2 conditions — same approved indications as DARIFENACIN HYDROBROMIDE.

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Data Sources

FDA Approval: NDA021513 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment