DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) (dicyclomine hydrochloride)
Dicyclomine hydrochloride helps patients with functional bowel and irritable bowel syndrome. This medication acts as an antispasmodic and anticholinergic agent to manage gastrointestinal distress. It is used to provide relief from smooth muscle spasms within the digestive tract.
How DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) Works
This drug works by relieving smooth muscle spasms in the gastrointestinal tract using a dual mechanism. It targets acetylcholine-receptor sites to produce an anticholinergic effect and acts directly on the smooth muscle to block spasms caused by bradykinin and histamine.
Details
- Status
- Prescription
- First Approved
- 2003-06-30
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) Approval History
What DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) Treats
1 indicationsDICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) is approved for 1 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Irritable Bowel Syndrome
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
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Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
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.
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) FDA Label Details
Indications & Usage
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) is indicated for the treatment of Irritable Bowel Syndrome.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.