KINEVAC (sincalide)
Kinevac is a diagnostic tool used in adults to assist with imaging and functional testing of the gallbladder, pancreas, and intestinal tract. It helps patients by triggering gallbladder contraction, which allows clinicians to analyze bile samples or view the organ through diagnostic imaging. Additionally, it is used to speed up the movement of barium through the small intestine to limit radiation exposure and can be used alongside secretin to evaluate pancreatic enzyme activity.
How KINEVAC Works
As a cholecystokinin analog, the drug works by stimulating the gallbladder to contract and empty in a way that mimics the body's natural physiological response. It also increases intestinal motility and boosts the output of pancreatic secretions, which helps healthcare providers assess specific organ functions and accelerate the transit of imaging agents.
Details
- Status
- Prescription
- First Approved
- 1976-07-21
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
KINEVAC Approval History
What KINEVAC Treats
3 indicationsKINEVAC is approved for 3 conditions since its original approval in 1976. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gallbladder contraction for imaging or bile analysis
- Pancreatic secretion stimulation for functional analysis
- Small bowel transit acceleration during barium imaging
KINEVAC Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00706381 results posted | 080165 08-DK-0165 | Ph 3 | completed | Thyroid Hormones Homeostasis and Energy Metabolism Changes During Stimulation of Endogenously Secreted Bile Acids (BAs) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
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.
KINEVAC FDA Label Details
Indications & Usage
FDA Label (PDF)KINEVAC is indicated for the treatment of Gallbladder contraction for imaging or bile analysis; Pancreatic secretion stimulation for functional analysis; Small bowel transit acceleration during barium imaging.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.