SINCALIDE · MAIA PHARMS INC
Sincalide is a cholecystokinin analog used in adults to assist with various diagnostic procedures involving the digestive system. It helps patients by stimulating the gallbladder to contract, which allows healthcare providers to image the organ or collect bile samples for analysis. Additionally, it is used to speed up the movement of barium through the small intestine during imaging tests and works alongside other medications to help evaluate pancreatic function.
How SINCALIDE Works
This drug works by mimicking the natural hormone cholecystokinin to trigger the gallbladder to contract and release bile. When injected, it also increases intestinal movement and stimulates the pancreas to release enzymes and bicarbonate. These actions help clinicians assess how well the gallbladder and pancreas are functioning or move materials through the gut more quickly during X-rays.
Details
- Status
- Prescription
- First Approved
- 1976-07-21
- Patent Cliff
- 2038
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
SINCALIDE Approval History
What SINCALIDE Treats
3 indicationsSINCALIDE is approved for 3 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gallbladder contraction for diagnostic imaging or bile sampling
- Pancreatic secretion stimulation for enzyme and composition analysis
- Small bowel transit acceleration during barium meal examinations
SINCALIDE 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.
SINCALIDE FDA Label Details
Indications & Usage
FDA Label (PDF)Sincalide for Injection is indicated in adults to: stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray exa...
Pro Intelligence Preview
Deep insights for SINCALIDE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 9 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.