NDAINTRAVENOUSPOWDERPriority Review
Approved
Nov 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
SINCALIDE (sincalide) by MAIA Biotechnology. Approved for cholecystokinin analog [epc]. First approved in 2022.
Drug data last refreshed 7h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SINCALIDE is a cholecystokinin (CCK) analog administered intravenously as a powder formulation, approved by the FDA in November 2022. It functions as a diagnostic agent to stimulate gallbladder contraction and assess biliary and pancreatic function. The drug targets patients undergoing hepatobiliary imaging studies who require pharmacologic stimulation of gallbladder ejection.
Peak11.5 years to LOE
Early-stage peak lifecycle product with no measured Part D claims suggests limited current penetration; commercial teams are likely building market access infrastructure and expanding awareness among imaging centers.
Mechanism of Action
Pharmacologic Class:
Cholecystokinin Analog
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying
Started May 2008
60 enrolled
Healthy
Career Relevance
SINCALIDE offers early-career opportunities in a niche diagnostic specialty with stable, long-term patent protection and minimal competitive pressure. Roles emphasize market access, clinical education, and imaging center partnerships rather than high-volume sales or large-scale infrastructure.
Brand Manager
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.