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 3d 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 under sponsor MAIA Biotechnology. It functions as a CCK receptor agonist used in diagnostic imaging procedures to assess gallbladder function and bile duct patency. The drug targets patients requiring functional assessment of the hepatobiliary system.
Peak12.0 years to LOE
Early-stage peak lifecycle with no direct Part D data suggests limited retail market penetration; hospital/diagnostic center focus drives institutional sales models and smaller field teams.
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
This product offers career opportunities in diagnostic device-pharma hybrid roles focused on institutional and hospital sales rather than field or retail pharmacy. Working on SINCALIDE means specializing in niche diagnostic imaging markets with limited growth potential but stable, long-term patent protection.
Diagnostic Sales Specialist
Worked on SINCALIDE at MAIA Biotechnology? Share your interview experience or compensation data (+7 days Pro)
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.