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 9h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SINCALIDE is a cholecystokinin (CCK) analog administered intravenously as a lyophilized powder. It is indicated for diagnostic imaging to assess gallbladder function and motility. The drug mimics CCK, a natural hormone that stimulates gallbladder contraction, enabling visualization during hepatobiliary imaging studies.
Peak11.7 years to LOE
Product is in peak commercial phase with no direct competitive pressure, suggesting stable team headcount and focused execution on market penetration within diagnostic imaging.
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
Working on SINCALIDE offers stable, specialized career development in diagnostic pharmaceuticals and niche imaging markets. The peak lifecycle stage and extended patent protection provide predictable career trajectory with focus on market optimization rather than launch intensity.
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.