NDAINTRAVENOUSPOWDERPriority Review
Approved
Apr 2024
Lifecycle
Growth
Competitive Pressure
0/100
Data completeness
3/8 — Basic
Priority Review
LUMISIGHT (pegulicianine) by Lumicell is 12. First approved in 2024.
Drug data last refreshed 3d ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LUMISIGHT (pegulicianine) is an intravenous small-molecule fluorescent imaging agent approved by the FDA in April 2024. It is a prodrug that remains optically inactive until cleaved by tumor-associated enzymes (cathepsins and matrix metalloproteases), producing a fluorescent signal at 675 nm to help surgeons visualize tumor tissue during procedures. The drug enables real-time optical guidance by exploiting the elevated protease activity in and around malignant cells compared to normal tissue.
Growth8.4 years to LOE
LUMISIGHT is in early growth phase post-approval with minimal established market share, signaling opportunity for rapid team expansion in commercial and quality functions.
Mechanism of Action
12.1 Mechanism of Action Pegulicianine is a prodrug that is optically inactive when intact and produces a fluorescent signal after its peptide chain is cleaved by cathepsins and matrix metalloproteases (MMPs). The levels of these enzymes are higher in and around tumor and tumor-associated cells…
Indications
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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.