NDAINTRAVENOUSPOWDERPriority Review
Approved
Apr 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
LUMISIGHT (pegulicianine) by Lumicell is 12. First approved in 2024.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LUMISIGHT (pegulicianine) is an intravenous small-molecule prodrug that fluoresces in the near-infrared spectrum (675 nm peak emission) after enzymatic cleavage by tumor-associated cathepsins and matrix metalloproteases. It enables real-time surgical visualization of tumor tissue by converting an optically inactive molecule into fluorescent fragments at the site of disease. The mechanism exploits the elevated protease activity in and around tumors compared to normal tissue.
Growth8.1 years to LOE
Early-stage growth product with minimal competitive pressure and expanding intraoperative imaging market opportunity.
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.