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 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LUMISIGHT (pegulicianine) is a fluorescent prodrug administered intravenously that activates in the tumor microenvironment through cleavage by cathepsins and matrix metalloproteases to emit near-infrared fluorescence at 675 nm peak emission. The mechanism enables real-time optical visualization of tumors and tumor-associated tissue during surgical procedures. Patient populations include those undergoing cancer surgery where intraoperative tumor identification and margin delineation are clinically relevant.
Growth7.9 years to LOE
Early-stage commercial build-out with minimal current market penetration; Account Executive and Commercial Marketing Manager roles indicate active field and marketing team expansion post-approval.
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.