ArticleBritish journal of clinical pharmacology2026
Pharmacokinetics, safety, tolerability and fluorescence imaging of nizaracianine triflutate administered in three divided doses to healthy volunteers.
Article in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Pharmacokinetics, safety, tolerability and fluorescence imaging of nizaracianine triflutate administered in three divided doses to healthy volunteers.British journal of clinical pharmacology · 2026Article
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimFluorescence-guided surgery enhances intraoperative visualization of anatomical structures. Nizaracianine is a near-infrared fluorescent agent that is exclusively renally cleared in animal models. It enables real-time ureteral imaging and identification, potentially reduces risk of injury and facilitates assessment before surgical closure. While a single dose has shown to be safe, repeated administration may be necessary during prolonged abdominopelvic procedures.
methodsThis Phase 1 study evaluated the safety, pharmacokinetics and fluorescence properties of repeated nizaracianine dosing in healthy volunteers. Participants received three doses at 0, 1 and 2 h across four dose cohorts: 3 × 0.5, 3 × 1.0, 3 × 2.5 and 3 × 5.0 mg. Safety assessments included vital signs, electrocardiography and laboratory testing. Plasma and urine samples were collected to determine pharmacokinetics. A Foley catheter was used for urine collection and measurement of fluorescence intensity over time.
resultsTwenty-one participants were included in the final analysis. Thirty-six adverse events were reported, mostly related to catheter placement. Nine events were possibly related to nizaracianine. In all cohorts, geometric means of C
conclusionRepeated intravenous doses of nizaracianine were well tolerated. PK suggests dose proportionality for C
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