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Pudexacianinium — ASP-5354

Pudexacianinium chloride (ASP5354) remains an investigational NIR fluorophore for ureteral visualization. Astellas' April 2026 pipeline lists phase III, and a 2026 primary pharmacokinetic paper describes phase III studies completed in 2025. An FDA approval or US prescribing label was not identified in this review. A substance identifier in an FDA database does not establish approval. Do not treat this agent as a routinely available replacement for indigo carmine.[1][2][3]

Mechanism and intended role​

Unlike IV ICG, which is predominantly hepatically cleared, pudexacianinium is excreted largely unchanged through the kidneys, primarily by glomerular filtration. It can therefore highlight the urinary ureteral lumen after IV administration. The purpose is to aid identification without retrograde catheter instillation; visualization alone does not establish prevention of ureteral injury or prove patency and tissue viability.[2][4]

Human evidence​

Albert 2023: a randomized dose-ranging phase II study enrolled 12 adults undergoing laparoscopic colorectal surgery. Successful visualization at 30 minutes and the end of surgery occurred in 2/3 at 0.3 mg, 5/6 at 1 mg and 3/3 at 3 mg. One drug-related grade-1 proteinuria event occurred; two serious events were not attributed to the drug. This small feasibility study cannot quantify rare harms or demonstrate fewer surgical injuries.[4]

Renal pharmacokinetics, 2026: a 28-participant phase I study used a single 3 mg IV study dose. Exposure rose with renal impairment; severe impairment produced approximately 3.69-fold AUC versus matched normal function. Tolerability in this small study does not establish a clinical renal-dosing schedule.[2]

Administration and limitations​

  • Research protocols govern dose, administration, eligibility and redosing. There is no verified US manufacturer prescribing regimen to recommend here.
  • Renal function affects exposure and urinary delivery; do not invent a “reduce dose in CKD” rule from pharmacokinetics alone.
  • Camera compatibility must be established for the specific device/protocol. NIR capability or the presence of Firefly, SPY or Rubina does not automatically establish compatibility or authorization for every fluorophore.
  • No routine price, formulary access or same-case sequencing with ICG is established here.
  • Large comparative studies with meaningful injury and patient outcomes are needed before calling this a standard of care.
AgentMain distinction
ICGIV perfusion imaging; direct urinary instillation is off-label
Indigo carmineBLUDIGO is a currently labeled IV aid for cystoscopic ureteral assessment
Methylene blueVisible dye; surgical applications are off-label and have important systemic safety concerns
Sodium fluoresceinOff-label urinary-efflux dye; ophthalmic indication is separately labeled

References​

1. Astellas Pharma. FY2025 supplementary documents; Rx+ pipeline as of April 2026, p21. Pipeline.

2. Effects of renal impairment on the pharmacokinetics, safety, and tolerability of pudexacianinium (ASP5354) after IV administration: a mechanistic exploration. Eur J Clin Pharmacol. 2026. doi:10.1007/s00228-026-04063-1.

3. FDA Substance Registration System. Pudexacianinium chloride; UNII D23R36L5QY. Record and approval-status caveat.

4. Albert M, Delgado-Herrera L, Paruch J, et al. Pudexacianinium (ASP5354) chloride for ureter visualization in participants undergoing laparoscopic, minimally invasive colorectal surgery. Surg Endosc. 2023;37:7336–7347. doi:10.1007/s00464-023-10193-9.