Drug updated on 6/2/2024

Dosage FormInjection (intravenous; 3.2 mg/1.6 mL (2 mg/mL))
Drug ClassOptical imaging agents
Ongoing and
Completed Studies


  • Indicated as an adjunct for intraoperative identification of malignant lesions in adult patients with ovarian cancer.
  • Indicated as an adjunct for intraoperative identification of malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung.

Latest News

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  • Pafolacianine (Cytalux) is a folate receptor-targeted fluorescent agent indicated for the intraoperative identification of malignant and non-malignant lesions in adult patients with suspected or confirmed cancer in the lung and ovarian cancer. It assists in revealing folate receptor α-positive cancers and potentially narrows surgical margins during operations.
  • A review of two randomized controlled trials was conducted to gather information on Cytalux. Only one study was relevant to Cytalux's clinical utility and safety profile; the other addressed unrelated ethical concerns related to Electronic Health Records (EHRs).
  • The study showed that Cytalux successfully identified occult synchronous malignant lesions not detected using traditional white light visualization methods. Specifically, it found 10 such lesions across 8 subjects (8%), most of which were outside the planned resection field.
  • No drug-related serious adverse events were reported according to the study, indicating that Cytalux has a favorable safety profile when used correctly during surgical procedures.
  • Compared with conventional methods like white light visualization and palpation, intraoperative molecular imaging with Cytalux improved surgical outcomes by identifying otherwise undetectable tumors and closer surgical margins. Without its assistance, primary nodules could not be located in 19 subjects (19%).
  • The use of Pafolacianine led to changes in the overall scope of surgery for 29 subjects - an increase for 22 individuals and a decrease for seven others, highlighting its potential impact on altering surgical strategy towards better patient outcomes.

Product Monograph / Prescribing Information

Document TitleYearSource
Cytalux (pafolacianine) Prescribing Information.2022On Target Laboratories, Inc., West Lafayette, IN

Randomized Controlled Trials

Document TitleSex DistributionYearSource
Pafolacianine for intraoperative molecular imaging of cancer in the lung: The ELUCIDATE trial.
Data not availableSubjects
F: null%
M: null%
2023The Journal of Thoracic and Cardiovascular Surgery
A phase III study of pafolacianine injection (otl38) for intraoperative imaging of folate receptor–positive ovarian cancer (study 006).
F: 100%
M: 0%
2022Journal of Clinical Oncology

Sex Distribution:

No Data



Source:The Journal of Thoracic and Cardiovascular Surgery

Sex Distribution:




Source:Journal of Clinical Oncology