Last reviewed · How we verify
Cytalux
At a glance
| Generic name | Cytalux |
|---|---|
| Also known as | Pafolacianine injection, OTL38 injection |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago |
| Target | Folate receptor alpha |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Imaging ovarian cancer and malignant lesions
Common side effects
- Nausea
- Vomiting
- Abdominal pain
- Flushing
- Dyspepsia
- Chest discomfort
- Pruritus
- Hypersensitivity
Key clinical trials
- CYTALUX Dose Extension Study (PHASE4)
- PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis (EARLY_PHASE1)
- CYTALUX for Intraoperative Imaging of Patients With Endometrial Cancer (EARLY_PHASE1)
- CYTALUX™for the Intraoperative Imaging of Prostate Cancer (PHASE2)
- An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors (PHASE3)
- Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer. (PHASE2)
- Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™) (PHASE4)
- Safety and Feasibility of Intraoperative Visualization With Cytalux in Children (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cytalux CI brief — competitive landscape report
- Cytalux updates RSS · CI watch RSS
- Ann & Robert H Lurie Children's Hospital of Chicago portfolio CI