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Cytalux (PAFOLACIANINE)
Cytalux (PAFOLACIANINE) is a small molecule optical imaging agent developed by On Target Laboratories, Inc. and currently owned by On Target Labs. It targets the folate receptor alpha and is FDA-approved for imaging ovarian cancer and malignant lesions. Cytalux is a patented product with no generic manufacturers available. Key safety considerations include its use as an imaging agent, and its potential effects on patients with certain medical conditions.
At a glance
| Generic name | PAFOLACIANINE |
|---|---|
| Sponsor | On Target Labs |
| Drug class | Optical Imaging Agent |
| Target | Folate receptor alpha |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2021 |
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)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
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
- On Target Labs portfolio CI