CYTALUX (pafolacianine sodium)
CYTALUX is indicated for the treatment of Ovarian Cancer; Lung Cancer.
Details
- Status
- Prescription
- First Approved
- 2021-11-29
- Patent Cliff
- 2033
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
CYTALUX Approval History
What CYTALUX Treats
2 indicationsCYTALUX is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ovarian Cancer
- Lung Cancer
CYTALUX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in CYTALUX's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CYTALUX treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to CYTALUX
3 of 14FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06915727 | MC250701 24-012249 | Ph 3 | recruiting | An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors |
| NCT06235125 Cytalux | 2023-6263 | Ph 1 | recruiting | Safety and Feasibility of Intraoperative Visualization With Cytalux in Children |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CYTALUX FDA Label Details
Indications & Usage
FDA Label (PDF)CYTALUX is indicated for the treatment of Ovarian Cancer; Lung Cancer.
CYTALUX Patents & Exclusivity
Patents (6 active)
Exclusivity
Pro Intelligence Preview
Deep insights for CYTALUX
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 6 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 14 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.