Cytalux

(CYTALUX™ (pafolacianine) injection preoperatively)

Small molecule

OOn Target Laboratories, LLC

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Timeline

Expected Milestones

Q4 2027

Phase 2Recruiting

Intraoperative

NCT07039526

Clinical

Trials by Indication[1]

Intraoperative1 trial

Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer.

Recruiting·JJohn Waters·Phase 2·NCT07039526·50 enrolled

Regulatory

FDA Approval Timeline[3]

Nov 29, 2021

CYTALUX

NDA NDA214907

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for CYTALUX™ (pafolacianine) injection preoperatively. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — CYTALUX™ (pafolacianine) injection preoperatively compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA214907). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Cytalux. U.S. Food & Drug Administration.
[5]
SEC EDGAR — On Target Laboratories, LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: OOn Target Laboratories, LLC

Patent Landscape[4]

Patent Cliff

Aug 26, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9333270Aug 26, 2033

9061057Aug 26, 2033

10881747Aug 26, 2033

9789208Aug 26, 2033

9341629Aug 26, 2033

1 more patents

9254341Oct 4, 2033