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Cytalux

(CYTALUX (pafolacianine) injection)

Small molecule

OOn Target Laboratories, LLC

0

Indications

1

Total Trials

1

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Timeline

Expected Milestones

Q1 2027

ApprovedNot yet recruiting

Lung

NCT07469202

Clinical

Trials by Indication[1]

Lung1 trial

Prospective, Multi Center, Open Label Non Inferiority Trial Evaluating the Clinical Adequacy of Intraoperative Tumor Fluorescence With Cytalux™ (Pafolacianine) Across Two Preoperative Administration Windows in Adults Undergoing Surgery for Suspected Lung Cancer or Confirmed Ovarian Cancer

Not yet recruiting·OOn Target Laboratories, LLC·Approved·NCT07469202·106 enrolled

Regulatory

FDA Approval Timeline[3]

Nov 28, 2021

CYTALUX

NDA NDA214907

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for CYTALUX (pafolacianine) injection. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — CYTALUX (pafolacianine) injection compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA214907). U.S. Food & Drug Administration.
[4]
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

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