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Cytalux

(Pafolacianine Sodium)

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

Q2 2027

Phase 3Recruiting

Metastatic Solid Tumors

NCT06915727

Clinical

Trials by Indication[1]

Metastatic Solid Tumors1 trial

An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors

Recruiting·MMayo Clinic·Phase 3·NCT06915727·20 enrolled

Regulatory

FDA Approval Timeline[3]

Nov 29, 2021

CYTALUX

NDA NDA214907

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Pafolacianine Sodium. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Pafolacianine Sodium 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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