Pafolacianine

Overview

Pafolacianine, or OTL38, is a folate analogue conjugated with a fluorescent dye that absorbs light in the near-infrared (NIR) spectrum within a range of 760 nm to 785 nm, with a peak absorption of 776 nm. It emits fluorescence within a range of 790 nm to 815 nm with a peak emission of 796 nm. The longer wavelength allows for deeper penetration of the fluorescent light through tissues for better imaging and detection of tumours. Pafolacianine targets the folate receptor alpha (FRα) which is upregulated in numerous epithelial malignancies. On November 29, 2021, the FDA approved pafolacianine as an adjunct imaging agent for intraoperative identification of malignant lesions in adult patients with ovarian cancer. It is currently under investigation for use in FRα-positive pituitary adenoma, lung cancer, and renal-cell carcinoma, which is thought to be the second-highest folate receptor-expressing cancer.

Indication

Pafolacianine is an optical imaging agent indicated in adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions.

Associated Conditions

Malignant Lesions

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors	2025/04/08	NCT06915727	Phase 3	Recruiting	Mayo Clinic
PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis	2024/07/19	NCT06511037	Early Phase 1	Recruiting	University of California, Irvine
Safety and Feasibility of Intraoperative Visualization With Cytalux in Children	2024/01/31	NCT06235125	Phase 1	Recruiting	Ann & Robert H Lurie Children's Hospital of Chicago
OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer	2021/06/28	NCT04941378	Phase 1	Withdrawn	Abramson Cancer Center at Penn Medicine
OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer	2017/06/08	NCT03180307	Phase 3	Completed	On Target Laboratories, LLC
Solid Tumor Cancer Surgery With or Without Intraoperative Imaging: A Registry	2016/08/02	NCT02852252	N/A	Completed	University of Pennsylvania
Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma	2016/01/01	NCT02645409	Not Applicable	Completed	Chandru Sundaram
Intraoperative Imaging of Pituitary Adenomas by OTL	2015/12/14	NCT02629549	Phase 1	Terminated	University of Pennsylvania
Intraoperative Imaging of Pulmonary Nodules by OTL38	2015/11/11	NCT02602119	Phase 1	Completed	University of Pennsylvania
Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer	2014/12/16	NCT02317705	Phase 2	Completed	On Target Laboratories, LLC

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Cytalux	On Target Laboratories, Inc.	81052-138	INTRAVENOUS	3.2 mg in 1.6 mL	7/12/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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