Pafolacianine

Generic Name: Pafolacianine

Drug Type: Small Molecule

Chemical Formula: C_₆₁H_₆₇N_₉O_₁₇S_₄

CAS Number: 1628423-76-6

Unique Ingredient Identifier: F7BD3Z4X8L

Background: 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

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

Phase 3

Recruiting

Conditions: Childhood Malignant Solid Neoplasm
Childhood Malignant Thoracic Neoplasm
Malignant Neck Neoplasm
Malignant Abdominal Neoplasm
Malignant Pelvic Neoplasm
Metastatic Childhood Malignant Solid Neoplasm

Interventions: Procedure: Biospecimen Collection
Procedure: Near Infrared Imaging
Drug: Pafolacianine Sodium
Procedure: Surgical Procedure

First Posted Date: 2025-04-08

Last Posted Date: 2025-04-17

Lead Sponsor: Mayo Clinic

Target Recruit Count: 20

Registration Number: NCT06915727

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis

Early Phase 1

Recruiting

Conditions: Gastrointestinal Cancer
Peritoneal Carcinomatosis

Interventions: Drug: Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging

First Posted Date: 2024-07-19

Last Posted Date: 2025-02-11

Lead Sponsor: University of California, Irvine

Target Recruit Count: 10

Registration Number: NCT06511037

Locations: 🇺🇸
Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, California, United States

Safety and Feasibility of Intraoperative Visualization With Cytalux in Children

Phase 1

Recruiting

Conditions: Osteosarcoma
Pulmonary Metastasis
Fluorescence
Pediatrics
Metastatic Sarcoma

Interventions: Drug: Cytalux

First Posted Date: 2024-01-31

Last Posted Date: 2024-08-22

Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Target Recruit Count: 10

Registration Number: NCT06235125

Locations: 🇺🇸
Ann & Robert H. Lurie Children's Hospital, Chicago, Illinois, United States

OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer

Phase 1

Withdrawn

Conditions: Ovarian Cancer

Interventions: Drug: OTL38
Device: intraoperative imaging camera system

First Posted Date: 2021-06-28

Last Posted Date: 2022-06-27

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Registration Number: NCT04941378

Locations: 🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer

Phase 3

Completed

Conditions: Ovarian Cancer

Interventions: Drug: OTL38
Procedure: laparotomy
Device: near infrared camera imaging system

First Posted Date: 2017-06-08

Last Posted Date: 2022-02-04

Lead Sponsor: On Target Laboratories, LLC

Target Recruit Count: 140

Registration Number: NCT03180307

Locations: 🇺🇸
University of Arizona, Tucson, Arizona, United States
🇺🇸
Mayo Clinic-Rochester, Rochester, Minnesota, United States
🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States

and more 8 locations

Solid Tumor Cancer Surgery With or Without Intraoperative Imaging: A Registry

Completed

Conditions: Bladder Cancer
Gastric Cancer

First Posted Date: 2016-08-02

Last Posted Date: 2021-06-18

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 291

Registration Number: NCT02852252

Locations: 🇺🇸
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma

Not Applicable

Completed

Conditions: Renal Cell Carcinoma

Interventions: Drug: OTL38
Device: Intraoperative fluorescence imaging system

First Posted Date: 2016-01-01

Last Posted Date: 2020-02-25

Lead Sponsor: Chandru Sundaram

Target Recruit Count: 14

Registration Number: NCT02645409

Locations: 🇺🇸
Indiana University Health Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
🇺🇸
Indiana University Health Hospital, Indianapolis, Indiana, United States

Intraoperative Imaging of Pituitary Adenomas by OTL

Phase 1

Terminated

Conditions: Neoplasms
Pituitary Neoplasms

Interventions: Drug: OTL38

First Posted Date: 2015-12-14

Last Posted Date: 2019-08-06

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 33

Registration Number: NCT02629549

Locations: 🇺🇸
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Intraoperative Imaging of Pulmonary Nodules by OTL38

Phase 1

Completed

Conditions: Neoplasms

Interventions: Drug: OTL38

First Posted Date: 2015-11-11

Last Posted Date: 2022-06-28

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 262

Registration Number: NCT02602119

Locations: 🇺🇸
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer

Phase 2

Completed

Conditions: Ovarian Cancer

Interventions: Drug: OTL38
Device: Near infrared camera imaging system
Procedure: Laparotomy

First Posted Date: 2014-12-16

Last Posted Date: 2022-06-21

Lead Sponsor: On Target Laboratories, LLC

Target Recruit Count: 48

Registration Number: NCT02317705

Locations: 🇺🇸
University of CA at Irvine Chao Cancer Center, Orange, California, United States
🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
Mayo Clinic-Rochester, Rochester, Minnesota, United States

and more 1 locations

Drug Development Updates

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