Drugs / pafolacianine
pafolacianine
also known as
OTL38 · CYTALUX · CYTALUX (pafolacianine) injection · OTL 0038 · OTL 0038 SODIUM · OTL 38 SODIUM · OTL-0038 TETRASODIUM · OTL-38 TETRASODIUM · +2 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | CYTALUX | — | 2022-12-16 | fda.gov ↗ |
| Approved | US (FDA) | CYTALUX | — | 2021-11-29 | fda.gov ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT07278986 | Oct 2025 → Oct 2027 expected | endometrial cancer | Abramson Cancer Center at Penn Medicine | Recruiting | No outcome recorded |
| Phase 0 | NCT06511037 | Nov 2024 → Nov 2026 expected | digestive system cancer, peritoneal carcinomatosis | University of California, Irvine | Recruiting | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT06235125 | Apr 2024 → Aug 2026 overdue | osteosarcoma | Ann & Robert H Lurie Children's Hospital of Chicago | Recruiting | No outcome recorded |
| Phase 1 | NCT04941378 | May 2022 | ovarian cancer | Abramson Cancer Center at Penn Medicine | Withdrawn | No outcome recorded |
| Phase 1 | NCT02629549 | Oct 2015 → Aug 2018 | pituitary tumor | University of Pennsylvania | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02602119 | May 2015 → May 2022 | neoplasm | University of Pennsylvania | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07039526 | Aug 2025 → Dec 2027 expected | esophageal cancer, female reproductive organ cancer | John Waters | Recruiting | No outcome recorded |
| Phase 2 | NCT06434909 | Sep 2024 → Sep 2025 | prostate cancer | Indiana University | Completed | No outcome recorded |
| Phase 2 | NCT02872701 | May 2017 → Oct 2018 | lung cancer | On Target Laboratories, LLC | Completed | No outcome recorded |
| Phase 2 | NCT02317705 | Dec 2014 → Nov 2015 | ovarian cancer | On Target Laboratories, LLC | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT06915727 | Apr 2025 → May 2027 expected | childhood malignant neoplasm, malignant tumor of neck | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 3 | NCT04241315 | Mar 2020 → Oct 2021 | lung cancer | On Target Laboratories, LLC | Completed | No outcome recorded |
| Phase 3 | NCT03180307 | Jan 2018 → Apr 2020 | ovarian cancer | On Target Laboratories, LLC | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT07469202 | May → Nov 2026 expected | lung cancer, ovarian cancer | On Target Laboratories, LLC | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07124351 | Sep 2025 → Aug 2026 overdue | appendix cancer, esophageal cancer, gastric cancer | Cedars-Sinai Medical Center | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02645409 | Dec 2015 → Mar 2018 | renal cell carcinoma | Chandru Sundaram | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2025-06-01 | On Target Laboratories, LLC | Results Real World Localization of Cancer in Lungs with CYTALUX ontargetlabs.com ↗ |
| 2025-05-19 | On Target Laboratories, LLC | Results New Study Shows CYTALUX® Clinical Trial Findings Translate to the Real World ontargetlabs.com ↗
The trial concluded that early post market experience with CYTALUX for cancer in the lung demonstrated a high rate of nodule localization. |
| 2025-02-13 | On Target Laboratories, LLC | Results On Target Cancer Innovation Featured in Two Journal Articles ontargetlabs.com ↗
The results showed CYTALUX identified 29 occult lesions in 23 (23%) participants. |
| 2024-12-18 | On Target Laboratories, LLC | Results Intraoperative Molecular Imaging With Pafolacianine: Histologic Characteristics of Identified Nodules ontargetlabs.com ↗ |
| 2024-12-12 | On Target Laboratories, LLC | Results New Case Report Demonstrates the Promise of CYTALUX In Detection and Resection of Metastatic Osteosarcoma Lesions ontargetlabs.com ↗
In one case, CYTALUX identified a pleural-based lesion that had not been previously noted under white light, and which was found to contain viable malignancy upon pathologic evaluation. |
| 2024-10-01 | On Target Laboratories, LLC | Results Intraoperative Molecular Imaging With Pafolacianine in Resection of Occult Pulmonary Malignancy in the ELUCIDATE Trial ontargetlabs.com ↗ |
| 2024-04-28 | On Target Laboratories, LLC | Results First Reported Real-World Use of Pafolacianine ontargetlabs.com ↗
Pafolacianine-IMI was detected and visualized in 22 of 25 patients (88%). |
| 2023-06-06 | On Target Laboratories, LLC | Regulatory CMS Issues Two New ICD-10 PCS Codes for CYTALUX® (pafolacianine) injection ontargetlabs.com ↗
On June 6, 2023, the Centers for Medicare & Medicaid Services published two new ICD-10-PCS codes for CYTALUX® (pafolacianine) injection, in ovarian and lung cancer surgery for use beginning October 1, 2023. |
All press releases naming this drug 9 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | pafolacianine | “A Phase III Study of Pafolacianine Injection (OTL38) for Intraoperative Imaging of Folate Receptor-Positive Ovarian Cancer (Study 006).” PMID 36070540 ↗ Sep 20228“CYTALUX (Pafolacianine) as a diagnostic tool during cancer resection has already been investigated in adults (approved NDA 214907)” NCT06235125 ↗ |
| Known as | CYTALUX | “The research study is being done to assess the safety and ability of an investigational drug called CYTALUX (pafolacianine) and a special camera system for the detection of...” NCT07278986 ↗6“Cytalux™ (pafolacianine) injection: folate analog ligand conjugated with an indole cyanine green-like dye for real-time cancer margin status.” NCT06434909 ↗ “CYTALUX™ (pafolacianine) is an intravenously administered imaging agent developed by On Target Laboratories, Inc.” NCT07039526 ↗ “Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging” NCT06511037 ↗ “CYTALUX™ (pafolacianine) injection” NCT07124351 ↗ “CYTALUX (pafolacianine) injection” NCT07469202 ↗ |
| Known as | CYTALUX (pafolacianine) injection | “CYTALUX™ (pafolacianine) injection” NCT04241315 ↗ |
| Known as | OTL 0038 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297412 ↗ |
| Known as | OTL 0038 SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297412 ↗ |
| Known as | OTL 38 SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297412 ↗ |
| Known as | OTL-0038 TETRASODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297412 ↗ |
| Known as | OTL-38 TETRASODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297412 ↗ |
| Known as | OTL38 | “A Phase III Study of Pafolacianine Injection (OTL38) for Intraoperative Imaging of Folate Receptor-Positive Ovarian Cancer (Study 006).” PMID 36070540 ↗ Sep 2022 |
| Known as | Pafolacianine Sodium | “Drug: Pafolacianine Sodium” NCT06915727 ↗ |
| Known as | Pafolacianine tetrasodium | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297412 ↗ |
| Modality | Diagnostic / imaging agent | “OTL38 for Intra-operative Imaging” NCT02317705 ↗ |
| Route | Other | “Infusion of OTL38 prior to surgery” NCT02602119 ↗ |