{"id":"otl38-for-injection","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Anemia"},{"rate":null,"effect":"Thrombocytopenia"},{"rate":null,"effect":"Peripheral neuropathy"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"OTL38 consists of a humanized monoclonal antibody against folate receptor alpha conjugated to a cytotoxic agent. The antibody binds to folate receptor alpha, which is overexpressed on many cancer cells, allowing selective delivery of the cytotoxic payload to tumor cells while sparing normal tissues. This targeted approach aims to improve efficacy and reduce systemic toxicity compared to conventional chemotherapy.","oneSentence":"OTL38 is a folate receptor alpha-targeted immunoconjugate that delivers a cytotoxic payload to cancer cells expressing folate receptor alpha.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:25:03.004Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Ovarian cancer (folate receptor alpha positive)"},{"name":"Non-small cell lung cancer (folate receptor alpha positive)"},{"name":"Triple-negative breast cancer (folate receptor alpha positive)"}]},"trialDetails":[{"nctId":"NCT06235125","phase":"PHASE1","title":"Safety and Feasibility of Intraoperative Visualization With Cytalux in Children","status":"RECRUITING","sponsor":"Ann & Robert H Lurie Children's Hospital of Chicago","startDate":"2024-04-08","conditions":"Osteosarcoma, Pulmonary Metastasis, Fluorescence","enrollment":10},{"nctId":"NCT02872701","phase":"PHASE2","title":"OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules","status":"COMPLETED","sponsor":"On Target Laboratories, LLC","startDate":"2017-05-04","conditions":"Lung Neoplasms, Lung Cancer","enrollment":100},{"nctId":"NCT04241315","phase":"PHASE3","title":"ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting","status":"COMPLETED","sponsor":"On Target Laboratories, LLC","startDate":"2020-03-26","conditions":"Lung Neoplasms, Lung Cancer","enrollment":112},{"nctId":"NCT04941378","phase":"PHASE1","title":"OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer","status":"WITHDRAWN","sponsor":"Abramson Cancer Center at Penn Medicine","startDate":"2022-05-28","conditions":"Ovarian Cancer","enrollment":""},{"nctId":"NCT02317705","phase":"PHASE2","title":"Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer","status":"COMPLETED","sponsor":"On Target Laboratories, LLC","startDate":"2014-12","conditions":"Ovarian Cancer","enrollment":48},{"nctId":"NCT03180307","phase":"PHASE3","title":"OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer","status":"COMPLETED","sponsor":"On Target Laboratories, LLC","startDate":"2018-01-26","conditions":"Ovarian Cancer","enrollment":140},{"nctId":"NCT02629549","phase":"PHASE1","title":"Intraoperative Imaging of Pituitary Adenomas by OTL","status":"TERMINATED","sponsor":"University of Pennsylvania","startDate":"2015-10","conditions":"Neoplasms, Pituitary Neoplasms","enrollment":33}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["OTL38","CYTALUX™ (pafolacianine) injection"],"phase":"phase_3","status":"active","brandName":"OTL38 for Injection","genericName":"OTL38 for Injection","companyName":"On Target Laboratories, LLC","companyId":"on-target-laboratories-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"OTL38 for Injection is being studied in a Phase 2 clinical trial for the intraoperative imaging of folate receptor positive lung nodules in patients with Lung Neoplasms, Lung Cancer, Ovarian Cancer, Neoplasms, and Pituitary Neoplasms. The study involves a single dose of OTL38 for Injection and near infrared camera imaging system, in addition to endoscopic or thoracic surgery.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}