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SKL35501 is an experimental radioactive medicine from SK Life Science that seeks out tumour cells carrying the NTSR1 receptor and irradiates them from close range. It is in a first trial in people, and the FDA has given it orphan drug status for pancreatic cancer.
SKL35501 (FL-091) is SK Life Science's alpha-emitter radiopharmaceutical targeting neurotensin receptor 1 (NTSR1). The company describes a first-in-human, open-label, multicentre phase 1 study of safety, dose range and biologically active dose in advanced solid tumours expressing NTSR1, in the United States and South Korea; ClinicalTrials.gov lists it as NCT07812805, with the imaging agent SKL35502, in selected advanced solid tumours including colorectal, pancreatic ductal, biliary tract, gastric, oesophageal and head and neck squamous cell cancers. On 5 October 2026 the FDA granted orphan drug designation for the treatment of pancreatic cancer to 225Ac chelated with SKL35500.
An NTSR1-targeting ligand (SKL35500) linked through a DOTA chelator to the alpha emitter actinium-225, so that tumour cells carrying the neurotensin receptor 1 receive a short-range, high-energy radiation dose, as the FDA record and the developer describe it.
1.SKL35501 binds its target on the cancer cell or is taken up by it.
treatment of pancreatic cancer
FDA orphan drug designation for pancreatic cancer, granted to SK Life Science for actinium-225 chelated with the NTSR1-targeting ligand SKL35500 source
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Query for this drug: (TITLE:"SKL35501" OR ABSTRACT:"SKL35501" OR TITLE:"FL-091" OR ABSTRACT:"FL-091" OR TITLE:"225Ac-SKL35500" OR ABSTRACT:"225Ac-SKL35500") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about SKL35501, not a curated reading list.
Shares the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
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