{"entity":{"id":"renew-indocyanine-green","kind":"drug","name":"Indocyanine green (Renew Pharmaceuticals)","aka":["ICG","Diagnostic Green indocyanine green"],"tldr":"This is indocyanine green, a glowing dye, as developed by Renew Pharmaceuticals for liver cancer. The FDA has given it orphan drug status as a diagnostic for managing hepatocellular carcinoma, the commonest liver cancer.","summary":"Renew Pharmaceuticals supplies indocyanine green imaging agents under the Diagnostic Green brand. On 30 September 2026 the FDA granted orphan drug designation to indocyanine green as a diagnostic for the management of hepatocellular carcinoma (HCC), sponsored by Renew Pharmaceuticals Limited. A designation is not an approval, and the record does not describe the planned use or trials; this record carries the designation only.","asOf":"2026-11-04","links":[{"label":"FDA orphan designation record","url":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1100325"},{"label":"Renew Pharmaceuticals","url":"https://renewpharmaceuticals.com/"}],"tags":["pipeline","orphan-designation"],"related":[],"cancers":["hcc"],"sections":[],"technologies":["fluorescence-guided-surgery"],"targets":[],"drugs":[],"companies":["renew-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo startup monitors","editedOn":"2026-11-04"},"modality":"Near-infrared fluorescence imaging agent","mechanism":"Indocyanine green is a dye that fluoresces under near-infrared light; given into a vein it is taken up and cleared by the liver, which is the property used to show liver tissue and tumours during surgery.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2026-09-30","type":"designation","region":"US","note":"FDA orphan drug designation of indocyanine green as a diagnostic in hepatocellular carcinoma, granted to Renew Pharmaceuticals Limited","source":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1100325","indication":"as a diagnostic for the management of hepatocellular carcinoma (HCC)"}]},"route":"/drugs/renew-indocyanine-green/","neighbours":{"cancer":[{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"}],"technology":[{"id":"fluorescence-guided-surgery","kind":"technology","name":"Fluorescence-guided surgery","route":"/technologies/fluorescence-guided-surgery/"}],"company":[{"id":"renew-pharmaceuticals","kind":"company","name":"Renew Pharmaceuticals","route":"/companies/renew-pharmaceuticals/"}]}}