{"entity":{"id":"pegylated-liposomal-doxorubicin","kind":"drug","name":"Pegylated liposomal doxorubicin","aka":[],"tldr":"Doxorubicin wrapped in a fatty bubble so it reaches tumours with less heart damage; a workhorse of relapsed ovarian cancer.","summary":"Approved 1995 (Kaposi sarcoma) and 1999 for platinum-refractory ovarian cancer. Standard single agent or partner (with carboplatin in CALYPSO, with trabectedin in OVA-301, with bevacizumab in AURELIA) in relapsed disease; the comparator arm in MIRASOL and KEYNOTE-B96. Hand-foot syndrome and mucositis replace the alopecia and cardiotoxicity of free doxorubicin.\n\nIt was invented in Jerusalem. Yechezkel Barenholz's Laboratory of Membrane and Liposome Research at the Hebrew University, with the clinician Alberto Gabizon, combined three unrelated ideas: a polyethylene-glycol coat that keeps the liposome circulating and away from the reticuloendothelial system, remote loading of doxorubicin down a transmembrane ammonium sulfate gradient that holds the drug in and releases it at the tumour, and a bilayer kept in a liquid-ordered phase by a high-melting phosphatidylcholine with cholesterol. Licensed through the university's Yissum company, it became in 1995 the first nano-drug approved by any regulator; Barenholz's own retrospective sets out what the first twenty years taught.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Liposomal_doxorubicin","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Pegylated%20liposomal%20doxorubicin"},{"label":"Barenholz, Doxil, the first FDA-approved nano-drug: lessons learned (J Control Release 2012)","url":"https://doi.org/10.1016/j.jconrel.2012.03.020"}],"tags":[],"related":[],"cancers":["ovarian","multiple-myeloma","sarcoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":[],"companies":["cspc"],"institutions":["hebrew-university-of-jerusalem"],"pathways":[],"terms":[],"trials":["nct06072781","nct07604766","nct06619236","nct06014528","actuate-1801","nct04274426","nct07286266","nct07109414"],"people":["yechezkel-barenholz","alberto-gabizon"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Doxil / Caelyx","code":"PLD","modality":"Cytotoxic (liposomal anthracycline)","mechanism":"Topoisomerase II poisoning and DNA intercalation by doxorubicin, delivered by long-circulating PEGylated liposomes that extravasate in tumours.","approvals":[{"region":"US","year":1995,"indication":"AIDS-related Kaposi sarcoma after prior chemotherapy (Doxil, NDA 050718)"},{"region":"US","year":1999,"indication":"Ovarian cancer refractory to platinum and paclitaxel"}],"mechanismSteps":[],"dosing":{"route":"Intravenous","schedule":"40-50 mg/m² every 4 weeks (ovarian)","monitoring":"LVEF at cumulative doses; skin"},"toxicity":[{"event":"Palmar-plantar erythrodysaesthesia","anyGradePct":51,"grade3PlusPct":24,"note":"Doxil label, ovarian"},{"event":"Stomatitis","anyGradePct":41,"grade3PlusPct":8}],"access":[],"regulatoryEvents":[{"date":"1995-11-17","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Kaposi's sarcoma in AIDS patients with disease progression on prior combination chemotherapy or who are intolerant to such therapy"},{"date":"1999-06-28","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Metastatic ovarian carcinoma refractory to paclitaxel and platinum-based chemotherapy"},{"date":"2005-01-28","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 1999 converted to traditional approval 5.6 years after it was granted.","indication":"Metastatic ovarian carcinoma refractory to paclitaxel and platinum-based chemotherapy"},{"date":"2008-06-10","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 1995 converted to traditional approval 12.6 years after it was granted.","indication":"Kaposi's sarcoma in AIDS patients with disease progression on prior combination chemotherapy or who are intolerant to such therapy"}]},"route":"/drugs/pegylated-liposomal-doxorubicin/","neighbours":{"cancer":[{"id":"angiosarcoma","kind":"cancer","name":"Angiosarcoma","route":"/cancers/angiosarcoma/"},{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"},{"id":"kaposi-sarcoma","kind":"cancer","name":"Kaposi sarcoma","route":"/cancers/kaposi-sarcoma/"},{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"mycosis-fungoides","kind":"cancer","name":"Mycosis fungoides","route":"/cancers/mycosis-fungoides/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"platinum-resistant-ovarian-cancer","kind":"cancer","name":"Platinum-resistant ovarian cancer","route":"/cancers/platinum-resistant-ovarian-cancer/"},{"id":"platinum-sensitive-ovarian-cancer","kind":"cancer","name":"Platinum-sensitive ovarian cancer","route":"/cancers/platinum-sensitive-ovarian-cancer/"},{"id":"sarcoma","kind":"cancer","name":"Sarcomas (soft tissue, bone, GIST)","route":"/cancers/sarcoma/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"anthracycline-cardioprotection","kind":"technology","name":"Protecting the heart during anthracycline treatment: dexrazoxane, beta blockers and ACE inhibitors","route":"/technologies/anthracycline-cardioprotection/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"company":[{"id":"cspc","kind":"company","name":"CSPC Pharmaceutical Group","route":"/companies/cspc/"}],"institution":[{"id":"hebrew-university-of-jerusalem","kind":"institution","name":"Hebrew University of Jerusalem","route":"/institutions/hebrew-university-of-jerusalem/"}],"trial":[{"id":"nct06072781","kind":"trial","name":"A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer","route":"/trials/nct06072781/"},{"id":"nct07286266","kind":"trial","name":"A Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer (BEHOLD-Ovarian01)","route":"/trials/nct07286266/"},{"id":"actuate-1801","kind":"trial","name":"Actuate 1801 Part 3B (elraglusib)","route":"/trials/actuate-1801/"},{"id":"nct07604766","kind":"trial","name":"An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Can","route":"/trials/nct07604766/"},{"id":"aurelia","kind":"trial","name":"AURELIA","route":"/trials/aurelia/"},{"id":"nct06014528","kind":"trial","name":"IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurren","route":"/trials/nct06014528/"},{"id":"nct06787612","kind":"trial","name":"Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer","route":"/trials/nct06787612/"},{"id":"nct04274426","kind":"trial","name":"Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer","route":"/trials/nct04274426/"},{"id":"nct05271318","kind":"trial","name":"Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab (Phase 1a) and Pegylated Liposomal Doxorubicin (Phase 1b) ","route":"/trials/nct05271318/"},{"id":"nct03268382","kind":"trial","name":"p53 Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Study of PLD With APR-246","route":"/trials/nct03268382/"},{"id":"nct05870748","kind":"trial","name":"REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1","route":"/trials/nct05870748/"},{"id":"nct06619236","kind":"trial","name":"Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer","route":"/trials/nct06619236/"},{"id":"nct07109414","kind":"trial","name":"Trial of NP-G2-044 (Prilukae) Combined With PLD for Treatment of Platinum-Resistant Ovarian Cancer (ULTIMUS-1)","route":"/trials/nct07109414/"}],"person":[{"id":"alberto-gabizon","kind":"person","name":"Alberto Gabizon","route":"/people/alberto-gabizon/"},{"id":"yechezkel-barenholz","kind":"person","name":"Yechezkel Barenholz","route":"/people/yechezkel-barenholz/"}]}}