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In December 2017, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorization for the treatment of multiple myeloma. In July 2025, PharmaMar withdrew its application for a marketing authorization of Aplidin for the treatment of multiple myeloma."},"commercial":{},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=plitidepsin","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=plitidepsin","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://en.wikipedia.org/wiki/Plitidepsin","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-31T10:21:43.703790","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:08:26.852080+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"plitidepsin","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06766825","phase":"PHASE2","title":"Study to Evaluate the Efficacy and Safety of Plitidepsin in Adults with Post-COVID-19 Condition (PCC)","status":"RECRUITING","sponsor":"Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia","startDate":"2025-02-07","conditions":["Post COVID-19 Condition","Long COVID Syndrome","Persistent COVID-19","Persistent COVID Condition","Long COVID"],"enrollment":90,"completionDate":"2026-06-01"},{"nctId":"NCT04784559","phase":"PHASE3","title":"Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection","status":"TERMINATED","sponsor":"PharmaMar","startDate":"2021-06-04","conditions":["COVID-19 Infection"],"enrollment":205,"completionDate":"2023-03-01"},{"nctId":"NCT05121740","phase":"PHASE1,PHASE2","title":"Extension Study in a Cohort of Adult Patients With COVID-19 Infection","status":"COMPLETED","sponsor":"PharmaMar","startDate":"2022-01-25","conditions":["COVID-19 Infection"],"enrollment":34,"completionDate":"2022-03-16"},{"nctId":"NCT05705167","phase":"PHASE2","title":"Plitidepsin Versus Control in Immunocompromised Adult Participants With Symptomatic COVID-19 Requiring Hospital Care (NEREIDA)","status":"TERMINATED","sponsor":"PharmaMar","startDate":"2023-04-19","conditions":["COVID-19"],"enrollment":37,"completionDate":"2024-04-19"},{"nctId":"NCT04382066","phase":"PHASE1","title":"Proof of Concept Study to Evaluate the Safety Profile of Plitidepsin in Patients With COVID-19","status":"COMPLETED","sponsor":"PharmaMar","startDate":"2020-05-12","conditions":["COVID-19"],"enrollment":46,"completionDate":"2020-11-26"},{"nctId":"NCT01876043","phase":"PHASE2","title":"Efficacy and Safety of Plitidepsin in Patients With Advanced Unresectable or Metastatic, Relapsed/Refractory, Dedifferentiated Liposarcoma (DLPS): an Exploratory Phase II Multicenter Trial","status":"TERMINATED","sponsor":"Institut Bergonié","startDate":"2012-02","conditions":["Adult Patients With Unresectable Locally Advanced or Metastatic, Relapsed/Refractory Dedifferentiated Liposarcoma"],"enrollment":24,"completionDate":"2015-04"},{"nctId":"NCT03117361","phase":"PHASE2","title":"Trial of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Multiple Myeloma Patients Double Refractory to Bortezomib and Lenalidomide","status":"TERMINATED","sponsor":"PharmaMar","startDate":"2017-05-08","conditions":["Multiple Myeloma"],"enrollment":10,"completionDate":"2018-07-30"},{"nctId":"NCT00780975","phase":"PHASE2","title":"A Study of Aplidin ( Plitidepsin) in Subjects With Advanced Prostate Cancer","status":"TERMINATED","sponsor":"PharmaMar","startDate":"2005-02","conditions":["Prostate Cancer"],"enrollment":8,"completionDate":"2008-03"},{"nctId":"NCT01102426","phase":"PHASE3","title":"Aplidin - Dexamethasone in Relapsed/Refractory Myeloma","status":"COMPLETED","sponsor":"PharmaMar","startDate":"2010-06","conditions":["Relapsed/Refractory Multiple Myeloma"],"enrollment":255,"completionDate":"2017-11"},{"nctId":"NCT03070964","phase":"PHASE2","title":"A Study of Plitidepsin in Patients With Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma","status":"TERMINATED","sponsor":"PharmaMar","startDate":"2016-10-25","conditions":["Lymphoma"],"enrollment":14,"completionDate":"2018-07"},{"nctId":"NCT02100657","phase":"PHASE1","title":"Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma","status":"COMPLETED","sponsor":"PharmaMar","startDate":"2014-06","conditions":["Multiple Myeloma"],"enrollment":39,"completionDate":"2018-06"},{"nctId":"NCT01149681","phase":"PHASE2","title":"Clinical Trial of Aplidin® in Patients With Primary Myelofibrosis","status":"COMPLETED","sponsor":"PharmaMar","startDate":"2010-07","conditions":["Myelofibrosis"],"enrollment":12,"completionDate":"2011-02"},{"nctId":"NCT00780143","phase":"PHASE1,PHASE2","title":"Clinical Study of Plitidepsin (Aplidin®) in Combination With Cytarabine in Patients With Relapsed/Refractory Leukemia","status":"TERMINATED","sponsor":"PharmaMar","startDate":"2007-11","conditions":["Relapsed/Refractory Leukemia"],"enrollment":3,"completionDate":"2009-06"},{"nctId":"NCT00884286","phase":"PHASE2","title":"Multicenter Trial to Treat Patients With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma","status":"COMPLETED","sponsor":"PharmaMar","startDate":"2004-12","conditions":["Leukemia","Lymphoma"],"enrollment":67,"completionDate":"2010-06"},{"nctId":"NCT00788099","phase":"PHASE1","title":"Study of Plitidepsin in Combination With Sorafenib or Gemcitabine in Patients With Advanced Solid Tumors or Lymphomas","status":"COMPLETED","sponsor":"PharmaMar","startDate":"2008-12","conditions":["Advanced Solid Tumors","Lymphomas"],"enrollment":45,"completionDate":"2011-06"},{"nctId":"NCT00229203","phase":"PHASE2","title":"A Study of Aplidin (Plitidepsin) 3 h iv in Subjects With Relapsing or Refractory Multiple Myeloma","status":"COMPLETED","sponsor":"PharmaMar","startDate":"2005-02","conditions":["Multiple Myeloma"],"enrollment":51,"completionDate":"2008-08"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"chemblId":"CHEMBL451930"},"formularyStatus":[],"_enricherVersion":"v2-openfda","developmentCodes":[],"ownershipHistory":[],"publicationCount":115,"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"recentPublications":[{"date":"2026 Mar 23","pmid":"41879493","title":"Marine-Derived Anticancer Compounds and their Clinical Status.","journal":"Anti-cancer agents in medicinal chemistry"},{"date":"2026 May","pmid":"41732213","title":"Exploring marine-derived compounds as potential anti-cancer agents: Mechanisms and therapeutic implications.","journal":"Cancer pathogenesis and therapy"},{"date":"2026 Jan 17","pmid":"41545603","title":"Plitidepsin in combination with dexamethasone (ADMYRE trial) versus an external control arm of pomalidomide plus dexamethasone in patients with relapsed/refractory multiple myeloma.","journal":"Annals of hematology"},{"date":"2025 Dec 23","pmid":"41277830","title":"Can plitidepsin be used as an antiviral against RSV?","journal":"mSphere"},{"date":"2025 Oct 29","pmid":"41228275","title":"Randomized Phase III Study (ADMYRE) of Plitidepsin in Combination with Dexamethasone vs. Dexamethasone Alone in Relapsed/Refractory Multiple Myeloma: Results for Patients Aged <75 Years.","journal":"Cancers"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","brandName":"PLITIDEPSIN","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"2018","aiSummary":"","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"EU","regulator":"EMA","status":"application withdrawn","approval_date":null,"mah":null,"brand_name_local":"Aplidin","application_number":"EMEA/H/C/004354"},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Aplidin","application_number":null},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":2,"withResults":1},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:08:26.852080+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"enriching","dataCompleteness":{"mechanism":false,"indications":false,"safety":false,"trials":true,"score":1}}