{"id":"darinaparsin","rwe":[{"pmid":"40457386","year":"2025","title":"Disulfidptosis in pediatric AML: a multi-omics approach to risk stratification and potential therapeutic strategy.","finding":"","journal":"Cancer cell international","studyType":"Clinical Study"},{"pmid":"39768226","year":"2024","title":"Harnessing Arsenic Derivatives and Natural Agents for Enhanced Glioblastoma Therapy.","finding":"","journal":"Cells","studyType":"Clinical Study"},{"pmid":"37794793","year":"2024","title":"Efficacy of darinaparsin for EBV-associated B-cell lymphoma in a heavily treated elderly patient with angioimmunoblastic T-cell lymphoma: a case report.","finding":"","journal":"Leukemia & lymphoma","studyType":"Clinical Study"},{"pmid":"37673618","year":"2023","title":"[Pharmacological profile and clinical study results of darinaparsin (DARVIAS(®) injection 135 ‍mg), an organic arsenic product, for relapsed or refractory peripheral t-cell lymphoma].","finding":"","journal":"Nihon yakurigaku zasshi. Folia pharmacologica Japonica","studyType":"Clinical Study"},{"pmid":"37380467","year":"2023","title":"Japanese subgroup analysis in the Asian phase II study of darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma.","finding":"","journal":"Journal of clinical and experimental hematopathology : JCEH","studyType":"Clinical Study"}],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Active","category":"status"},{"label":"Refractory peripheral T-cell lymphoma","category":"indication"},{"label":"Solasia Pharma K.K","category":"company"}],"phase":"discontinued","safety":{},"trials":[],"aliases":[],"company":"Solasia Pharma K.K","patents":[],"pricing":[],"allNames":"darvias","offLabel":[],"synonyms":["darinaparsin","darvias","ZIO-101"],"timeline":[{"date":"2022-06-20","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Solasia Pharma K.K)"}],"aiSummary":"Darvias (DARINAPARSIN) is a small molecule developed by Solasia Pharma K.K. It is used to treat refractory peripheral T-cell lymphoma, a type of blood cancer. The exact mechanism of action is not well understood, but it is believed to work by interfering with the cell's ability to produce proteins. Darvias is a patented medication, and its commercial status is owned by Solasia Pharma K.K. Key safety considerations include potential side effects such as neuropathy and myelosuppression.","approvals":[{"date":"2022-06-20","orphan":false,"company":"SOLASIA PHARMA K.K","regulator":"PMDA"}],"brandName":"Darvias","ecosystem":[{"indication":"Refractory peripheral T-cell lymphoma","otherDrugs":[{"name":"denileukin diftitox","slug":"denileukin-diftitox","company":"Eisai Inc"}],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","explanation":"Think of it like a cell's recycling center. GSTP1 helps the cell get rid of bad stuff, but Darvias blocks this process, causing the cell to accumulate toxic waste and eventually die. This can be effective against cancer cells, but it also affects healthy cells, leading to potential side effects.","oneSentence":"Darvias works by inhibiting the enzyme glutathione S-transferase pi (GSTP1), which is involved in the cell's detoxification process.","technicalDetail":"Darvias specifically targets the GSTP1 enzyme, which is overexpressed in certain cancer cells, leading to increased sensitivity to oxidative stress and ultimately cell death."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5685","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=DARINAPARSIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DARINAPARSIN","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T10:25:29.678776","biosimilars":[],"competitors":[],"genericName":"darinaparsin","indications":{"approved":[{"name":"Refractory peripheral T-cell lymphoma","source":"DrugCentral","snomedId":109977009,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT02653976","phase":"PHASE2","title":"A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)","status":"COMPLETED","sponsor":"Solasia Pharma K.K.","startDate":"2016-03-25","conditions":["Peripheral T-Cell Lymphoma"],"enrollment":67,"completionDate":"2021-06-17"},{"nctId":"NCT01435863","phase":"PHASE1","title":"A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)","status":"COMPLETED","sponsor":"Solasia Pharma K.K.","startDate":"2011-09","conditions":["Peripheral T-cell Lymphoma"],"enrollment":17,"completionDate":"2015-07"},{"nctId":"NCT01689220","phase":"PHASE1","title":"A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in Korea","status":"COMPLETED","sponsor":"Solasia Pharma K.K.","startDate":"2012-09","conditions":["Peripheral T-cell Lymphoma"],"enrollment":6,"completionDate":"2014-09"},{"nctId":"NCT00423306","phase":"PHASE2","title":"A Phase-II Trial of ZIO 101 in Advanced Hepatocellular Carcinoma","status":"UNKNOWN","sponsor":"Alaunos Therapeutics","startDate":"2007-01","conditions":["HEPATOCELLULAR CARCINOMA"],"enrollment":15,"completionDate":"2013-12"},{"nctId":"NCT00423644","phase":"PHASE2","title":"A Phase II Trial of ZIO-101 in Advanced Multiple Myeloma: Protocol SGL2001b","status":"UNKNOWN","sponsor":"Alaunos Therapeutics","startDate":"2007-01","conditions":["Multiple Myeloma"],"enrollment":17,"completionDate":"2013-12"},{"nctId":"NCT00509782","phase":"PHASE1","title":"Phase I Trial of ZIO-101 in Patients With Solid Tumors","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","startDate":"2005-05","conditions":["Solid Tumors"],"enrollment":47,"completionDate":"2008-04"},{"nctId":"NCT00592163","phase":"PHASE1","title":"Phase I Study of Oral ZIO-101-C in Advanced Solid Tumors and Lymphomas","status":"UNKNOWN","sponsor":"Alaunos Therapeutics","startDate":"2007-12","conditions":["Advanced Solid Tumors","Lymphomas"],"enrollment":20,"completionDate":"2013-06"},{"nctId":"NCT00591396","phase":"PHASE1","title":"A Phase I Trial of ZIO-101 in Solid Tumors","status":"COMPLETED","sponsor":"Alaunos Therapeutics","startDate":"2005-07","conditions":["Solid Tumors"],"enrollment":40,"completionDate":"2008-07"},{"nctId":"NCT00421213","phase":"PHASE2","title":"Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers","status":"COMPLETED","sponsor":"Alaunos Therapeutics","startDate":"2006-12","conditions":["Hematologic Neoplasms","Bone Marrow Neoplasms","Non-Hodgkin's Lymphoma"],"enrollment":50,"completionDate":"2012-04"},{"nctId":"NCT00303199","phase":"PHASE1,PHASE2","title":"Study of ZIO-101 in Multiple Myeloma","status":"COMPLETED","sponsor":"Alaunos Therapeutics","startDate":"2006-01","conditions":["Multiple Myeloma"],"enrollment":35,"completionDate":"2007-08"},{"nctId":"NCT00592046","phase":"PHASE1","title":"A Phase I Trial of ZIO-101 in Hematologic 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23","pmid":"39768226","title":"Harnessing Arsenic Derivatives and Natural Agents for Enhanced Glioblastoma Therapy.","journal":"Cells"},{"date":"2024 Jan","pmid":"37794793","title":"Efficacy of darinaparsin for EBV-associated B-cell lymphoma in a heavily treated elderly patient with angioimmunoblastic T-cell lymphoma: a case report.","journal":"Leukemia & lymphoma"},{"date":"2023","pmid":"37673618","title":"[Pharmacological profile and clinical study results of darinaparsin (DARVIAS(®) injection 135 ‍mg), an organic arsenic product, for relapsed or refractory peripheral t-cell lymphoma].","journal":"Nihon yakurigaku zasshi. 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