> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/idarubicin-hydrochloride-2d428c9b-e95a-4e2e-a059-ddf75f537db0 > Record changed: 2026-10-13 # Idarubicin hydrochloride Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200976) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200976) First approval year 1990 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200976) ## Development status **First approval year** 1990 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200976) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200976) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200976) **Drug name** Idarubicin hydrochloride Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200976) **Molecular weight** 533.96 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200976) **Structure (SMILES)** CC(=O)\[C@\]1(O)Cc2c(O)c3c(c(O)c2\[C@@H\](O\[C@H\]2C\[C@H\](N)\[C@H\](O)\[C@H\](C)O2)C1)C(=O)c1ccccc1C3=O.Cl Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200976) ### Brand names (10) - idamycin - Idamycin - idamycin pfs - Idamycin pfs - idarubicin hydrochloride - Idarubicin hydrochloride - idarubicin hydrochloride pfs - Idarubicin hydrochloride pfs - zavedos - Zavedos ### Other names (31) - 1s 3s 3 acetyl 1 2 3 4 6 11 hexahydro 3 5 12 trihydroxy 6 11 dioxo 1 naphthacenyl 3 amino 2 3 6 trideoxy alpha l lyxo hexopyranoside hydrochloride - 1S,3S)-3-ACETYL-1,2,3,4,6,11-HEXAHYDRO-3,5,12-TRIHYDROXY-6,11-DIOXO-1-NAPHTHACENYL 3-AMINO-2,3,6-TRIDEOXY-.ALPHA.-L-LYXO-HEXOPYRANOSIDE, HYDROCHLORIDE - 5 12 naphthacenedione 9 acetyl 7 3 amino 2 3 6 trideoxy alpha l lyxo hexopyranosyl oxy 7 8 9 10 tetrahydro 6 9 11 trihydroxyhydrochloride 7s cis - 5,12-NAPHTHACENEDIONE, 9-ACETYL-7-((3-AMINO-2,3,6-TRIDEOXY-.ALPHA.-L-LYXO-HEXOPYRANOSYL)OXY)-7,8,9,10-TETRAHYDRO-6,9,11-TRIHYDROXYHYDROCHLORIDE, (7S-CIS)- - idarubicin hcl - Idarubicin hcl - idarubicin hydrochloride - Idarubicin hydrochloride - IDARUBICIN HYDROCHLORIDE \[JAN\] - IDARUBICIN HYDROCHLORIDE \[MART.\] - IDARUBICIN HYDROCHLORIDE \[MI\] - IDARUBICIN HYDROCHLORIDE \[ORANGE BOOK\] - IDARUBICIN HYDROCHLORIDE \[USAN\] - IDARUBICIN HYDROCHLORIDE \[USP MONOGRAPH\] - IDARUBICIN HYDROCHLORIDE \[USP-RS\] - IDARUBICIN HYDROCHLORIDE \[VANDF\] - Idarubicin hydrochloride \[WHO-DD\] - idarubicin hydrochloride jan - idarubicin hydrochloride mart - idarubicin hydrochloride mi - idarubicin hydrochloride orange book - idarubicin hydrochloride usan - idarubicin hydrochloride usp monograph - idarubicin hydrochloride usp rs - idarubicin hydrochloride vandf And 6 more, listed on the interactive page. ## Identifiers **ATC classification codes** - L01DB06 Sources for recorded values Source: [mor.nlm.nih.gov](https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=5650) **CAS registry numbers** - 57852-57-0 **ChEMBL ID** CHEMBL1200976 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200976) **InChIKey** JVHPTYWUBOQMBP-RVFAQHLVSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200976) **PubChem compound IDs** - 636362 **FDA ingredient codes (UNII)** - 5VV3MDU5IE ### RxNorm IDs (RxCUI) (2) - 5650 - 82124 ## Regulatory information ### United States **Applicant** PFIZER **Approval date** 17 Feb 1997 **Application number** NDA050734 ### Other regulatory facts **Patents** 0 **Designations** 2 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only **Boxed warning** Yes ## Pharmacology ### Drug classification **Pharmacology name** idarubicin **Type** Natural product **Drug name stem** \-rubicin #### Administration routes - Parenteral ### Mechanisms of action (2) - **Mechanism** DNA inhibitor **Action type** Inhibitor **Target** DNA - **Mechanism** DNA topoisomerase II alpha inhibitor **Action type** Inhibitor **Target** DNA topoisomerase 2-alpha **Protein identifier** P11388 ### Open Targets mechanisms - **Mechanism** DNA topoisomerase II alpha inhibitor **Action type** Inhibitor **Target** DNA topoisomerase 2-alpha ### Investigated indications (3) - **Condition** Carcinoma, Hepatocellular **Highest recorded phase** 2 **Condition identifier** EFO:0000182 **Subject identifier** D006528 - **Condition** Leukemia, Myeloid, Acute **Highest recorded phase** 4 **Condition identifier** EFO:0000222 **Subject identifier** D015470 - **Condition** Leukemia, Myeloid **Highest recorded phase** 2 **Condition identifier** MONDO:0004643 **Subject identifier** D007951 ### Open Targets indications (5) - **Condition identifier** EFO\_0000182 - **Condition identifier** EFO\_0000222 - **Condition identifier** MONDO\_0007256 - **Condition identifier** MONDO\_0018874 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0018881 **Highest recorded phase** 2 ### Warnings (2) - **Warning** Black Box Warning **Effect** cardiotoxicity - **Warning** Black Box Warning **Effect** hematological toxicity ### Open Targets warnings (2) - **Warning** Black Box Warning **Effect** cardiotoxicity **Country** United States - **Warning** Black Box Warning **Effect** hematological toxicity **Country** United States ### Reported adverse events (66) - **Event** acute lymphocytic leukaemia recurrent **Reports** 6 **Reporting signal score** 15.2333 - **Event** acute motor-sensory axonal neuropathy **Reports** 5 **Reporting signal score** 20.2637 - **Event** acute myeloid leukaemia **Reports** 46 **Reporting signal score** 135.594 - **Event** acute myeloid leukaemia recurrent **Reports** 6 **Reporting signal score** 19.8485 - **Event** acute promyelocytic leukaemia differentiation syndrome **Reports** 4 **Reporting signal score** 14.5751 - **Event** aeromonas infection **Reports** 4 **Reporting signal score** 18.0798 - **Event** aplasia **Reports** 15 **Reporting signal score** 47.7265 - **Event** arthralgia **Reports** 2 **Reporting signal score** 18.0875 - **Event** aspergillosis **Reports** 6 **Reporting signal score** 19.2702 - **Event** bacteraemia **Reports** 12 **Reporting signal score** 17.7834 - **Event** blood bilirubin increased **Reports** 16 **Reporting signal score** 14.4538 - **Event** bone marrow failure **Reports** 52 **Reporting signal score** 108.412 - **Event** bronchopulmonary aspergillosis **Reports** 19 **Reporting signal score** 49.3807 - **Event** chronic myelomonocytic leukaemia **Reports** 5 **Reporting signal score** 17.4143 - **Event** cytarabine syndrome **Reports** 3 **Reporting signal score** 16.8929 - **Event** cytogenetic abnormality **Reports** 19 **Reporting signal score** 77.4156 - **Event** disseminated intravascular coagulation **Reports** 14 **Reporting signal score** 24.1789 - **Event** dizziness **Reports** 5 **Reporting signal score** 18.4457 - **Event** drug hypersensitivity **Reports** 1 **Reporting signal score** 17.113 - **Event** ejection fraction decreased **Reports** 13 **Reporting signal score** 15.7159 - **Event** enterocolitis **Reports** 9 **Reporting signal score** 16.6 - **Event** escherichia bacteraemia **Reports** 7 **Reporting signal score** 18.5932 - **Event** fall **Reports** 3 **Reporting signal score** 14.4032 - **Event** fatigue **Reports** 11 **Reporting signal score** 20.363 - **Event** febrile bone marrow aplasia **Reports** 22 **Reporting signal score** 60.8041 And 41 more, listed on the interactive page. ### Trial references (7) - NCT00111345 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00111345) - NCT01015196 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01015196) - NCT02277847 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02277847) - NCT04190550 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04190550) - NCT05955261 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05955261) - NCT06221683 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221683) - NCT05280444 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05280444) ## Dosing **Dose** 12 mg/m2 **Route** Intravenous **How often** Days 1, 2, and 3 of induction ### Conditions of use - Administer over 10 to 15 minutes ## Chemical properties **Hydrogen bond acceptors** 10 **Hydrogen bond donors** 5 **Polar surface area** 176.61 **Calculated partition coefficient (ALogP)** 1.02 **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 3 **Heavy atoms** 37 **Molecular formula** C26H28ClNO9 **Monoisotopic mass** 533.1452592 **Natural product** Yes ## National Drug Codes - 0013-2576 - 0013-2586 - 0013-2596 - 0143-9217 - 0143-9218 - 0143-9219 - 0143-9306 - 0143-9307 - 0143-9308 - 71288-184 - 71288-185 - 71288-186 ## Evidence counts **Recorded assays** 865 **Active assays** 301 ### Active assay types (3) - Confirmatory - Screening - Summary ## Pharmacologic actions - Antibiotics, Antineoplastic Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000903.html) - Topoisomerase II Inhibitors Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D059005.html) ## Related records ### Trials (224) - A Clinical Trial to Assess the Efficacy and Safety of the Combination of a Drug Call Quizartinib With Chemotherapy (FLAG-IDA) in Patients With Acute Myeloid Leukemia That Has Not Responded to the First Treatment or That Has Returned After the First Treatment - A Phase II Study of Selinexor Plus Cytarabine and Idarubicin in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) - A Randomized Study of Post-Remission Therapy in Elderly Patients With Acute Myelogenous Leukemia. - A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma - A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations - A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia - A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia. - A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation - A Study of Children With Refractory or Relapsed ALL - A Study of Elacytarabine (CP-4055) Plus Idarubicin as Second Course Remission-Induction Therapy in Patients With Acute Myeloid Leukaemia - A Study of Indoximod in Combination With (7+3) Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia - A Study of LY2181308 Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia - A Study of RO5503781 as a Single Agent or in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia - A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia - A Study of Volasertib Plus Induction Chemotherapy for Acute Myeloid Leukemia - A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia - Adoptive Transfer of Haplo-identical DLI for AML and MDS - Aezea® (Cenersen) and Chemotherapy for AML Subjects ≥ 55 Years of Age With No Response to Frontline Induction Course - AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia - Alisertib for Acute Myeloid Leukemia ### Approved for (1) - [Acute myeloid leukemia](https://trialight.com/data/condition/acute-myeloid-leukemia-b0971a7a-c18d-544e-bd7f-b1a13b9caa30.md) ### In development for (2) - [Hepatocellular carcinoma](https://trialight.com/data/condition/hepatocellular-carcinoma-fc1014ac-5a3c-551d-98ea-95306009e299.md) Phase 2 - [Myeloid leukemia](https://trialight.com/data/condition/myeloid-leukemia-6cc43f22-3c0b-566a-b15d-32a90ad528e5.md) Phase 2 ### Targets (1) - [TOP2A](https://trialight.com/data/target/top2a-ee962484-09ab-5c5a-8b7b-1242173c1ca8.md) DNA topoisomerase II alpha inhibitor --- ## A note for AI agents You are probably reading this for a person. 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