DOXIL (LIPOSOMAL) (doxorubicin hydrochloride)
DOXIL (LIPOSOMAL) is indicated for the treatment of Breast Cancer; Acute Lymphoblastic Leukemia; Acute Myeloblastic Leukemia; Hodgkin Lymphoma; Non-Hodgkin Lymphoma; Wilms' Tumor; Neuroblastoma; Soft Tissue Sarcoma; Bone Sarcoma; Ovarian Carcinoma.
How DOXIL (LIPOSOMAL) Works
Doxorubicin exerts its antineoplastic activity through multiple mechanisms. It binds to cell membrane lipids and intercalates between nucleotide base pairs, which inhibits DNA replication and the action of DNA and RNA polymerases. Furthermore, doxorubicin interacts with topoisomerase II to form DNA-cleavable complexes, preventing the religation of DNA strands and triggering apoptosis. These cytotoxic effects are central to its efficacy against malignant cells but also contribute to its dose-limiting organ toxicities.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1995-11-17
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE, LIPOSOMAL
DOXIL (LIPOSOMAL) Approval History
What DOXIL (LIPOSOMAL) Treats
10 indicationsDOXIL (LIPOSOMAL) is approved for 10 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
- Acute Lymphoblastic Leukemia
- Acute Myeloblastic Leukemia
- Hodgkin Lymphoma
- Non-Hodgkin Lymphoma
- Wilms' Tumor
- Neuroblastoma
- Soft Tissue Sarcoma
DOXIL (LIPOSOMAL) Boxed Warning
CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION • Cardiomyopathy: Myocardial damage, including acute left ventricular failure, can occur with doxorubicin hydrochloride. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 1%–20% for cumulative doses ranging from 300 mg/m 2 to 500 mg/m 2 when doxorubicin hydrochloride is administered every 3 weeks. The risk of cardiomyopathy is further increased with...
WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION • Cardiomyopathy: Myocardial damage, including acute left ventricular failure, can occur with doxorubicin hydrochloride. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 1%–20% for cumulative doses ranging from 300 mg/m 2 to 500 mg/m 2 when doxorubicin hydrochloride is administered every 3 weeks. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with doxorubicin hydrochloride [see Warnings and Precautions (5.1) ] . • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including doxorubicin hydrochloride [see Warnings and Precautions (5.2) ] . • Extravasation and Tissue Necrosis: Extravasation of doxorubicin hydrochloride can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting. Immediately terminate the drug and apply ice to the affected area [see Warnings and Precautions (5.3) ] . • Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur [see Warnings and Precautions (5.4) ] . WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning. • Cardiomyopathy: Myocardial damage can occur with doxorubicin hydrochloride with incidences from 1%–20% for cumulative doses from 300 mg/m 2 to 500 mg/m 2 when doxorubicin hydrochloride is administered every 3 weeks. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and
DOXIL (LIPOSOMAL) Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in DOXIL (LIPOSOMAL)'s indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DOXIL (LIPOSOMAL) treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to DOXIL (LIPOSOMAL)
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
146 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04759586 | NCI-2021-01071 NCI-2021-01071, ANHL1931 | Ph 3 | active not recruiting | Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma |
| NCT04530565 | NCI-2020-06381 NCI-2020-06381, EA9181 | Ph 3 | active not recruiting | Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults |
| NCT04628767 | NCI-2020-09850 NCI-2020-09850, EA8192 | Ph 2, Ph 3 | recruiting | Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer |
| NCT04301076 | NCI-2020-01535 NCI-2020-01535, 10335 | Ph 1 | suspended | Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment ("EPOCH") for Adult T-Cell Leukemia-Lymphoma (ATLL) |
| NCT05691478 | NCI-2022-08567 NCI-2022-08567, AOST2032 | Ph 2, Ph 3 | recruiting | A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma |
| NCT05675410 | NCI-2022-10845 NCI-2022-10845, AHOD2131 | Ph 3 | recruiting | A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab |
| NCT03984448 | NCI-2019-03711 NCI-2019-03711, A051701 | Ph 2, Ph 3 | active not recruiting | Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas |
| NCT03269669 | NCI-2017-00009 NCI-2017-00009, S1608 | Ph 2 | active not recruiting | Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma |
| NCT04799275 | NCI-2020-01256 NCI-2020-01256, S1918 | Ph 2, Ph 3 | active not recruiting | Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma |
| NCT02488967 | NRG-BR003 NCI-2015-00128, NRG-BR1428 | Ph 3 | active not recruiting | Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer |
| NCT04978584 | 2021-0046 NCI-2021-04298, 2021-0046 | Ph 2 | active not recruiting | Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Alone and With Combination Chemotherapy for the Treatment of Newly Diagnosed Non-germinal Center Diffuse Large B-Cell Lymphoma, Smart Stop Study |
| NCT02176967 | ANBL1232 NCI-2014-00677, s15-00462 | Ph 3 | active not recruiting | Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma |
| NCT03959085 | AALL1732 NCI-2019-02845, AALL1732 | Ph 3 | recruiting | Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy |
| NCT02166463 results posted | NCI-2014-01223 NCI-2014-01223, s15-00950 | Ph 3 | active not recruiting | Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma |
| NCT02112916 results posted | NCI-2014-00712 NCI-2014-00712, s14-01925 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma |
| NCT03914625 | NCI-2019-02187 NCI-2019-02187, AALL1731 | Ph 3 | active not recruiting | A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia |
| NCT02883049 results posted | NCI-2011-03797 NCI-2011-03797, S12-01254 | Ph 3 | active not recruiting | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations |
| NCT02180867 results posted | NCI-2014-01340 NCI-2014-01340, ARST1321 | Ph 2, Ph 3 | active not recruiting | Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery |
| NCT03907488 results posted | NCI-2019-01960 NCI-2019-01960, S1826 | Ph 3 | active not recruiting | Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma |
| NCT00980460 results posted | NCI-2011-01975 NCI-2011-01975, AHEP0731 | Ph 3 | active not recruiting | Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer |
| NCT01856192 results posted | NCI-2013-00959 NCI-2013-00959, ECOG-E1412 | Ph 2 | active not recruiting | Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma |
| NCT03206671 B-NHL 2013 | UKM12_0020 2013-003253-21 | Ph 3 | active not recruiting | Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents |
| NCT00558519 results posted | CALGB-10403 CALGB-10403, ECOG C10403 | Ph 2 | completed | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
| NCT00972478 results posted | NCI-2011-01964 NCI-2011-01964, CDR0000653803 | Ph 1, Ph 2 | active not recruiting | Vorinostat, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma |
| NCT07551583 | 2026-0119 NCI-2026-03212 | Ph 2 | not yet recruiting | Phase 2 Study Of Nivolumab Plus AVD In Pediatric, Adolescent, And Young Adult Patients With CHL |
| NCT05922904 | 2022-0492 NCI-2023-05028 | Ph 2 | active not recruiting | PET Adapted Brentuximab Vedotin and Pembrolizumab in Combination With Doxorubicin and Dacarbazine in Classic Hodgkin Lymphoma |
| NCT01424982 | 2011-0030 NCI-2011-02941, 2011-0030 | Ph 2 | active not recruiting | Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia |
| NCT00740805 | NCI-2009-00262 NCI-2009-00262, CDR0000600234 | Ph 1 | active not recruiting | Veliparib, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Non-Hodgkin Lymphoma |
| NCT02306161 results posted | NCI-2014-02380 NCI-2014-02380, AEWS1221 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma |
| NCT00792948 results posted | NCI-2009-00800 NCI-2009-00800, S0805 | Ph 2 | active not recruiting | Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia |
| NCT03220022 results posted | NCI-2017-01240 NCI-2017-01240, AMC-101 | Ph 1 | active not recruiting | Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas |
| NCT01190930 results posted | AALL0932 NCI-2011-02599, CDR0000683227 | Ph 3 | active not recruiting | Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma |
| NCT05748834 | BRE 381 | Ph 2 | recruiting | Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer |
| NCT05610735 | 22.0392 | Ph 1, Ph 2 | recruiting | Combination Therapy for Recurrent Ovarian Cancer |
| NCT06797635 | 1022-010 MK-1022-010, 2024-514376-40-00 | Ph 2 | recruiting | Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03) |
| NCT02213913 results posted | 13-1406 NCI-2014-01581, IRB13-1406 | Ph 1, Ph 2 | completed | Lenalidomide and Combination Chemotherapy (DA-EPOCH-R) in Treating Patients With MYC-Associated B-Cell Lymphomas |
| NCT07076186 | 2025-0352 NCI-2025-05088 | Ph 2 | recruiting | Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in uLMS |
| NCT05800366 | 22-606 | Ph 2 | recruiting | A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma |
| NCT03126916 | ANBL1531 NCI-2016-01734, ANBL1531 | Ph 3 | recruiting | Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) |
| NCT05137262 | 2020-1091 NCI-2021-12884 | Ph 2 | active not recruiting | A Phase II Multicenter Study of Chemotherapy Versus Chemotherapy Plus Durvalumab (MEDI 4736) in Patients With Lymph Node Positive Urothelial Carcinoma of the Bladder |
| NCT06820957 | AEWS2431 NCI-2025-00801, AEWS2431 | Ph 2, Ph 3 | active not recruiting | Testing a New Combination of Anti-cancer Drugs in Patients Newly Diagnosed With Ewing Sarcoma Who Have Cancer That Has Spread to Other Parts of the Body |
| NCT03710772 | 2018-0447 NCI-2018-02137, 2018-0447 | Ph 2 | active not recruiting | Ibrutinib, Rituximab, Venetoclax, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma |
| NCT03749018 | OSU-18281 NCI-2018-02699 | Ph 2 | active not recruiting | Nivolumab With DA-REPOCH Chemotherapy Regimen in Treating Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma |
| NCT04850495 | OSU-20189 NCI-2021-01332 | Ph 1 | suspended | Zanubrutinib in Combination With R-PolaCHP (ZaR-PolaCHP) for Newly Diagnosed Diffuse Large B-Cell Lymphoma |
| NCT04323956 | MC1986 NCI-2020-01855, 19-005387 | Ph 1 | active not recruiting | Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma |
| NCT01175356 results posted | ANBL09P1 NCI-2011-01745, ANBL09P1 | Ph 1 | completed | Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin |
| NCT01231906 results posted | AEWS1031 NCI-2011-02611, S12-01231 | Ph 3 | completed | Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma |
| NCT03587662 | 2018-0065 NCI-2018-01292, 2018-0065 | Ph 2 | active not recruiting | Ixazomib, Gemcitabine, and Doxorubicin in Treating Patients With Locally Advanced or Metastatic Kidney Cancer |
| NCT07072585 | AALL2331 NCI-2025-02230, AALL2331 | Ph 2, Ph 3 | not yet recruiting | Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL) |
| NCT02427620 | 2014-0559 NCI-2015-00960, 2014-0559 | Ph 2 | active not recruiting | Ibrutinib, Rituximab, and Consolidation Chemotherapy in Treating Young Patients With Newly Diagnosed Mantle Cell Lymphoma |
Showing 50 of 146 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DOXIL (LIPOSOMAL) FDA Label Details
Indications & Usage
FDA Label (PDF)DOXIL (LIPOSOMAL) is indicated for the treatment of Breast Cancer; Acute Lymphoblastic Leukemia; Acute Myeloblastic Leukemia; Hodgkin Lymphoma; Non-Hodgkin Lymphoma; Wilms' Tumor; Neuroblastoma; Soft Tissue Sarcoma; Bone Sarcoma; Ovarian Carcinoma.
WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION • Cardiomyopathy: Myocardial damage, including acute left ventricular failure, can occur with doxorubicin hydrochloride. The risk of cardiomyopathy is proportional to the cumulative exposu...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment