Liposomal Doxorubicin: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Liposomal Doxorubicin appears in the FDA drug-label database. Marketed as Doxorubicin Hydrochloride.
- Boxed warning
- The FDA label for Liposomal Doxorubicin carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Doxorubicin Hydrochloride Injection is an anthracycline topoisomerase inhibitor indicated: • as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer ( 1.1 ) • for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms' tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma ( 1.2 ) 1.1 Adjuvant Breast Cancer Doxorubicin Hydrochloride Injection is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer . 1.2 Other Cancers Doxorubicin Hydrochloride Injection is indicated for the treatment of • acute lymphoblastic leukemia • acute myeloblastic leukemia • Hodgkin lymphoma • non-Hodgkin lymphoma (NHL) • metastatic breast cancer • metastatic Wilms' tumor • metastatic neurob…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Cross Contamination with Other Products: trace amounts of octreotide found during testing — Fresenius Kabi USA, LLC | Class III (FDA: unlikely to cause harm) | Terminated | 2020-11-17 |
| CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake. — Baxter Healthcare Corporation | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2023-08-24 |
| Presence of Particulate matter: Particulate matter identified as glass. — SUN PHARMACEUTICAL INDUSTRIES INC | Class I (FDA: reasonable probability of serious harm or death) | Ongoing | 2026-05-12 |
| Lack Of Assurance Of Sterility — Sun Pharmaceutical Industries, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2018-01-16 |
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| Breast Neoplasms | 2 |
| Breast cancer | 2 |
| Cardiotoxicity | 1 |
| Diffuse Large B-cell Lymphoma (DLBCL) | 1 |
| HHV-8 | 1 |
| HIV | 1 |
| Heart failure | 1 |
| KSHV | 1 |
| KSHV Inflammatory Cytokine Syndrome (KICS) | 1 |
| Lymphoma | 1 |
Recruiting trials involving Liposomal Doxorubicin
- A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
- A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
- Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)
- The CARDIOPROTECT Trial
Common questions
Is Liposomal Doxorubicin FDA-approved?
Yes, marketed as Doxorubicin Hydrochloride. Its FDA label carries a boxed warning.
How many recruiting trials involve Liposomal Doxorubicin?
4 recruiting trials across 10 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.