NDAINJECTIONINJECTABLEPriority Review
Approved
Dec 1987
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
15
Data completeness
4/8 — Partial
Priority Review
DOXORUBICIN HYDROCHLORIDE (doxorubicin hydrochloride) by Pfizer is doxorubicin. First approved in 1987.
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Doxorubicin hydrochloride is a small-molecule anthracycline chemotherapy agent approved in 1987 that intercalates into DNA and inhibits topoisomerase II, preventing nucleotide replication and polymerase function. It is used across multiple cancer indications including breast cancer, lymphomas, leukemias, and solid tumors. The drug remains a foundational chemotherapy backbone despite its age, with significant off-label utilization across oncology.
LOE Approaching
As a legacy chemotherapy with approaching loss of exclusivity and moderate competitive pressure (30/100), brand teams face portfolio transition planning rather than growth opportunities.
Mechanism of Action
doxorubicin. Intercalation inhibits nucleotide replication and action of DNA and RNA polymerases. The interaction of doxorubicin with topoisomerase II to form DNA-cleavable complexes appears to be an important mechanism of doxorubicin hydrochloride cytocidal activity.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (15)
A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Started Feb 2023
900 enrolled
Diffuse Large B-Cell Lymphoma
Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma
Started Mar 2022
80 enrolled
Advanced Soft-tissue SarcomaMetastatic Soft-tissue Sarcoma
A Phase 2 Clinical Study of Evaluation of Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection (609A) Combined With Doxorubicin Hydrochloride in the Treatment of Metastatic/Unresectable Non-specific Soft Tissue Sarcoma
Started Dec 2021
70 enrolled
Sarcoma, Soft Tissue
Pembrolizumab and Doxorubicin Hydrochloride or Anti-Estrogen Therapy in Treating Patients With Triple-Negative or Hormone Receptor-Positive Metastatic Breast Cancer
Started Mar 2016
30 enrolled
Estrogen Receptor NegativeEstrogen Receptor PositiveHER2/Neu Negative+4 more
Assess Bioequivalence of Two Formulations of Doxorubicin Hydrochloride Liposome in Female Patients With Ovarian Cancer
Started Sep 2014
30 enrolled
Ovarian Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.