NDAINJECTIONINJECTABLE, LIPOSOMAL
Approved
Nov 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
4/8 — Partial
DOXIL (LIPOSOMAL) (doxorubicin hydrochloride liposome) by Baxter is hydrochloride. First approved in 1995.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DOXIL is a liposomal formulation of doxorubicin hydrochloride, a cytotoxic chemotherapy agent approved for ovarian and breast cancer. It works by binding to DNA and inhibiting nucleic acid synthesis, leading to rapid cell cycle arrest and apoptosis. The liposomal encapsulation improves pharmacokinetics and reduces cardiotoxicity compared to conventional doxorubicin.
LOE Approaching
Product is in late-stage lifecycle with moderate competitive pressure (30/100); commercial teams are likely focused on lifecycle extension strategies and managing market share erosion.
Mechanism of Action
hydrochloride. The mechanism of action of doxorubicin hydrochloride is thought to be related to its ability to bind DNA and inhibit nucleic acid synthesis. Cell structure studies have demonstrated rapid cell penetration and perinuclear chromatin binding, rapid inhibition of mitotic activity and…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Assess Bioequivalence of Two Formulations of Doxorubicin Hydrochloride Liposome in Female Patients With Ovarian Cancer
Started Sep 2014
30 enrolled
Ovarian Cancer
Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection
Started Jul 2014
49 enrolled
Ovarian Epithelial Cancer Recurrent
A Study of JNS002 (Doxorubicin Hydrochloride Liposome Injection) in Relapsed or Refractory Multiple Myeloma
Started Apr 2011
3 enrolled
Multiple Myeloma
Lenalidomide and Doxorubicin Hydrochloride Liposome in Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Started Apr 2009
15 enrolled
Fallopian Tube CancerOvarian CancerPeritoneal Cavity Cancer
Vorinostat, Bortezomib, and Doxorubicin Hydrochloride Liposome in Treating Patients With Relapsed or Refractory Multiple Myeloma
Started Oct 2008
32 enrolled
Multiple Myeloma and Plasma Cell Neoplasm
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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.