NDAINTRAVENOUSINJECTABLEPriority Review
Approved
Oct 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
IXEMPRA KIT (ixabepilone) by R-Pharm US is semi-synthetic analog of epothilone b. First approved in 2007.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IXEMPRA KIT is an intravenous chemotherapy agent containing ixabepilone, a semi-synthetic epothilone B analog that binds directly to β-tubulin and suppresses microtubule dynamics. It blocks cells in mitosis, triggering apoptosis, and demonstrates low susceptibility to common tumor resistance mechanisms including P-glycoprotein efflux. The drug is indicated for advanced breast cancer and other solid tumors where taxane resistance or intolerance is a concern.
LOE Approaching
With LOE approaching and moderate competitive pressure (30/100), brand teams should anticipate portfolio transition planning and a shift toward lifecycle management and cost optimization strategies.
Mechanism of Action
semi-synthetic analog of epothilone B. Ixabepilone binds directly to β-tubulin subunits on microtubules, leading to suppression of microtubule dynamics. Ixabepilone suppresses the dynamic instability of αβ-II and αβ-III microtubules. Ixabepilone possesses low in vitro susceptibility to multiple…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Anti-tumor Effect of Ixabepilone in Metastatic Breast Cancer (mBC) Selected by the Ixabepilone DRP.
Started Mar 2021
13 enrolled
Metastatic Breast Cancer
Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab
Started Apr 2017
78 enrolled
Epithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer
A Phase I Study of Lapatinib (Tykerb) Plus Ixabepilone (Ixempra) as 2nd-line Treatment for Patients With HER-2 Overexpressed Recurrent or Persistent Endometrial Carcinoma or Carcinosarcoma
Started Mar 2011
24 enrolled
Recurrent Endometrial Cancer
Ixabepilone and Vorinostat in Treating Patients With Metastatic Breast Cancer
Started May 2010
Trial of Bevacizumab and Ixabepilone for Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Started Feb 2010
6 enrolled
Non-squamous Non-small Cell Lung 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.