NDAINTRAVENOUSSOLUTION
Approved
Dec 2022
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
4/8 — Partial
BENDAMUSTINE HYDROCHLORIDE (bendamustine hydrochloride) by Baxter is purine-like benzimidazole ring. First approved in 2022.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Bendamustine hydrochloride is a nitrogen mustard alkylating agent that forms DNA interstrand crosslinks to induce cell death in both quiescent and dividing malignant cells. It is administered intravenously as a solution for the treatment of hematologic malignancies. The exact mechanism remains incompletely understood, though its bifunctional covalent DNA binding is central to its cytotoxic activity.
Peak
Product is in peak commercial phase with moderate competitive pressure (30%), suggesting active brand-building and field presence expansion opportunities.
Mechanism of Action
purine-like benzimidazole ring. Mechlorethamine and its derivatives form electrophilic alkyl groups. These groups form covalent bonds with electron-rich nucleophilic moieties, resulting in interstrand DNA crosslinks. The bifunctional covalent linkage can lead to cell death via several pathways.…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
A Study of Safety and Effectiveness of Bendamustine Hydrochloride in Adult Filipino Patients With Chronic Lymphocytic Leukemia
Started Oct 2014
0Chronic Lymphocytic Leukemia
Everolimus and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory Hematologic Cancer
Started Oct 2014
20 enrolled
Recurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Hodgkin LymphomaRecurrent Grade 1 Follicular Lymphoma+5 more
Bendamustine Hydrochloride, Clofarabine, and Etoposide in Treating Younger Patients With Relapsed or Refractory Hematologic Malignancies
Started Aug 2013
16 enrolled
Hodgkin LymphomaNon-Hodgkin LymphomaAcute Leukemia
Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients With Refractory or Relapsed Indolent Non-Hodgkin Lymphoma
Started May 2012
26 enrolled
Refractory/Relapsed Indolent Non-Hodgkin Lymphoma
A Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection
Started May 2012
91 enrolled
Indolent B-Cell Non-Hodgkin's Lymphomas
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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.