NDAINTRAVENOUSPOWDER
Approved
Jan 2005
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
ABRAXANE (paclitaxel) by Bristol Myers Squibb is depolymerization. First approved in 2005.
Drug data last refreshed 8h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ABRAXANE is a nanoparticle albumin-bound formulation of paclitaxel, a microtubule-stabilizing chemotherapy agent approved in 2005 for multiple cancer indications. It works by promoting microtubule polymerization and inhibiting depolymerization, leading to abnormal microtubule bundle formation that disrupts cell division. The albumin-bound formulation improves solubility and allows for higher doses without the toxicity associated with traditional solvent-based paclitaxel.
$0.007BPart D
Peak7.7 years to LOEProduct is at peak commercial performance with stable market position, suggesting established team infrastructure but limited growth opportunities before LOE in 7.8 years.
Mechanism of Action
depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. Paclitaxel induces abnormal arrays or "bundles" of microtubules throughout the cell cycle and multiple…
Pharmacologic Class:
Microtubule Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Two Part (Phase1b/ Phase3) Trial of Subcutaneous Dostarlimab Plus Carboplatin-Paclitaxel in Participants With Primary Advanced or Recurrent Endometrial Cancer
Started Nov 2026
378 enrolled
Endometrial CarcinomaNeoplasms, Endometrial
Chidamide Combined With Benmelstobart, Nab-paclitaxel, and SBRT as Second-Line Treatment for Advanced BTC
Started Nov 2026
41 enrolled
BTC
Albumin-Bound Paclitaxel (Ⅱ) in Patients With Advanced Breast Cancer
Started Oct 2026
1,372 enrolled
Breast CancerHER2-negative Breast CancerAdvanced Breast Cancer
Paclitaxel Polymeric Micelles Plus Ivonescimab in Recurrent or Refractory SCLC
Started Oct 2026
47 enrolled
SCLC, Recurrent
A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)
Started Sep 2026
50 enrolled
Small Cell Lung Cancer ( SCLC )
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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.