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 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ABRAXANE is a nanoparticle albumin-bound paclitaxel formulation approved in 2005 for multiple cancer indications. It works as a microtubule inhibitor, disrupting the dynamic reorganization of cellular microtubules essential for cell division, thereby inducing abnormal microtubule bundles and triggering apoptosis. The albumin-bound formulation improves solubility and reduces hypersensitivity reactions compared to conventional paclitaxel.
$0.007BPart D
Peak8.1 years to LOEProduct is at peak lifecycle stage with stable Medicare utilization; teams focused on maintaining market position and managing potential generic/biosimilar erosion over the next 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)
A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)
Started Sep 2026
50 enrolled
Small Cell Lung Cancer ( SCLC )
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Started Aug 2026
20 enrolled
Colon and Rectal Cancer
Phase 2 Study of NAI, HPV Vaccine, and Nab-Paclitaxel in HPV-Positive Oropharyngeal Cancer Followed by De-Intensified Radiation Compared With Standard Chemoradiation
Started Jul 2026
70 enrolled
HPV-Positive Oropharyngeal Squamous Cell CarcinomaOropharyngeal Squamous Cell CarcinomaHead and Neck Cancer
Open-Label, Phase 1 Clinical Trial of Neoadjuvant Nogapendekin Alfa Inbakicept, Sotevtamab, and Zabadinostat in Combination With Gemcitabine and Nab-Paclitaxel for Participants With Borderline Resectable or Locally Advanced Pancreatic Cancer
Started Jun 2026
30 enrolled
Pancreatic Cancer ResectablePancreatic Cancer
Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
Started Jun 2026
300 enrolled
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
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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.