NDAINJECTIONINJECTABLE
Approved
Jun 2011
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
DOCETAXEL (docetaxel) by Accord Biopharma is functions. First approved in 2011.
Drug data last refreshed 23m ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Docetaxel is a microtubule-stabilizing chemotherapy agent (taxane class) administered intravenously for multiple solid tumors. It binds to free tubulin and promotes microtubule assembly while inhibiting disassembly, leading to mitotic inhibition and cell death. The drug has been a cornerstone of oncology regimens since its 2011 NDA approval by Accord Biopharma.
Peak
Peak-stage product with 30% competitive pressure indicates mature franchise requiring defensive strategy and operational excellence from commercial teams.
Mechanism of Action
functions. Docetaxel binds to free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. This leads to the production of microtubule bundles without normal function and to the stabilization of microtubules, which results in the…
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)
Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial.
Started Jun 2026
320 enrolled
Metastatic Hormone-sensitive Prostate Cancer
Docetaxel Plus Plinabulin vs Docetaxel Plus Placebo in Advanced/Metastatic Non-Squamous NSCLC After PD-1/PD-L1 Therapy and Platinum Chemotherapy (DUBLIN-4)
Started Jun 2026
442 enrolled
Non-Small Cell Lung CancerNon-squamous Non-Small Cell Lung Cance
A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer
Started Jun 2026
393 enrolled
Bladder (Urothelial, Transitional Cell) CancerBladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)Urothelial Carcinoma Bladder+2 more
A Study of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for HER2-Positive Recurrent or Metastatic Breast Cancer
Started May 2026
60 enrolled
HER2-positive Recurrent or Metastatic Breast Cancer
A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBT
Started May 2026
0Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)Bladder (Urothelial, Transitional Cell) CancerUrothelial Carcinoma Bladder+1 more
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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.