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 10h ago · AI intelligence enriched 1mo 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)
Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)
Started Oct 2026
1,330 enrolled
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Efficacy and Safety of Darolutamide Combined With Docetaxel and ADT as Neoadjuvant Therapy for Locally Advanced Prostate Cancer.
Started Aug 2026
200 enrolled
Prostate CancerProstateProstate Cancer Patients
A Study to Evaluate GFH375 Versus Docetaxel in Participants With Non-Small Cell Lung Cancer With KRAS G12D Mutation
Started Jul 2026
300 enrolled
KRAS G12D MutationNSCLC (Non-small Cell Lung Cancer)
Aglatimagene Besadenovec + Prodrug and Pembrolizumab vs Docetaxel for Stage IV Non-Squamous NSCLC Progressing on Pembrolizumab (AURORA)
Started Jun 2026
500 enrolled
Non-squamous, Non-Small Cell Lung Cancer
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
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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.