DOCETAXEL

Post-LOE

docetaxel

Sanofi

ANDAINJECTIONINJECTABLE

Approved

Jan 2017

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

DOCETAXEL (docetaxel) by Sanofi is functions. Approved for metastatic breast cancer after failure of prior chemotherapy, metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy, locally advanced and 8 more indications. First approved in 2017.

Drug data last refreshed 18h ago

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…

Indications (8)

metastatic breast cancer after failure of prior chemotherapy metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy

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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.

Clinical Trials (20)

NCT07464145Phase 3Not Yet Recruiting

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

NCT07361484Phase 3Not Yet Recruiting

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

NCT07545044Phase 2Not Yet Recruiting

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

NCT07313891Phase 3Withdrawn

A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBT

Started May 2026

Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)Bladder (Urothelial, Transitional Cell) CancerUrothelial Carcinoma Bladder+1 more

NCT07518173Phase 3Not Yet Recruiting

A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer

Started Apr 2026

596 enrolled

HER2-positive Breast Cancer