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Docetaxel

Generic Name
Docetaxel
Brand Names
Taxotere, Docetaxel Accord, Docetaxel Kabi
Drug Type
Small Molecule
Chemical Formula
C43H53NO14
CAS Number
114977-28-5
Unique Ingredient Identifier
699121PHCA

Overview

Docetaxel is a clinically well established anti-mitotic chemotherapy medication used for the treatment of different types of cancer, including breast, ovarian, and non-small cell lung cancer. Docetaxel is a complex diterpenoid molecule and a semisynthetic analogue of paclitaxel. Docetaxel reversibly binds to microtubulin with high affinity in a 1:1 stoichiometric ratio, allowing it to prevent cell division and promote to cell death. Compared to paclitaxel, docetaxel is two times more potent as an inhibitor of microtubule depolymerization. Docetaxel binds to microtubules but does not interact with dimeric tubulin. The use of docetaxel may lead to udesired outcomes such as hepatic impairment, hematologic effects, enterocolitis and neutropenic colitis, hypersensitivity reactions, fluid retention, second primary malignancies, embryo-fetal toxicity, and tumor lysis syndrome. Docetaxel was approved by the FDA in 1996 and is available in solution for injection for intravenous or parenteral administration.

Background

Docetaxel is a clinically well established anti-mitotic chemotherapy medication used for the treatment of different types of cancer, including breast, ovarian, and non-small cell lung cancer. Docetaxel is a complex diterpenoid molecule and a semisynthetic analogue of paclitaxel. Docetaxel reversibly binds to microtubulin with high affinity in a 1:1 stoichiometric ratio, allowing it to prevent cell division and promote to cell death. Compared to paclitaxel, docetaxel is two times more potent as an inhibitor of microtubule depolymerization. Docetaxel binds to microtubules but does not interact with dimeric tubulin. The use of docetaxel may lead to udesired outcomes such as hepatic impairment, hematologic effects, enterocolitis and neutropenic colitis, hypersensitivity reactions, fluid retention, second primary malignancies, embryo-fetal toxicity, and tumor lysis syndrome. Docetaxel was approved by the FDA in 1996 and is available in solution for injection for intravenous or parenteral administration.

Indication

Docetaxel is indicated as a single agent for the treatment of locally advanced or metastatic breast cancer after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC. It is also indicated as a single agent for locally advanced or metastatic non-small cell lung cancer (NSCLC) after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC. For the treatment of metastatic castration-resistant prostate cancer, docetaxel is indicated with prednisone. Docetaxel is also indicated with cisplatin and fluorouracil for untreated, advanced gastric adenocarcinoma, including the gastroesophageal junction, and with cisplatin and fluorouracil for induction treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN).

Associated Conditions

  • Esophageal Cancer
  • Ewing's Sarcoma
  • Locally Advanced Breast Cancer (LABC)
  • Metastatic Bladder Cancer
  • Metastatic Breast Cancer
  • Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)
  • Node Positive Breast Cancer
  • Ovarian Cancer Metastatic
  • Small Cell Lung Cancer (SCLC)
  • Soft Tissue Sarcoma
  • Advanced untreated gastric adenocarcinoma
  • Locally advanced Squamous cell carcinoma of head and neck
  • Locally advanced untreated non small cell lung cancer
  • Metastatic untreated non small cell lung cancer
  • Refractory, locally advanced Non small cell lung cancer
  • Refractory, metastatic Non small cell lung cancer
  • Refractory, metastatic hormone-refractory Prostate cancer

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/12
Phase 2
Not yet recruiting
2025/06/12
Phase 2
Not yet recruiting
2025/06/03
Phase 2
Not yet recruiting
2025/05/25
Phase 3
Recruiting
2025/05/01
Phase 3
Recruiting
2025/04/27
Phase 2
Not yet recruiting
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2025/04/24
Phase 1
Recruiting
2025/04/23
Phase 2
Recruiting
Glenn J. Hanna
2025/04/17
Phase 3
Not yet recruiting
2025/04/16
Phase 3
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Winthrop U.S, a business of sanofi-aventis U.S. LLC
0955-1022
INTRAVENOUS
160 mg in 8 mL
12/7/2023
Alembic Pharmaceuticals Inc.
62332-678
INTRAVENOUS
10 mg in 1 mL
9/4/2023
Meitheal Pharmaceuticals Inc
71288-144
INTRAVENOUS
10 mg in 1 mL
2/22/2022
AuroMedics Pharma LLC
55150-380
INTRAVENOUS
10 mg in 1 mL
2/16/2021
Amneal Pharmaceuticals LLC
70121-1223
INTRAVENOUS
160 mg in 8 mL
3/21/2023
Gland Pharma Limited
68083-401
INTRAVENOUS
10 mg in 1 mL
6/16/2023
Xiromed LLC
70700-176
INTRAVENOUS
10 mg in 1 mL
10/25/2021
Baxter Healthcare Corporation
43066-010
INTRAVENOUS
10 mg in 1 mL
12/20/2017
Mylan Institutional LLC
67457-533
INTRAVENOUS
10 mg in 1 mL
9/5/2023
Sun Pharmaceutical Industries, Inc.
47335-323
INTRAVENOUS
20 mg in 1 mL
2/4/2021

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
DOCEHOPE Concentrate for Solution for Infusion 80 mg/ 4 ml
SIN16942P
INFUSION, SOLUTION CONCENTRATE
80 mg / 4 ml
2/7/2024
Hospira Docetaxel Concentrate for Solution for Infusion 20 mg / 2 ml
SIN14218P
INFUSION, SOLUTION
20mg per 2ml
8/27/2012
Taxotere Concentrate for Solution for Infusion 20mg/ml
SIN14106P
INFUSION, SOLUTION CONCENTRATE
20mg/ml
2/16/2012
Taxotere Concentrate for Solution for Infusion 80mg/4ml
SIN14107P
INFUSION, SOLUTION CONCENTRATE
80mg/4ml
2/16/2012
TEXTAS 80 CONCENTRATE FOR SOLUTION FOR INFUSION 80 MG/ 4 ML VIAL
SIN15589P
INJECTION, SOLUTION, CONCENTRATE
80 mg / 4 mL
12/3/2018
Daxotel Concentrate for Solution for Infusion 20mg/ml
SIN15109P
INJECTION, SOLUTION, CONCENTRATE
20.0mg/ml
10/26/2016
DOCETAXEL STADA CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML
SIN15393P
INJECTION, SOLUTION, CONCENTRATE
20mg/ml
12/12/2017
DOCETAXEL ADVAGEN CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML
SIN15449P
INFUSION, SOLUTION CONCENTRATE
20mg/ml
3/13/2018
Hospira Docetaxel Concentrate for Solution for Infusion 80 mg / 8 ml
SIN14219P
INFUSION, SOLUTION
80mg per 8ml
8/27/2012
DOCEHOPE Concentrate for Solution for Infusion 20 mg/ ml
SIN16943P
INFUSION, SOLUTION CONCENTRATE
20 mg / ml
2/7/2024

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Docetaxel Injection
国药准字HJ20140086
化学药品
注射剂
3/29/2023
Docetaxel Injection
国药准字HJ20140085
化学药品
注射剂
3/29/2023
Docetaxel Injection
国药准字H20093744
化学药品
注射剂
2/25/2020
Docetaxel Injection
国药准字H20198001
化学药品
注射剂
10/16/2023
Docetaxel Injection
国药准字H20051045
化学药品
注射剂
7/15/2024
Docetaxel Injection
国药准字H20237179
化学药品
注射剂
12/20/2023
Docetaxel Injection
国药准字H20103665
化学药品
注射剂(注射液)
11/4/2020
Docetaxel Injection
国药准字H20198003
化学药品
注射剂
10/16/2023
Docetaxel Injection
国药准字H20093755
化学药品
注射剂
5/14/2024
Docetaxel Injection
国药准字H20080366
化学药品
注射剂
8/31/2020
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