MedPath

Paclitaxel

Generic Name
Paclitaxel
Brand Names
Abraxane, Taxol, Naveruclif, Pazenir, Apexelsin
Drug Type
Small Molecule
Chemical Formula
C47H51NO14
CAS Number
33069-62-4
Unique Ingredient Identifier
P88XT4IS4D

Overview

Paclitaxel is a chemotherapeutic agent marketed under the brand name Taxol among others. Used as a treatment for various cancers, paclitaxel is a mitotic inhibitor that was first isolated in 1971 from the bark of the Pacific yew tree which contains endophytic fungi that synthesize paclitaxel. It is available as an intravenous solution for injection and the newer formulation contains albumin-bound paclitaxel marketed under the brand name Abraxane.

Indication

Used in the treatment of Kaposi's sarcoma and cancer of the lung, ovarian, and breast. Abraxane® is specfically indicated for the treatment of metastatic breast cancer and locally advanced or metastatic non-small cell lung cancer.

Associated Conditions

  • Advanced Cervical Cancer
  • Advanced Head and Neck Cancer
  • Advanced Ovarian Cancer
  • Advanced Soft Tissue Sarcoma
  • Esophageal Cancer
  • Fallopian Tube Cancer
  • Gastric Cancer
  • Kaposi's Sarcoma
  • Locally Advanced Non-Small Cell Lung Cancer
  • Metastatic Bladder Cancer
  • Metastatic Breast Cancer
  • Metastatic Melanoma
  • Metastatic Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer (NSCLC)
  • Ovarian Cancer
  • Pancreatic Adenocarcinoma Metastatic
  • Peritoneal Cancer
  • Recurrent Small Cell Lung Cancer (SCLC)
  • Advanced Bladder cancer
  • Advanced Thymoma
  • Metastatic Penile cancer
  • Refractory Testicular germ cell cancer

Research Report

Published: May 27, 2025

Paclitaxel: A Comprehensive Oncological Drug Profile

1. Introduction

1.1. Paclitaxel as a Cornerstone Antineoplastic Agent

Paclitaxel is a highly influential taxoid chemotherapeutic agent, integral to modern oncology as both a first-line and subsequent therapeutic option for a spectrum of advanced carcinomas. Its most prominent applications are in the treatment of ovarian, breast, and lung cancers.[1] Beyond these, paclitaxel's therapeutic reach extends to AIDS-related Kaposi's sarcoma and pancreatic cancer, among other solid tumor malignancies.[1] The drug's primary anticancer activity stems from its function as a mitotic inhibitor, which critically interferes with the normal process of microtubule function during cellular division.[1]

1.2. Historical Context: Discovery and Development

The journey of paclitaxel began with its initial isolation in 1971 from the bark of the Pacific yew tree, Taxus brevifolia.[1] This discovery was a product of systematic screening efforts for natural antineoplastic compounds conducted by the National Cancer Institute (NCI) during the late 1960s and early 1970s.[2] Originally designated "taxol," this name is now primarily associated with the registered trademark Taxol®, one of its commercial formulations.[4] The conventional injectable formulation, TAXOL (paclitaxel) Injection, is derived through a semi-synthetic pathway from Taxus baccata, a more renewable yew species.[5] Further research has revealed that endophytic fungi, which live symbiotically within the Pacific yew, are also capable of synthesizing paclitaxel, suggesting potential alternative avenues for its production.[1]

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/11
Not Applicable
Not yet recruiting
2025/07/09
Not Applicable
Recruiting
2025/07/01
Not Applicable
Not yet recruiting
2025/06/30
Not Applicable
Not yet recruiting
2025/06/29
Not Applicable
Not yet recruiting
2025/06/27
Not Applicable
Not yet recruiting
2025/06/26
Phase 2
Not yet recruiting
Ming-Yu Lien
2025/06/22
Phase 1
Not yet recruiting
2025/06/19
Phase 2
Not yet recruiting
GERCOR - Multidisciplinary Oncology Cooperative Group
2025/06/17
Phase 1
Not yet recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Alembic Pharmaceuticals Limited
46708-621
INTRAVENOUS
6 mg in 1 mL
10/20/2022
Teva Parenteral Medicines, Inc.
0703-3213
INTRAVENOUS
6 mg in 1 mL
7/7/2020
Sagent Pharmaceuticals
25021-255
INTRAVENOUS
6 mg in 1 mL
1/20/2024
Gland Pharma Limited
68083-178
INTRAVENOUS
6 mg in 1 mL
8/31/2016
Novadoz Pharmaceuticals LLC
72205-063
INTRAVENOUS
6 mg in 1 mL
8/20/2020
Alvogen Inc.
47781-594
INTRAVENOUS
100 mg in 16.7 mL
3/24/2017
Alvogen Inc.
47781-595
INTRAVENOUS
300 mg in 50 mL
3/24/2017
BluePoint Laboratories
68001-516
INTRAVENOUS
6 mg in 1 mL
7/7/2025
Teva Parenteral Medicines, Inc.
0703-3213
INTRAVENOUS
6 mg in 1 mL
7/31/2015
TWi Pharmaceuticals, Inc.
24979-710
INTRAVENOUS
100 mg in 20 mL
4/1/2022

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
INTAXEL INJECTION 6 mg/ml
SIN13180P
INJECTION, SOLUTION, CONCENTRATE
6.0 mg/ml
2/6/2006
GENEXOL INJECTION 6 mg/ml
SIN12050P
INJECTION
6 mg/ml
8/23/2002
PACLITAXEL INJECTION 6 MG/ML
Mylan Laboratories Limited [OTL]
SIN14476P
INJECTION, SOLUTION, CONCENTRATE
6mg/ml
1/6/2014
Aclipak Concentrate for Solution for Infusion 6mg/ ml
SIN13752P
INFUSION, SOLUTION CONCENTRATE
6.00 mg
1/19/2010
PACLITERO 300 SOLUTION FOR INJECTION 300MG/50ML
SIN16438P
INJECTION, SOLUTION
300mg/50mL
3/2/2022
FONKOPAC CONCENTRATE FOR SOLUTION FOR INFUSION 6MG/ML
SIN16410P
INFUSION, SOLUTION CONCENTRATE
6mg/ml
12/30/2021
PAXEL INJECTION 6 mg/ml
Mylan Laboratories Limited [OTL]
SIN14102P
INJECTION, SOLUTION, CONCENTRATE
6mg/ml
2/14/2012
PACLITAXEL ADVAGEN CONCENTRATE FOR SOLUTION FOR INFUSION 6MG/ML
SIN16392P
INFUSION, SOLUTION CONCENTRATE
6mg/mL
12/3/2021
CYTAX PACLITAXEL INJECTION USP CONCENTRATE 6 MG/ ML
SIN15632P
INJECTION, SOLUTION, CONCENTRATE
6 mg/ ml
2/20/2019
EBETAXEL INJECTION 6MG/ML
SIN13701P
INFUSION, SOLUTION CONCENTRATE
6mg/ml
9/17/2009

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Paclitaxel Polymeric Micelles for Injection
国药准字H20210047
化学药品
注射剂
10/26/2021
Paclitaxel Injection
国药准字H20093882
化学药品
注射剂
3/18/2024
Paclitaxel Injection
国药准字H10980170
化学药品
注射剂
3/5/2020
Paclitaxel Injection
国药准字HJ20150351
化学药品
注射剂
11/4/2024
Paclitaxel Injection
国药准字HJ20150350
化学药品
注射剂
11/4/2024
Paclitaxel Injection
国药准字H20053006
化学药品
注射剂
9/3/2020
Paclitaxel Injection
国药准字H20056466
化学药品
注射剂
7/27/2020
Paclitaxel Injection
国药准字H20043045
化学药品
注射剂
3/5/2020
Paclitaxel Injection
国药准字H20056879
化学药品
注射剂
3/13/2020
Paclitaxel Injection
国药准字H20065072
化学药品
注射剂
8/16/2024

PPB Drug Approvals

Help Us Improve

Your feedback helps us provide better drug information and insights.

© Copyright 2025. All Rights Reserved by MedPath