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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.

Background

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

FDA Approved Products

Paclitaxel
Manufacturer:Teva Parenteral Medicines, Inc.
Route:INTRAVENOUS
Strength:6 mg in 1 mL
Approved: 2020/07/07
NDC:0703-3213
Paclitaxel
Manufacturer:Teva Parenteral Medicines, Inc.
Route:INTRAVENOUS
Strength:6 mg in 1 mL
Approved: 2020/07/07
NDC:0703-3216
Paclitaxel
Manufacturer:Novadoz Pharmaceuticals LLC
Route:INTRAVENOUS
Strength:6 mg in 1 mL
Approved: 2020/08/20
NDC:72205-062
Paclitaxel
Manufacturer:Alvogen Inc.
Route:INTRAVENOUS
Strength:300 mg in 50 mL
Approved: 2017/03/24
NDC:47781-595
Paclitaxel
Manufacturer:MSN LABORATORIES PRIVATE LIMITED
Route:INTRAVENOUS
Strength:6 mg in 1 mL
Approved: 2020/08/04
NDC:69539-159

Singapore Approved Products

INTAXEL INJECTION 6 mg/ml
Manufacturer:FRESENIUS KABI ONCOLOGY LIMITED, Fresenius Kabi Oncology Limited (Baddi II)
Form:INJECTION, SOLUTION, CONCENTRATE
Strength:6.0 mg/ml
Online:Yes
Approved: 2006/02/06
Approval:SIN13180P
GENEXOL INJECTION 6 mg/ml
Manufacturer:SAMSUNG PHARMACEUTICAL IND CO LTD
Form:INJECTION
Strength:6 mg/ml
Online:Yes
Approved: 2002/08/23
Approval:SIN12050P
PACLITAXEL INJECTION 6 MG/ML
Manufacturer:Mylan Laboratories Limited [OTL]
Form:INJECTION, SOLUTION, CONCENTRATE
Strength:6mg/ml
Online:Yes
Approved: 2014/01/06
Approval:SIN14476P
Aclipak Concentrate for Solution for Infusion 6mg/ ml
Manufacturer:S.C. Sindan - Pharma S.R.L
Form:INFUSION, SOLUTION CONCENTRATE
Strength:6.00 mg
Online:Yes
Approved: 2010/01/19
Approval:SIN13752P
PACLITERO 300 SOLUTION FOR INJECTION 300MG/50ML
Manufacturer:HETERO LABS LIMITED
Form:INJECTION, SOLUTION
Strength:300mg/50mL
Online:Yes
Approved: 2022/03/02
Approval:SIN16438P

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