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
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]
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 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 5/6/2019 | ||
Authorised | 1/5/2024 | ||
Authorised | 7/24/2024 | ||
Authorised | 1/11/2008 |
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
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
PACLITAXEL ADVAGEN CONCENTRATE FOR SOLUTION FOR INFUSION 30MG/5ML | N/A | N/A | N/A | 1/12/2024 | |
PAXEL CONCENTRATE FOR SOLUTION FOR INFUSION 300MG/50ML | N/A | N/A | N/A | 10/15/2012 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Paclitaxel I.V. Infusion 30 mg/5 mL Hospira | 228432 | Medicine | A | 9/26/2014 | |
PACLITAXEL APOTEX paclitaxel (nanoparticle albumin-bound) 100 mg powder for injection (suspension) vial | 300354 | Medicine | A | 2/14/2020 | |
PACLITAXEL INTAS paclitaxel 300 mg/50 mL concentrated injection vial | 219553 | Medicine | A | 2/2/2016 | |
PACLICCORD paclitaxel 30 mg/5 mL concentrated injection vial | 168528 | Medicine | A | 7/21/2011 | |
PACLITAXEL AN paclitaxel 300mg/50mL concentrated injection vial | 176334 | Medicine | A | 1/20/2011 | |
Hospira Paclitaxel 6 mg/mL Concentrated Solution for Infusion, 150 mg/25 mL Vial | 152445 | Medicine | A | 5/21/2008 | |
CIPLA PACLITAXEL Paclitaxel (nanoparticle albumin-bound) 100 mg powder for injection (suspension) vial | 328529 | Medicine | A | 10/29/2020 | |
PACLITAXEL EBEWE paclitaxel 300 mg/50 mL concentrated injection vial | 98551 | Medicine | A | 2/14/2005 | |
ANZATAX 30mg/5mL injection | 50578 | Medicine | A | 1/12/1995 | |
Hospira Paclitaxel Concentrate for Solution for Infusion 300 mg/50 mL Vial | 155459 | Medicine | A | 9/30/2008 |
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