Wednesday, July 8, 2026

Drug profile · INN

paclitaxel

paclitaxel (PACLITAXEL ACCORD) is a tubulin inhibitor. Associated with Accord Healthcare Pty.. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01CD01
US status approved
Patents linked 12
Pipeline programs 230
News articles 1
Drug details — paclitaxel
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
INJECTION
Patents
12
Programs
230
Data quality
0.89

Quick answer

paclitaxel (PACLITAXEL ACCORD) is a tubulin inhibitor. Associated with Accord Healthcare Pty.. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN paclitaxel
Brand PACLITAXEL ACCORD
Mechanism Tubulin inhibitor
Target Tubulin
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route INJECTION
Formulation INJECTABLE
ATC code L01CD01

Mechanism of action

Tubulin inhibitor

Primary target: Tubulin

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved
NMPA clinical trials

Recent coverage

Pipeline programs

  1. 1407-GUCG Phase 3 · Ningbo Cancer Hospital · Progressive or recurrent germ cell tumor (measurable or non-
  2. 2022-009 Phase 3 · Ningbo Cancer Hospital · metastatic breast cancer
  3. 7465-CL-0301 Phase 3 · Astellas Pharma · Locally advanced or metastatic urothelial cancer
  4. ALKS 4230-007 Phase 3 · Createrna Science and · Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Pr
  5. AT148006 Phase 3 · Createrna Science and · Patients with HER2-overexpressing advanced or metastatic gas
  6. Abraxane /ml powder for dispersion for infusion. for metastatic NSCLC patients Phase 3 · Telethon Foundation · metastatic NSCLC patients
  7. B013+Nab-Paclitaxel Phase 3 · BRIGHT MINDS BIOSCIENCES · Triple Negative Breast Cancer (TNBC)
  8. BNT323-01 Phase 3 · BioNTech SE · Endometrial cancer

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)
  1. US 11944617

    Concomitant administration of glucocorticoid receptor modulator relacorilant and paclitaxel, a dual substrate of CYP2C8 and CYP3A4

    Expires Mon Mar 28 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11439709

    Phospholipid ether analogs as cancer-targeting drug vehicles

    Expires Mon Sep 08 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11285145

    Concomitant administration of glucocorticoid receptor modulator relacorilant and paclitaxel, a dual substrate of CYP2C8 and CYP3A4

    Expires Mon Mar 24 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 9925269

    Phospholipid ether analogs as cancer-targeting drug vehicles

    Expires Mon Mar 22 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 9616140

    Fluorescent phospholipid ether compounds, compositions, and methods of use

    Expires Mon Apr 06 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 9579406

    Phospholipid ether analogs as agents for detecting and locating cancer, and methods thereof

    Expires Mon Feb 23 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 9550002

    Phospholipid analogs as diapeutic agents and methods thereof

    Expires Mon Jan 19 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 9480754

    Phospholipid ether analogs as cancer-targeting drug vehicles

    Expires Mon Oct 27 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 9345718

    Phospholipid ether analogs as cancer-targeting drug vehicles

    Expires Mon May 19 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 8426385

    Pharmaceutical composition comprising cyclodextrin paclitaxel inclusion and preparation method thereof

    Expires Mon Apr 18 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 7179588

    Assay for the detection of paclitaxel resistant cells in human tumors

    Expires Mon Feb 15 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 6569459

    Method of administration of paclitaxel-plasma protein formulation

    Expires Mon May 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is paclitaxel?

paclitaxel (PACLITAXEL ACCORD) is a tubulin inhibitor. Associated with Accord Healthcare Pty.. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for paclitaxel?

PACLITAXEL ACCORD is a marketed brand name for paclitaxel. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of paclitaxel?

paclitaxel has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.