Back to discover
Drug

Docetaxel

Approved · EMA
ClassTubulin inhibitorActively researchedLate-stage developmentRising momentum
Also known as Beizray, Docefrez, Docivyx, TXL+1 more

Beizray, Docefrez, Docivyx, TXL, Taxotere.

31
Research papers
37
Active clinical trials
15
Protein targets
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study.

Research2024-05-31Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Approval: Docetaxel Accord (EMA)

Regulatory2012-05-22EMA

Approval: Docetaxel Kabi (EMA)

Regulatory2012-05-22EMA

Approval: Taxotere (EMA)

Regulatory1995-11-27EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Docetaxel
Aliases & brands
BeizrayDocefrezDocivyxTXLTaxotere
RxNorm CUI
72962
ChEMBL ID
CHEMBL3545252
ATC codes
L01CD02
UNII
15H5577CQD
Primary mechanism
Tubulin inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

15 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Tubulin beta-4B chain
TUBB4B · P68371
INHIBITORTubulin inhibitor
Tubulin beta-1 chain
TUBB1 · Q9H4B7
INHIBITORTubulin inhibitor
Tubulin alpha-3C chain
TUBA3C · P0DPH7
INHIBITORTubulin inhibitor
Tubulin alpha-4A chain
TUBA4A · P68366
INHIBITORTubulin inhibitor
Tubulin beta-3 chain
TUBB3 · Q13509
INHIBITORTubulin inhibitor
Tubulin alpha-1A chain
TUBA1A · Q71U36
INHIBITORTubulin inhibitor
Tubulin beta-4A chain
TUBB4A · P04350
INHIBITORTubulin inhibitor
Tubulin beta-8 chain
TUBB8 · Q3ZCM7
INHIBITORTubulin inhibitor
Tubulin beta chain
TUBB · P07437
INHIBITORTubulin inhibitor
Tubulin alpha-1B chain
TUBA1B · P68363
INHIBITORTubulin inhibitor
Tubulin alpha-1C chain
TUBA1C · Q9BQE3
INHIBITORTubulin inhibitor
Tubulin alpha-3E chain
TUBA3E · Q6PEY2
INHIBITORTubulin inhibitor
Tubulin beta-2A chain
TUBB2A · Q13885
INHIBITORTubulin inhibitor
Tubulin beta-2B chain
TUBB2B · Q9BVA1
INHIBITORTubulin inhibitor
Tubulin beta-6 chain
TUBB6 · Q9BUF5
INHIBITORTubulin inhibitor

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
1995-11-27
Latest approval
2012-05-22
Authorities
EMA
Total events
3
emaEuropean Medicines Agency· 3 events
2012-05-22Approval
Approval: Docetaxel Kabi (EMA)
Indication: Breast cancer Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer;Show full indication

Breast cancer Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Kabi in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Kabi monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Kabi in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Kabi in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Kabi is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Kabi in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Kabi in combination with prednisone or prednisolone is indicated for the treatment of patients with castration-resistant metastatic prostate cancer. Docetaxel Kabi in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer. Gastric adenocarcinoma Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Evidence ↗
2012-05-22Approval
Approval: Docetaxel Accord (EMA)
Indication: Breast cancer Docetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breastShow full indication

Breast cancer Docetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Accord in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Accord is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Accord in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Evidence ↗
1995-11-27Approval
Approval: Taxotere (EMA)
Indication: Breast cancer Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer;Show full indication

Breast cancer Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Taxotere in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Taxotere monotherapy is indicated for the treatment of patients with locally advanced ormetastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Taxotere in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Taxotere in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Taxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Taxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

195 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
195
registered trials across all phases
LATEST COMPLETION 2025
37
Active studies
23
Recruiting
59
Late-stage (III+)
100
Completed
58
Discontinued
PHASE DISTRIBUTIONn = 195
Phase 121Phase 1 / 214Phase 2101Phase 2 / 311Phase 343Phase 42Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

31 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
19992025
Most influential

Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer.

The New England journal of medicine · 2015 · 7,498 cites

Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer.

The New England journal of medicine · 2015 · 6,639 cites

Increased survival with enzalutamide in prostate cancer after chemotherapy.

The New England journal of medicine · 2012 · 3,415 cites

Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma.

The New England journal of medicine · 2017 · 2,620 cites

Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer.

The New England journal of medicine · 2015 · 2,037 cites

Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2004 · 1,749 cites
Recent papers
Major research themes8
Carcinoma, Non-Small-Cell Lung6Lung Neoplasms6Docetaxel5Antibodies, Monoclonal, Humanized3Antineoplastic Agents2Antineoplastic Combined Chemotherapy Protocols2Immune Checkpoint Inhibitors2Prostatic Neoplasms, Castration-Resistant2
Journals, researchers & institutions
Top journals
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology12
  • The New England journal of medicine7
  • Annals of oncology : official journal of the European Society for Medical Oncology2
  • Clinical breast cancer2
  • Investigational new drugs2
  • BMJ (Clinical research ed.)1
Leading researchers
  • Felip E5
  • Spigel DR4
  • Vokes EE4
  • Arrieta O3
  • Barlesi F3
  • Brahmer J3
  • Burgio MA3
  • Crinò L3
Leading institutions
free-text, unnormalised
  • Dana-Farber Cancer Institute3
  • Hospital Universitario 12 de Octubre3
  • Yale Comprehensive Cancer Center3
  • Catalan Institute of Oncology2
  • Cross Cancer Institute2
  • Duke University Medical Center2

Related diseases

8 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

8 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Acts on the same molecular target as Docetaxel, with 9 overlapping disease areas.

15 shared targets9 shared diseases1 shared paper

Acts on the same molecular target as Docetaxel, with 3 overlapping disease areas.

15 shared targets3 shared diseases1 shared paper

Acts on the same molecular target as Docetaxel, with 2 overlapping disease areas.

15 shared targets2 shared diseases1 shared paper

Studied across 11 of the same disease areas as Docetaxel in the shared literature.

11 shared diseases3 shared papers

Studied across 12 of the same disease areas as Docetaxel in the shared literature.

12 shared diseases2 shared papers

Studied across 10 of the same disease areas as Docetaxel in the shared literature.

10 shared diseases2 shared papers

Studied across 7 of the same disease areas as Docetaxel in the shared literature.

7 shared diseases2 shared papers

Studied across 7 of the same disease areas as Docetaxel in the shared literature.

7 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.