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docetaxel

Generic: DOCETAXEL·Brand: BEIZRAY, Beizray, DOCEFREZ, DOCETAXEL, DOCIVYX, Docivyx, TAXOTERE

docetaxel: developed by 2 companies · 149 clinical trials tracked · 2 FDA decisions.

docetaxel evidence translation

What we can confirm

2 FDA records · 149 tracked trials

What it means

More than one developer is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

What is verified about docetaxel, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence8 indications · 48 study sponsors
Development Pipeline (2)
CompanyPhase
PFIZER INC (PFE)
Metastatic Castration Sensitive Prostate Cancer (mCSPC); Met…
Approved
DR REDDYS LABORATORIES LTD (RDY)Approved
Clinical Trials (149)showing 10 most recent

A Randomized, 2-Arm Study to Evaluate the Efficacy and Safety of CRB-701 Compared With Investigator's Choice of Capecitabine, Cetuximab, or Docetaxel in Participants With Recurrent or Metastatic Oropharyngeal Squamous Cell Carcinoma Previously Treated With Platinum-based Chemotherapy and a PD-(L)1 Inhibitor

NCT07768189·Phase 3·CRBP
Not yet recruiting

Primary endpoint: Objective Response Rate (%)

InterventionalRandomizedsingle260 targetStarted 2026-09Completion 2029-0328 sites · Austria, United Kingdom, United StatesCorbus Pharmaceuticals Inc.

A Prospective, Randomized, Open-Label, Phase II Trial Comparing Sequential Intravesical Gemcitabine Plus Docetaxel With Sequential Intravesical Gemcitabine Plus Mitomycin C in Patients With BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer

NCT07747740·Phase 2·GHRS
Recruiting

Primary endpoint: 12-Month Event-Free Survival

InterventionalRandomizedopen228 targetStarted 2026-07Completion 2030-121 site · RussiaBlokhin's Russian Cancer Research Center

A Phase 3, Randomized, Open-Label Study of Rinzimetostat (ORIC-944) in Combination With Darolutamide Compared With ARPI or Docetaxel in Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Abiraterone Acetate (Himalayas-1)

NCT07723248·Phase 3·ORIC
Recruiting

Primary endpoint: Radiographic Progression Free Survival assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)

InterventionalRandomizedopen600 targetStarted 2026-07Completion 2030-092 sites · United StatesORIC Pharmaceuticals

A Phase 3, Multicenter, Randomized, Controlled, Open-Label Clinical Trial of Aglatimagene Besadenovec (CAN-2409) Plus Prodrug and Pembrolizumab Versus Docetaxel for Stage IV Non-Squamous Non-Small Cell Lung Cancer Progressing on Pembrolizumab-based Treatment

NCT07660094·Phase 3·CADL
Recruiting

Primary endpoint: Overall Survival

InterventionalRandomizedopen500 targetStarted 2026-06Completion 2031-101 site · United StatesCandel Therapeutics, Inc.

A Phase Ib/II, Open-label, Multi-centre, Platform Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Multiple Anti-Cancer Agents in Metastatic Prostate Cancer

NCT07590934·Phase 1/Phase 2·AZN
Recruiting

Primary endpoint: Part A: Number of participants with treatment-emergent adverse events (TEAEs)including serious adverse events (SAEs), treatment-related AEs (TRAEs) and adverse events of special interests (AESIs)

InterventionalRandomizedopen152 targetStarted 2026-06Completion 2029-0935 sites · Australia, Germany, Italy, South Korea…AstraZeneca

A Global, Multicenter, Randomized, Double-blinded, Phase 3 Study of Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer With EGFR, ALK, ROS, and RET Wild Type After Progressing on Prior Immunotherapy (Anti-PD-1/L1 Antibody) and Platinum-based Chemotherapy (DUBLIN-4)

NCT07361484·Phase 3·BYSI
Not yet recruiting

Primary endpoint: Overall Survival (OS)

InterventionalRandomizedquadruple442 targetStarted 2026-06Completion 2029-12BeyondSpring Pharmaceuticals Inc.

A Randomized, Open-Label, Multi-center, Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) Monotherapy or HLX43 in Combination With HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

NCT07459751·Phase 2/Phase 3
Recruiting

Primary endpoint: Overall survival (OS)

InterventionalRandomizedopen706 targetStarted 2026-05Completion 2030-011 site · ChinaShanghai Henlius Biotech

Solid Tumor Study for Long Term Treatment of Cancer Patients Who Have Participated in BMS Parent Studies Investigating Adagrasib (BMS-986503)

NCT07415031·Phase 2·MRTX
Recruiting

Primary endpoint: Number of Participants With Adverse Events (AEs)

Interventionalopen170 targetStarted 2026-05Completion 2028-0250 sites · Australia, Belgium, Canada, France…Mirati Therapeutics Inc.

A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator's Choice of Non-platinum Chemotherapy in Participants With Pretreated Locally Advanced/Metastatic Urothelial Carcinoma

NCT07419295·Phase 3
Recruiting

Primary endpoint: Overall Survival (OS)

InterventionalRandomizedopen590 targetStarted 2026-04Completion 2030-0450 sites · Argentina, Australia, Belgium, Brazil…Merck Sharp & Dohme LLC

A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer

NCT07365995·Phase 3·BNTX
Recruiting

Primary endpoint: rPFS assessed by BICR

InterventionalRandomizedopen736 targetStarted 2026-04Completion 2031-0215 sites · United StatesBioNTech SE
FDA Decisions2 records
Approval1 INDICATIONS AND USAGE Docetaxel injection is a microtubule inhibitor indicated for: Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1 ) Non-small Cell Lung Cancer (NSCLC) : single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.2 (RDY)FDA ↗
ANDA204193UNKNOWNOtherInjectable
Approval1 INDICATIONS AND USAGE Docetaxel Injection is a microtubule inhibitor indicated for: • Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1 ) • Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.(PFE)FDA ↗
NDA202356Type 5 - New Formulation or New ManufacturerStandardOtherInjectable

Frequently asked questions

Who is developing docetaxel?

docetaxel is being developed by PFIZER INC, DR REDDYS LABORATORIES LTD.

How many clinical trials involve docetaxel?

BioSniper tracks 149 clinical trials involving docetaxel.

What is docetaxel's latest FDA decision?

The most recent tracked FDA decision for docetaxel is Approval for 1 INDICATIONS AND USAGE Docetaxel injection is a microtubule inhibitor indicated for: Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1 ) Non-small Cell Lung Cancer (NSCLC) : single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.2 , dated November 5, 2014.