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Priya Life Science Compound trial record
Compound · clinical trials

Utidelone clinical trials

Also listed in trial records as UTD1
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 16 trials in our China and USA registers that name Utidelone as an intervention. Synced 10 Nov 2026
16Current trials
8Recruiting now
11Lead sponsors
2Country registers
At a glance

Utidelone is named as an intervention in 16 current clinical trials in our China and USA registers. 8 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Beijing Biostar Pharmaceuticals Co., Ltd (3). The most-studied condition is Breast Neoplasms.

Patient leaflets for Utidelone

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

  • Recruiting850%
  • Not yet open638%
  • Active, closed213%

Trials by phase

  • Phase 2956%
  • Phase 3425%
  • Phase 1/2213%
  • Phase 2/316%
01

Clinical trials of Utidelone

16 trials
StudyPhaseStatusLead sponsorRegisters
Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer
NCT05430399 · ClinicalTrials.gov ↗ · Breast Neoplasms, Locally Advanced or Metastatic Breast Cancer
Phase 3 Recruiting Sun Yat-sen University China
Adaptive Chemotherapy for the Treatment of Advanced Breast Cancer
NCT07088263 · ClinicalTrials.gov ↗ · Breast Neoplasms
Phase 3 Recruiting Sun Yat-sen University China
Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
NCT06841679 · Gastric or Gastroesophageal Junction Adenocarcinoma
Phase 2/3 Recruiting Beijing Biostar Pharmaceuticals Co., Ltd USA, China
Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer
NCT05398861 · ClinicalTrials.gov ↗ · HER-2 Negative Breast Cancer
Phase 2 Recruiting Henan Cancer Hospital China
Organoid-based Functional Precision Therapy for Advanced Breast Cancer
NCT06102824 · ClinicalTrials.gov ↗ · HER2-negative Breast Cancer, Advanced Breast Cancer
Phase 2 Recruiting Guangdong Provincial People's Hospital China
Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy
NCT06385990 · ClinicalTrials.gov ↗ · Triple Negative Breast Neoplasms
Phase 2 Recruiting Hunan Cancer Hospital China
A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases
NCT06764940 · HER2-negative Breast Cancer Patients With Brain Metastases
Phase 2 Recruiting Biostar Pharma, Inc USA
UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases
NCT05535413 · ClinicalTrials.gov ↗ · Metastatic HER2 Negative Breast Carcinoma, Brain Metastases, Capecitabine
Phase 1/2 Recruiting Hunan Cancer Hospital China
Utidelone Plus Capecitabine Versus Taxane Plus Capecitabine in HER2-negative Locally Advanced or Metastatic Breast Cancer
NCT05172518 · ClinicalTrials.gov ↗ · Breast Neoplasms, Locally Advanced or Metastatic Breast Cancer
Phase 3 Not yet open Sun Yat-sen University China
Efficacy and Safety of Utidelone Capsule and Utidelone Injection in Patients With HER-2 Negative Advanced Breast Cancer
NCT07684456 · ClinicalTrials.gov ↗ · Advanced Breast Cancer
Phase 3 Not yet open Beijing Biostar Pharmaceuticals Co., Ltd China
Study of Utidelone Based Neoadjuvant Treatment on Early High-risk or Locally Advanced Breast Cancer
NCT05983094 · ClinicalTrials.gov ↗ · Breast Cancer, Neoadjuvant Therapy
Phase 2 Not yet open Cancer Institute and Hospital, Chinese Academy of Medical Sciences China
Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA)
NCT06510465 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 2 Not yet open RenJi Hospital China
Phase II Study of Utidelone Plus Fruquintinib Combination Therapy for Platinum-Resistant Recurrent Ovarian Cancer
NCT06973421 · ClinicalTrials.gov ↗ · Platinum Resistant Ovarian Cancer
Phase 2 Not yet open Fudan University China
A Phase II Study of Utidelone With Toripalimab in Advanced Cervical Cancer
NCT07363330 · ClinicalTrials.gov ↗ · Cervical Cancer, Recurrent, Metastatic
Phase 2 Not yet open Zhongnan Hospital China
Utidelone Capsule Plus Capecitabine (CAP) for Metastatic Breast Cancer
NCT06458413 · ClinicalTrials.gov ↗ · Breast Cancer Recurrent
Phase 2 Active, closed Min Yan, MD China
Phase I-II Clinical Trial of Utidelone Capsule in Patients With Advanced Solid Tumors
NCT05700084 · ClinicalTrials.gov ↗ · Advanced Solid Tumor
Phase 1/2 Active, closed Beijing Biostar Pharmaceuticals Co., Ltd China

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Utidelone

20 conditions
Breast Neoplasms3Breast Cancer2Advanced Breast Cancer2Locally Advanced or Metastatic Breast Cancer2HER2-negative Breast Cancer Patients With Brain Metastases1Gastric or Gastroesophageal Junction Adenocarcinoma1Cervical Cancer1Recurrent1Metastatic1Platinum Resistant Ovarian Cancer1Breast Cancer Recurrent1HER2-negative Breast Cancer1
All 20 conditions
Condition (as registered)Trials
Breast Neoplasms3
Breast Cancer2
Advanced Breast Cancer2
Locally Advanced or Metastatic Breast Cancer2
HER2-negative Breast Cancer Patients With Brain Metastases1
Gastric or Gastroesophageal Junction Adenocarcinoma1
Cervical Cancer1
Recurrent1
Metastatic1
Platinum Resistant Ovarian Cancer1
Breast Cancer Recurrent1
HER2-negative Breast Cancer1
Advanced Solid Tumor1
Neoadjuvant Therapy1
HER-2 Negative Breast Cancer1
Metastatic HER2 Negative Breast Carcinoma1
Brain Metastases1
Capecitabine1
UDT11
Triple Negative Breast Neoplasms1
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
Beijing Biostar Pharmaceuticals Co., Ltd3
Sun Yat-sen University3
Hunan Cancer Hospital2
Biostar Pharma, Inc1
Zhongnan Hospital1
RenJi Hospital1
Fudan University1
Min Yan, MD1
Guangdong Provincial People's Hospital1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1
Henan Cancer Hospital1
04

By country register

RegisterTrialsRecruiting
Clinical trials in China157
Clinical trials in USA22

A trial with sites in more than one country appears in each of those registers.

05

Related compounds

06

Questions about Utidelone trials

How many clinical trials are testing Utidelone?

16 current trials in our China and USA registers name Utidelone (also registered as UTD1) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.

Are Utidelone trials recruiting patients?

Yes. 8 of the 16 trials are recruiting: 7 with sites in China and 2 with sites in USA. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Utidelone clinical trials?

Beijing Biostar Pharmaceuticals Co., Ltd (3), Sun Yat-sen University (3), Hunan Cancer Hospital (2) and Biostar Pharma, Inc (1), among 11 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Utidelone works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Utidelone works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Utidelone (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.