Utidelone

Phase 3Small molecule

BBeijing Biostar Pharmaceuticals Co., Ltd.

Utidelone is one of 271 small molecule programs targeting HER2-negative Breast Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

270

Competitors

Pipeline

Status by Indication[3][1]

Indication

HER2-Negative Breast CancerRecruiting

Solid TumorActive, not recruiting

Patients With Advanced Solid TumorsNot yet recruiting

MetastasisRecruiting

Triple-Negative Breast CancerRecruiting

Non-Small Cell Lung CancerCompleted

Breast CancerRecruiting

Ovarian CancerNot yet recruiting

HER2-Negative Breast CancerPhase 2

Recruiting

Solid TumorPreclinical

Active, not recruiting

Patients With Advanced Solid TumorsPhase 2

Not yet recruiting

MetastasisPhase 2

Recruiting

Triple-Negative Breast CancerPhase 2

Recruiting

Non-Small Cell Lung CancerPhase 2

Completed

Breast CancerPhase 3

Recruiting

Ovarian CancerPhase 2

Not yet recruiting

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Utidelone

BBeijing Biostar Pharmaceuticals Co., Ltd.

Phase 3

7 2

Adenocard

Astellas

Preclinical

2 3

Blenoxane

Bristol-Myers Squibb

Preclinical

1 4

Lexiscan

Astellas

Preclinical

1 5

Zolymbus

AbbVie

Preclinical

1 6

Spravato

WWim Janssens

Preclinical

2 7

Acupan

YYonsei University

Preclinical

1 8

Chantix

PPrism Pharmaceuticals

Preclinical

1 9

Vfend

PPrism Pharmaceuticals

Paracetamol

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Triple-Negative Breast Cancer

NCT06125080

Phase 2Not yet recruiting

Patients With Advanced Solid Tumors

NCT06730581

PreclinicalActive, not recruiting

Solid Tumor

NCT05700084

Q2 2027

Phase 3Recruiting

Breast Cancer

NCT05430399

Q3 2027

Phase 2Recruiting

HER2-Negative Breast Cancer

NCT06764940

Phase 2Not yet recruiting

Breast Cancer

NCT05983094

Clinical

Trials by Indication[1]

Breast Cancer7 trials

Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA)

Not yet recruiting·RRenJi Hospital·Phase 2·NCT06510465·143 enrolled

Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer

Unknown status·HHenan Cancer Hospital·Phase 2·NCT05398861·71 enrolled

Organoid-based Functional Precision Therapy for Advanced Breast Cancer

Recruiting·GGuangdong Provincial People's Hospital·Phase 2·NCT06102824·252 enrolled

Show 4 more trials

Study of Utidelone Based Neoadjuvant Treatment on Early High-risk or Locally Advanced Breast Cancer

Not yet recruiting·—·Phase 2·NCT05983094·181 enrolled

Utidelone Plus Bevacizumab for Advanced Breast Cancer With Brain Metastases

Unknown status·HHenan Cancer Hospital·Phase 2·NCT05357417·100 enrolled

Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer

Recruiting·SSun Yat-sen University·Phase 3·NCT05430399·349 enrolled

Weekly Utidelone in HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer

Unknown status·FFudan University·Phase 2·NCT05403333·61 enrolled

Non-Small Cell Lung Cancer3 trials

Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Unknown status·BBeijing Biostar Pharmaceuticals Co., Ltd.·Phase 3·NCT05673590·612 enrolled

Clinical Study of Utidelone Injection in Patients With Advanced Non-small Cell Lung Cancer（NSCLC）

Completed·BBeijing Biostar Pharmaceuticals Co., Ltd.·Phase 2·NCT03693547·26 enrolled

Utidelone Injection Combined with Bevacizumab Injection for Non-small Cell Lung Cancer Patients with Brain Metastases

Not yet recruiting·BBeijing Biostar Pharmaceuticals Co., Ltd.·Phase 2·NCT06683703·118 enrolled

Patients With Advanced Solid Tumors2 trials

Tolerability of Utidelone Capsule in Patients With Advanced Solid Tumors

Unknown status·BBiostar Pharma, Inc.·Phase 1·NCT05681000·28 enrolled

Utidelone Capsule Monotherapy for Patients with Advanced Solid Tumors

Not yet recruiting·BBeijing Biostar Pharmaceuticals Co., Ltd.·Phase 2·NCT06730581·100 enrolled

Gastroesophageal Junction Adenocarcinoma1 trial

Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

Recruiting·BBeijing Biostar Pharmaceuticals Co., Ltd.·Phase 2/3·NCT06841679·778 enrolled

Metastatic Colorectal Cancer1 trial

Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Colorectal Cancer

Suspended·BBeijing Biostar Pharmaceuticals Co., Ltd.·Phase 2·NCT03906565·30 enrolled

10 more indications

Ovarian Cancer1 trial

Phase II Study of Utidelone Plus Fruquintinib Combination Therapy for Platinum-Resistant Recurrent Ovarian Cancer

Not yet recruiting·FFudan University·Phase 2·NCT06973421·35 enrolled

Advanced or Metastatic Solid Tumors1 trial

Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Solid Tumors

Unknown status·BBeijing Biostar Pharmaceuticals Co., Ltd.·Phase 2·NCT04911907·120 enrolled

Metastasis1 trial

A Single-arm, Prospective Phase Ⅱ Clinical Study of Utidelone Combined with Capecitabine in the Treatment of Active Brain Metastasis of TNBC

Recruiting·HHenan Cancer Hospital·Phase 2·NCT06598046·48 enrolled

Urothelial Carcinoma1 trial

Utidelone Treated for the Recurrent or Metastatic Urothelial Carcinoma

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT05895864·34 enrolled

Small Cell Lung Cancer1 trial

Utidelone in Third-line and Above Treatment of Small Cell Lung Cancer

Unknown status·HHenan Cancer Hospital·Phase 2·NCT05299255·40 enrolled

Advanced Breast Cancer1 trial

PK and Drug Interaction Study of Utidelone Plus Capecitabine in Patients With Advanced Breast Cancer

Completed·BBeijing Biostar Pharmaceuticals Co., Ltd.·Phase 1·NCT05052437·16 enrolled

Triple-Negative Breast Cancer1 trial

The Efficacy and Safety of Utidelone Plus Tirelizumab and Bevacizumab for Advanced or Metastatic Triple-negative Breast Cancer (UTILIZABLE) ：Single-arm, Prospective, Open Clinical Study

Recruiting·HHuihua Xiong·Phase 2·NCT06125080·78 enrolled

Solid Tumor1 trial

Phase I-II Clinical Trial on Tolerability and Bioavailability of Utidelone Capsule in Patients With Advanced Solid Tumors

Active, not recruiting·BBeijing Biostar Pharmaceuticals Co., Ltd.·Preclinical·NCT05700084·84 enrolled

HER2-negative Breast Cancer1 trial

A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients With Brain Metastases

Recruiting·BBiostar Pharma, Inc.·Phase 2·NCT06764940·120 enrolled

Malignant Solid Tumor1 trial

A Single-Arm, Open-Label, Phase II Clinical Study of Utidelone and Bevacizumab With or Without Etoposide in Patients With Brain Metastases From Malignant Solid Tumors

Withdrawn·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT07449481

Sources

References

[1]
ClinicalTrials.gov — 24 trial records for Utidelone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Utidelone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Utidelone. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Beijing Biostar Pharmaceuticals Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: BBeijing Biostar Pharmaceuticals Co., Ltd.

Utidelone

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Trials by Indication[1]

Breast Cancer7 trials

Non-Small Cell Lung Cancer3 trials

Patients With Advanced Solid Tumors2 trials

Gastroesophageal Junction Adenocarcinoma1 trial

Metastatic Colorectal Cancer1 trial

Ovarian Cancer1 trial

Advanced or Metastatic Solid Tumors1 trial

Metastasis1 trial

Urothelial Carcinoma1 trial

Small Cell Lung Cancer1 trial

Advanced Breast Cancer1 trial

Triple-Negative Breast Cancer1 trial

Solid Tumor1 trial

HER2-negative Breast Cancer1 trial

Malignant Solid Tumor1 trial

References

Drug Info

Quick Facts

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