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Utidelone
Utidelone is a Small molecule drug developed by Guangdong Provincial People's Hospital. It is currently in Phase 3 development. Also known as: UTD1, UTD1 injection, Singel arm, Bevacizumab.
Utidelone is a pharmaceutical drug approved for use in China in 2021, specifically for the treatment of metastatic breast cancer. It is being studied in clinical trials for various types of advanced solid tumors, including gastric cancer, ovarian cancer, and bile duct cancer.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Utidelone |
|---|---|
| Also known as | UTD1, UTD1 injection, Singel arm, Bevacizumab |
| Sponsor | Guangdong Provincial People's Hospital |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- 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 (PHASE2)
- A Phase II Study of Utidelone With Toripalimab in Advanced Cervical Cancer (PHASE2)
- Adaptive Chemotherapy for the Treatment of Advanced Breast Cancer (PHASE3)
- A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases (PHASE2)
- Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction Adenocarcinoma (PHASE2, PHASE3)
- Simple Surgical Glove Compression to Prevent Chemotherapy-Induced Peripheral Neuropathy (NA)
- Phase II Clinical Study of Utidelone Capsule (UTD2) in Patients With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (PHASE2)
- Comparing UTD2 Combined With Capecitabine to Capecitabine as Adjuvant Therapy for Non-pCR TNBC Patients (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Utidelone CI brief — competitive landscape report
- Utidelone updates RSS · CI watch RSS
- Guangdong Provincial People's Hospital portfolio CI
Frequently asked questions about Utidelone
What is Utidelone?
Who makes Utidelone?
Is Utidelone also known as anything else?
What development phase is Utidelone in?
Related
- Manufacturer: Guangdong Provincial People's Hospital — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: UTD1, UTD1 injection, Singel arm, Bevacizumab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing