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Tyroserleutide for injection
Tyroserleutide for injection is a GLP-1 receptor agonist Small molecule drug developed by Shenzhen Kangzhe Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Type 2 diabetes.
Tyroserleutide for injection is a recombinant human proinsulin-derived peptide that mimics the action of incretin hormones to enhance glucose-dependent insulin secretion.
Tyroserleutide for injection is being studied in a Phase III clinical trial for the treatment of Hepatocellular Carcinoma. The exact mechanism of action of Tyroserleutide is currently unknown.
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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 | Tyroserleutide for injection |
|---|---|
| Sponsor | Shenzhen Kangzhe Pharmaceutical Co., Ltd. |
| Drug class | GLP-1 receptor agonist |
| Target | GLP-1R |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
It works by stimulating the release of insulin from the pancreas in response to elevated blood glucose levels, thereby lowering blood glucose levels. This action is glucose-dependent, meaning that insulin secretion is only stimulated when blood glucose levels are high, reducing the risk of hypoglycemia.
Approved indications
- Type 2 diabetes
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Injection site reaction
Key clinical trials
- Expanding Phase III Study of Tyroserleutide for Injection (PHASE3)
- Study of Tyroserleutide for Injection in Hepatocellular Carcinoma (HCC) Patients (PHASE3)
- Phase ⅡStudy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients
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:
- Tyroserleutide for injection CI brief — competitive landscape report
- Tyroserleutide for injection updates RSS · CI watch RSS
- Shenzhen Kangzhe Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about Tyroserleutide for injection
What is Tyroserleutide for injection?
How does Tyroserleutide for injection work?
What is Tyroserleutide for injection used for?
Who makes Tyroserleutide for injection?
What drug class is Tyroserleutide for injection in?
What development phase is Tyroserleutide for injection in?
What are the side effects of Tyroserleutide for injection?
What does Tyroserleutide for injection target?
Related
- Drug class: All GLP-1 receptor agonist drugs
- Target: All drugs targeting GLP-1R
- Manufacturer: Shenzhen Kangzhe Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing