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PEX168(100µg)
PEX168(100µg) is a GLP-1 receptor agonist Small molecule drug developed by Jiangsu Hansoh Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Type 2 diabetes mellitus. Also known as: Polyethylene Glycol Loxenatide.
PEX168 is a long-acting GLP-1 receptor agonist that stimulates insulin secretion and reduces glucagon in response to elevated blood glucose.
PEX168(100µg) is a protein-based intervention being studied in a Phase III clinical trial for the treatment of Type 2 Diabetes Mellitus. PEX168 is a synthetic protein that is administered in combination with metformin in this trial.
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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 | PEX168(100µg) |
|---|---|
| Also known as | Polyethylene Glycol Loxenatide |
| Sponsor | Jiangsu Hansoh Pharmaceutical Co., Ltd. |
| Drug class | GLP-1 receptor agonist |
| Target | GLP-1R (GLP-1 receptor) |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
PEX168 is a pegylated exenatide derivative designed to provide extended duration of action compared to immediate-release GLP-1 agonists. It binds to and activates the GLP-1 receptor on pancreatic beta cells, enhancing glucose-dependent insulin secretion, while simultaneously suppressing glucagon secretion and slowing gastric emptying to improve glycemic control in type 2 diabetes.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Injection site reactions
Key clinical trials
- Efficacy and Safety Study of PEX168 in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin (PHASE3)
- Efficacy and Safety Study of PEX168 in Monotherapy Diabetes Mellitus Type 2 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:
- PEX168(100µg) CI brief — competitive landscape report
- PEX168(100µg) updates RSS · CI watch RSS
- Jiangsu Hansoh Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about PEX168(100µg)
What is PEX168(100µg)?
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Related
- Drug class: All GLP-1 receptor agonist drugs
- Target: All drugs targeting GLP-1R (GLP-1 receptor)
- Manufacturer: Jiangsu Hansoh Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes mellitus
- Also known as: Polyethylene Glycol Loxenatide
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing