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HU-014 Inj
HU-014 Inj is a GLP-1 receptor agonist Biologic drug developed by Huons Co., Ltd.. It is currently in Phase 3 development for Type 2 diabetes mellitus.
HU-014 is a long-acting GLP-1 receptor agonist that enhances insulin secretion and reduces glucagon levels to improve glycemic control.
HU-014 is a long-acting GLP-1 receptor agonist that enhances insulin secretion and reduces glucagon levels to improve glycemic control. Used for Type 2 diabetes mellitus.
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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 | HU-014 Inj |
|---|---|
| Sponsor | Huons Co., Ltd. |
| Drug class | GLP-1 receptor agonist |
| Target | GLP-1R |
| Modality | Biologic |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
HU-014 binds to and activates the glucagon-like peptide-1 (GLP-1) receptor on pancreatic beta cells, stimulating glucose-dependent insulin secretion. It also suppresses glucagon release and slows gastric emptying, collectively reducing postprandial and fasting blood glucose levels. The long-acting formulation allows for less frequent dosing compared to short-acting GLP-1 agonists.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Injection site reactions
Key clinical trials
- To Evaluate HU-014 in the Treatment of Post Stroke Upper Limb (PHASE3)
- A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity (PHASE1)
- A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines (PHASE3)
- The Safety and Efficacy Study of HU-014 Versus Botox® in Subject With Moderate to Severe Glabellar Lines (PHASE1, PHASE2)
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:
- HU-014 Inj CI brief — competitive landscape report
- HU-014 Inj updates RSS · CI watch RSS
- Huons Co., Ltd. portfolio CI
Frequently asked questions about HU-014 Inj
What is HU-014 Inj?
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What drug class is HU-014 Inj in?
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What does HU-014 Inj target?
Related
- Drug class: All GLP-1 receptor agonist drugs
- Target: All drugs targeting GLP-1R
- Manufacturer: Huons Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes mellitus
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing