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NBP607-V
NBP607-V is a GLP-1 receptor agonist Biologic drug developed by SK Chemicals Co., Ltd.. It is currently in Phase 3 development for Type 2 diabetes mellitus.
NBP607-V is a recombinant human albumin-fused glucagon-like peptide-1 (GLP-1) receptor agonist that enhances insulin secretion and reduces glucagon levels to improve glycemic control.
NBP607-V is a small molecule intervention being studied for its effects on influenza. It is part of a quadrivalent influenza vaccine, specifically NBP607-QIV, which is being tested for immunogenicity and safety in adults and elderly subjects.
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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 | NBP607-V |
|---|---|
| Sponsor | SK Chemicals Co., Ltd. |
| Drug class | GLP-1 receptor agonist |
| Target | GLP-1R |
| Modality | Biologic |
| Therapeutic area | Endocrinology / Diabetes |
| Phase | Phase 3 |
Mechanism of action
NBP607-V binds to GLP-1 receptors on pancreatic beta cells, stimulating glucose-dependent insulin secretion while simultaneously suppressing glucagon release. The fusion with human albumin extends the drug's half-life, allowing for less frequent dosing. This mechanism addresses both fasting and postprandial hyperglycemia in type 2 diabetes.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Hypoglycemia
Key clinical trials
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:
- NBP607-V CI brief — competitive landscape report
- NBP607-V updates RSS · CI watch RSS
- SK Chemicals Co., Ltd. portfolio CI
Frequently asked questions about NBP607-V
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Related
- Drug class: All GLP-1 receptor agonist drugs
- Target: All drugs targeting GLP-1R
- Manufacturer: SK Chemicals Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Endocrinology / Diabetes
- Indication: Drugs for Type 2 diabetes mellitus
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing