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Gemigliptin/Glimepiride combination
Gemigliptin/Glimepiride combination is a DPP-4 inhibitor + sulfonylurea combination Small molecule drug developed by LG Life Sciences. It is currently in Phase 3 development for Type 2 diabetes mellitus.
Gemigliptin inhibits dipeptidyl peptidase-4 (DPP-4) to increase incretin levels and insulin secretion, while glimepiride stimulates pancreatic beta cells to release insulin directly.
Gemigliptin and glimepiride are a combination of medications used to treat type 2 diabetes mellitus. This combination works by blocking the sulfonylurea receptor 1, Kir6.2, which helps to lower blood sugar levels.
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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 | Gemigliptin/Glimepiride combination |
|---|---|
| Sponsor | LG Life Sciences |
| Drug class | DPP-4 inhibitor + sulfonylurea combination |
| Target | DPP-4 (dipeptidyl peptidase-4) and sulfonylurea receptor (SUR1) |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
This is a dual-mechanism combination therapy for type 2 diabetes. Gemigliptin, a DPP-4 inhibitor, prolongs the action of incretin hormones (GLP-1 and GIP) to enhance glucose-dependent insulin secretion. Glimepiride, a meglitinide-class sulfonylurea, directly stimulates insulin release from pancreatic beta cells. Together, they address both incretin-based and direct insulin secretion pathways to lower blood glucose.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Hypoglycemia
- Nasopharyngitis
- Headache
- Dizziness
- Gastrointestinal disturbances
Key clinical trials
- Initial Combination of Gemigliptin and Metformin on Microbiota Change (NA)
- Effects of Gemigliptin Versus Sitagliptin or Glimepiride With Metformin on Glucose Variability(MAGE, Glucose SD) Patients With Type 2 DM(STABLE Study) (PHASE4)
- Phase III Trial to Evaluate the Efficacy and Safety of Gemigliptin 50mg qd Added to Ongoing Glimepiride as Fix-dose Combination in Patients With Type 2 Diabetes (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:
- Gemigliptin/Glimepiride combination CI brief — competitive landscape report
- Gemigliptin/Glimepiride combination updates RSS · CI watch RSS
- LG Life Sciences portfolio CI
Frequently asked questions about Gemigliptin/Glimepiride combination
What is Gemigliptin/Glimepiride combination?
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Related
- Drug class: All DPP-4 inhibitor + sulfonylurea combination drugs
- Target: All drugs targeting DPP-4 (dipeptidyl peptidase-4) and sulfonylurea receptor (SUR1)
- Manufacturer: LG Life Sciences — 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