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Placebo(Gemigliptin)
Placebo(Gemigliptin) is a DPP-4 inhibitor 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 improve blood glucose control in type 2 diabetes.
Gemigliptin inhibits dipeptidyl peptidase-4 (DPP-4) to increase incretin levels and improve blood glucose control in type 2 diabetes. 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 | Placebo(Gemigliptin) |
|---|---|
| Sponsor | LG Life Sciences |
| Drug class | DPP-4 inhibitor |
| Target | DPP-4 (Dipeptidyl peptidase-4) |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Gemigliptin is a DPP-4 inhibitor that prevents the degradation of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), thereby prolonging their action. This leads to increased insulin secretion and decreased glucagon secretion in a glucose-dependent manner, resulting in improved glycemic control. The drug is selective for DPP-4 and has a long half-life allowing once-daily dosing.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Nasopharyngitis
- Headache
- Hypoglycemia
- Upper respiratory tract infection
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of Gemigliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Dapagliflozin and Metformin (SOLUTION Study) (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Dual add-on Therapy With Gemigliptin 50 mg and Dapagliflozin 10 mg Added to Metformin Who Have Inadequate Glycemic Control on Metformin Alone (PHASE3)
- Trial to Evaluate the Efficacy and Safety of Gemigliptin Compared With Placebo Added on Insulin Alone or on Insulin in Combination With Metformin in Type 2 DM (ZEUS II Study) (PHASE3)
- Gemigliptin-Rosuvastatin Fix-dose Combination Phase 3(BALANCE) (PHASE3)
- Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia (NA)
- Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury (PHASE2, PHASE3)
- Efficacy and Safety of Gemigliptin 50mg qd Added in Patients With Type 2 Diabetes Inadequately Controlled on Glimepiride and Metformin (PHASE3)
- A Phase IIIb Study to Evaluate the Safety and Efficacy of Gemigliptin in Type 2 Diabetes Mellitus Patients With Moderate or Severe Renal Impairment(GUARD Study) (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:
- Placebo(Gemigliptin) CI brief — competitive landscape report
- Placebo(Gemigliptin) updates RSS · CI watch RSS
- LG Life Sciences portfolio CI
Frequently asked questions about Placebo(Gemigliptin)
What is Placebo(Gemigliptin)?
How does Placebo(Gemigliptin) work?
What is Placebo(Gemigliptin) used for?
Who makes Placebo(Gemigliptin)?
What drug class is Placebo(Gemigliptin) in?
What development phase is Placebo(Gemigliptin) in?
What are the side effects of Placebo(Gemigliptin)?
What does Placebo(Gemigliptin) target?
Related
- Drug class: All DPP-4 inhibitor drugs
- Target: All drugs targeting DPP-4 (Dipeptidyl peptidase-4)
- 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