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DWP14012 X mg
DWP14012 X mg is a DPP-4 inhibitor Small molecule drug developed by Daewoong Pharmaceutical Co. LTD.. It is currently in Phase 3 development for Type 2 diabetes mellitus.
DWP14012 is a dipeptidyl peptidase-4 (DPP-4) inhibitor that increases incretin hormone levels to improve blood glucose control in type 2 diabetes.
DWP14012 X mg is a small molecule being studied for its efficacy and safety in treating Acute Gastritis and Chronic Gastritis. It is being investigated in a Phase 3 clinical trial, comparing its effects to a placebo.
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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 | DWP14012 X mg |
|---|---|
| Sponsor | Daewoong Pharmaceutical Co. LTD. |
| Drug class | DPP-4 inhibitor |
| Target | DPP-4 (Dipeptidyl peptidase-4) |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
DWP14012 works by inhibiting the DPP-4 enzyme, which normally breaks down incretin hormones (GLP-1 and GIP). By preventing this degradation, the drug increases circulating levels of these hormones, which stimulate insulin secretion in response to meals and suppress glucagon secretion, thereby lowering blood glucose levels. This mechanism is particularly effective in postprandial (after-meal) glucose control.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Nasopharyngitis
- Headache
- Upper respiratory tract infection
- Hypoglycemia
Key clinical trials
- Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis (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:
- DWP14012 X mg CI brief — competitive landscape report
- DWP14012 X mg updates RSS · CI watch RSS
- Daewoong Pharmaceutical Co. LTD. portfolio CI
Frequently asked questions about DWP14012 X mg
What is DWP14012 X mg?
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What does DWP14012 X mg target?
Related
- Drug class: All DPP-4 inhibitor drugs
- Target: All drugs targeting DPP-4 (Dipeptidyl peptidase-4)
- Manufacturer: Daewoong Pharmaceutical 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