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Fexuprazan Injection_part 3
Fexuprazan Injection_part 3 is a Potassium-competitive acid blocker (P-CAB) Small molecule drug developed by Daewoong Pharmaceutical Co. LTD.. It is currently in Phase 1 development.
Expected to inhibit gastric acid secretion through potassium-competitive acid blocker (P-CAB) mechanism, similar to oral fexuprazan.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Fexuprazan Injection_part 3 |
|---|---|
| Sponsor | Daewoong Pharmaceutical Co. LTD. |
| Drug class | Potassium-competitive acid blocker (P-CAB) |
| Modality | Small molecule |
| Phase | Phase 1 |
Mechanism of action
Fexuprazan is a potassium-competitive acid blocker that reversibly inhibits the gastric H+/K+-ATPase enzyme. This injectable formulation likely provides rapid acid suppression for patients unable to take oral medications, though the specific clinical rationale for this Part 3 formulation remains undisclosed in Phase 1 development.
Approved indications
Common side effects
Key clinical trials
- to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics of DWP14012 Injection (PHASE1)
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:
- Fexuprazan Injection_part 3 CI brief — competitive landscape report
- Fexuprazan Injection_part 3 updates RSS · CI watch RSS
- Daewoong Pharmaceutical Co. LTD. portfolio CI
Frequently asked questions about Fexuprazan Injection_part 3
What is Fexuprazan Injection_part 3?
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Who makes Fexuprazan Injection_part 3?
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Related
- Drug class: All Potassium-competitive acid blocker (P-CAB) drugs
- Manufacturer: Daewoong Pharmaceutical Co. LTD. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing