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HCP1904-3
HCP1904-3 is a GLP-1 receptor agonist Small molecule drug developed by Hanmi Pharmaceutical Company Limited. It is currently in Phase 3 development for Type 2 diabetes mellitus.
HCP1904-3 is a long-acting GLP-1 receptor agonist designed to improve glycemic control in diabetes by enhancing insulin secretion and reducing glucagon release.
HCP1904-3 is an intervention being studied in a clinical trial for its pharmacokinetics, safety, and tolerability in healthy male volunteers. The conditions being studied in this trial include hypertension and healthy individuals.
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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 | HCP1904-3 |
|---|---|
| Sponsor | Hanmi Pharmaceutical Company Limited |
| Drug class | GLP-1 receptor agonist |
| Target | GLP-1 receptor |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
GLP-1 receptor agonists mimic the glucagon-like peptide-1 hormone, which stimulates insulin secretion in response to elevated blood glucose levels while simultaneously suppressing glucagon secretion. The long-acting formulation of HCP1904-3 allows for less frequent dosing while maintaining sustained therapeutic effects on blood glucose regulation.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Hypoglycemia
Key clinical trials
- A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers. (PHASE1)
- Clinical Efficacy and Safety Evaluation of HCP1904-3 in Essential Hypertension Patients (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:
- HCP1904-3 CI brief — competitive landscape report
- HCP1904-3 updates RSS · CI watch RSS
- Hanmi Pharmaceutical Company Limited portfolio CI
Frequently asked questions about HCP1904-3
What is HCP1904-3?
How does HCP1904-3 work?
What is HCP1904-3 used for?
Who makes HCP1904-3?
What drug class is HCP1904-3 in?
What development phase is HCP1904-3 in?
What are the side effects of HCP1904-3?
What does HCP1904-3 target?
Related
- Drug class: All GLP-1 receptor agonist drugs
- Target: All drugs targeting GLP-1 receptor
- Manufacturer: Hanmi Pharmaceutical Company Limited — 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