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HGP0904
HGP0904 is a selective estrogen receptor degrader (SERD) that binds to and degrades estrogen receptors, blocking estrogen-dependent signaling in hormone-sensitive cancers.
HGP0904 is a selective estrogen receptor degrader (SERD) that binds to and degrades estrogen receptors, blocking estrogen-dependent signaling in hormone-sensitive cancers. Used for Estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer.
At a glance
| Generic name | HGP0904 |
|---|---|
| Also known as | amlodipine |
| Sponsor | Hanmi Pharmaceutical Company Limited |
| Drug class | Selective Estrogen Receptor Degrader (SERD) |
| Target | Estrogen Receptor (ER) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
HGP0904 functions as a SERD by binding to the estrogen receptor with high affinity and promoting its proteasomal degradation, thereby eliminating both ligand-dependent and ligand-independent estrogen receptor signaling. This mechanism differs from selective estrogen receptor modulators (SERMs) by achieving complete receptor elimination rather than modulation. The drug is designed to overcome resistance mechanisms that develop with standard endocrine therapies in estrogen receptor-positive breast cancer.
Approved indications
- Estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer
Common side effects
- Hot flashes
- Fatigue
- Nausea
- Vaginal dryness
Key clinical trials
- A Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension (PHASE2)
- A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia (PHASE3)
- A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects. (PHASE1)
- A Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions Between HGP0904, HGP0608, and HCP1306 in Healthy Male Subjects. (PHASE1)
- Trial to Evaluate the Efficacy and Safety of HCP1302 (PHASE3)
- Investigating the Pharmacokinetic Drug Interactions Between HGP1201 and HGP0904 (PHASE1)
- Clinical Efficacy and Safety Evaluation of Co-administered HGP0904, HGP0608 and HGP0816 in Patients With Hypertension and Dyslipidemia (PHASE3)
- Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405 (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:
- HGP0904 CI brief — competitive landscape report
- HGP0904 updates RSS · CI watch RSS
- Hanmi Pharmaceutical Company Limited portfolio CI