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HRS-8080 Tablet ; Dalpiciclib Isethionate
Dalpiciclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor that blocks cell cycle progression by preventing phosphorylation of the retinoblastoma protein.
Dalpiciclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor that blocks cell cycle progression by preventing phosphorylation of the retinoblastoma protein. Used for Hormone receptor-positive, HER2-negative breast cancer (in combination with endocrine therapy).
At a glance
| Generic name | HRS-8080 Tablet ; Dalpiciclib Isethionate |
|---|---|
| Sponsor | Shandong Suncadia Medicine Co., Ltd. |
| Drug class | CDK4/6 inhibitor |
| Target | CDK4/6 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
CDK4/6 inhibitors like dalpiciclib work by binding to and inhibiting cyclin-dependent kinases 4 and 6, which are critical regulators of the G1/S cell cycle checkpoint. By preventing the phosphorylation of retinoblastoma (Rb) protein, the drug halts cell cycle progression and induces G1 arrest, thereby suppressing proliferation of cancer cells. This mechanism is particularly effective in hormone receptor-positive breast cancers and other CDK4/6-dependent malignancies.
Approved indications
- Hormone receptor-positive, HER2-negative breast cancer (in combination with endocrine therapy)
Common side effects
- Neutropenia
- Leukopenia
- Anemia
- Diarrhea
- Nausea
- Fatigue
Key clinical trials
- A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy. (PHASE3)
- Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer (PHASE1, PHASE2)
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 |
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