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SYH2053/placebo injection
SYH2053 is a monoclonal antibody targeting PCSK9.
SYH2053 is a monoclonal antibody targeting PCSK9. Used for Hypercholesterolemia.
At a glance
| Generic name | SYH2053/placebo injection |
|---|---|
| Sponsor | CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. |
| Drug class | PCSK9 inhibitor |
| Target | PCSK9 |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
It works by inhibiting the PCSK9 protein, leading to increased LDL receptor expression on the liver surface and subsequent reduction in circulating LDL cholesterol levels.
Approved indications
- Hypercholesterolemia
Common side effects
- Injection site reaction
- Musculoskeletal pain
Key clinical trials
- A Study to Evaluate the SYH2053 Injection in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) (PHASE3)
- A Study to Evaluate the Safety, Efficacy of SYH2053 as Monotherapy in Chinese Participants With Non-familial Hypercholesterolemia or Mixed Hyperlipidemia (PHASE3)
- A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia (PHASE2)
- A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia on a Background of Lipid-lowering Therapy (PHASE3)
- A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2053 (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 |
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