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CT-P43
CT-P43 is a biosimilar of trastuzumab that targets HER2-positive cancer cells by binding to the HER2 receptor and blocking growth signaling.
CT-P43 is a biosimilar of trastuzumab that targets HER2-positive cancer cells by binding to the HER2 receptor and blocking growth signaling. Used for HER2-positive metastatic breast cancer, HER2-positive early-stage breast cancer (adjuvant/neoadjuvant setting).
At a glance
| Generic name | CT-P43 |
|---|---|
| Sponsor | Celltrion |
| Drug class | HER2-targeted monoclonal antibody (trastuzumab biosimilar) |
| Target | HER2 (human epidermal growth factor receptor 2) |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
CT-P43 is a monoclonal antibody designed as a biosimilar to trastuzumab (Herceptin). It binds to the human epidermal growth factor receptor 2 (HER2) on cancer cells, preventing ligand binding and receptor dimerization, which leads to inhibition of downstream signaling pathways and induction of antibody-dependent cellular cytotoxicity (ADCC). This mechanism is effective in HER2-overexpressing cancers.
Approved indications
- HER2-positive metastatic breast cancer
- HER2-positive early-stage breast cancer (adjuvant/neoadjuvant setting)
Common side effects
- Cardiotoxicity / left ventricular dysfunction
- Infusion-related reactions
- Nausea and vomiting
- Fatigue
- Diarrhea
Key clinical trials
- A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P43 in Healthy Male Subjects (PHASE1)
- A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis (PHASE3)
- Study to Compare PK and Safety of Subcutaneous Injection of Ustekinumab and CT-P43 in Healthy Subjects (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:
- CT-P43 CI brief — competitive landscape report
- CT-P43 updates RSS · CI watch RSS
- Celltrion portfolio CI