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CT-P41
CT-P41 is a biosimilar of trastuzumab that targets HER2-positive cancer cells by binding to the HER2 receptor and blocking growth signaling.
CT-P41 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), HER2-positive gastric cancer.
At a glance
| Generic name | CT-P41 |
|---|---|
| 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-P41 is a monoclonal antibody designed as a biosimilar to trastuzumab (Herceptin), which binds to the human epidermal growth factor receptor 2 (HER2) on cancer cells. This binding blocks HER2-mediated signaling pathways and triggers antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), leading to cancer cell death. As a biosimilar, CT-P41 is intended to have comparable efficacy and safety to the reference trastuzumab product.
Approved indications
- HER2-positive metastatic breast cancer
- HER2-positive early-stage breast cancer (adjuvant/neoadjuvant setting)
- HER2-positive gastric cancer
Common side effects
- Cardiotoxicity/left ventricular dysfunction
- Infusion-related reactions
- Nausea and vomiting
- Diarrhea
- Fatigue
- Headache
Key clinical trials
- A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis (PHASE3)
- Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects (PHASE1)
- A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male 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-P41 CI brief — competitive landscape report
- CT-P41 updates RSS · CI watch RSS
- Celltrion portfolio CI