Last reviewed · How we verify
Regkirona (REGDANVIMAB)
At a glance
| Generic name | REGDANVIMAB |
|---|---|
| Sponsor | Celltrion Healthcare Hungary Kft. |
| Modality | Monoclonal antibody |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2021 |
Approved indications
- COVID-19
Common side effects
Key clinical trials
- Study of Tixagevimab/Cilgavimab and Regdanvimab Efficacy for Treatment of COVID-19 (PHASE4)
- A Phase 2/3 Study to Evaluate the Efficacy and Safety of CT-P59 in Patients With Mild to Moderate SARS-CoV-2 Infection (PHASE2,PHASE3)
- A Real-World Study of Anti-SARS-CoV-2 Monoclonal Antibodies
- This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19) (PHASE1)
- To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Regkirona CI brief — competitive landscape report
- Regkirona updates RSS · CI watch RSS
- Celltrion Healthcare Hungary Kft. portfolio CI