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IMDEVIMAB
IMDEVIMAB works by binding to the SARS-CoV-2 virus to prevent it from entering host cells.
IMDEVIMAB is a monoclonal antibody originally developed by Regeneron Pharmaceuticals, Inc. and approved by the FDA in 2020 for the treatment of COVID-19. The commercial status of IMDEVIMAB is patented, as it is owned by Regeneron Pharmaceuticals, Inc. Key safety considerations include potential allergic reactions and infusion-related reactions. IMDEVIMAB is a small molecule modality, but the target and drug class are unknown.
At a glance
| Generic name | IMDEVIMAB |
|---|---|
| Sponsor | Regeneron Pharmaceuticals, Inc. |
| Modality | Monoclonal antibody |
| Therapeutic area | Infectious Disease |
| Phase | discontinued |
| First approval | 2020 |
Mechanism of action
Casirivimab (IgG1) and imdevimab (IgG1) are two recombinant human mAbs which are unmodified in the Fc regions. Casirivimab and imdevimab bind to non-overlapping epitopes of the spike protein receptor binding domain (RBD) of SARS-CoV-2 with dissociation constants KD 45.8 pM and 46.7 pM, respectively. Casirivimab, imdevimab and casirivimab and imdevimab together blocked RBD binding to the human ACE2 receptor with IC50 values of 56.4 pM, 165 pM and 81.8 pM, respectively and prevents viral attachment to host cells [see Microbiology/Resistance Information (15) ].
Approved indications
- COVID-19
Common side effects
- Injection site reactions
- Hypersensitivity reactions
- Urticaria
- Pruritus
- Flushing
- Pyrexia
- Shortness of breath
- Chest tightness
- Nausea
- Vomiting
- Rash
- Erythema
Key clinical trials
- Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) (PHASE2)
- TURN-COVID Biobank: The Dutch Cohort Study for the Evaluation of the Use of Neutralizing Monoclonal Antibodies and Other Antiviral Agents Against SARS-CoV-2
- COVID-19 Study to Evaluate Safety, Tolerability, and Efficacy of REGN14256+Imdevimab for the Treatment of COVID-19 Adult and Adolescent Patients Without Risk Factors for Progression to Severe Disease (PHASE1,PHASE2)
- A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults (PHASE3)
- COVID-19 Administration of Single-Dose Subcutaneous Anti- Spike(s) SARS-CoV-2 Monoclonal Antibodies Casirivimab and Imdevimab in High-Risk Pediatric Participants Under 12 Years of Age (PHASE2)
- COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers (PHASE2)
- COVID-19 Study of Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19 (PHASE1)
- COVID-19 Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers (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:
- IMDEVIMAB CI brief — competitive landscape report
- IMDEVIMAB updates RSS · CI watch RSS
- Regeneron Pharmaceuticals, Inc. portfolio CI