Imdevimab
Ronapreve (imdevimab) is an antibody pharmaceutical. Imdevimab was first approved as Ronapreve on 2021-11-12. It is used to treat covid-19 in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| respiratory tract diseases | D012140 |
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| casirivimab casirivimab with imdevimab imdevimab regen-cov | unapproved drug other | 2022-04-06 |
| casirivimab imdevimab | unapproved drug other | 2020-12-18 |
| casirivimab imdevimab regen-cov | unapproved drug other | 2021-08-17 |
| regen-cov | unapproved drug other | 2021-03-18 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
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Patent Expiration
No data
ATC Codes
No data
HCPCS
Code | Description |
|---|---|
| M0240 | Intravenous infusion or subcutaneous injection, casirivimab and imdevimab includes infusion or injection, and post administration monitoring, subsequent repeat doses |
| M0241 | Intravenous infusion or subcutaneous injection, casirivimab and imdevimab includes infusion or injection, and post administration monitoring in the home or residence; this includes a beneficiary's home that has been made provider-based to the hospital during the covid-19 public health emergency, subsequent repeat doses |
| M0243 | Intravenous infusion or subcutaneous injection, casirivimab and imdevimab includes infusion or injection, and post administration monitoring |
| M0244 | Intravenous infusion or subcutaneous injection, casirivimab and imdevimab includes infusion or injection, and post administration monitoring in the home or residence; this includes a beneficiary's home that has been made provider-based to the hospital during the covid-19 public health emergency |
| Q0240 | Injection, casirivimab and imdevimab, 600 mg |
| Q0243 | Injection, casirivimab and imdevimab, 2400 mg |
| Q0244 | Injection, casirivimab and imdevimab, 1200 mg |
Clinical
Clinical Trials
29 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | — | 5 | 7 | 7 | 2 | 7 | 25 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | 1 | 1 | — | — | 4 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | — | — | 1 | — | 1 | 2 |
| Syndrome | D013577 | — | — | — | — | 1 | — | 1 | 2 |
| Immunocompromised host | D016867 | — | D84.9 | — | — | 1 | — | 1 | 2 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | 1 | — | — | 1 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | 1 | 1 | — | — | 1 |
| Coronavirus | D017934 | — | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic disease | D002908 | — | — | 2 | 1 | — | — | — | 3 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Organ transplantation | D016377 | — | — | 1 | — | — | — | — | 1 |
| Sars-cov-2 | D000086402 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Post-acute covid-19 syndrome | D000094024 | — | — | — | — | — | — | 1 | 1 |
| Disease progression | D018450 | — | — | — | — | — | — | 1 | 1 |
| Critical illness | D016638 | — | — | — | — | — | — | 1 | 1 |
| Fatal outcome | D017809 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Imdevimab |
| INN | imdevimab |
| Description | Casirivimab/imdevimab, sold under the brand name REGEN‑COV among others, is a combination medicine used for the treatment and prevention of COVID‑19. It consists of two human monoclonal antibodies, casirivimab and imdevimab that must be mixed together and administered as an infusion or subcutaneous injection. The combination of two antibodies is intended to prevent mutational escape. It is also available as a co-formulated product. It was developed by the American biotechnology company Regeneron Pharmaceuticals.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4650249 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB15691 |
| UNII ID | 2Z3DQD2JHM (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Ronapreve – Regeneron Pharmaceuticals
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Ronapreve – Roche
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,381 documents
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Safety
Black-box Warning
Black-box warning for: Casirivimab casirivimab with imdevimab imdevimab regen-cov, Casirivimab imdevimab, Casirivimab imdevimab regen-cov, Regen-cov
Adverse Events
Top Adverse Reactions
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4,621 adverse events reported
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