Atoltivimab
Inmazeb (atoltivimab) is an antibody pharmaceutical. Atoltivimab was first approved as Inmazeb on 2020-10-14.
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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Combinations
Inmazeb
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Atoltivimab
+
Maftivimab
+
Odesivimab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Inmazeb | atoltivimab, maftivimab, and odesivimab-ebgn | Regeneron Pharmaceuticals | N-761169 RX | 2020-10-14 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| inmazeb | Biologic Licensing Application | 2020-10-14 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
atoltivimab / maftivimab / odesivimab, Inmazeb, Regeneron Pharmaceuticals, Inc. | |||
| 2027-10-14 | Orphan excl. | ||
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
3 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ebola hemorrhagic fever | D019142 | EFO_0007243 | A98.4 | — | 1 | — | — | 1 | 2 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ATOLTIVIMAB |
| INN | atoltivimab |
| Description | Atoltivimab is a Zaire ebolavirus glycoprotein-directed human monoclonal antibody that is part of the fixed-dose combination atoltivimab/maftivimab/odesivimab that is used for the treatment of Zaire ebolavirus (Ebola virus).
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >7TN9:A,C,E|REGN3471 heavy chain
EVQLVESGGGLVQPGGSLRLSCAASGFTFSSYDMHWVRQATGKGLEWVSAIGTAGDTYYPGSVKGRFTISRENAKNSLYL
QMNSLRAGDTAVYYCARTWFGELYFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWN
SGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVE
>7TN9:F,B,D|REGN3471 light chain
DIVMTQSPDSLAVSLGERATINCKSSQSVLYSSNNKNYLAWYQQKPGQPPKLLIYWASTRESGVPDRFSGSGSGTEFTLT
ITSLQAEDVAVYYCQQYYSSPLTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNAL
QSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
>7TN9:G,I|REGN3470 heavy chain
QVQLVESGGGVVQPGRSLRLSCAASGFTFNNYGMHWVRQAPGMGLEWVAVIWHDGSDKYYADSVKGRFTISRDNSKNTLY
LQMNSLRAEDTAVYYCARNWNLFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSG
ALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVE
>7TN9:H,J|REGN3470 light chain
DIQMTQSPSSLSASVGDRITITCRASQSISTYLHWYQQKPGKAPKLLIYAASTLQSGVPSRFSGSGSGTDFTLTISSLQP
EDFATYYCQQSFSTPPINFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNS
QESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
>7TN9:Q,M,O|REGN3479 heavy chain
EVQLVESGGGLVQPGGSLRLSCAASGFTSSSYAMNWVRQAPGKGLEWVSTISGMGGSTYYADSVKGRFTISRDNSKNTLY
LQMNSLRAEDTAVYYCAKRGYPHSFDIWGQGTMVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWN
SGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVE
>7TN9:R,N,P|REGN3479 light chain
DIQMTQSPSSLSASVGDRVTITCRASQSISSFLNWYQQKPGKAPKLLIYAASSLQSGVPSRFSGSGSGTDFTLTISSLQP
EDFATYYCQQSYSTLTFGQGTRLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQE
SVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
>7TN9:T,S,U|Envelope glycoprotein
RSIPLGVIHNSTLQVSDVDKLVCRDKLSSTNQLRSVGLNLEGNGVATDVPSATKRWGFRSGVPPKVVNYEAGEWAENCYN
LEIKKPDGSECLPAAPDGIRGFPRCRYVHKVSGTGPCAGDFAFHKEGAFFLYDRLASTVIYRGTTFAEGVVAFLILPQAK
KDFFSSHPLREPVNATEDPSSGYYSTTIRYQATGFGTNETEYLFEVDNLTYVQLESRFTPQFLLQLNETIYTSGKRSNTT
GKLIWKVNPEIDTTIGEWAFWETKKNLTRKIRSEELSFTVVNTHHQDTGEESASSGKLGLITNTIAGVAGLITGGRRTRR
E
>7TN9:W,V,X|GP2
AIVNAQPKCNPNLHYWTTQDEGAAIGLAWIPYFGPAAEGIYTEGLMHNQDGLICGLRQLANETTQALQLFLRATTELRTF
SILNRKAIDFLLQRWGGTCHILGPDCCIEPHDWTKNITDKIDQIIHDFVDKTLPDDDDDK |
Identifiers
| PDB | 7TN9 |
| CAS-ID | 2135632-29-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4298183 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB15898 |
| UNII ID | FJZ07Q63VY (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Inmazeb - Regeneron Pharmaceuticals
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 114 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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19,131 adverse events reported
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