Omidubicel
Omisirge (omidubicel) is a cell pharmaceutical. Omidubicel was first approved as Omisirge on 2023-04-17.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Omisirge
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)
Omidubicel
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| OMISIRGE | omidubicel-onlv | Gamida Cell Ltd. | N-125738 RX | 2023-04-17 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| omisirge | Biologic Licensing Application | 2023-05-12 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
No data
Patent Expiration
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ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
7 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | D46 | 3 | 3 | 1 | — | — | 4 | |
| Hematologic neoplasms | D019337 | 1 | 1 | 2 | — | — | 3 | ||
| Myeloid leukemia acute | D015470 | C92.0 | 2 | 2 | 1 | — | — | 3 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 2 | 2 | 1 | — | — | 3 | |
| Lymphoma | D008223 | C85.9 | — | — | 1 | — | — | 1 | |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aplastic anemia | D000741 | HP_0001915 | D61.9 | 1 | 1 | — | — | — | 1 |
| Thalassemia | D013789 | EFO_1001996 | D56 | 1 | 1 | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | C85.9 | 1 | 1 | — | — | — | 1 | |
| Hodgkin disease | D006689 | C81 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | OMIDUBICEL |
| INN | omidubicel |
| Description | Omidubicel, sold under the brand name Omisirge, is a blood-based cell therapy used for the treatment of blood cancers. Omidubicel is a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from cord blood.
|
| Classification | Cell |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4298190 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB17132 |
| UNII ID | ET4JC4S66E (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 25 documents
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Safety
Black-box Warning
Black-box warning for: Omisirge
Adverse Events
Top Adverse Reactions
0 adverse events reported
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