Zynteglo(betibeglogene autotemcel)
Zynteglo (betibeglogene autotemcel) is a gene pharmaceutical. Betibeglogene autotemcel was first approved as Zynteglo on 2019-05-29. It is used to treat beta-thalassemia in the USA. It has been approved in Europe to treat beta-thalassemia.
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Commercial
Therapeutic Areas
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Zynteglo
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)
Betibeglogene autotemcel
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Zynteglo | betibeglogene autotemcel | bluebird bio | N-125717 RX | 2022-08-17 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| zynteglo | Biologic Licensing Application | 2023-11-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| beta-thalassemia | Orphanet_848 | D017086 | D56.1 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
betibeglogene autotemcel, Zynteglo, Bluebird Bio Inc. | |||
| 2034-08-17 | Reference product excl. | ||
| 2029-08-17 | Orphan excl. | ||
Patent Expiration
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HCPCS
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Clinical
Clinical Trials
8 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 |
|---|---|---|---|---|---|---|---|---|---|
| Beta-thalassemia | D017086 | Orphanet_848 | D56.1 | 2 | 2 | 2 | — | 2 | 6 |
| Thalassemia | D013789 | EFO_1001996 | D56 | 2 | 2 | 2 | — | 2 | 6 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 2 | 2 | 1 | — | — | 3 |
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Betibeglogene autotemcel |
| INN | betibeglogene autotemcel |
| Description | Betibeglogene autotemcel, sold under the brand name Zynteglo, is a gene therapy for the treatment for beta thalassemia. It was developed by Bluebird Bio and was given breakthrough therapy designation by the US Food and Drug Administration in February 2015.
|
| Classification | Gene |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4594311 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16900 |
| UNII ID | MEE8487RTP (ChemIDplus, GSRS) |
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Zynteglo – bluebird bio
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Safety
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Adverse Events
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