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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
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
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
Zynteglobetibeglogene autotemcelbluebird bioN-125717 RX2022-08-17
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
zyntegloBiologic Licensing Application2022-08-26
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
beta-thalassemiaOrphanet_848D017086D56.1
Agency Specific
FDA
EMA
Expiration
Code
betibeglogene autotemcel, Zynteglo, Bluebird Bio Inc.
2034-08-17Reference product excl.
2029-08-17Orphan excl.
Patent Expiration
No data
ATC Codes
B: Blood and blood forming organ drugs
— B06: Other hematological agents in atc
— B06A: Other hematological agents in atc
— B06AX: Other hematological agents in atc
— B06AX02: Betibeglogene autotemcel
HCPCS
No data
Clinical
Clinical Trials
4 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Beta-thalassemiaD017086Orphanet_848D56.1222——4
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Sickle cell anemiaD000755EFO_0000697D5711———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 nameBETIBEGLOGENE AUTOTEMCEL
INNbetibeglogene autotemcel
Description
Betibeglogene autotemcel, sold under the brand name Zynteglo, is a medication for the treatment for beta thalassemia. It was developed by Bluebird Bio and was given breakthrough therapy designation by the U.S. 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 IDCHEMBL4594311
ChEBI ID—
PubChem CID—
DrugBank—
UNII IDMEE8487RTP (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 169 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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46 adverse events reported
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