Cystadane(betaine)
Cystadane (betaine) is a small molecule pharmaceutical. Betaine was first approved as Cystadane on 1996-10-25. It is used to treat homocystinuria in the USA. It has been approved in Europe to treat homocystinuria.
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Commercial
Trade Name
FDA
EMA
Cystadane (generic drugs available since 2021-11-23)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Betaine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CYSTADANE | Recordati | N-020576 RX | 1996-10-25 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| betaine anhydrous | ANDA | 2022-11-28 |
| cystadane | New Drug Application | 2019-10-03 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A09: Digestives, incl. enzymes
— A09A: Digestives, incl. enzymes
— A09AB: Acid preparations, digestives
— A09AB02: Betaine hydrochloride
— A16: Other alimentary tract and metabolism products in atc
— A16A: Other alimentary tract and metabolism products in atc
— A16AA: Amino acids and derivatives
— A16AA06: Betaine
HCPCS
No data
Clinical
Clinical Trials
8 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 1 | 1 | 1 | 1 | 3 |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | — | — | — | 1 | — | 1 |
| Newborn respiratory distress syndrome | D012127 | P22 | — | — | — | 1 | — | 1 | |
| Patent ductus arteriosus | D004374 | HP_0001643 | Q25.0 | — | — | — | 1 | — | 1 |
Indications Phases 2
No data
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 | BETAINE |
| INN | — |
| Description | N,N,N-trimethylglycinium is a quaternary ammonium ion in which the substituents on nitrogen are methyl (three) and carboxymethyl. It has a role as a fundamental metabolite. It is a conjugate acid of a glycine betaine. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | C[N+](C)(C)CC(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 107-43-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL95889 |
| ChEBI ID | 41139 |
| PubChem CID | 248 |
| DrugBank | DB04455 |
| UNII ID | — |
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 28,890 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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341 adverse events reported
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