Cystadane(betaine)
Amversio, 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
Betaine, Cystadane
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| antibacterial lotions | C200263 | 2024-05-16 |
| anubis barcelona total hydrating | OTC monograph final | 2023-09-01 |
| atono2 oxygen baby | unapproved drug other | 2016-10-13 |
| balmers hanryeoncho w | unapproved drug other | 2015-07-20 |
| betaine | ANDA | 2022-11-04 |
| betaine anhydrous | ANDA | 2023-12-18 |
| betaine anhydrous for oral solution | ANDA | 2020-05-01 |
| celraum pheromone fragrance lovely perfume | unapproved drug other | 2022-10-13 |
| cystadane | New Drug Application | 2025-06-30 |
| dr.bro man of sense mans cleanser | unapproved drug other | 2020-11-25 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| homocystinuria | — | D006712 | E72.11 |
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
76 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Xerostomia | D014987 | — | K11.7 | — | — | 1 | 1 | 1 | 3 |
| Surgical wound infection | D013530 | — | — | — | — | — | 3 | — | 3 |
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | — | — | — | 1 | 1 | 2 |
| Syndrome | D013577 | — | — | — | — | — | 1 | 1 | 2 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | 1 | 1 | 2 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | 1 | — | 1 |
| Wound infection | D014946 | — | — | — | — | — | 1 | — | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | — | 1 | — | 1 |
| Oral hygiene | D009910 | — | — | — | — | — | 1 | — | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | 1 | — | 1 |
Show 2 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | 2 | 1 | — | 1 | 4 |
| Hyperhomocysteinemia | D020138 | — | — | — | 1 | 1 | — | 2 | 4 |
| Hepatitis c | D006526 | — | B19.2 | 1 | 1 | 1 | — | 1 | 3 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 1 | 1 | 1 | — | 1 | 3 |
| Hepatitis | D006505 | — | K75.9 | 1 | 1 | 1 | — | 1 | 3 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 1 | 1 | 1 | — | 1 | 3 |
| Fatty liver | D005234 | EFO_0003934 | — | — | 2 | 1 | — | 1 | 3 |
| Inflammation | D007249 | MP_0001845 | — | — | 1 | 1 | — | 2 | 3 |
| Ulcer | D014456 | MPATH_579 | — | — | — | 1 | — | 1 | 2 |
| Dysbiosis | D064806 | — | — | — | 1 | 1 | — | 1 | 2 |
Show 2 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | — | — | 4 | 5 |
| Overweight | D050177 | — | E66.3 | 1 | 1 | — | — | 3 | 4 |
| Micronutrients | D018977 | — | — | — | 1 | — | — | — | 1 |
| Hypoglycemia | D007003 | — | E16.2 | — | 1 | — | — | — | 1 |
| Hyperoxaluria | D006959 | — | E72.53 | — | 1 | — | — | — | 1 |
| Primary hyperoxaluria | D006960 | — | E72.53 | — | 1 | — | — | — | 1 |
| Skin diseases | D012871 | — | L00-L99 | — | 1 | — | — | — | 1 |
| Homocystinuria | D006712 | — | E72.11 | — | 1 | — | — | — | 1 |
| Gallbladder diseases | D005705 | EFO_0003832 | K82.9 | — | 1 | — | — | — | 1 |
| Chronic pain | D059350 | — | — | — | 1 | — | — | — | 1 |
Show 1 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | 8 | 10 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 2 | — | — | — | — | 2 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | 2 | — | — | — | — | 2 |
| Chronic hepatitis | D006521 | — | K73.9 | 1 | — | — | — | 1 | 2 |
| Male infertility | D007248 | EFO_0004248 | N46 | 1 | — | — | — | 1 | 2 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | — | — | — | — | 1 |
| Recurrence | D012008 | — | — | 1 | — | — | — | — | 1 |
| Homozygote | D006720 | — | — | 1 | — | — | — | — | 1 |
| Infertility | D007246 | EFO_0000545 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Wound healing | D014945 | GO_0042060 | — | — | — | — | — | 2 | 2 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 2 | 2 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | — | — | — | 2 | 2 |
| Gastritis | D005756 | EFO_0000217 | K29.7 | — | — | — | — | 2 | 2 |
| Dyslipidemias | D050171 | — | — | — | — | — | — | 1 | 1 |
| Cognition | D003071 | EFO_0003925 | — | — | — | — | — | 1 | 1 |
| Ataxia | D001259 | — | R27.0 | — | — | — | — | 1 | 1 |
| Nervous system diseases | D009422 | — | G00-G99 | — | — | — | — | 1 | 1 |
| Intellectual disability | D008607 | EFO_0003847 | F73 | — | — | — | — | 1 | 1 |
| Learning disabilities | D007859 | — | F81.9 | — | — | — | — | 1 | 1 |
Show 33 more
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 | — |
| DrugBank | DB04455 |
| UNII ID | — |
Target
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Variants
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Financial
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Estimated US medical usage
Betaine
Total medical expenditures per year (USD, in millions)
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Trends
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Additional graphs summarizing 38,906 documents
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Safety
Black-box Warning
Black-box warning for: Enlyte
Adverse Events
Top Adverse Reactions
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959 adverse events reported
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