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Cysteamine
Cystadrops, Cystagon, Cystaran, Procysbi (cysteamine) is a small molecule pharmaceutical. Cysteamine was first approved as Cystagon on 1994-08-15. It is used to treat cystinosis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Cystadrops, Cystagon, Cystaran, Procysbi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cysteamine bitartrate
Tradename
Company
Number
Date
Products
PROCYSBIHorizon PharmaceuticalN-203389 RX2013-04-30
2 products, RLD, RS
PROCYSBIHorizon PharmaceuticalN-213491 RX2020-02-14
2 products, RLD, RS
CYSTAGONMylanN-020392 RX1994-08-15
2 products, RLD, RS
Cysteamine hydrochloride
Tradename
Company
Number
Date
Products
CYSTARANLeadiant BiosciencesN-200740 RX2012-10-02
1 products, RLD, RS
CYSTADROPSRecordatiN-211302 RX2020-08-19
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
cystadropsNew Drug Application2020-09-08
cystagonNew Drug Application2019-01-29
cystaranNew Drug Application2021-11-04
procysbiNew Drug Application2020-03-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
cystinosis—D003554E72.04
Agency Specific
FDA
EMA
Expiration
Code
CYSTEAMINE BITARTRATE, PROCYSBI, HORIZON
2025-06-22PED
2024-12-22ODE*, ODE-162
2023-02-14PED
CYSTEAMINE HYDROCHLORIDE, CYSTADROPS, RECORDATI RARE
2023-08-19NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Cysteamine Bitartrate, Procysbi, Horizon
101436652036-08-16U-1399
103280372036-08-16U-1399
105488592036-08-16U-1399
109056622036-08-16U-1399
91738512034-06-17DP
92330772034-06-17DP
80262842027-09-22U-1399
91925902027-01-26U-1399
91988822027-01-26U-1399
99251562027-01-26DS, DPU-1399
99251572027-01-26DS, DPU-1399
99251582027-01-26DS, DPU-1399
ATC Codes
A: Alimentary tract and metabolism drugs
— A16: Other alimentary tract and metabolism products in atc
— A16A: Other alimentary tract and metabolism products in atc
— A16AA: Amino acids and derivatives
— A16AA04: Mercaptamine
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01X: Other ophthalmologicals in atc
— S01XA: Other ophthalmologicals in atc
— S01XA21: Mercaptamine
HCPCS
No data
Clinical
Clinical Trials
29 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Neuronal ceroid-lipofuscinosesD009472E75.4———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CystinosisD003554E72.04225—614
PneumoniaD011014EFO_0003106J18——1——1
Huntington diseaseD006816G10—11——1
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.81—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mitochondrial diseasesD028361EFO_0000591—2———2
Cystic fibrosisD003550EFO_0000390E8412———2
Fatty liverD00523411———1
Hiv infectionsD015658EFO_0000764B20—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AsthmaD001249EFO_0000270J451————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SchizophreniaD012559EFO_0000692F20————11
Major depressive disorderD003865EFO_0003761F22————11
HyperpigmentationD017495————11
MelanosisD008548EFO_0003963L81.1————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCYSTEAMINE
INNmercaptamine
Description
Cysteamine is an amine that consists of an ethane skeleton substituted with a thiol group at C-1 and an amino group at C-2. It has a role as a radiation protective agent, a human metabolite, a mouse metabolite and a geroprotector. It is an amine and a thiol. It is functionally related to an ethylamine. It is a conjugate base of a cysteaminium.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
NCCS
Identifiers
PDB—
CAS-ID60-23-1
RxCUI3022
ChEMBL IDCHEMBL602
ChEBI ID17141
PubChem CID6058
DrugBankDB00847
UNII ID5UX2SD1KE2 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Procysbi - Horizon Therapeutics Public
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,903 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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18,288 adverse events reported
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