Skip to content
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.
Download report
Favorite
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
cystinosisD003554E72.04
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
View more details
Mock data
Subscribe for the real data
Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Neuronal ceroid-lipofuscinosesD009472E75.411
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CystinosisD003554E72.04225614
PneumoniaD011014EFO_0003106J1811
Huntington diseaseD006816G10111
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.81111
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mitochondrial diseasesD028361EFO_000059122
Cystic fibrosisD003550EFO_0000390E84122
Fatty liverD005234111
Hiv infectionsD015658EFO_0000764B2011
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AsthmaD001249EFO_0000270J4511
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SchizophreniaD012559EFO_0000692F2011
Major depressive disorderD003865EFO_0003761F2211
HyperpigmentationD01749511
MelanosisD008548EFO_0003963L81.111
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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
$
£
Mock data
Subscribe for the real data
Mock data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Additional graphs summarizing 6,903 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
18,288 adverse events reported
View more details