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AboutPricing
Drug ReportsCysteamine
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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FDA approval date
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Study first post date
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Results first post date
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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 Therapeutics PublicN-203389 RX2013-04-30
2 products, RLD, RS
PROCYSBIHorizon Therapeutics PublicN-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 Application2024-10-02
cystagonNew Drug Application2021-08-16
cystaranNew Drug Application2024-05-16
procysbiNew Drug Application2022-02-22
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
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
39 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
CystinosisD003554—E72.04——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 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—
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Structure (InChI/SMILES or Protein Sequence)
NCCS
Identifiers
PDB—
CAS-ID60-23-1
RxCUI—
ChEMBL IDCHEMBL602
ChEBI ID17141
PubChem CID6058
DrugBankDB00847
UNII ID5UX2SD1KE2 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Procysbi – Horizon Therapeutics Public
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 8,394 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,728 adverse events reported
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