PharmaKB logo
Company Reports
Company Reports
Drug Reports
Drug Reports
Disease Reports
Disease Reports
Sets
Sets
Favorites
Favorites
Log in
Log in
AboutPricing
Drug ReportsCysteamine
Cystagon(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
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Plot placeholder
Mock data
Subscribe for the real data
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 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
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
Labels
FDA
EMA
Brand Name
Status
Last Update
2-oak mix, red/white pollen 3-oak mix, black/blackjack/post pollen 3-ragweed mix, giant/short/western pollen 4-pine mix, austrian/loblolly/scotch/w...Biologic Licensing Application2011-03-11
almond apple apricot asparagus avocado bakers yeast banana basil bay leaf beet black pepper black walnut meat black-eyed pea blackberry blueberry b...Biologic Licensing Application2009-11-17
beef beef liver chicken meat duck meat egg white egg yolk lamb pork turkey veal whole eggBiologic Licensing Application2009-12-10
beef chicken cow milk duck meat egg white goat milk goose meat lamb pork rabbit meat turkey venison whole eggBiologic Licensing Application2009-11-13
bermuda grass, standardized kentucky bluegrass (june), standardized meadow fescue grass, standardized orchard grass, standardized redtop grass, sta...Biologic Licensing Application2009-05-07
cvs pharmacy pre-measured spoon childrensOTC monograph final2011-08-23
cystadropsNew Drug Application2025-06-06
cystagonNew Drug Application2021-08-16
cystaranNew Drug Application2025-04-30
meadow and bark spf 45 mineral shimmer sunscreenC2002632024-04-03
Show 17 more
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
82 clinical trials
View more details
Plot placeholder
Mock data
Subscribe for the real data
Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rare diseasesD035583——————11
CystinosisD003554—E72.04————11
Urogenital diseasesD000091642——————11
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)Loading
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
Plot placeholder
Mock data
Subscribe for the real data
Plot placeholder
Mock data
Subscribe for the real data
Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Plot placeholder
Mock data
Subscribe for the real data
Additional graphs summarizing 38,665 documents
View more details
Safety
Black-box Warning
Black-box warning for: 2-oak mix, red/white pollen 3-oak mix, black/blackjack/post pollen 3-ragweed mix, giant/short/western pollen 4-pine mix, austrian/loblolly/scotch/w..., Almond apple apricot asparagus avocado bakers yeast banana basil bay leaf beet black pepper black walnut meat black-eyed pea blackberry blueberry b..., Beef beef liver chicken meat duck meat egg white egg yolk lamb pork turkey veal whole egg, Beef chicken cow milk duck meat egg white goat milk goose meat lamb pork rabbit meat turkey venison whole egg, Bermuda grass, standardized kentucky bluegrass (june), standardized meadow fescue grass, standardized orchard grass, standardized redtop grass, sta..., Mixture of eight standardized grasses mixture of five standardized grasses mixture of four standardized grasses mixture of seven standardized grass..., Pollens - trees, sycamore, american (eastern) platanus occidentallis animal allergens, ap cattle hair and dander animal allergens, ap dog hair and ..., Standardized bermuda grass pollen standardized kentucky (june) bluegrass pollen standardized meadow fescue grass pollen standardized orchard grass ..., Standardized bermuda grass pollen standardized kentucky bluegrass pollen standardized meadow fescue grass pollen standardized orchard grass pollen ..., Standardized bermuda grass standardized kentucky blue (june) grass standardized meadow fescue grass standardized orchard grass standardized perenni..., Standardized grass pollen, bermuda grass standardized grass pollen, bluegrass, kentucky (june) standardized grass pollen, fescue, meadow standardiz...
Adverse Events
Top Adverse Reactions
Plot placeholder
Mock data
Subscribe for the real data
3,953 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use