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
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cystadrops | New Drug Application | 2024-10-02 |
| cystagon | New Drug Application | 2021-08-16 |
| cystaran | New Drug Application | 2024-05-16 |
| procysbi | New Drug Application | 2022-02-22 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CYSTEAMINE BITARTRATE, PROCYSBI, HORIZON | |||
| 2025-06-22 | PED | ||
| 2024-12-22 | ODE*, ODE-162 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Cysteamine Bitartrate, Procysbi, Horizon | |||
| 10143665 | 2036-08-16 | U-1399 | |
| 10328037 | 2036-08-16 | U-1399 | |
| 10548859 | 2036-08-16 | U-1399 | |
| 10905662 | 2036-08-16 | U-1399 | |
| 9173851 | 2034-06-17 | DP | |
| 9233077 | 2034-06-17 | DP | |
| 8026284 | 2027-09-22 | U-1399 | |
| 9192590 | 2027-01-26 | U-1399 | |
| 9198882 | 2027-01-26 | U-1399 | |
| 9925156 | 2027-01-26 | DS, DP | U-1399 |
| 9925157 | 2027-01-26 | DS, DP | U-1399 |
| 9925158 | 2027-01-26 | DS, DP | U-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
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Clinical
Clinical Trials
38 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-lipofuscinoses | D009472 | — | E75.4 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cystinosis | D003554 | — | E72.04 | 3 | 3 | 5 | — | 8 | 17 |
| Melanosis | D008548 | HP_0001480 | L81.1 | — | — | 1 | — | 2 | 3 |
| Covid-19 | D000086382 | — | — | — | 1 | 1 | — | — | 2 |
| Fatty liver | D005234 | EFO_0003934 | — | 1 | 2 | 1 | — | — | 2 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | 1 | — | — | 1 |
| Huntington disease | D006816 | Orphanet_399 | G10 | — | 1 | 1 | — | — | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | 1 | 1 | — | — | 1 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mitochondrial diseases | D028361 | EFO_0000591 | — | — | 2 | — | — | — | 2 |
| Fibrosis | D005355 | — | — | 1 | 2 | — | — | — | 2 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | 2 | — | — | — | 2 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | 1 | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | — | 1 | — | — | — | 1 |
| Leigh disease | D007888 | Orphanet_506 | G31.82 | — | 1 | — | — | — | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | — | 1 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | 1 | — | — | — | 1 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 1 | — | — | — | 1 |
| Acute lung injury | D055371 | EFO_0004610 | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Asthma | D001249 | EFO_0000270 | J45 | 1 | — | — | — | — | 1 |
| Hepatitis b | D006509 | — | — | 1 | — | — | — | — | 1 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 1 | — | — | — | — | 1 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fanconi syndrome | D005198 | — | — | — | — | — | — | 3 | 3 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | — | — | 1 | 1 |
| Depression | D003863 | — | F33.9 | — | — | — | — | 1 | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | — | 1 | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | — | — | 1 | 1 |
| Hyperpigmentation | D017495 | HP_0000953 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cysteamine |
| INN | mercaptamine |
| 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-ID | 60-23-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL602 |
| ChEBI ID | 17141 |
| PubChem CID | 6058 |
| DrugBank | DB00847 |
| UNII ID | 5UX2SD1KE2 (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Procysbi – Horizon Therapeutics Public
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Trends
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Safety
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Adverse Events
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1,550 adverse events reported
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