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.
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Commercial
Therapeutic Areas
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 |
|---|---|---|---|---|
| CYSTARAN | Leadiant Biosciences | N-200740 RX | 2012-10-02 | 1 products, RLD, RS |
| CYSTADROPS | Recordati | N-211302 RX | 2020-08-19 | 1 products, RLD, RS |
Cysteamine bitartrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PROCYSBI | Horizon Therapeutics Public | N-203389 RX | 2013-04-30 | 2 products, RLD, RS |
| PROCYSBI | Horizon Therapeutics Public | N-213491 RX | 2020-02-14 | 2 products, RLD, RS |
| CYSTAGON | Mylan | N-020392 RX | 1994-08-15 | 2 products, RLD, RS |
Labels
FDA
EMA
Show 17 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| cystinosis | — | D003554 | E72.04 |
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
No data
Clinical
Clinical Trials
79 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | — | — | 1 | 2 | 3 |
| Helicobacter infections | D016481 | EFO_1000961 | — | — | — | — | 1 | 2 | 3 |
| Neuronal ceroid-lipofuscinoses | D009472 | — | E75.4 | — | — | — | 1 | — | 1 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | — | 1 | — | 1 |
| Communicable diseases | D003141 | — | — | — | — | — | 1 | — | 1 |
| Cross infection | D003428 | — | — | — | — | — | 1 | — | 1 |
| Bacteriuria | D001437 | — | R82.71 | — | — | — | 1 | — | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | 1 | — | 1 |
| Uterine hemorrhage | D014592 | — | — | — | — | — | 1 | — | 1 |
| Metrorrhagia | D008796 | — | N92.1 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cystinosis | D003554 | — | E72.04 | 4 | 4 | 5 | — | 9 | 19 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | — | 1 | 1 | — | 3 | 5 |
| Islet cell adenoma | D007516 | EFO_0007331 | D13.7 | — | — | 1 | — | 3 | 4 |
| Melanosis | D008548 | EFO_0003963 | L81.1 | — | — | 1 | — | 2 | 3 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | 1 | — | — | 2 |
| Hyperparathyroidism | D006961 | EFO_0008506 | E21.3 | — | — | 1 | — | 1 | 2 |
| Fatty liver | D005234 | EFO_0003934 | — | 1 | 2 | 1 | — | — | 2 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | 1 | — | — | 1 |
| Primary hyperparathyroidism | D049950 | EFO_0008519 | E21.0 | — | — | 1 | — | — | 1 |
| Hypercalcemia | D006934 | HP_0003072 | E83.52 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endocrine gland neoplasms | D004701 | EFO_0003769 | D35 | 1 | 1 | — | — | 13 | 14 |
| Multiple endocrine neoplasia | D009377 | — | E31.2 | 1 | 1 | — | — | 13 | 14 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | 13 | 14 |
| Fanconi syndrome | D005198 | — | — | 1 | 1 | — | — | 4 | 5 |
| Syndrome | D013577 | — | — | — | 2 | — | — | 3 | 5 |
| Mitochondrial diseases | D028361 | EFO_0000591 | — | — | 2 | — | — | 1 | 3 |
| Leigh disease | D007888 | Orphanet_506 | G31.82 | — | 2 | — | — | 1 | 3 |
| Fibrosis | D005355 | — | — | 1 | 2 | — | — | — | 2 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | 2 | — | — | — | 2 |
| Multiple endocrine neoplasia type 2a | D018813 | — | E31.22 | 1 | 1 | — | — | 1 | 2 |
Show 16 more
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 | — | K75.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple endocrine neoplasia type 1 | D018761 | — | E31.21 | — | — | — | — | 6 | 6 |
| Gastrointestinal diseases | D005767 | — | — | — | — | — | — | 3 | 3 |
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | — | — | — | — | 3 | 3 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | — | — | 2 | 2 |
| Hemostatic disorders | D020141 | — | — | — | — | — | — | 2 | 2 |
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | — | — | — | — | 2 | 2 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 2 | 2 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | — | — | — | 2 | 2 |
| Rare diseases | D035583 | — | — | — | — | — | — | 2 | 2 |
| Hypertrophy | D006984 | EFO_0002460 | — | — | — | — | — | 2 | 2 |
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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
No data
Financial
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Procysbi – Horizon Therapeutics Public
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Trends
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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
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1,758 adverse events reported
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