Cysteamine - PharmaKB

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

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

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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

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
hereditary congenital and neonatal diseases and abnormalities	D009358
nutritional and metabolic diseases	D009750

Trade Name

FDA

EMA

Cystadrops, Cystagon, Cystaran, Procysbi

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

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

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

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

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

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