mercaptamine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
aptamers, classical and mirror ones	768	60-23-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: mercaptamine hydrochloride mercaptamine bitartrate mercaptamine cysteamine thioethanolamine 2-mercaptoethylamine mercamine mercaptamin mercaptoethylamine cysteamine bitartrate procysbi cystagon cysteamine hydrochloride cysteamine HCl	A mercaptoethylamine compound that is endogenously derived from the COENZYME A degradative pathway. The fact that cysteamine is readily transported into LYSOSOMES where it reacts with CYSTINE to form cysteine-cysteamine disulfide and CYSTEINE has led to its use in CYSTINE DEPLETING AGENTS for the treatment of CYSTINOSIS. Molecular weight: 77.15 Formula: C2H7NS CLOGP: -0.25 LIPINSKI: 0 HAC: 1 HDO: 1 TPSA: 26.02 ALOGS: -0.52 ROTB: 1

Molecule

Description

Molfile Inchi Smiles

Synonyms:

mercaptamine hydrochloride
mercaptamine bitartrate
mercaptamine
cysteamine
thioethanolamine
2-mercaptoethylamine
mercamine
mercaptamin
mercaptoethylamine
cysteamine bitartrate
procysbi
cystagon
cysteamine hydrochloride
cysteamine HCl

A mercaptoethylamine compound that is endogenously derived from the COENZYME A degradative pathway. The fact that cysteamine is readily transported into LYSOSOMES where it reacts with CYSTINE to form cysteine-cysteamine disulfide and CYSTEINE has led to its use in CYSTINE DEPLETING AGENTS for the treatment of CYSTINOSIS.

Molecular weight: 77.15
Formula: C2H7NS
CLOGP: -0.25
LIPINSKI: 0
HAC: 1
HDO: 1
TPSA: 26.02
ALOGS: -0.52
ROTB: 1

Drug dosage:

Dose	Unit	Route
2	g	O

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Aug. 15, 1994	FDA	MYLAN
June 23, 1997	EMA

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Eye irritation	131.91	55.39	29	313	21942	63466738

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Eye irritation	105.41	43.25	23	390	7538	34948980
Amino acid level increased	73.33	43.25	11	402	431	34956087

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Amino acid level increased	95.69	37.91	14	600	714	79743060
Vomiting	61.46	37.91	46	568	665782	79077992
Renal transplant	58.74	37.91	11	603	2536	79741238
Eye irritation	48.99	37.91	14	600	20667	79723107
Treatment noncompliance	39.85	37.91	15	599	52253	79691521

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A16AA04	ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Amino acids and derivatives
ATC	S01XA21	SENSORY ORGANS OPHTHALMOLOGICALS OTHER OPHTHALMOLOGICALS Other ophthalmologicals
CHEBI has role	CHEBI:66987	radiation protective drugs
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
CHEBI has role	CHEBI:176497	geroprotectors
FDA EPC	N0000187051	Cystine Depleting Agent
FDA MoA	N0000175549	Cystine Disulfide Reduction
MeSH PA	D065104	Cystine Depleting Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Cystinosis	indication	190681003
Depressive disorder	contraindication	35489007
Gastrointestinal ulcer	contraindication	40845000
Benign intracranial hypertension	contraindication	68267002	DOID:11459
Gastrointestinal hemorrhage	contraindication	74474003
Disorder of brain	contraindication	81308009	DOID:936
Leukopenia	contraindication	84828003	DOID:615
Disorder of skin	contraindication	95320005	DOID:37
Fracture of bone	contraindication	125605004
Seizure disorder	contraindication	128613002

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	10.54	acidic
pKa2	9.41	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 25MG BASE	PROCYSBI	HORIZON	N203389	April 30, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	9192590	Jan. 26, 2027	MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
EQ 25MG BASE	PROCYSBI	HORIZON	N203389	April 30, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	9198882	Jan. 26, 2027	MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
EQ 25MG BASE	PROCYSBI	HORIZON	N203389	April 30, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	9925156	Jan. 26, 2027	MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
EQ 25MG BASE	PROCYSBI	HORIZON	N203389	April 30, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	9925157	Jan. 26, 2027	MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
EQ 25MG BASE	PROCYSBI	HORIZON	N203389	April 30, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	9925158	Jan. 26, 2027	MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
EQ 25MG BASE	PROCYSBI	HORIZON	N203389	April 30, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	8026284	Sept. 22, 2027	MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
EQ 25MG BASE	PROCYSBI	HORIZON	N203389	April 30, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	10143665	Aug. 16, 2036	MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
EQ 25MG BASE	PROCYSBI	HORIZON	N203389	April 30, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	10328037	Aug. 16, 2036	MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
EQ 25MG BASE	PROCYSBI	HORIZON	N203389	April 30, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	10548859	Aug. 16, 2036	MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
EQ 25MG BASE	PROCYSBI	HORIZON	N203389	April 30, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	10905662	Aug. 16, 2036	MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 0.37% BASE	CYSTADROPS	RECORDATI RARE	N211302	Aug. 19, 2020	RX	SOLUTION/DROPS	OPHTHALMIC	Aug. 19, 2023	NEW PRODUCT
EQ 25MG BASE	PROCYSBI	HORIZON	N203389	April 30, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	Feb. 14, 2023	PEDIATRIC EXCLUSIVITY
EQ 25MG BASE	PROCYSBI	HORIZON	N203389	April 30, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	Dec. 22, 2024	TREATMENT OF NEPHROPATHIC CYSTINOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE TO LESS THAN 2 YEARS OF AGE
EQ 25MG BASE	PROCYSBI	HORIZON	N203389	April 30, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	June 22, 2025	PEDIATRIC EXCLUSIVITY
EQ 300MG BASE/PACKET	PROCYSBI	HORIZON	N213491	Feb. 14, 2020	RX	GRANULE, DELAYED RELEASE	ORAL	Feb. 14, 2023	PEDIATRIC EXCLUSIVITY
EQ 300MG BASE/PACKET	PROCYSBI	HORIZON	N213491	Feb. 14, 2020	RX	GRANULE, DELAYED RELEASE	ORAL	Dec. 22, 2024	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
EQ 300MG BASE/PACKET	PROCYSBI	HORIZON	N213491	Feb. 14, 2020	RX	GRANULE, DELAYED RELEASE	ORAL	June 22, 2025	PEDIATRIC EXCLUSIVITY
EQ 75MG BASE	PROCYSBI	HORIZON	N203389	April 30, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	Feb. 14, 2023	PEDIATRIC EXCLUSIVITY
EQ 75MG BASE	PROCYSBI	HORIZON	N203389	April 30, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	Dec. 22, 2024	TREATMENT OF NEPHROPATHIC CYSTINOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE TO LESS THAN 2 YEARS OF AGE
EQ 75MG BASE	PROCYSBI	HORIZON	N203389	April 30, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	June 22, 2025	PEDIATRIC EXCLUSIVITY

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Bioactivity Summary:

None

External reference:

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ID	Source
003510	NDDF
004750	NDDF
013719	NDDF
109109007	SNOMEDCT_US
109111003	SNOMEDCT_US
1421468	RXNORM
156-57-0	SECONDARY_CAS_RN
195	INN_ID
201127	MMSL
27761-19-9	SECONDARY_CAS_RN

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
CYSTADROPS	HUMAN PRESCRIPTION DRUG LABEL	1	55292-410	SOLUTION	3.50 mg	OPHTHALMIC	NDA	25 sections
CYSTADROPS	HUMAN PRESCRIPTION DRUG LABEL	1	55292-410	SOLUTION	3.50 mg	OPHTHALMIC	NDA	25 sections
Cystagon	HUMAN PRESCRIPTION DRUG LABEL	1	0378-9040	CAPSULE	50 mg	ORAL	NDA	25 sections
Cystagon	HUMAN PRESCRIPTION DRUG LABEL	1	0378-9040	CAPSULE	50 mg	ORAL	NDA	25 sections
Cystagon	HUMAN PRESCRIPTION DRUG LABEL	1	0378-9045	CAPSULE	150 mg	ORAL	NDA	25 sections
Cystagon	HUMAN PRESCRIPTION DRUG LABEL	1	0378-9045	CAPSULE	150 mg	ORAL	NDA	25 sections
CYSTARAN	HUMAN PRESCRIPTION DRUG LABEL	1	54482-020	SOLUTION	6.50 mg	OPHTHALMIC	NDA	25 sections
CYSTARAN	HUMAN PRESCRIPTION DRUG LABEL	1	54482-020	SOLUTION	6.50 mg	OPHTHALMIC	NDA	25 sections
CYSTARAN	HUMAN PRESCRIPTION DRUG LABEL	1	54482-020	SOLUTION	6.50 mg	OPHTHALMIC	NDA	25 sections
PROCYSBI	HUMAN PRESCRIPTION DRUG LABEL	1	75987-100	CAPSULE, DELAYED RELEASE PELLETS	25 mg	ORAL	NDA	29 sections

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