prucalopride

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Property	Value	Reference
Vd (Volume of distribution)	8.73 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	4.55 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.70 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	22.50 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	97 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Bocci G, Oprea TI, Benet LZ
BA (Bioavailability)	70 %

Property	Description	Value	Unit	Confidence	Similarity
azlogd74	LogD at pH 7.4	0.855		High	1
caco2-efflux	Caco-2 efflux ratio (BA/AB)	4.667		High	1
caco2-intrinsic-papp	Caco-2 intrinsic apparent permeability	7.551	10^-6 cm/s	High	1
dh-clint	Dog hepatocyte intrinsic clearance	1.932	uL/min/10^6 cells	High	1
dppb	Dog plasma protein binding (% unbound)	74.780	%	High	1
fcs-ppb	Fetal calf serum protein binding (% unbound)	82.050	%	High	1
herg	hERG pIC50	5.003	pIC50	High	1
hh-clint	Human hepatocyte intrinsic clearance	0.979	uL/min/10^6 cells	High	1
hlm-clint	Human liver microsomal intrinsic clearance	3.090	uL/min/mg protein	High	1
hppb	Human plasma protein binding (% unbound)	72.870	%	High	1
kinase-safety-class	ACVR2B,AKT3,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAP3K7,MAPK10,MAPK7,MET,NTRK2,PDK2,PDK4,PIK3CB,PIM2,PRKDC,SIK2,SIK3,STK33,TEK,TGFBR1	31
kinase-selectivity-class	AXL,BRAF,EIF2AK3,EPHB4,SIK2,STK33	6
mdck-mdr1-efflux	MDCK-MDR1 efflux ratio	6.471		High	1
mh-clint	Mouse hepatocyte intrinsic clearance	5.358		High	1
mppb	Mouse plasma protein binding (% unbound)	75.120		High	1
nih-mdck-mdr1-efflux	NIH MDCK-MDR1 efflux ratio	24.774		High	1
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pppb	Pig plasma protein binding (% unbound)	81.190	%	High	1
rh-clint	Rat hepatocyte intrinsic clearance	2.679	uL/min/10^6 cells	High	1
rh-fuinc	Rat hepatocyte fraction unbound in incubation	87.650	%	High	1
rppb	Rat plasma protein binding (% unbound)	71.530	%	High	1
solubility-dd	Solubility at pH 7.4 in DMSO	924.698	uM	High	1

Date	Agency	Company	Orphan
Dec. 14, 2018	FDA	SHIRE DEV LLC
Oct. 15, 2009	EMA

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
Pituitary tumour benign	132.69	24.41	28	3829	2104	90622486
Hyperprolactinaemia	92.39	24.41	25	3832	5408	90619182
Secondary adrenocortical insufficiency	81.10	24.41	19	3838	2299	90622291
Head banging	72.34	24.41	13	3844	419	90624171
Insurance issue	63.31	24.41	22	3835	10936	90613654
Inability to afford medication	63.14	24.41	17	3840	3605	90620985
No adverse event	57.80	24.41	36	3821	67946	90556644
Screaming	53.34	24.41	15	3842	3735	90620855
Headache	49.24	24.41	111	3746	862635	89761955
Psychiatric symptom	47.80	24.41	16	3841	7102	90617488
Anger	44.33	24.41	18	3839	13702	90610888
Serum amyloid A protein increased	42.22	24.41	9	3848	708	90623882
Arthropod bite	40.81	24.41	15	3842	8752	90615838
Crying	39.30	24.41	20	3837	25625	90598965
Heliotrope rash	38.58	24.41	7	3850	238	90624352
Poikiloderma	36.76	24.41	7	3850	311	90624279
Therapeutic drug monitoring analysis not performed	36.69	24.41	9	3848	1320	90623270
Wrist fracture	35.59	24.41	16	3841	15608	90608982
Transferrin decreased	35.19	24.41	7	3850	391	90624199
Mental disorder	34.96	24.41	20	3837	32298	90592292
Iron binding capacity total decreased	34.09	24.41	7	3850	459	90624131
Inappropriate schedule of product administration	32.78	24.41	36	3821	149897	90474693
Feeling jittery	32.67	24.41	15	3842	15356	90609234
Suicidal ideation	32.15	24.41	26	3831	73829	90550761
Depressed mood	31.48	24.41	22	3835	50200	90574390
Abdominal pain	29.55	24.41	57	3800	395664	90228926
Hypoacusis	29.49	24.41	17	3840	27833	90596757
Pollakiuria	29.35	24.41	18	3839	32987	90591603
Nervousness	28.83	24.41	18	3839	34038	90590552
Impaired gastric emptying	28.80	24.41	13	3844	12796	90611794
Product availability issue	28.41	24.41	11	3846	7393	90617197
Laryngectomy	28.34	24.41	4	3853	25	90624565
Emotional distress	27.62	24.41	18	3839	36644	90587946
Vasculitis	27.13	24.41	15	3842	22678	90601912
Lip pruritus	26.63	24.41	7	3850	1353	90623237
Adrenal insufficiency	25.80	24.41	16	3841	29905	90594685
Product monitoring error	25.77	24.41	9	3848	4535	90620055
Nausea	25.72	24.41	104	3753	1110212	89514378
Mitochondrial myopathy	25.51	24.41	5	3852	259	90624331
Rib fracture	25.00	24.41	15	3842	26420	90598170

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
Duplicate therapy error	51.38	35.79	8	685	288	42620354
Delirium tremens	45.32	35.79	8	685	624	42620018
Serum amyloid A protein increased	44.61	35.79	7	686	265	42620377

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prucalopride 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

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

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products:

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
Pituitary tumour benign	130.63	25.62	28	3767	2819	110582685
Hyperprolactinaemia	93	25.62	25	3770	6550	110578954
Serum amyloid A protein increased	83.34	25.62	16	3779	926	110584578
Secondary adrenocortical insufficiency	72.92	25.62	19	3776	4415	110581089
Head banging	65.11	25.62	12	3783	556	110584948
Headache	54.08	25.62	103	3692	882274	109703230
Screaming	52.62	25.62	15	3780	4866	110580638
Psychiatric symptom	43.24	25.62	15	3780	9198	110576306
Duplicate therapy error	42.22	25.62	8	3787	431	110585073
Arthropod bite	38.75	25.62	14	3781	9657	110575847
Delirium tremens	37.94	25.62	8	3787	743	110584761
Wrist fracture	36.70	25.62	15	3780	14402	110571102
Feeling jittery	36.40	25.62	15	3780	14707	110570797
Therapeutic drug monitoring analysis not performed	35.28	25.62	9	3786	1922	110583582
Impaired gastric emptying	34.43	25.62	14	3781	13261	110572243
Crying	34.26	25.62	17	3778	25611	110559893
Heliotrope rash	33.46	25.62	6	3789	238	110585266
Suicidal ideation	31.57	25.62	26	3769	93911	110491593
Mental disorder	30.25	25.62	18	3777	38773	110546731
Vision blurred	30.01	25.62	29	3766	128993	110456511
Anger	29.61	25.62	14	3781	18993	110566511
Poikiloderma	29.26	25.62	6	3789	486	110585018
Transferrin decreased	28.62	25.62	6	3789	542	110584962
Laryngectomy	28.45	25.62	4	3791	31	110585473
Iron binding capacity total decreased	28.41	25.62	6	3789	561	110584943
Mast cell activation syndrome	27.32	25.62	7	3788	1521	110583983
Abdominal pain	26.61	25.62	56	3739	512933	110072571
Hypoacusis	26.58	25.62	16	3779	35175	110550329
Nervousness	25.90	25.62	16	3779	36835	110548669
Pollakiuria	25.63	25.62	17	3778	44178	110541326

Source	Code	Description
ATC	A06AX05	ALIMENTARY TRACT AND METABOLISM DRUGS FOR CONSTIPATION DRUGS FOR CONSTIPATION Other drugs for constipation
MeSH PA	D005765	Gastrointestinal Agents
MeSH PA	D017366	Serotonin Receptor Agonists
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D018490	Serotonin Agents
MeSH PA	D054368	Laxatives
MeSH PA	D058828	Serotonin 5-HT4 Receptor Agonists
FDA MoA	N0000193870	Serotonin 4 Receptor Agonists
FDA EPC	N0000193871	Serotonin-4 Receptor Agonist
CHEBI has role	CHEBI:35469	antidepressant
CHEBI has role	CHEBI:50503	laxative
CHEBI has role	CHEBI:53784	antispasmodic drug
CHEBI has role	CHEBI:55324	gastrointestinal drug

Disease	Relation	SNOMED_ID	DOID
Constipation	indication	14760008	DOID:2089
Perforation of intestine	contraindication	56905009	DOID:2074
Ulcerative colitis	contraindication	64766004	DOID:8577

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 1MG BASE	MOTEGRITY	TAKEDA PHARMS USA	N210166	Dec. 14, 2018	RX	TABLET	ORAL	July 10, 2028	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
EQ 2MG BASE	MOTEGRITY	TAKEDA PHARMS USA	N210166	Dec. 14, 2018	RX	TABLET	ORAL	July 10, 2028	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
5-hydroxytryptamine receptor 4	GPCR	Q13639	5HT4R_HUMAN	AGONIST	Ki	8.60	CHEMBL	DRUG LABEL
D(4) dopamine receptor	GPCR	P21917	DRD4_HUMAN		Ki	5.63	PDSP
5-hydroxytryptamine receptor 3A	Ion channel	P46098	5HT3A_HUMAN		Ki	5.40	CHEMBL
5-hydroxytryptamine receptor 4	GPCR		5HT4R_RAT		EC50	7.58	CHEMBL

ID	Source
D09205	KEGG_DRUG
179474-85-2	SECONDARY_CAS_RN
4038160	VANDF
CHEBI:135552	CHEBI
CHEMBL117287	ChEMBL_ID
CHEMBL2105748	ChEMBL_ID
C406662	MESH_SUPPLEMENTAL_RECORD_UI
243	IUPHAR_LIGAND_ID
DB06480	DRUGBANK_ID
0A09IUW5TP	UNII
2107309	RXNORM
26947	MMSL
304089	MMSL
346516	MMSL
d07541	MMSL
013402	NDDF
013403	NDDF
1149428003	SNOMEDCT_US
699273008	SNOMEDCT_US
774192009	SNOMEDCT_US
C0913506	UMLSCUI
7702	INN_ID
3052762	PUBCHEM_CID
0A09IUW5TP	INXIGHT DRUGS

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Prucalopride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0749	TABLET, FILM COATED	1 mg	ORAL	ANDA	26 sections
Prucalopride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0750	TABLET, FILM COATED	2 mg	ORAL	ANDA	26 sections
Prucalopride	HUMAN PRESCRIPTION DRUG LABEL	1	0406-6301	TABLET, FILM COATED	1 mg	ORAL	ANDA	28 sections
Prucalopride	HUMAN PRESCRIPTION DRUG LABEL	1	0406-6302	TABLET, FILM COATED	2 mg	ORAL	ANDA	28 sections
PRUCALOPRIDE	Human Prescription Drug Label	1	0781-8158	TABLET, FILM COATED	1 mg	ORAL	ANDA	26 sections
PRUCALOPRIDE	Human Prescription Drug Label	1	0781-8159	TABLET, FILM COATED	2 mg	ORAL	ANDA	26 sections
Prucalopride	Human Prescription Drug Label	1	27241-294	TABLET	1 mg	ORAL	ANDA	26 sections
Prucalopride	Human Prescription Drug Label	1	27241-295	TABLET	2 mg	ORAL	ANDA	26 sections
PRUCALOPRIDE	HUMAN PRESCRIPTION DRUG LABEL	1	31722-391	TABLET, FILM COATED	1 mg	ORAL	ANDA	26 sections
PRUCALOPRIDE	HUMAN PRESCRIPTION DRUG LABEL	1	31722-392	TABLET, FILM COATED	2 mg	ORAL	ANDA	26 sections
MOTEGRITY	HUMAN PRESCRIPTION DRUG LABEL	1	54092-546	TABLET, FILM COATED	1 mg	ORAL	NDA	28 sections
MOTEGRITY	HUMAN PRESCRIPTION DRUG LABEL	1	54092-547	TABLET, FILM COATED	2 mg	ORAL	NDA	28 sections
Prucalopride	HUMAN PRESCRIPTION DRUG LABEL	1	60505-4806	TABLET, FILM COATED	1 mg	ORAL	ANDA	26 sections
Prucalopride	HUMAN PRESCRIPTION DRUG LABEL	1	60505-4807	TABLET, FILM COATED	2 mg	ORAL	ANDA	26 sections
Prucalopride	HUMAN PRESCRIPTION DRUG LABEL	1	69097-218	TABLET, FILM COATED	1 mg	ORAL	ANDA	17 sections
Prucalopride	HUMAN PRESCRIPTION DRUG LABEL	1	69097-219	TABLET, FILM COATED	2 mg	ORAL	ANDA	17 sections
Prucalopride	HUMAN PRESCRIPTION DRUG LABEL	1	69238-2698	TABLET, FILM COATED	1 mg	ORAL	ANDA	27 sections
Prucalopride	HUMAN PRESCRIPTION DRUG LABEL	1	69238-2699	TABLET, FILM COATED	2 mg	ORAL	ANDA	27 sections
Prucalopride succinate	HUMAN PRESCRIPTION DRUG LABEL	1	70069-821	TABLET	1 mg	ORAL	ANDA	25 sections
Prucalopride succinate	HUMAN PRESCRIPTION DRUG LABEL	1	70069-822	TABLET	2 mg	ORAL	ANDA	25 sections
Prucalopride	HUMAN PRESCRIPTION DRUG LABEL	1	70748-389	TABLET, FILM COATED	1 mg	ORAL	ANDA	24 sections
Prucalopride	HUMAN PRESCRIPTION DRUG LABEL	1	70748-390	TABLET, FILM COATED	2 mg	ORAL	ANDA	24 sections
prucalopride	HUMAN PRESCRIPTION DRUG LABEL	1	70771-1899	TABLET, FILM COATED	1 mg	ORAL	ANDA	1 sections
prucalopride	HUMAN PRESCRIPTION DRUG LABEL	1	70771-1900	TABLET, FILM COATED	2 mg	ORAL	ANDA	1 sections
Prucalopride	Human Prescription Drug Label	1	70954-596	TABLET	1 mg	ORAL	ANDA	26 sections
Prucalopride	Human Prescription Drug Label	1	70954-597	TABLET	2 mg	ORAL	ANDA	26 sections
PRUCALOPRIDE	Human Prescription Drug Label	1	72205-218	TABLET, FILM COATED	1 mg	ORAL	ANDA	24 sections
PRUCALOPRIDE	Human Prescription Drug Label	1	72205-218	TABLET, FILM COATED	1 mg	ORAL	ANDA	24 sections
PRUCALOPRIDE	Human Prescription Drug Label	1	72205-219	TABLET, FILM COATED	2 mg	ORAL	ANDA	24 sections
PRUCALOPRIDE	Human Prescription Drug Label	1	72205-219	TABLET, FILM COATED	2 mg	ORAL	ANDA	24 sections

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	10.83	acidic
pKa2	8.57	Basic
pKa3	1.07	Basic