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

Stem definition	Drug id	CAS RN
	4627	25126-32-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: sincalide cholecystokinin-8 SQ-19844 SQ 19844	An octapeptide hormone present in the intestine and brain. When secreted from the gastric mucosa, it stimulates the release of bile from the gallbladder and digestive enzymes from the pancreas. Molecular weight: 1143.27 Formula: C49H62N10O16S3 CLOGP: -6.94 LIPINSKI: 3 HAC: 26 HDO: 13 TPSA: 426.80 ALOGS: -5.41 ROTB: 33 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

sincalide
cholecystokinin-8
SQ-19844
SQ 19844

An octapeptide hormone present in the intestine and brain. When secreted from the gastric mucosa, it stimulates the release of bile from the gallbladder and digestive enzymes from the pancreas.

Molecular weight: 1143.27
Formula: C49H62N10O16S3
CLOGP: -6.94
LIPINSKI: 3
HAC: 26
HDO: 13
TPSA: 426.80
ALOGS: -5.41
ROTB: 33

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
July 21, 1976	FDA	BRACCO

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
Multiple use of single-use product	164.01	105.39	21	123	1471	63487407

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FDA Adverse Event Reporting System (Male)

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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
Multiple use of single-use product	246.04	92.16	28	122	896	79743342
Therapeutic product effect decreased	145.38	92.16	37	113	163826	79580412

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FDA Adverse Event Reporting System (Pediatric)

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Pharmacologic Action:

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Source	Code	Description
ATC	V04CC03	VARIOUS DIAGNOSTIC AGENTS OTHER DIAGNOSTIC AGENTS Tests for bile duct patency
FDA CS	M0004235	Cholecystokinin
FDA EPC	N0000175798	Cholecystokinin Analog

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

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Disease	Relation	SNOMED_ID
Diagnostic aid	indication	2949005
Diagnostic Test for Pancreas Function	indication
Gastrointestinal obstruction	contraindication	126765001
Pregnancy, function	contraindication	289908002
Gallstone Complications	contraindication

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🐶 Veterinary Drug Use

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🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.68	acidic
pKa2	3.79	acidic
pKa3	12.75	acidic
pKa4	12.79	acidic
pKa5	13.18	acidic
pKa6	13.27	acidic
pKa7	13.67	acidic
pKa8	13.79	acidic
pKa9	8.42	Basic

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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
0.005MG/VIAL	SINCALIDE	MAIA PHARMS INC	N210850	Nov. 22, 2022	RX	POWDER	INTRAVENOUS	11110063	April 20, 2038	DIAGNOSIS OF GALL BLADDER DISORDERS OR OTHER DIAGNOSTIC IMAGING BY STIMULATING GALLBLADDER CONTRACTION, AS MAY BE ASSESSED BY VARIOUS METHODS OF DIAGNOSTIC IMAGING, OR TO OBTAIN BY DUODENAL ASPIRATION A SAMPLE OF CONCENTRATED BILE FOR ANALYSIS
0.005MG/VIAL	SINCALIDE	MAIA PHARMS INC	N210850	Nov. 22, 2022	RX	POWDER	INTRAVENOUS	11110063	April 20, 2038	DIAGNOSIS OF PANCREATIC DISORDERS BY STIMULATING PANCREATIC SECRETION IN COMBINATION WITH SECRETIN PRIOR TO OBTAINING A DUODENAL ASPIRATE FOR ANALYSIS
0.005MG/VIAL	SINCALIDE	MAIA PHARMS INC	N210850	Nov. 22, 2022	RX	POWDER	INTRAVENOUS	11110063	April 20, 2038	DIAGNOSTIC IMAGING BY ACCELERATING THE TRAN IT OFA BARIUM MEAL THROUGH THE SMALL BOWEL, THEREBY DECREASING THE TIME AND EXTENT OF RADIATION ASSOCIATED WITH FLUOROSCOPY AND X-RAY EXAMINATION OF THE INTESTINAL TRACT
0.005MG/VIAL	SINCALIDE	MAIA PHARMS INC	N210850	Nov. 22, 2022	RX	POWDER	INTRAVENOUS	11318100	April 20, 2038	ACCELERATE THE TRANSIT OF A BARIUM MEAL THROUGH THE SMALL BOWEL, THEREBY DECREASING THE TIME AND EXTENT OF RADIATION ASSOCIATED WITH FLUOROSCOPY AND X-RAY EXAMINATION OF THE INTESTINAL TRACT
0.005MG/VIAL	SINCALIDE	MAIA PHARMS INC	N210850	Nov. 22, 2022	RX	POWDER	INTRAVENOUS	11318100	April 20, 2038	STIMULATE GALLBLADDER CONTRACTION, AS MAY BE ASSESSED BY VARIOUS METHODS OF DIAGNOSTIC IMAGING, OR TO OBTAIN BY DUODENAL ASPIRATION A SAMPLE OF CONCENTRATED BILE FOR ANALYSIS
0.005MG/VIAL	SINCALIDE	MAIA PHARMS INC	N210850	Nov. 22, 2022	RX	POWDER	INTRAVENOUS	11318100	April 20, 2038	STIMULATE GALLBLADDER CONTRACTION. AS MAY BE ASSESSED BY VARIOUS METHODS OF DIAGNOSTIC IMAGING, OR TO OBTAIN BY DUODENAL ASPIRATION A SAMPLE OF CONCENTRATED BILE FOR ANALYSIS
0.005MG/VIAL	SINCALIDE	MAIA PHARMS INC	N210850	Nov. 22, 2022	RX	POWDER	INTRAVENOUS	11318100	April 20, 2038	STIMULATE PANCREATIC SECRETION IN COMBINATION WITH SECRETIN PRIOR TO OBTAINING A DUODENAL ASPIRATE FOR ANALYSIS

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Orange Book exclusivity data (new drug applications)

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Type	Activity value (-log[M])	Bioact source
Cholecystokinin receptor type A	GPCR	P32238	CCKAR_HUMAN	Ki	9.55	CHEMBL
Gastrin/cholecystokinin type B receptor	GPCR	P32239	GASR_HUMAN	Ki	9.55	CHEMBL
Cholecystokinin receptor type A	GPCR		CCKAR_RAT	Ki	10.05	CHEMBL
Gastrin/cholecystokinin type B receptor	GPCR		GASR_RAT	Ki	9.39	CHEMBL
Gastrin/cholecystokinin type B receptor	GPCR		GASR_MOUSE	IC50	9.52	CHEMBL
Cholecystokinin receptor type A	GPCR		CCKAR_CAVPO	Ki	9.55	CHEMBL
Cholecystokinin receptor	GPCR		CCKAR_MOUSE GASR_MOUSE	Ki	9.52	CHEMBL

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External reference:

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ID	Source
001215	NDDF
126222003	SNOMEDCT_US
35765001	SNOMEDCT_US
3617	INN_ID
367299	MMSL
4017721	VUID
4017721	VANDF
5466	MMSL
9800	RXNORM
9833444	PUBCHEM_CID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
KINEVAC	HUMAN PRESCRIPTION DRUG LABEL	1	0270-0556	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	5 ug	INTRAVENOUS	NDA	24 sections
KINEVAC	HUMAN PRESCRIPTION DRUG LABEL	1	0270-0556	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	5 ug	INTRAVENOUS	NDA	24 sections
KINEVAC	HUMAN PRESCRIPTION DRUG LABEL	1	0270-0556	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	5 ug	INTRAVENOUS	NDA	24 sections
SIncalide	HUMAN PRESCRIPTION DRUG LABEL	1	51808-203	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3 ug	INTRAVENOUS	Unapproved drug other	8 sections
SINCALIDE	HUMAN PRESCRIPTION DRUG LABEL	1	63323-579	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	5 ug	INTRAVENOUS	NDA	24 sections
Sincalide	HUMAN PRESCRIPTION DRUG LABEL	1	70511-131	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	5 ug	INTRAVENOUS	NDA	23 sections
Sincalide	HUMAN PRESCRIPTION DRUG LABEL	1	72266-248	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	5 ug	INTRAVENOUS	NDA	23 sections

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