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 |
|---|---|
|
Synonyms:
|
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.
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)
| 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 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| 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 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| 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 |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Diagnostic aid | indication | 2949005 | |
| Diagnostic Test for Pancreas Function | indication | ||
| Gastrointestinal obstruction | contraindication | 126765001 | |
| Pregnancy, function | contraindication | 289908002 | |
| Gallstone Complications | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| 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 |
Orange Book patent data (new drug applications)
| 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 |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Cholecystokinin receptor type A | GPCR | Ki | 9.55 | CHEMBL | |||||
| Gastrin/cholecystokinin type B receptor | GPCR | Ki | 9.55 | CHEMBL | |||||
| Cholecystokinin receptor type A | GPCR | Ki | 10.05 | CHEMBL | |||||
| Gastrin/cholecystokinin type B receptor | GPCR | Ki | 9.39 | CHEMBL | |||||
| Gastrin/cholecystokinin type B receptor | GPCR | IC50 | 9.52 | CHEMBL | |||||
| Cholecystokinin receptor type A | GPCR | Ki | 9.55 | CHEMBL | |||||
| Cholecystokinin receptor | GPCR | Ki | 9.52 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D05845 | KEGG_DRUG |
| 4017721 | VUID |
| N0000146090 | NUI |
| 4017721 | VANDF |
| CHEBI:135946 | CHEBI |
| CHEMBL1121 | ChEMBL_ID |
| C410885 | MESH_SUPPLEMENTAL_RECORD_UI |
| 3617 | INN_ID |
| DB09142 | DRUGBANK_ID |
| M03GIQ7Z6P | UNII |
| 9800 | RXNORM |
| 367299 | MMSL |
| 5466 | MMSL |
| d03895 | MMSL |
| 001215 | NDDF |
| 126222003 | SNOMEDCT_US |
| 35765001 | SNOMEDCT_US |
| C0037167 | UMLSCUI |
| D012844 | MESH_DESCRIPTOR_UI |
| 9833444 | PUBCHEM_CID |
Pharmaceutical products:
| 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 |