Motegrity, Resolor(prucalopride)
Motegrity, Resolor (prucalopride) is a small molecule pharmaceutical. Prucalopride was first approved as Resolor on 2009-10-14. It is used to treat constipation in the USA. It has been approved in Europe to treat constipation. It is known to target 5-hydroxytryptamine receptor 4.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Motegrity
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Prucalopride succinate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MOTEGRITY | Takeda | N-210166 RX | 2018-12-14 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| motegrity | New Drug Application | 2021-03-22 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| constipation | HP_0002019 | D003248 | K59.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PRUCALOPRIDE SUCCINATE, MOTEGRITY, TAKEDA PHARMS USA | |||
| 2023-12-14 | NCE | ||
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
62 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Constipation | D003248 | HP_0002019 | K59.0 | 5 | 5 | 9 | 2 | 3 | 24 |
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | — | 1 | 1 | 1 | — | 2 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | — | — | — | 2 | — | 2 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | 1 | 1 | — | 2 | |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | — | — | 1 | — | 1 |
| Celiac disease | D002446 | EFO_0001060 | K90.0 | — | — | — | 1 | — | 1 |
| Gastrointestinal hemorrhage | D006471 | K92.2 | — | — | — | 1 | — | 1 | |
| Intestinal diseases | D007410 | HP_0002242 | K63.9 | — | — | — | 1 | — | 1 |
| Patient satisfaction | D017060 | — | — | — | 1 | — | 1 | ||
| Esophageal motility disorders | D015154 | K22.4 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | 1 | — | — | 1 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | 1 | 1 | — | — | 1 |
| Critical illness | D016638 | — | — | 1 | — | — | 1 | ||
| Intestinal pseudo-obstruction | D007418 | EFO_1000988 | K56.0 | — | — | 1 | — | — | 1 |
| Postoperative complications | D011183 | — | — | 1 | — | — | 1 | ||
| Opioid-induced constipation | D000079689 | — | — | 1 | — | — | 1 | ||
| Colonic neoplasms | D003110 | C18 | — | — | 1 | — | — | 1 | |
| Colonic polyps | D003111 | K63.5 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyspepsia | D004415 | EFO_0008533 | K30 | 1 | 1 | — | — | 1 | 2 |
| Deglutition disorders | D003680 | HP_0002015 | R13.1 | — | 1 | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | C67 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 4 | — | — | — | — | 4 | ||
| Hepatic insufficiency | D048550 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | F33.9 | — | — | — | — | 2 | 2 | |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | — | — | — | — | 2 | 2 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | — | — | — | 2 | 2 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | — | — | 2 | 2 |
| Cognition | D003071 | EFO_0003925 | — | — | — | — | 2 | 2 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | PRUCALOPRIDE |
| INN | prucalopride |
| Description | Prucalopride is a member of benzamides. |
| Classification | Small molecule |
| Drug class | sulpride derivatives and analogs |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | COCCCN1CCC(NC(=O)c2cc(Cl)c(N)c3c2OCC3)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 179474-81-8 |
| RxCUI | 2107310 |
| ChEMBL ID | CHEMBL117287 |
| ChEBI ID | — |
| PubChem CID | 3052762 |
| DrugBank | DB06480 |
| UNII ID | 0A09IUW5TP (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
HTR4
HTR4
Variants
Clinical Variant
No data
Financial
Resolor - Shire
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,038 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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14,000 adverse events reported
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