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Drug ReportsPrucalopride
Motegrity, Resolor(prucalopride)
Motegrity, Prucalopride, 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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Target
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Motegrity, Prucalopride (discontinued: Prucalopride)
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
MOTEGRITYTakedaN-210166 RX2018-12-14
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
motegrityNew Drug Application2025-07-17
prucaloprideANDA2026-07-31
prucalopride succinateANDA2025-07-10
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
constipation—D003248K59.0
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A06: Drugs for constipation
— A06A: Drugs for constipation
— A06AX: Other drugs for constipation in atc
— A06AX05: Prucalopride
HCPCS
No data
Clinical
Clinical Trials
74 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ConstipationD003248—K59.068155537
GastroparesisD018589EFO_1000948K31.84—111—2
Irritable bowel syndromeD043183EFO_0000555K58—111—2
Gastroesophageal refluxD005764EFO_0003948K21———2—2
Inflammatory bowel diseasesD015212EFO_0003767———11—2
Gastrointestinal hemorrhageD006471—K92.2——11—2
HemorrhageD006470MP_0001914R58———1—1
Crohn diseaseD003424EFO_0000384K50———1—1
Celiac diseaseD002446EFO_0001060K90.0———1—1
Intestinal diseasesD007410—K63.9———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
IleusD045823—K56.7—22——4
Intestinal pseudo-obstructionD007418EFO_1000988K56.0—11——2
Postoperative complicationsD011183————2——2
Colonic polypsD003111—K63.5——1—12
Diabetes mellitusD003920EFO_0000400E08-E13—11——1
SyndromeD013577———11——1
Critical illnessD016638————1——1
Opioid-induced constipationD000079689————1——1
Colonic neoplasmsD003110—C18——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DyspepsiaD004415EFO_0008533K3011——12
Deglutition disordersD003680—R13.1—1——12
Urinary bladder neoplasmsD001749—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
Liver diseasesD008107EFO_0001421K70-K771————1
Hepatic insufficiencyD048550——1————1
Indications Without Phase
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePrucalopride
INNprucalopride
Description
Prucalopride is a member of benzamides.
Classification
Small molecule
Drug classsulpride derivatives and analogs
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COCCCN1CCC(NC(=O)c2cc(Cl)c(N)c3c2OCC3)CC1
Identifiers
PDB—
CAS-ID179474-81-8
RxCUI—
ChEMBL IDCHEMBL117287
ChEBI ID—
PubChem CID3052762
DrugBankDB06480
UNII ID0A09IUW5TP (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
HTR4
HTR4
Organism
Homo sapiens
Gene name
HTR4
Gene synonyms
NCBI Gene ID
Protein name
5-hydroxytryptamine receptor 4
Protein synonyms
5-hydroxytryptamine (serotonin) receptor 4, G protein-coupled, cardiac 5-HT4 receptor, Serotonin receptor 4
Uniprot ID
Mouse ortholog
Htr4 (15562)
5-hydroxytryptamine receptor 4 (Q9R2A4)
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Resolor – Shire
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,708 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,545 adverse events reported
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