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Drug ReportsPlecanatide
Plecanatide
Trulance (plecanatide) is a protein pharmaceutical. Plecanatide was first approved as Trulance on 2017-01-19. It is used to treat constipation in the USA. It is known to target guanylyl cyclase C.
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Trulance
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Plecanatide
Tradename
Company
Number
Date
Products
TRULANCESalix PharmaceuticalsN-208745 RX2017-01-19
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
trulanceNew Drug Application2024-04-04
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
constipationHP_0002019D003248K59.0
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Plecanatide, Trulance, Salix
100116372034-06-05DP
111425492034-06-05DP
118345212034-06-05DP
96160972032-08-20DP
113193462032-03-01DP
96103212031-09-15U-1999, U-2230
99190242031-09-15U-1999, U-2230
99252312031-09-15DP
70417862028-01-30DP
ATC Codes
A: Alimentary tract and metabolism drugs
A06: Drugs for constipation
A06A: Drugs for constipation
A06AX: Other drugs for constipation in atc
A06AX07: Plecanatide
HCPCS
No data
Clinical
Clinical Trials
14 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ConstipationD003248HP_0002019K59.057112
Irritable bowel syndromeD043183EFO_0000555K58235
SyndromeD013577235
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gastrointestinal neoplasmsD005770C26.911
Digestive system neoplasmsD00406711
Barrett esophagusD001471EFO_0000280K22.711
Gastroesophageal refluxD005764EFO_0003948K2111
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePlecanatide
INNplecanatide
Description
Plecanatide (brand name Trulance), is a drug approved by the FDA for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation. Plecanatide is an agonist of guanylate cyclase-C. Plecanatide increases intestinal transit and fluid through a buildup of cGMP.
Classification
Protein
Drug classpeptides
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(C)C[C@H](NC(=O)[C@@H]1CSSC[C@@H]2NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(=O)O)NC(=O)[C@@H](N)CC(N)=O)CSSC[C@H](NC(=O)[C@H](C)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](C(C)C)NC2=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)NCC(=O)N1)C(=O)O
Identifiers
PDB
CAS-ID467426-54-6
RxCUI
ChEMBL IDCHEMBL2103867
ChEBI ID
PubChem CID70693500
DrugBankDB13170
UNII ID7IK8Z952OK (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
GUCY2C
GUCY2C
Organism
Homo sapiens
Gene name
GUCY2C
Gene synonyms
GUC2C, STAR
NCBI Gene ID
Protein name
guanylyl cyclase C
Protein synonyms
Heat-stable enterotoxin receptor, hSTAR, Intestinal guanylate cyclase, STA receptor
Uniprot ID
Mouse ortholog
Gucy2c (14917)
guanylyl cyclase C (Q8JZQ6)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 338 documents
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Safety
Black-box Warning
Black-box warning for: Trulance
Adverse Events
Top Adverse Reactions
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881 adverse events reported
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