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Tenapanor
Ibsrela (tenapanor) is a small molecule pharmaceutical. Tenapanor was first approved as Ibsrela on 2019-09-12. It is used to treat irritable bowel syndrome in the USA. It is known to target sodium/hydrogen exchanger 3.
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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
Trade Name
FDA
EMA
Ibsrela
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tenapanor hydrochloride
Tradename
Company
Number
Date
Products
IBSRELAArdelyxN-211801 RX2019-09-12
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ibsrelaNew Drug Application2020-08-27
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
irritable bowel syndromeEFO_0000555D043183K58
Agency Specific
FDA
EMA
Expiration
Code
TENAPANOR HYDROCHLORIDE, IBSRELA, ARDELYX INC
2024-09-12NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Tenapanor Hydrochloride, Ibsrela, Ardelyx Inc
85414482033-08-01DS, DP
90062812030-05-02U-2626
89693772029-12-30DS, DP
94088402029-12-30U-2626
ATC Codes
A: Alimentary tract and metabolism drugs
— A06: Drugs for constipation
— A06A: Drugs for constipation
— A06AX: Other drugs for constipation in atc
— A06AX08: Tenapanor
HCPCS
No data
Clinical
Clinical Trials
31 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperphosphatemiaD054559HP_0002905—572—13
Chronic renal insufficiencyD051436N18—2—1—3
Chronic kidney failureD007676EFO_0003884N18.6—1—1—2
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Irritable bowel syndromeD043183EFO_0000555K58—25——6
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Type 2 diabetes mellitusD003924EFO_0001360E11—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—9————9
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTENAPANOR
INNtenapanor
Description
Tenapanor, used in form of tenapanor hydrochloride and sold under the brand name Ibsrela, is a treatment for adults with a disease of the gut called irritable bowel syndrome with constipation commonly referred to as IBS-C.
Classification
Small molecule
Drug classsodium-hydrogen antiporter (also called sodium-proton exchanger) inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CN1Cc2c(Cl)cc(Cl)cc2[C@H](c2cccc(S(=O)(=O)NCCOCCOCCNC(=O)NCCCCNC(=O)NCCOCCOCCNS(=O)(=O)c3cccc([C@@H]4CN(C)Cc5c(Cl)cc(Cl)cc54)c3)c2)C1
Identifiers
PDB—
CAS-ID1234423-95-0
RxCUI—
ChEMBL IDCHEMBL3304485
ChEBI ID—
PubChem CID71587953
DrugBankDB11761
UNII IDWYD79216A6 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
SLC9A3
SLC9A3
Organism
Homo sapiens
Gene name
SLC9A3
Gene synonyms
NHE3
NCBI Gene ID
6550
Protein name
sodium/hydrogen exchanger 3
Protein synonyms
Na(+)/H(+) exchanger 3, NHE-3, solute carrier family 9 (sodium/hydrogen exchanger), member 3, Solute carrier family 9 member 3, solute carrier family 9, subfamily A (NHE3, cation proton antiporter 3), member 3
Uniprot ID
P48764
Mouse ortholog
Slc9a3 (105243)
sodium/hydrogen exchanger 3 (Q8BZU0)
Variants
Clinical Variant
No data
Financial
Ibsrela - Ardelyx
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 230 documents
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Safety
Black-box Warning
Black-box warning for: Ibsrela
Adverse Events
Top Adverse Reactions
0 adverse events reported
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