Tenapanor

{{Short description|Medication}}

{{Use dmy dates|date=November 2023}}

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{{Infobox drug

| image = Tenapanor.svg

| width = 300

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| pronounce =

| tradename = Ibsrela, Xphozah, others

| Drugs.com = {{drugs.com|monograph|tenapanor-hydrochloride}}

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| licence_EU =

| DailyMedID = Tenapanor

| licence_US =

| pregnancy_AU =

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| routes_of_administration = By mouth

| class = NHE3 inhibitors

| ATCvet =

| ATC_prefix = A06

| ATC_suffix = AX08

| ATC_supplemental =

| legal_AU =

| legal_AU_comment =

| legal_BR =

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| legal_CA = Rx-only

| legal_CA_comment = {{cite web | title=Summary Basis of Decision (SBD) for Ibsrela | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00492&lang=en | access-date=29 May 2022 | archive-date=30 May 2022 | archive-url=https://web.archive.org/web/20220530055427/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00492&lang=en | url-status=live }}{{cite web | title=Regulatory Decision Summary - Ibsrela | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?linkID=RDS00677 | access-date=4 June 2022 | archive-date=13 November 2021 | archive-url=https://web.archive.org/web/20211113103050/https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?linkID=RDS00677 | url-status=live }}

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| legal_US = Rx-only

| legal_US_comment = {{cite web | title=Ibsrela- tenapanor hydrochloride tablet | website=DailyMed | date=14 April 2022 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2102da5f-a1a0-4ac7-a1f6-38698cf7273a | access-date=19 October 2023 | archive-date=19 October 2023 | archive-url=https://web.archive.org/web/20231019034035/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2102da5f-a1a0-4ac7-a1f6-38698cf7273a | url-status=live }}{{cite web | title=Xphozah 10 MG- tenapanor tablet, film coated; Xphozah 20 MG- tenapanor tablet, film coated; Xphozah 30 MG- tenapanor tablet, film coated | website=DailyMed | date=17 October 2023 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c57e279c-0f1b-4238-81b7-4e0dc0cc60c5 | access-date=10 November 2023}}

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| CAS_number = 1234423-95-0

| CAS_supplemental =

| PubChem = 71587953

| IUPHAR_ligand =

| DrugBank = DB11761

| ChemSpiderID = 32056950

| UNII = WYD79216A6

| UNII2 = 50605O2ZNS

| KEGG = D11652

| KEGG2 = D11653

| ChEBI =

| ChEMBL = 3304485

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| synonyms = Tenapanor hydrochloride

| IUPAC_name = N,N'-(10,17,-dioxo-3,6,21,24-tetraoxa-9,11,16,18-tetraazahexacosane-1,26-diyl)bis([(4S)-6,8-dichloro-2-methyl-1,2,3,4-tetrahydroisoquinolin-4-yl]benzenesulfonamide)

| C=50 | H=66 | Cl=4 | N=8 | O=10 | S=2

| SMILES = CN1C[C@H](C2=C(C1)C(=CC(=C2)Cl)Cl)C3=CC(=CC=C3)S(=O)(=O)NCCOCCOCCNC(=O)NCCCCNC(=O)NCCOCCOCCNS(=O)(=O)C4=CC=CC(=C4)[C@@H]5CN(CC6=C5C=C(C=C6Cl)Cl)C

| StdInChI = 1S/C50H66Cl4N8O10S2/c1-61-31-43(41-27-37(51)29-47(53)45(41)33-61)35-7-5-9-39(25-35)73(65,66)59-15-19-71-23-21-69-17-13-57-49(63)55-11-3-4-12-56-50(64)58-14-18-70-22-24-72-20-16-60-74(67,68)40-10-6-8-36(26-40)44-32-62(2)34-46-42(44)28-38(52)30-48(46)54/h5-10,25-30,43-44,59-60H,3-4,11-24,31-34H2,1-2H3,(H2,55,57,63)(H2,56,58,64)/t43-,44-/m0/s1

| StdInChI_comment =

| StdInChIKey = DNHPDWGIXIMXSA-CXNSMIOJSA-N

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Tenapanor, sold under the brand name Ibsrela among others, is a medication used for the treatment of adults with a disease of the gut called irritable bowel syndrome with constipation commonly referred to as IBS-C.{{cite web | title=Drug Trials Snapshots: Ibsrela | website=U.S. Food and Drug Administration (FDA) | date=27 September 2019 | url=https://www.fda.gov/drugs/drug-trials-snapshots-ibsrela | archive-url=https://web.archive.org/web/20191119051931/https://www.fda.gov/drugs/drug-trials-snapshots-ibsrela | archive-date=19 November 2019 | url-status=dead | access-date=18 November 2019}} {{PD-notice}} It is used in form of tenapanor hydrochloride. It is also used in the treatment of hyperphosphatemia associated with chronic kidney disease. Tenapanor is a sodium hydrogen exchanger 3 (NHE3) inhibitor.

Tenapanor is a drug developed by Ardelyx, which acts as an inhibitor of the sodium-proton exchanger NHE3. This antiporter protein is found in the kidney and intestines, and normally acts to regulate the levels of sodium absorbed and secreted by the body. When administered orally, tenapanor selectively inhibits sodium uptake in the intestines, limiting the amount absorbed from food, and thereby reduces levels of sodium in the body.{{cite journal |vauthors=Spencer AG, Labonte ED, Rosenbaum DP, Plato CF, Carreras CW, Leadbetter MR, Kozuka K, Kohler J, Koo-McCoy S, He L, Bell N, Tabora J, Joly KM, Navre M, Jacobs JW, Charmot D | title = Intestinal inhibition of the na+/h+ exchanger 3 prevents cardiorenal damage in rats and inhibits na+ uptake in humans | journal = Sci Transl Med | volume = 6 | issue = 227 | pages = 227ra36 | year = 2014 | pmid = 24622516 | doi = 10.1126/scitranslmed.3007790 | s2cid = 10741924 }} This may make it useful in the treatment of chronic kidney disease and hypertension, both of which are exacerbated by excess sodium in the diet.{{cite journal |vauthors=Spencer AG, Labonte ED, Rosenbaum DP, Plato CF, Carreras CW, Leadbetter MR, Kozuka K, Kohler J, Koo-McCoy S, He L, Bell N, Tabora J, Joly KM, Navre M, Jacobs JW, Charmot D |title=Intestinal inhibition of the Na+/H+ exchanger 3 prevents cardiorenal damage in rats and inhibits Na+ uptake in humans |journal=Sci Transl Med |volume=6 |issue=227 |pages=227ra36 |date=March 2014 |pmid=24622516 |doi=10.1126/scitranslmed.3007790 |s2cid=10741924}}

It was approved for medical use in the United States in September 2019.{{cite web | title=Ibsrela (tenapanor) FDA Approval History | website=Drugs.com | date=12 September 2019 | url=https://www.drugs.com/history/ibsrela.html | access-date=19 November 2019 | archive-date=28 November 2020 | archive-url=https://web.archive.org/web/20201128231709/https://www.drugs.com/history/ibsrela.html | url-status=live }}{{cite web | title=Drug Approval Package: Ibsrela | website=U.S. Food and Drug Administration (FDA) | date=19 November 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211801Orig1s000TOC.cfm | archive-url=https://web.archive.org/web/20191119053550/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211801Orig1s000TOC.cfm | archive-date=19 November 2019 | url-status=live | access-date=18 November 2019}} The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.{{cite web | title=New Drug Therapy Approvals 2019 | website=U.S. Food and Drug Administration (FDA) | date=31 December 2019 | url=https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2019 | access-date=15 September 2020 | archive-date=16 September 2020 | archive-url=https://web.archive.org/web/20200916144738/https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2019 | url-status=dead }} In October 2023, tenapanor was approved by the FDA for the treatment of hyperphosphatemia.{{Cite news |date=18 October 2023 |title=US FDA approves Ardelyx's kidney disease-related drug |work=Reuters |url=https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-ardelyxs-kidney-disease-related-drug-2023-10-17/ |access-date=24 October 2023 |archive-date=24 October 2023 |archive-url=https://web.archive.org/web/20231024023324/https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-ardelyxs-kidney-disease-related-drug-2023-10-17/ |url-status=live }}

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