Tenapanor Explained

Width:300
Tradename:Ibsrela, Xphozah, others
Dailymedid:Tenapanor
Routes Of Administration:By mouth
Class:NHE3 inhibitors
Atc Prefix:A06
Atc Suffix:AX08
Legal Ca:Rx-only
Legal Ca Comment:[1] [2]
Legal Us:Rx-only
Legal Us Comment:[3] [4]
Cas Number:1234423-95-0
Pubchem:71587953
Drugbank:DB11761
Chemspiderid:32056950
Unii:WYD79216A6
Unii2:50605O2ZNS
Kegg:D11652
Kegg2:D11653
Chembl:3304485
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
Stdinchikey:DNHPDWGIXIMXSA-CXNSMIOJSA-N

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.[5] It is used in form of tenapanor hydrochloride. It is also used in the treatment of 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.[6] 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.[7]

It was approved for medical use in the United States in September 2019.[8] [9] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[10] In October 2023, tenapanor was approved by the FDA for the treatment of hyperphosphatemia.[11]

Notes and References

  1. Web site: Summary Basis of Decision (SBD) for Ibsrela . Health Canada . 23 October 2014 . 29 May 2022 . 30 May 2022 . https://web.archive.org/web/20220530055427/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00492&lang=en . live .
  2. Web site: Regulatory Decision Summary - Ibsrela . Health Canada . 23 October 2014 . 4 June 2022 . 13 November 2021 . https://web.archive.org/web/20211113103050/https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?linkID=RDS00677 . live .
  3. Web site: Ibsrela- tenapanor hydrochloride tablet . DailyMed . 14 April 2022 . 19 October 2023 . 19 October 2023 . https://web.archive.org/web/20231019034035/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2102da5f-a1a0-4ac7-a1f6-38698cf7273a . live .
  4. Web site: Xphozah 10 MG- tenapanor tablet, film coated; Xphozah 20 MG- tenapanor tablet, film coated; Xphozah 30 MG- tenapanor tablet, film coated . DailyMed . 17 October 2023 . 10 November 2023.
  5. Web site: Drug Trials Snapshots: Ibsrela . U.S. Food and Drug Administration (FDA) . 27 September 2019 . https://web.archive.org/web/20191119051931/https://www.fda.gov/drugs/drug-trials-snapshots-ibsrela . 19 November 2019 . live . 18 November 2019.
  6. 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 . Intestinal inhibition of the na+/h+ exchanger 3 prevents cardiorenal damage in rats and inhibits na+ uptake in humans . Sci Transl Med . 6 . 227 . 227ra36 . 2014 . 24622516 . 10.1126/scitranslmed.3007790 . 10741924 .
  7. 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 . Intestinal inhibition of the Na+/H+ exchanger 3 prevents cardiorenal damage in rats and inhibits Na+ uptake in humans . Sci Transl Med . 6 . 227 . 227ra36 . March 2014 . 24622516 . 10.1126/scitranslmed.3007790 . 10741924.
  8. Web site: Ibsrela (tenapanor) FDA Approval History . Drugs.com . 12 September 2019 . 19 November 2019 . 28 November 2020 . https://web.archive.org/web/20201128231709/https://www.drugs.com/history/ibsrela.html . live .
  9. Web site: Drug Approval Package: Ibsrela . U.S. Food and Drug Administration (FDA) . 19 November 2019 . https://web.archive.org/web/20191119053550/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211801Orig1s000TOC.cfm . 19 November 2019 . live . 18 November 2019.
  10. Web site: New Drug Therapy Approvals 2019 . U.S. Food and Drug Administration (FDA) . 31 December 2019 . 15 September 2020 . 16 September 2020 . 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 . live .
  11. News: 18 October 2023 . US FDA approves Ardelyx's kidney disease-related drug . Reuters . 24 October 2023 . 24 October 2023 . https://web.archive.org/web/20231024023324/https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-ardelyxs-kidney-disease-related-drug-2023-10-17/ . live .

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