Chemistry:Tenapanor

From HandWiki

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.[1][2] It is used in form of tenapanor hydrochloride.[1] It is also used in the treatment of hyperphosphatemia associated with chronic kidney disease.[3] Tenapanor is a sodium hydrogen exchanger 3 (NHE3) inhibitor.[3]

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.[4] 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.[5]

It was approved for medical use in the United States in September 2019.[1][6][2][7] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[8] In October 2023, tenapanor was approved by the FDA for the treatment of hyperphosphatemia.[9]

References

  1. ↑ 1.0 1.1 1.2 Cite error: Invalid <ref> tag; no text was provided for refs named Ibsrela FDA label
  2. ↑ 2.0 2.1 "Drug Trials Snapshots: Ibsrela". 27 September 2019. https://www.fda.gov/drugs/drug-trials-snapshots-ibsrela.  Public Domain This article incorporates text from this source, which is in the public domain.
  3. ↑ 3.0 3.1 Cite error: Invalid <ref> tag; no text was provided for refs named Xphozah FDA label
  4. ↑ "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. doi:10.1126/scitranslmed.3007790. PMID 24622516. 
  5. ↑ "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. doi:10.1126/scitranslmed.3007790. PMID 24622516. 
  6. ↑ "Ibsrela (tenapanor) FDA Approval History". 12 September 2019. https://www.drugs.com/history/ibsrela.html. 
  7. ↑ "Drug Approval Package: Ibsrela". 19 November 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211801Orig1s000TOC.cfm. 
  8. ↑ "New Drug Therapy Approvals 2019". 31 December 2019. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2019. 
  9. ↑ "US FDA approves Ardelyx's kidney disease-related drug". Reuters. 18 October 2023. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-ardelyxs-kidney-disease-related-drug-2023-10-17/. 
  • Clinical trial number NCT02686138 for "A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C (T3MPO-2)" at ClinicalTrials.gov
  • Clinical trial number NCT02621892 for "A 12-Week Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of IBS-C (T3MPO-1)" at ClinicalTrials.gov
  • Clinical trial number NCT02675998 for "An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)" at ClinicalTrials.gov
  • Clinical trial number NCT03427125 for "A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis" at ClinicalTrials.gov
  • Clinical trial number NCT03824587 for "Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy" at ClinicalTrials.gov




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