Tenapanor

Unassigned

New Medicines

Ibsrela (US) · Irritable bowel syndrome, constipation-predominant

Information

Ibsrela (US)
New molecular entity
Ardelyx
Ardelyx

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Approved (Licensed)
Sep 19 · Approved in US for treatment of IBS with constipation (IBS-C) [8].
Sep 18 · NDA filed in US [6].
Mar 18 · In its annual 10K form, Ardelyx states its ambition to build a multi-product company that commercializes its renal products (including tenapanor) in the US & to leverage ex-U.S. collaborations with established industry leaders to efficiently bring our renal medicines to patients outside the US. An agreement has been reached with Fosun Pharma to develop & commercialise tenapanor for IBS in China. No agreements have yet been signed with European companies for tenapanor for any indication [7].

Category

First-in-class inhibitor of gastrointestinal NHE3 sodium transporter reduces dietary sodium absorption, more fluid in gut.
IBS occurs in 10-20% of the population in the UK, but prevalence is thought to be higher than this as many people with the disorder do not seek medical advice. Approximately one third of patients have IBS with constipation (IBS-C) = loose stools 25% of the time [2].
Irritable bowel syndrome, constipation-predominant
Oral

Trial or other data

Jan 18 · Ardelyx report safety trial data from an extension study. Study found that 9.2% of patients experienced diarrhoea, with 1.7% discontinuing treatment due to this adverse reaction [5].
Oct 17 · Further PIII data announched by Ardelyx from the ongoing T3MPO2 study (NCT02686138) for tenapanor vs. placebo. The 26-week, randomised, double-blind, placebo-controlled, study is evaluating the safety and efficacy tenapanor (50mg BD or matched placebo) in 600 pts with constipation-predominant IBS. Tenapenor achieved a 36.5% combined responder rate in the latest TEMPO2 study compared to 23.7% for placebo, compared to 27% and 19% respectively in the earlier TEMPO 1 trial, and the effects were sustained throughout the 26-week trial period. The rate of diarrhoea reported in this study was 12% [3,4].
May 17 · PIII T3MPO-1 trial (n=610) achieved statistical significance for the primary endpoint and seven of eight secondary endpoints. The primary endpoint, the combined responder rate for six of 12 weeks, showed that a greater proportion of tenapanor-treated patients (50mg bd) compared to placebo-treated (27.0% vs 18.7%, p=0.02) had at least a 30 percent reduction in abdominal pain and an increase of one or more complete spontaneous bowel movements (CSBM) in the same week for at least six of the 12 weeks of the treatment period [1]. 22/05/2017 15:56:23

Evidence based evaluations

Ibsrela (US) · Hyperphosphataemia in patients with chronic kidney disease (CKD) on dialysis

Information

Ibsrela (US)
Licence extension / variation
Ardelyx
Ardelyx

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

First-in-class inhibitor of gastrointestinal NHE3 sodium transporter reduces dietary sodium absorption which causes a reduction in phosphate uptake. Paracellular phosphate permeability is reduced by tenapanor.
Hyperphosphataemia occurs because of insufficient filtering of phosphate from the blood by poorly functioning kidneys. High serum phosphate levels can directly and indirectly increase PTH secretion, leading to secondary hyperparathyroidism. Left untreated, secondary hyperparathyroidism increases morbidity and mortality and may lead to renal bone disease with bone and muscular pain, increased incidence of fracture, bone and joint abnormalities and vascular and soft tissue calcification [1].
Hyperphosphataemia in patients with chronic kidney disease (CKD) on dialysis
Oral