Page contentsPage contents Key facts Decision Key facts Active substance tenapanor Therapeutic area Metabolism and nutrition disorders Decision number EMA/PE/0000220986 PIP number EMA/PE/0000220986 Pharmaceutical form(s) Coated tablet Condition(s) / indication(s) Treatment of hyperphosphataemia Route(s) of administration Oral use Contact for public enquiries Pharma Gateway ABE-mail : info@ardelyx.com Decision type W: decision granting a waiver in all age groups for all conditions or indications Compliance check done No Decision EMA/PE/0000220986 : EMA decision of 6 December 2024 on the granting of a product specific waiver for tenapanorAdopted Reference Number: EMADOC-1700519818-1793255 Corr English (EN) (260.65 KB - PDF)First published: 17/12/2025 View Share this page