Phase I onset of action trial in patients with hyperkalaemia.
Active, no longer recruiting
Phase of Trial: Phase I
Latest Information Update: 21 Jul 2017
At a glance
- Drugs Patiromer (Primary)
- Indications Hyperkalaemia
- Focus Registrational; Therapeutic Use
- Sponsors Relypsa
- 21 Jul 2017 According to a Relypsa media release, the European Commission (EC) approved the Marketing Authorization Application (MAA) for Veltassa (patiromer) for the treatment of hyperkalemia.
- 19 May 2017 According to a Vifor media release, based on the results from this trial, Phase 2 AMETHYST-DN trial, and Phase III OPAL-HK trial, The Committee For Medicinal Products For Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorisation for patiromer for the treatment of hyperkalemia.
- 25 Apr 2016 According to Relypsa media release, patiromer was approved by the US Food and Drug Administration (FDA) for the treatment of hyperkalemia in the US in October 2015 under the name Veltassa, becoming the first new medicine in more than 50 years for people with elevated serum potassium.