Expanded Access Policy
Akebia Therapeutics, Inc. does not currently accept or grant requests for expanded access to any of its investigational drugs outside of clinical trials. To learn more about our ongoing clinical programs, please see the Clinical Development section of our Research and Development webpage.
This Expanded Access Policy applies generally to all investigational drugs manufactured or distributed by Akebia for use in serious diseases or conditions.
21st Century Cures Act:
The 21st Century Cures Act asks investigational drug manufacturers like Akebia to publicly post our policy on evaluating and responding to requests submitted for expanded access under section 561(b) of the US Federal Food, Drug, and Cosmetic Act.
At such time as Akebia begins to make expanded access to any of our investigational drugs available, this website and policy will be updated to notify the public of the procedures for making expanded access requests and our criteria for evaluating such requests.
Additional questions may be directed to 1-844-445-3799. Akebia typically responds to inquiries about our Expanded Access Policy within two (2) working days.