Last year, we finalized our first clinical study, a randomized, double-blind placebo-controlled study of 30 healthy participants. The results were as great as we expected: on average a 30% reduction in urinary oxalate. Our parent company, Captozyme, presented the clinical study summary at the American Urological Association’s Annual Meeting in May, and many physicians in attendance were pleased to see the results.
Why are you pulling Nephure from the market?
While Nephure has been effective for many people, we hope to expand its ability to improve lives. Both physicians and consumers have asked for more data and more clinical studies on the oxalate-reducing enzyme in Nephure, and we respect this need for additional research and development. We are now fully committed to additional years of development and clinical research to build the confidence of all communities we serve.
Why can’t you keep Nephure on the market while you are conducting clinical trials?
Many physicians have asked for more data and more clinical studies on the oxalate-reducing enzyme in Nephure. As a result, we are moving away from a nutritional supplement and toward the development of a clinical drug — a major undertaking that will require significant time and resources for the company. As a small business, it is imperative that we stay focused. We simply would not have the bandwidth to sustain both projects in parallel with a small team.
For how much longer will I be able to purchase Nephure?
You may purchase Nephure from our website, shop.nephure.com, until 11:59 p.m. on December 31, 2019, or while supplies last.
Does Nephure expire?
Our current inventory has a best-by date of January 2021.
Can I get money back for Nephure I’ve already bought?
We offer a 30-day money-back guarantee. If you have purchased Nephure within the last 30 days, you may be eligible for a full refund minus shipping costs.
Will the drug be called Nephure?
Our team is still early in the development and clinical trial process and have not chosen a name; however, the drug will be completely separate from Nephure and will not have the same name.
How long will I have to wait for the drug?
The clinical trial and drug development process is a long-term effort that can vary depending on many factors. We estimate it will take at least five to seven years before a prescription drug is available.
Will the prescription drug be the same as Nephure?
The prescription drug will include the active ingredient in Nephure, but will not be in the same current form.
When is your next clinical trial?
We will be filing an IND (Investigational New Drug) in early 2020 and plan for our Phase 2 trial to start in 2020 pending FDA’s agreement with the study design.
Can I be a part of your next clinical trial?
If you’re interested in more information on becoming a participant in the clinical trial, please visit Oxidien.com and fill out the contact form. We will be sharing more information about the clinical trial process soon.
Where can I learn more about the prescription drug product?
Stay tuned to Nephure.com to learn more information about the clinical trial, updates on clinical trial progress, and details about the prescription drug product.
How can I maintain a low-oxalate diet without Nephure?
Throughout this transition we are committed to our customers and will keep our helpful resources and information on our website for people seeking a low-oxalate diet.