> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Accepts NDA for Wilson’s Disease
- URL: https://www.fdaweb.com/fda-accepts-nda-for-wilsons-disease/
- Published: 2021-09-02T12:00:00.000Z
- Updated: 2026-09-14T17:12:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150074

FDA has accepted for review an Orphalan NDA for trientine tetrahydrochloride (TETA 4HCl) for the first-line treatment of Wilson’s Disease. The rare inherited disorder of copper transport primarily affects the liver and brain, according to the company. If approved, trientine tetrahydrochloride would be an alternative copper chelating agent to d-Penicillamine, the only approved first-line treatment for Wilson’s Disease for the last 70 years, to which about a third of patients develop intolerance.

The submission is based on data from the [CHELATE Phase 3 clinical trial](https://www.globenewswire.com/Tracker?data=4xhgZ6RF28dB2SeY5YQWrsv563WCO410iZiXx3YV3dK-H8dI6IF8XeS8GNgU7sKtjmVQdtg9P-5NI8Sq9arEeTur-myS8hyZhIl2X8-68GlFxCTninAmgjmtEP1AS15PHTNXySOa1VRebqp9SSYGvrvpxVtq%5FKPclVGz4ur6Zn%5FRRb2-HPuHK9aQ2Rk8iW6ggtJBccxLA1cX%5FHsduFE5hoqdKxoDghEHUNhjUKSOb3t48kiuimSiOqd7yWIORQlhn0OPcr2KBBogu3lfnZKoHw==&ref=fdaweb.com) that met its primary efficacy endpoint by demonstrating that the therapy was non-inferior to d-Penicillamine as measured by copper speciation evaluation of non-ceruloplasmin copper, Orphalan says.