> ## 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.

# Akari Therapeutics Gains Orphan Status for Nomacopan
- URL: https://www.fdaweb.com/akari-therapeutics-gains-orphan-status-for-nomacopan/
- Published: 2019-08-30T12:00:00.000Z
- Updated: 2026-09-15T01:47:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144897

FDA has granted Akari Therapeutics an orphan drug designation for nomacopan and its use in treating hematopoietic stem cell transplantation-associated thrombotic microangiopathy (HSCT-TMA). Orphan status follows a fast track designation given earlier this month for the same indication in pediatric patients. The company says it is planning a pivotal trial that is expected to start in the fourth quarter.

Nomacopan is Akari’s lead drug candidate, and it is described as a C5 complement inhibitor that also independently and specifically inhibits leukotriene B4 (LTB4) activity. Nomacopan is also currently being clinically evaluated in three other indications — bullous pemphigoid, atopic keratoconjunctivitis, and paroxysmal nocturnal hemoglobinuria.