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# FDA Agrees to New Nomacopan Trial Process
- URL: https://www.fdaweb.com/fda-agrees-to-new-nomacopan-trial-process/
- Published: 2022-01-19T12:00:00.000Z
- Updated: 2026-09-14T17:29:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150952

FDA has agreed to Akari Therapeutics using a next-generation manufacturing process to produce nomacopan for use in two Phase 3 trials. The company [says](http://investor.akaritx.com/news-releases/news-release-details/fda-agrees-use-new-higher-yielding-manufacturing-process?ref=fdaweb.com) the new process increases the final yield of nomacopan by at least five-fold, significantly lowering the cost of goods for clinical studies and commercialization. FDA agreed that the process produces a drug that is comparable to nomacopan from the prior manufacturing process, the company says.

Nomacopan, formerly known as coversin, is described as a C5 complement inhibitor that also independently and specifically inhibits leukotriene B4 activity. It is being evaluated in bullous pemphigoid, thrombotic microangiopathy, eyes, and lungs.