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# FDA Orders Partial Clinical Hold on BioCryst Therapy
- URL: https://www.fdaweb.com/fda-orders-partial-clinical-hold-on-biocryst-therapy/
- Published: 2022-05-05T12:00:00.000Z
- Updated: 2026-09-14T17:43:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151747

A 4/8 BioCryst voluntary decision to pause enrollment in clinical trials of its oral Factor D inhibitor, BCX9930, has transitioned to an FDA partial clinical hold. In a 5/5 quarterly financial report, the company says the hold was related to observed elevations in serum creatinine seen in some patients. BCX9930 is currently being studied in patients with C3 glomerulopathy, immunoglobulin A nephropathy and primary membranous nephropathy.

“Preliminary evidence from the investigation points to both the 500 mg twice-daily dosing level and the immediate start of that dose, without a period at a lower dose first, as plausible contributory factors for the observed increases in serum creatinine,” the [company says](https://ir.biocryst.com/news-releases/news-release-details/biocryst-reports-first-quarter-2022-financial-results-and?ref=fdaweb.com). “Based on the initial results of the investigation, and the safety and efficacy data observed in the BCX9930 clinical program at 400 mg twice-daily, the company plans to discuss with regulators whether clinical trials with amended protocols could resume using stepped dosing to 400 mg twice-daily. The company expects to have discussions with regulators by the end of the third quarter.”