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# Astellas Pauses ASPIRO Trial
- URL: https://www.fdaweb.com/astellas-pauses-aspiro-trial/
- Published: 2021-09-01T12:00:00.000Z
- Updated: 2026-09-14T17:12:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150059

Astellas Pharma says it has paused screening and dosing of additional participants in its ASPIRO clinical trial evaluating AT132 in patients with X-linked myotubular myopathy. A company [statement](https://www.astellas.com/en/news/17121?ref=fdaweb.com) says the pause follows reporting of a serious adverse event in a study participant due to abnormal liver function tests observed in the weeks following dosing of the AT132 invstigational gene therapy product at a lower dose.

The company says it is talking with regulatory authorities about the adverse event and that FDA has not imposed a clinical hold at this time.