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# Astellas ASPIRO Trial Patient Dies
- URL: https://www.fdaweb.com/astellas-aspiro-trial-patient-dies/
- Published: 2021-09-14T12:00:00.000Z
- Updated: 2026-09-14T17:14:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150136

Astellas says the patient in its ASPIROS trial evaluating an investigational drug in patients with X-linked myotubular myopathy who suffered a serious adverse event leading to a [pause](https://www.fdaweb.com/astellas-pauses-aspiro-trial/) in the trial has died. A company [statement](https://www.astellas.com/en/news/17161?ref=fdaweb.com) says the cause of death is still pending and the company is gathering the relevant clinical information and incorporating it into the ongoing investigation of other serious adverse events observed in the ASPIRO trial.

The company says it heard through an FDA email that the agency had placed the trial on a clinical hold. When it receives an official letter on the hold, Astellas says, it will discuss a path forward with regulators.