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# FDA Places Bright Minds Epilepsy Trial on Partial Clinical Hold
- URL: https://www.fdaweb.com/fda-places-bright-minds-epilepsy-trial-on-partial-clinical-hold/
- Published: 2026-11-02T19:38:00.000Z
- Updated: 2026-11-02T22:39:45.000Z
- Author: David McFarland
- Tags: Drugs

FDA has placed a partial clinical hold on Bright Minds Biosciences' planned Phase 2 trial of BMB-101 in patients with developmental and epileptic encephalopathies (DEEs), citing toxicity findings in mice and insufficient pharmacokinetic and juvenile toxicity data to support pediatric enrollment.

The proposed U.S. trial is a randomized, double-blind, placebo-controlled study evaluating ascending doses of BMB-101, up to the maximum tolerated dose, for seizures associated with DEEs.

Bright Minds said it believes the hold applies only to the planned U.S. Phase 2 DEE trial and does not affect its other ongoing clinical studies.

The company disputed the significance of the mouse toxicity findings, saying similar effects were not observed in other species. Based on its toxicology reports and independent expert assessments, Bright Minds believes the findings were incidental and unrelated to BMB-101.

Bright Minds said it intends to seek clarification from FDA and modify the proposed study as necessary to address the agency's concerns.