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BioWorld - Sunday, April 12, 2026
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Home » Hold lifted, as GH Research preps for pivotal GH-001 depression trial
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Hold lifted, as GH Research preps for pivotal GH-001 depression trial

Jan. 5, 2026
By Jennifer Boggs
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With plans in place to launch global pivotal testing of GH-001, its inhaled version of psychedelic mebufotenin (5-MeO-DMT), in treatment-resistant depression in 2026, GH Research plc reported the lifting of a U.S. FDA clinical hold, enabling U.S. subject enrollment. The firm now will seek a meeting with the agency to discuss trial design.
BioWorld Clinical Regulatory Small molecule U.S. FDA

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