Treatment-resistant depression
Late-stage trials · in progressTwo positive Phase 2b trials; Phase 3 started in 2026.
In a placebo-controlled Phase 2b trial of 81 people, published in JAMA Psychiatry, inhaled GH001 cut depression scores by 15.5 points more than placebo after 8 days; 58% were in remission, versus none on placebo.1
The FDA lifted its US clinical hold on GH001 in January 2026.2
Intranasal BPL-003 met its main goal in a 193-person Phase 2b trial. An earlier open-label study in 12 people found most were ready to go home about 1.5 hours after the dose.34
BPL-003's Phase 3 programme (ReConnection-1 and -2) was initiated in mid-2026, with results expected in early 2029. Eli Lilly agreed to buy the developer in July 2026.567
GH Research still plans to start its own Phase 3 in 2026.8
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