Ketabon GmbH is a Munich-based joint venture between HMNC Brain Health and Develco Pharma developing KET01, an oral prolonged-release (PR) racemic ketamine tablet for TRD. Founded in 2022, Ketabon's strategy centres on enabling at-home, unsupervised ketamine therapy by dramatically reducing dissociation and cardiovascular side effects through slow drug release. Two Phase 2 studies are complete: KET01-01 (UZH investigator-initiated PoC, ~zero dissociation, trend toward MADRS improvement at 240mg) and KET01-02 (n=122, 29 sites across Germany/Poland/Czech Republic, 240mg arm showed statistically significant rapid-onset MADRS improvement at Day 4 and 7, sustained through Day 21 and 4-week follow-up; primary Day 21 endpoint missed due to high placebo response). A head-to-head study vs. Spravato (esketamine nasal spray) confirmed significantly lower dissociation for KET01. Post-hoc analysis presented at ECNP Amsterdam (October 2025) demonstrated that KET01's antidepressant effect is dissociation-independent, strengthening the regulatory case for home use. Phase 3 initiation was targeted for 2025; IP exclusivity through 2039.
Drug Pipeline
1Treatment-Resistant Depression (TRD)
Quick Facts
- Type
- Private Biotech
- Lead Stage
- Phase II/III
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