Clexio Biosciences
Phase II2 active candidates1 trial
shared compound: Esketaminesame indication: Treatment-Resistant Depression (TRD)Phase II peersimilar active pipeline size
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Lead program: Phase II
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1 domain / 2 areas / 1 specialization
Ketabon
Data updated
1 Drug Candidate
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.
Pipeline Intelligence
Developer Momentum
- Active candidates
- 1
- Active programmes
- 1
- Lead stage
- Phase II
- Forecast coverage
- 1 of 1
All tracked candidates active
All tracked programmes active
Current furthest stage
1 active programme with forecast fields
Latest sourced update
Ketabon - KET01 Programme
Jun 26, 2026 - company-website - Ketabon - KET01
Next known catalyst
No next milestone forecast yet.
5 sources0 pipeline-linked trials0 pipeline-linked papers
Development Programmes
1KET01
EsketaminePhase II
Treatment-resistant depression
Programme Tracker
Treatment-Resistant Depression (TRD)
Primary: EU (EMA)
Phase IIActive
Phase 2 (KET01-02) completed; Phase 3 pivotal trial planned (enrollment not yet confirmed); head-to-head vs Spravato data published
Milestones
phase-3-initiated
PlannedPhase 3 pivotal trial for MDD planned
Why it matters: Phase 3 initiation represents the final clinical hurdle before potential MAA filing in Europe. First-patient-dosed not yet confirmed as of early 2026.
Watch next: Phase 3 first patient enrolled; trial design details (endpoints, sample size)
phase-2-results
CompletedActual: Aug 14, 2023
KET01-02 Phase 2 top-line results: 122 patients across 29 sites (Germany/Poland/Czech Republic). 240 mg/day showed statistically significant improvement vs placebo on Day 4 and Day 7, but MISSED primary endpoint at Day 21
Why it matters: The Phase 2 results are mixed — strong early efficacy (Day 4-7) but failure to sustain statistical significance at the Day 21 primary endpoint. However, the dissociation-free profile (CADSS score 0.7 vs 29.6 for Spravato) is the key differentiator. An oral at-home ketamine with no dissociation would eliminate the REMS monitoring requirement that limits Spravato adoption.
Watch next: Phase 3 pivotal trial enrollment start
Efficacy data
CompletedActual: Mar 1, 2024
KET01-03 head-to-head comparison with Spravato (esketamine nasal spray) published — CADSS dissociation score 0.7 for KET01 vs 29.6 for Spravato (statistically significant)
Why it matters: First direct comparison showing KET01 produces virtually zero dissociation compared to Spravato. Published in peer-reviewed journal (PubMed indexed). This data positions KET01 as a potential at-home oral ketamine option, vs Spravato which requires 2-hour in-clinic monitoring per dose.
Efficacy data
CompletedActual: Sep 1, 2024
Presented advancements in at-home ketamine therapy for TRD at ECNP Congress 2024
Why it matters: Major European psychiatry congress presentation builds KOL awareness ahead of Phase 3.
Efficacy data
CompletedActual: Oct 15, 2025
New post-hoc analysis of KET01-02 presented at ECNP 38th Congress (Amsterdam): antidepressant effects of oral ketamine are independent of dissociation
Why it matters: Critical mechanistic insight — demonstrates that ketamine's antidepressant action does not require the dissociative experience, challenging a long-held assumption in the field. Strengthens the regulatory narrative for at-home dosing without monitoring.
Recorded Events
Oct 15, 2025: Efficacy data
Sep 1, 2024: Efficacy data
Mar 1, 2024: Efficacy data
Aug 14, 2023: phase-2-results
Evidence Links
Ketabon - KET01 Programme
company-website - Ketabon - Jun 26, 2026 - Verified
Current site describes KET01 as an oral prolonged-release ketamine formulation for TRD/MDD, gives Phase 2 data, and states the programme is progressing toward pivotal Phase 3 trials.
First Patient Dosed in Second Phase 2 Add-on Ketamine Trial
Press release - Ketabon - Jun 8, 2022 - Verified
Ketabon announced first patient dosing in a 117-patient Phase 2 trial of oral prolonged-release ketamine in TRD.
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Quick Facts
- Type
- Private Biotech
- Lead Stage
- Phase II
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