Germany-based HMNC Brain Health reported peer-reviewed results from its Ketabon KET01 program in JAMA Network Open, showing that its oral prolonged-release ketamine formulation produced rapid antidepressant effects with minimal dissociation and cardiovascular side effects in patients with treatment-resistant depression (TRD). The publication is significant because it supports the company's strategy of developing an oral ketamine therapy that could potentially be administered at home, unlike Johnson & Johnson's clinic-based intranasal esketamine (Spravato).
The publication includes a Phase I crossover study and a randomized, placebo-controlled Phase II trial. While the Phase II study failed to meet its primary endpoint of change in Montgomery–Åsberg Depression Rating Scale (MADRS) score at Day 21 due to a high placebo response, patients receiving KET01 240 mg/day showed statistically significant improvements versus placebo on Days 4 and 7, with antidepressant effects observed as early as seven hours after dosing.
The Phase I study demonstrated markedly lower dissociation and fewer cardiovascular effects than intranasal ketamine, suggesting the prolonged-release formulation may overcome the tolerability issues that currently require supervised administration of ketamine-based therapies.
HMNC is preparing KET01 for Phase III development following a USD 50 million Series B financing announced in June 2026, led by MEDICE – The Health Family, which also holds exclusive European commercialization rights. The company is also advancing nelivabon, a precision psychiatry candidate for major depressive disorder.