- Oral prolonged-release ketamine formulation (KET01) demonstrates minimal dissociation and cardiovascular effects with early antidepressant efficacy signals in treatment-resistant depression
- Results support further development of oral KET01 for at-home administration
- Phase 3-readiness activities underway
MUNICH, Germany, July 7, 2026 – HMNC Brain Health ("HMNC" or the "Company"), a clinical-stage neuroscience company, today announced the publication of clinical data for Ketabon (KET01) in JAMA Network Open, demonstrating a differentiated tolerability profile and antidepressant properties that support further clinical development of this program for at-home administration.
Entitled ‘Oral Prolonged-Release Ketamine for Treatment-Resistant Depression,’ the publication reports results from two clinical trials evaluating KET01, an oral prolonged-release ketamine formulation for treatment-resistant depression (TRD). The studies included a phase 1 crossover randomized clinical trial (RCT) contrasting KET01 to intranasal ketamine as an active comparator and a phase 2 randomized, placebo-controlled, double-blind trial in adult outpatients with TRD.
Results from both trials demonstrated that KET01’s prolonged-release formulation addresses key limitations of currently available ketamine-based treatments, which commonly cause acute dissociation and blood pressure increases that require administration in specialized clinical settings. Conversely, KET01 exhibited minimal dissociation and cardiovascular effects at doses associated with clinically meaningful antidepressant effects. This favorable tolerability profile represents a significant advancement toward enabling at-home administration, which could significantly expand access to ketamine therapy.
In the phase 2 trial, KET01 demonstrated early improvements in depressive symptoms, as measured by the Montgomery–Åsberg Depression Rating Scale (MADRS). In the efficacy analysis, treatment with KET01 240 mg/day produced rapid reductions in MADRS scores, with effects emerging as early as 7 hours and improvements versus placebo observed on Days 4 and 7 (p<0.05). Patients receiving KET01 240mg continued to improve throughout the treatment period, with an overall change from baseline of -13.15 MADRS points. Although the primary endpoint at Day 21 was not met because of substantial improvement in the placebo group, the early separation between treatment groups supports a rapid antidepressant effect.
Together, these early efficacy signals indicating the potential of KET01 to provide rapid symptom relief in treatment-resistant depression, combined with its differentiated tolerability profile, provide a strong rationale for larger phase 3 studies with extended follow-up to evaluate the durability of response and the long-term maintenance of remission.
Dr. Maximilian Doebler, Managing Director & Chief Business Officer, HMNC, said: “Publication of our Ketabon clinical data in JAMA Network Open represents a significant milestone, providing peer-reviewed validation of results that support our commitment to developing more accessible treatment options for the approximately 100 million patients worldwide living with treatment-resistant depression. Importantly, findings clearly demonstrate that the unique prolonged-release formulation delivers on its promise of minimal dissociation and cardiovascular effects while maintaining antidepressant properties. Such differentiated tolerability addresses key limitations of currently available ketamine-based therapies and supports our plans for scalable at-home use, providing a strong rationale for global phase 3 development.”
Supported by proceeds from the successful $50 million first closing of a Series B financing, readiness activities are now underway to advance KET01 toward a phase 3 global program in TRD.
Contact
HMNC Brain Health
Dr. Maximilian Doebler, Managing Director & Chief Business Officer
E-mail: maximilian.doebler@hmnc-brainhealth.com
Dr. Dr. Jessica Burgstaller, VP Strategy & Corporate Development
E-mail: jessica.burgstaller@hmnc-brainhealth.com
ICR Healthcare
Tracy Cheung / Ashley Tapp / Kris Lam
E-mail: HMNCBrainHealth@icrhealthcare.com
About HMNC Brain Health (HMNC Holding GmbH)
HMNC Brain Health (HMNC) is a clinical-stage neuroscience company pioneering new therapies for mental health disorders. Its pipeline includes Nelivabon (BH-200), a vasopressin V1b receptor antagonist being developed as a biomarker-guided precision therapy for biologically defined depressive disorders. Used with a genetic test to identify patients most likely to benefit, Nelivabon offers a precision neuroscience approach to treatment. HMNC is also developing Ketabon (KET01), an oral prolonged-release ketamine formulation for treatment-resistant depression, designed as a differentiated and scalable option for outpatient and at-home use. By advancing targeted and accessible treatment options, HMNC aims to address significant unmet needs of millions of patients who are not helped sufficiently by existing mental health therapies. The Company is headquartered in Munich, Germany. Find out more at www.hmnc-brainhealth.com and connect with us on LinkedIn.
About the Ketabon Program
Ketabon is a joint venture between HMNC Brain Health and Develco Pharma focused on developing KET01, an oral prolonged-release ketamine formulation for treatment-resistant depression. Designed for safe and convenient at-home treatment, KET01 has demonstrated rapid antidepressant effects with minimal dissociative side effects in phase 2 studies, potentially offering an important differentiated alternative to existing ketamine-based therapies.
