Treatment-resistant depression (TRD) is currently considered one of the most significant challenges in psychiatry: Millions of patients do not respond adequately to existing medications, alongside heavy costs for healthcare systems and ongoing functional loss.
Against this backdrop, the Israeli biopharma company PsyRx is developing an innovative combination drug that seeks to address one of the main failure points of antidepressant treatments – the long time until a significant clinical effect is achieved.
PsyRx’s technology is based on combining a well-known SSRI antidepressant with ibogaine – a psychoactive substance with a unique pharmacological profile, administered in a precise and controlled dosage. The combination is designed to target the biological effect without relying on a conscious experience, as part of a pharmaceutical approach adapted to a full regulatory pathway. The company emphasizes that the development is conducted from the outset according to pharmaceutical industry standards, and not as an experimental or alternative therapy.
The focus on treatment-resistant depression is deliberate. This is a population with a clear medical need, low response rates to existing treatments, and a defined target market – primarily in the U.S., where there is greater regulatory openness to innovative mental health solutions. For investors, the combination of a targeted indication, a combination-based drug, and well-known components creates a risk-reward profile different from developing a new molecule from scratch. Alongside development activities, PsyRx is supported by a board of directors and an advisory team with medical and public experience, including Prof. Itamar Grutto, former Deputy Director-General of the Health Ministry.
Grutto places the initiative in a broader perspective: "Depression is not just an individual clinical challenge, but a widespread phenomenon with characteristics of a silent epidemic. Its impact is evident on life expectancy, daily functioning, and the economy. Solutions are needed that understand the medical urgency, while also meeting strict scientific and regulatory standards."
PsyRx, operating as a public company, is currently in advanced development stages toward first human clinical trials. The company’s current fundraising is intended to enable progress toward key clinical and regulatory milestones – a critical phase for early-stage pharma companies.