EPIK Biosciences has launched as a new psychedelic drug development company focused on ketamine-based therapies for mental health disorders, chronic pain and substance use disorders.

The Austin-based biotech said it is developing a portfolio of proprietary ketamine formulations designed to improve treatment options in areas where current therapies remain limited, including neuropsychiatric conditions, addiction and non-opioid pain management.

The company’s pipeline is centred on ketamine-based combination medicines and co-delivery formulations targeting NMDA receptor modulation, with the aim of improving efficacy, durability and patient accessibility compared with existing treatments.

EPIK said it has already initiated preclinical pharmacokinetic and animal studies across its lead programmes and is building an intellectual property portfolio covering formulations, delivery technologies and methods of use.

The company enters the psychedelic therapeutics sector at a time of increasing regulatory and political attention in the USA. In April, the White House issued an executive order aimed at accelerating the research, review and approval of psychedelic therapies for serious mental illness, while FDA continues to grant Breakthrough Therapy designations to selected psychedelic drug candidates.

Brandon Romanek, founder and chief executive officer of EPIK Biosciences, said: “Our proprietary medicines formulations are fundamentally different from anything currently available.

“We are building therapies designed to address the root causes of mental health disorders, chronic pain and addiction, and are focused on helping patients achieve consistent, long-term outcomes where existing therapies may fall short.”

Romanek began researching ketamine in 2012, before the rapid expansion of ketamine clinics across the United States. According to the company, that work led to the development of EPIK’s proprietary formulations following personal health experiences that reinforced the need for alternative treatment options.

The company is also positioning itself within the intellectual property landscape of psychedelic medicine. EPIK said it is working with life sciences intellectual property firm Casimir Jones on patent strategy and development support as it advances its formulations toward clinical testing and potential FDA approval.

David Casimir, founding partner at Casimir Jones, said: “EPIK’s approach stands out for its rigor and originality, and we believe the Company is building a meaningful and defensible IP position with the potential to shape the future of mental health and addiction treatment.”

The company said it is assembling its leadership team to support its clinical development plans, with further executive appointments and pipeline updates expected in the coming months.

As investment and regulatory support for psychedelic medicine continue to grow, newly launched companies such as EPIK are seeking to establish differentiated approaches in an increasingly competitive field, particularly in ketamine-based therapies where clinical and commercial activity has accelerated in recent years.