Growing Research in Psychedelics: Insights From Dan Karlin, MD

Dan Karlin, MD, chief medical officer of Definium Therapeutics, discussed emerging evidence around pharmaceutical lysergic acid diethylamide (LSD) as a potential novel treatment paradigm for generalized anxiety disorder (GAD) and major depressive disorder (MDD). He described the company’s “Rerouting Minds” campaign as an effort to highlight the substantial disease burden and persistent unmet needs associated with these conditions under current treatment paradigms.

Karlin noted that psychiatry had entered a transitional period marked by the growth of interventional approaches, including esketamine and transcranial magnetic stimulation, signaling openness to new models of care. He emphasized that conventional pharmacotherapies for GAD and MDD were largely symptom-suppressive, required daily administration, and were associated with adverse effect burdens that often limited long-term adherence and effectiveness.

He reported that phase 2 clinical studies of pharmaceutical LSD demonstrated prolonged clinical benefits following limited dosing sessions, supporting advancement into phase 3 trials intended to form the basis of a future US Food and Drug Administration approval application. This intermittent, session-based exposure represented a fundamentally different pharmacotherapeutic paradigm, in which sustained symptom improvement could occur without continuous drug administration.

Karlin discussed proposed mechanistic models, emphasizing neuroplasticity as a unifying framework. He explained that lasting clinical effects observed after drug clearance implied enduring changes in brain function, supported by both clinical outcomes and preclinical neurobiological data, as well as complementary psychological models of change.

He acknowledged the complex historical and cultural perceptions surrounding LSD, ranging from concerns about harm to strong optimism regarding therapeutic potential. He described ongoing efforts to understand and engage clinicians, researchers, and patients across this spectrum by emphasizing rigorous evidence generation.

References

1. Definium Therapeutics introduces Rerouting Minds, an educational campaign exploring the potential of pharmaceutical lysergide (LSD) in mental health care. Press release. January 20, 2026. Accessed January 30, 2026. https://ir.definiumtx.com/news-events/press-releases/detail/209/definium-therapeutics-introduces-rerouting-minds-an-educational-campaign-exploring-the-potential-of-pharmaceutical-lysergide-lsd-in-mental-health-care

2. Rerouting Minds. Definium Therapeutics. 2026. Accessed January 30, 2026. https://definiumtx.com/rerouting-minds/