Reunion is evaluating luvesilocin in the RECLAIM Phase 2 clinical trial as a potential treatment for generalized anxiety disorder (GAD). RECLAIM is designed to evaluate the safety and efficacy of both single and repeat-dosing regimens.

GAD is a mental health condition characterized by persistent, excessive and uncontrollable worry and anxiety, often about everyday situations, which cause distress and can interfere with daily functioning. GAD can manifest in a variety of physical, as well as psychological symptoms, including sleep disturbance, gastrointestinal issues, shortness of breath, chest discomfort, headaches and pain.

It is estimated that GAD affects 6.8 million adults in the United States annually. If left untreated, GAD can increase the likelihood of developing secondary disorders, including major depressive disorder (MDD) and other anxiety disorders, and increase the risk of suicide.

Current treatment options for GAD include medications like selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs), as well as psychosocial treatments such as Cognitive Behavioral Therapy (CBT). Benzodiazepines and antipsychotics are also commonly prescribed. As many as half the patients treated for GAD fail to respond to initial treatment, and only a minority achieve remission.

There remains a broad unmet need for safe and effective, fast-acting therapies for GAD, as current treatment options have significant limitations, which reduce their effectiveness and patient adherence.

Reunion is evaluating luvesilocin in the REKINDLE Phase 2 clinical trial as a potential treatment for adjustment disorder (AjD) in cancer and other medical illnesses.

AjD is a mental health condition defined as a disproportionate reaction to a stressful life event or change, which impacts the ability to function and is characterized by depression, anxiety and/or other behavioral and mood disturbances. Serious medical illnesses are known to be a key precipitant of AjD; it is estimated that approximately 500,000 people in the United States are diagnosed with AjD each year following a medical or health-related stressor, including 6-35% of cancer patients. A global survey of psychiatrists by the World Health Organization revealed that adjustment disorders play an enormous role in healthcare utilization; ranked 7th among 44 psychiatric categories they managed at least once a week in their practice.

Depressive and anxiety symptoms in medically ill patients with AjD can be associated with poorer medical outcomes, treatment compliance and quality of life as well as increased health care utilization. Current treatments for AjD are not consistently effective, and there are no therapies presently approved by the FDA for its treatment.

AjD in cancer patients is one of the initial indications studied by researchers on psychedelic treatment and several clinical trials indicate the potential for rapid and meaningful improvements in depression and anxiety with durable changes in attitude and behavior.

Reunion believes there is a significant unmet need for a rapid acting solution for these medically ill patients to positively impact treatment compliance, hospitalization time and improved quality of life.

Reunion plans to evaluate luvesilocin in a Phase 3 clinical trial as a potential treatment for major depressive disorder (MDD).

MDD is a highly prevalent and disabling mental health condition characterized by persistent low mood and a loss of interest in activities. MDD is diagnosed when five or more specific symptoms, including profound sadness, fatigue, or changes in sleep and appetite, are experienced daily for at least two weeks. MDD is estimated to affect approximately 22.7 million adults in the United States, or 8.4% of the adult population. As many as 30-50 percent of patients treated for MDD fail to achieve remission after an adequate trial of a first line therapy, creating a significant unmet need for new treatment options.

As part of this Phase 3 program, Reunion will evaluate luvesilocin in women with postpartum depression (PPD), a subset of MDD. In 2025, Reunion announced positive topline results from the RECONNECT Phase 2 clinical trial in PPD, demonstrating a statistically significant and clinically meaningful reduction from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS), as well as a robust safety tolerability profile. Additionally, data from RECONNECT suggest that patients reach discharge readiness rapidly, within four hours of treatment, consistent with luvesilocin’s differentiated pharmacology.