Reunion Neuroscience announced program updates and anticipated milestones for 2026, focusing on its lead compound RE104, a patented prodrug of 4-OH-DiPT administered via a single subcutaneous injection. RE104 is designed to deliver a shorter acute psychoactive experience compared to longer-duration psychedelics such as psilocybin or LSD.
For postpartum depression (PPD), the most common complication of pregnancy and childbirth affecting 12.5 percent of new mothers within the first year, Reunion completed an End-of-Phase 2 meeting with the FDA in December 2025. The company’s Phase 2 RECONNECT trial met its primary endpoint, demonstrating clinically meaningful reductions in depression and anxiety scores through Day 28 with a favorable safety and tolerability profile. Based on FDA feedback, a single successful Phase 3 trial would complete the pivotal studies needed to support registration of RE104 for PPD. The FDA also approved enrollment of women who are actively breastfeeding in the planned Phase 3 trial, allowing them to return to breastfeeding the same day after treatment. Reunion expects to initiate the Phase 3 trial in 2026.
Reunion is also enrolling patients in the REKINDLE Phase 2 trial evaluating RE104 in adjustment disorder (AjD), defined as a disproportionate reaction to a stressful life event. AjD is among the most frequent diagnoses managed by psychiatrists globally, with cancer and other medical illnesses as known precipitants. The company expects to complete patient enrollment by year-end and report topline clinical data in the first quarter of 2027.
For generalized anxiety disorder (GAD), a chronic mental health condition where a majority of patients fail to achieve remission with currently available therapies, Reunion plans to initiate the RECLAIM Phase 2 trial in the first quarter of 2026. The company also announced advancement of RE245, a non-psychedelic serotonergic neuroplastogen designed to deliver 5HT2A-mediated neuroplasticity without hallucinations or cardiotoxicity. Reunion plans to file an investigational new drug application for RE245 in 2026 and commence a Phase 1 clinical trial in 2027.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.globenewswire.com/news-release/2026/01/12/3216760/0/en/Reunion-Neuroscience-Announces-Program-Updates-and-Highlights-Anticipated-2026-Milestones.html