RE104 / Reunion Neurosci - LARVOL DELTA

RE104 Safety and Efficacy Study in Postpartum Depression (clinicaltrials.gov) - P2 | N=84 | Completed | Sponsor: Reunion Neuroscience Inc | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous RE104: A Double-Blind, Randomized, Single Ascending Dose Placebo-Controlled Study. (PubMed, J Clin Psychopharmacol) - "Single SC doses of RE104 resulted in a psychoactive experience and a favorable safety profile similar to psilocybin but with a shorter duration of psychoactive effect (3 to 4 hours). Results suggest a potential for therapeutic effect, warranting further study."

Journal • PK/PD data • Anesthesia

RE104 Safety and Efficacy Study in Postpartum Depression (clinicaltrials.gov) - P2 | N=72 | Active, not recruiting | Sponsor: Reunion Neuroscience Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry

Reunion Neuroscience Announces Participation in Premiere Maternal Mental Health Event (GlobeNewswire) - "Reunion’s President and Chief Executive Officer, Greg Mayes, will present on RE104 and the RECONNECT Phase 2 clinical trial as part of a panel discussion, 'New Treatment Options,' at the 2025 Maternal Mental Health FORUM taking place virtually March 18-19, 2025."

P2 data • Postpartum Depression

RE104 Safety and Efficacy Study in Postpartum Depression (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: Reunion Neuroscience Inc | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry

RE104: Synthesis and Activity of a Novel Serotonergic Psychedelic Prodrug of 4-Hydroxy-N,N-diisopropyltryptamine. (PubMed, ACS Chem Neurosci) - "In a forced swim test, a single dose of RE104 (1 mg/kg) significantly reduced mean immobility time at 1 week compared with vehicle (P < 0.001), confirming translational antidepressant potential. Taken together, these data with RE104 show that the glutarate ester can act as an efficient prodrug strategy for 4-HO-DiPT, a unique short-duration psychedelic with potential in depressive disorders."

Clinical • Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

Reunion Neuroscience Inc. Announces Upcoming Presentations at the Anxiety and Depression Association of America (ADAA) 2024 Conference (GlobeNewswire) - "Reunion Neuroscience Inc...announced that the clinical dataset from the Company’s Phase 1 study of its lead asset, RE104, will be presented in both a podium and poster at the Anxiety and Depression Association of America (ADAA) Conference taking place April 11-14, 2024, in Boston, MA. The presentations will highlight the Phase 1 findings on RE104, a proprietary, potential best-in-class, patented prodrug of 4-OH-DiPT, a psilocybin-like compound."

P1 data • CNS Disorders • Depression • Postpartum Depression

RE104 Safety and Efficacy Study in Postpartum Depression (clinicaltrials.gov) - P2 | N=72 | Not yet recruiting | Sponsor: Reunion Neuroscience Inc

New P2 trial • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry

Field Trip Health Ltd. to Pursue Treatment Resistant Depression and Postpartum Depression as Indications for FT-104 (Yahoo Finance) - "Field Trip Health Ltd...announced today the lead indications for FT-104...will be Treatment Resistant Depression (TRD) and Postpartum Depression (PPD)....Preclinical activities that will enable commencement of Phase I clinical trials in calendar Q1 2022 are ongoing and are expected to continue through to the end of calendar 2021. After completion of the Phase 1 and opening of a US-IND, Field Trip intends to initiate Phase IIA studies in TRD, following which Phase II studies in TRD and PPD are expected to be conducted substantially in parallel."

New indication • New P1 trial • Preclinical • CNS Disorders • Depression • Postpartum Depression

Ketamine Clinic Company Field Trip Health Debuts On Nasdaq (Forbes) - "Field Trip’s big plan is to bring its own hallucinogenic compound to market....The compound, which the company has named FT-104 for the time being, is similar to psilocybin but packs a trip that’s only two to three hours long, or half the time an experience with magic mushrooms lasts. The company plans to launch phase 1 clinical trials early next year."

New P1 trial • CNS Disorders • Depression • Major Depressive Disorder

"$FTRPF Field Trip Health Ltd. Announces Completion of DMPK Studies, Engineering Batch for FT-104, Its Novel Psychedelic Compound https://t.co/oSSMooAuaN" (@otcdynamics)

Field Trip Health Ltd. Provides Update on FT-104, Its Next Generation Psychedelic Molecule in Development (PRNewswire) - "Field Trip Health Ltd....today provided an update on its in-vivo and in-vitro studies on FT-104, its lead drug candidate....Field Trip announced that FT-104 is a potent psychedelic molecule with rapid onset and a short duration....These experiments demonstrate that: (i) FT-104 is a near equipotent 5HT2A receptor agonist to psilocybin that can be delivered with high bioavailability; and (ii) FT-104 will likely produce a reliably short-duration of psychedelic experience in the range of two to four hours, which is approximately half the duration of psilocybin."

Preclinical • CNS Disorders • Depression

Field Trip Psychedelics Inc. Announces Successful GLP Synthesis, Results From Initial Preclinical Testing for FT-104, its First Molecule in Development (PRNewswire) - "Field Trip Psychedelics Inc....has successfully completed GLP (Good Laboratory Practices) synthesis of its first molecule in development, FT-104. Preliminary assessment from in-vitro and in-vivo tests confirms the activity of FT-104 at the 5HT2A receptor, which is believed to be responsible for psychedelic experiences....Field Trip has filed a provisional patent with the USPTO with claims that include FT-104 structures and uses....Ongoing pre-clinical and CMC (chemistry, manufacturing and control) efforts to support Phase 1 are expected to be completed by Q3 2021."

New molecule • Patent • Preclinical • CNS Disorders • Depression • General Anxiety Disorder • Post-traumatic Stress Disorder