Luvesilocin; 4-OH-DiPT prodrug; 5-((3-(2-(diisopropylamino)ethyl)-1H-indol-4-yl)oxy)-5-oxopentanoic acid hydrochloride · Evidence-based safety and harm-reduction overview.
| Also known as | Luvesilocin; 4-OH-DiPT prodrug; 5-((3-(2-(diisopropylamino)ethyl)-1H-indol-4-yl)oxy)-5-oxopentanoic acid hydrochloride |
| Category | Research Chemical |
| Developer | Reunion Neuroscience, Inc. (Toronto, Ontario) |
| Parent active compound | 4-hydroxy-N,N-diisopropyltryptamine (4-OH-DiPT) |
| Primary receptor target | 5-HT2A agonist (Ki approximately 120 nM) |
| FDA designation | Breakthrough Therapy Designation granted February 23, 2026 for postpartum depression |
| Clinical stage | Phase 2 complete (PPD); Phase 3 pivotal planned 2026; Phase 2 enrolling for adjustment disorder and GAD |
| Active metabolite half-life | 2.72 to 4.12 hours (dose range 5-40 mg); substantially shorter duration than psilocybin |
| US legal status | Schedule I controlled substance (DEA) in the United States. Not approved for marketing or clinical use. An active Investigational New Drug (IND) application is in place with the FDA. RE104 received FDA Breakthrough Therapy Designation in February 2026 for postpartum depression, meaning it may undergo expedited development and review, but it remains an unapproved investigational drug. Clinical use is restricted to enrolled trial participants at authorized sites. |
RE104 (pharmaceutical designation: luvesilocin) is a proprietary subcutaneous prodrug of 4-hydroxy-N,N-diisopropyltryptamine (4-OH-DiPT), a serotonergic psychedelic structurally related to psilocin. It was developed by Reunion Neuroscience, Inc. (Toronto, Ontario) as a psychedelic-assisted therapy candidate designed to deliver a shorter and more clinically controllable psychoactive experience than psilocybin. The prodrug formulation is intended for subcutaneous injection and incorporates a glutarate ester moiety that undergoes rapid hydrolysis in plasma to release the active parent compound.
RE104 is a prodrug: a glutarate ester linked to 4-OH-DiPT is cleaved in plasma by albumin-mediated esterases, releasing the active tryptamine within approximately 5 minutes of subcutaneous administration. The active metabolite, 4-OH-DiPT, acts as a 5-HT2A receptor agonist (reported Ki of approximately 120 nM at the 5-HT2A receptor), the same primary target as psilocin. The psychoactive duration of the parent compound is reported to be substantially shorter than psilocybin -- approximately 2 to 4 hours vs. 6 to 8 hours for psilocybin -- which is the primary design rationale for the prodrug approach in a supervised clinical setting. Pharmacokinetics are dose-proportional across the 5 to 40 mg studied range, with an active metabolite half-life of approximately 2.72 to 4.12 hours.
4-OH-DiPT was first documented in the psychedelic literature as an analog of psilocin, but it did not gain significant clinical or pharmacological attention until the emergence of psychedelic-assisted therapy research in the 2010s and 2020s. Reunion Neuroscience (formerly Reunion Neuroscience Inc.) synthesized and patented RE104 as a subcutaneous prodrug formulation, with the glutarate ester modification intended to enable consistent pharmacokinetic delivery while reducing the session duration burden relative to psilocybin. An IND was granted, and Reunion initiated Phase 1/2 development in the early 2020s. In February 2026, the FDA granted Breakthrough Therapy Designation for postpartum depression based on Phase 2 RECONNECT trial data, which the company presented publicly in January 2026.
As of mid-2026, RE104 is in active Phase 2 and early Phase 3 planning stages. The RECONNECT trial (Phase 2, N=84 female patients with moderate-to-severe postpartum depression, 38 US sites) met its primary endpoint: the 30 mg dose reduced MADRS scores by 23.0 points versus 17.2 points in the active control (1.5 mg dose), a statistically significant difference of 5.80 points (p=0.0094). Response rates at Day 7 (defined as 50% or greater improvement) were 77.1% in the 30 mg arm versus 61.6% in the active control. Reductions were reported as clinically meaningful through the 28-day follow-up period. These are Phase 2 results; Phase 3 pivotal trials were announced as planned for 2026. Separate Phase 2 trials in adjustment disorder (REKINDLE, NCT07002034) and generalized anxiety disorder (RECLAIM) are enrolling or planned. Preclinical evidence includes rat forced-swim test data showing antidepressant-like effects at 1 mg/kg subcutaneous (reduced immobility, p less than 0.001) sustained through 28 days. No peer-reviewed Phase 2 efficacy publication has been independently located at the time of this entry; available data derives from company-reported presentations and regulatory announcements.
In the RECONNECT Phase 2 trial, doses studied ranged from 5 mg to 40 mg subcutaneous, with 30 mg identified as the primary efficacious dose. The active metabolite half-life was measured at 2.72 to 4.12 hours across the dose range. These figures are reported from clinical trial literature for informational and reference purposes only. They do not constitute dosing guidance. RE104 is an unapproved Schedule I investigational drug and cannot be legally self-administered. Any clinical use is restricted to enrolled trial participants under direct medical supervision. Consult a licensed clinician or refer to active trial listings for eligibility information.
This is general research/context information, not medical advice or a recommended protocol.
No stacking data exist for RE104. The compound is administered as a single-session therapeutic agent in supervised clinical contexts, not as part of a self-directed supplement stack. Combining serotonergic psychedelics with other psychoactive or serotonergic substances carries documented risks. No combination protocols should be inferred from the absence of stacking literature.
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Get tested with Ulta Lab Tests →RE104's active metabolite (4-OH-DiPT) produces a psychedelic experience with a reported duration of 2 to 4 hours, compared to 6 to 8 hours for psilocybin. It is also administered subcutaneously as a prodrug rather than orally, allowing more predictable pharmacokinetic onset. These features are the primary clinical rationale -- shorter session length and consistent delivery -- rather than a fundamentally different mechanism, since both act as 5-HT2A agonists.
Trials are actively enrolling in specific indications. The RECONNECT trial (postpartum depression, NCT06342310) has completed Phase 2 enrollment. The REKINDLE trial (adjustment disorder, NCT07002034) and a planned RECLAIM trial (generalized anxiety disorder) are enrolling or planned as of this writing. Eligibility criteria apply. Visit ClinicalTrials.gov and search by NCT number or by 'luvesilocin' or 'RE104' for current status and site information.
This entry does not provide dosing recommendations. RE104 is a Schedule I investigational drug available only in supervised clinical trial settings. The 30 mg dose was the primary efficacious dose in the Phase 2 RECONNECT trial, but this is trial-protocol information, not a clinician-independent protocol. Consult a licensed clinician or refer to the official trial documentation for any clinical questions.
No. As of mid-2026, RE104 is not FDA-approved for any indication. It holds FDA Breakthrough Therapy Designation for postpartum depression (granted February 2026), which is a designation intended to expedite development and review of promising investigational drugs -- not an approval. It remains a Schedule I controlled substance under DEA classification and is restricted to investigational use under an active IND.
The Phase 2 RECONNECT trial in postpartum depression met its primary endpoint with statistical significance (p=0.0094), a 30 mg vs. 1.5 mg active control design, N=84, with response rates of 77.1% vs. 61.6% at Day 7. These are Phase 2 results reported via company announcement and regulatory filings; full peer-reviewed publication has not been independently confirmed at the time of this entry. Phase 3 pivotal data will be required before any determination of efficacy sufficient for approval can be made.
In Phase 2 data, the most common adverse events were nausea (27.8%), sinus tachycardia (25.0%), restlessness (19.4%), and headache (16.6%). Acute agitation occurred at the highest studied doses (35-40 mg) and was managed with midazolam. Mild injection site reactions were noted in 19.4% of participants. No serious adverse events or deaths were reported across all dose levels. No increased suicidality signal was detected on the Columbia-Suicide Severity Rating Scale. These findings are from a single Phase 2 trial; larger and longer-term data are not yet available.
Medical & legal disclaimer. This site is for informational and harm-reduction purposes only. It is not medical advice and is not a substitute for a licensed healthcare professional. The compounds discussed are largely not approved by the FDA for human use and many are sold strictly as research chemicals 'not for human consumption.' Nothing here is an endorsement to purchase, possess, or use any substance. Laws vary by jurisdiction. Always consult a qualified physician and follow the law where you live.
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