Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPL026 · 3 trials · 1 indication
Values of potential clinical importance
Adverse Events (AEs)
pulse rate will be measured in bpm
arterial blood pressure
tympanic temperature
QTcX intervals
Full physical exam screening and a brief symptom guided exam at Day -1 and Day 1
The Beck Suicidal Ideation scale to monitor suicidal ideation
Adverse events (AEs)
Values of potential clinical importance
Heart rate
Blood pressure
Temperature
QTcX intervals
Columbia-Suicide Severity Rating Scale
Safety and tolerability measured by lab biochemistry, adverse events and intensity rating scale to measure tolerability of the psychedelic experience
Montgomery-Åsberg Depression Rating Scale (MADRS) score (where 7 - 19 is mild depression, 20 - 34 is moderate depression, and \>34 is severe depression) change from baseline at 2 weeks after the first dose (± 2 days)
| Arm | Type | Description |
|---|---|---|
| Psychedelic Experienced IM then IV crossover | EXPERIMENTAL | Participants will be dosed with IM SPL026 then IV SPL026 2-3 weeks later. |
| Psychedelic Naive IM dosing only | EXPERIMENTAL | Participants will be dosed with IM SPL026 one time. |
| Test Cohort | EXPERIMENTAL | Patients who are currently taking an SSRI that is not effective in fully relieving their depression (prescribed outside of study). Patients will be administered a single dose of SPL026 by intravenous infusion. |
| Control Cohort | EXPERIMENTAL | Patients who are not currently taking any pharmacological treatment for their depression. Patients will be administered a single dose of SPL026 by intravenous infusion. |
| Healthy volunteers (active) | EXPERIMENTAL | SPL026 to be administered by IV injection |
| Healthy volunteers (placebo) | EXPERIMENTAL | SPL026-matched placebo to be administered by IV injection |
| Patients (active) | EXPERIMENTAL | SPL026 to be administered by IV injection |
| Patients (placebo) | EXPERIMENTAL | SPL026-matched placebo to be administered by IV injection |
| Name | Type | Description |
|---|---|---|
| SPL026 IV | DRUG | IV dosing |
| SPL026 IM | DRUG | IM dosing |
| SPL026 | DRUG | Intravenous |
| Placebo | DRUG | SPL026-matched placebo |
Inclusion Criteria: Part A only 1. Healthy psychedelic-experienced female or male participants (psychedelic-experienced is defined as having at least 2 previous experiences, with breakthrough, of serotonergic psychedelic drugs, including but not limited to: DMT, ayahausca, LSD, LSA \[morning glory...
Top 20 of 29 competitors
SPL026 is an investigational small molecule being developed for the treatment of Major Depressive Disorder (MDD). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers and patients with MDD to evaluate its safety and tolerability.
SPL026 is being developed by Cybin Inc., a biopharmaceutical company focused on psychedelic-based therapeutics. Cybin Inc. trades on the stock exchange under the ticker symbol HELP. The company is conducting clinical trials of SPL026 in the United Kingdom.
SPL026 is in Phase 1 clinical development. All three clinical trials for SPL026 have been completed, with a total of 98 participants enrolled. The drug is still investigational and has not received FDA approval. It is being studied for the treatment of Major Depressive Disorder.
SPL026 has been studied in three completed Phase 1 clinical trials. NCT04673383 enrolled 66 healthy subjects and MDD patients, NCT05553691 enrolled 18 MDD patients with or without SSRIs, and NCT05644093 enrolled 14 healthy participants. All trials were conducted in the United Kingdom.
SPL026 is also known as DMT fumarate, as indicated in the clinical trial title NCT04673383. It is a small molecule being investigated for Major Depressive Disorder. The drug is in Phase 1 development and has not been approved for any use.