Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DMX-1002 · 1 trial · 1 indication
The SOWS-Gossop is a 10-item questionnaire to evaluate opioid withdrawal symptom severity. Each item is scored on a 4-point scale. Higher scores indicate greater severity (total score range 0-40).
| Arm | Type | Description |
|---|---|---|
| Single dose IMP (DMX-1002) | EXPERIMENTAL | Stage 1 (single blind, placebo controlled): initial dose of placebo, followed by treatment at one of 4 ascending dose levels of IMP (3, 6, 9 or 12 mg/kg) Stage 2 (blinded): MTD/TTD established in Stage 1 vs placebo (proof of concept) |
| Matching Placebo | PLACEBO_COMPARATOR | Placebo using capsules identical to the IMP (DMX-1002) |
| Name | Type | Description |
|---|---|---|
| DMX-1002 | DRUG | Investigation of the safety, tolerability and pharmacokinetics (PK) in healthy volunteers (Stage 1 - single blind), and the efficacy, safety, tolerability and PK in opioid-dependent patients (Stage 2 - double blind) |
| Placebo | DRUG | Matching placebo to the IMP (DMX-1002) |
Important Inclusion Criteria for both Stages 1 and 2: * Males and females between 18 years and 55 years of age. * For Stage 1, healthy volunteers; recreational opioid use is allowed but not required for inclusion in the study. * For Stage 2, opioid-dependent subjects (DSM-IV) seeking medically supe...
DMX-1002 is an investigational small molecule being developed for the treatment of Opiate Withdrawal Syndrome. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
DMX-1002 is being developed by AtaiBeckley Inc., a biopharmaceutical company focused on psychiatry. The company's stock is traded under the ticker symbol ATAI.
DMX-1002 is in Phase 1 clinical development. One Phase 1 trial has been completed, and the drug remains investigational, meaning it has not been approved for any use.
DMX-1002 has one completed Phase 1 trial, identified as NCT05029401, titled "A Study of Oral Ibogaine in Opioid Withdrawal." This trial enrolled 116 participants and was conducted in the United Kingdom.
DMX-1002 is an oral formulation of ibogaine, a naturally occurring psychoactive substance. The completed clinical trial specifically studied oral ibogaine for opioid withdrawal, indicating that DMX-1002 refers to this oral form.