Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Noribogaine · 1 trial · 1 indication
Determination of maximum plasma concentration of noribogaine
Determination of maximum plasma concentration of noribogaine
Determination of the time to reach the maximum plasma concentration of noribogaine
Determination of the time to reach the maximum plasma concentration of noribogaine
Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine
Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine
Determination of the area under the plasma concentration-time curve from time 0 to infinity of noribogaine
Determination of elimination half-life (t1/2) of noribogaine
Determination of elimination half-life (t1/2) of noribogaine
| Arm | Type | Description |
|---|---|---|
| Noribogaine 20mg | EXPERIMENTAL | 1 x Noribogaine 10mg capsule twice daily |
| Noribogaine 40mg | EXPERIMENTAL | 1 x Noribogaine 20mg capsule twice daily |
| Noribogaine 60mg | EXPERIMENTAL | 1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily |
| Noribogaine 80mg | EXPERIMENTAL | 2 x Noribogaine 20mg capsule twice daily |
| Name | Type | Description |
|---|---|---|
| Noribogaine | DRUG | Noribogaine capsules |
Inclusion Criteria: * Ability to provide written, personally signed, and dated informed consent. * Healthy male and female participants between the ages of 18 to 45 inclusive. * BMI 18 - 30 kg/m2. * Non- or ex-smoker. * Normal ECG findings i.e. QTcF interval ≤ 450 ms and normal morphology that woul...
Noribogaine is an investigational small molecule developed by AtaiBeckley Inc. (ticker ATAI). It is being studied in clinical trials as a potential therapeutic candidate. The specific medical conditions it is intended to treat have not been publicly disclosed, and it remains in early-stage clinical development.
Noribogaine is being developed by AtaiBeckley Inc., which trades under the ticker symbol ATAI. The company is the sponsor of the clinical program evaluating this small molecule candidate. No other development partners are identified in the public record for this asset.
Noribogaine is in Phase 1 clinical development. It has completed one Phase 1 trial and has no active trials at this time. It is an investigational drug and has not been approved by the FDA or any other regulatory authority for commercial use.
Noribogaine has been evaluated in one completed Phase 1 trial, NCT06480981, titled Multiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers. The trial enrolled 55 healthy adult volunteers in the United Kingdom and used a randomized, double-blind, controlled design to assess pharmacokinetics and pharmacodynamics.
Noribogaine is not FDA approved. It is an investigational small molecule in Phase 1 clinical development, and the only completed study to date is a Phase 1 pharmacokinetic and pharmacodynamic trial in healthy volunteers. No regulatory approval has been granted for any indication.