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Also known as Neurosteroid enantiomer
ONP-002 · 1 trial · 1 indication
Neurological questionnaires for patient symptoms including Rivermead
| Arm | Type | Description |
|---|---|---|
| 92mg of Hydroxy-propyl beta-cyclodextrin as a spray-dried powder | PLACEBO_COMPARATOR | The placebo is 92mg of Hydroxy-propyl beta-cyclodextrin as a spray-dried powder |
| ONP-002 treatment | ACTIVE_COMPARATOR | ONP-002 is 8mg API and 92 Hydroxy-propyl beta-cyclodextrin as a spray-dried powder |
| Name | Type | Description |
|---|---|---|
| Neurosteroid enantiomer | DRUG | A non-natural synthetic neurosteroid enantiomer considered a new chemical entity |
7.2.1 Inclusion Criteria Participants with suspected concussion presenting to the emergency department will be included in the study only if they satisfy all the following criteria: 1. Participant or legal representative is willing and capable of giving written informed consent before any study-re...
ONP-002 is an investigational small molecule developed by Oragenics Inc. (ticker: OGEN) for neurology. It is being studied as a treatment for mild traumatic brain injury and concussion. It is a Phase 2 clinical-stage candidate and has not been approved for any use.
ONP-002 is being developed to treat mild traumatic brain injury and concussion. The Phase 2a study is designed to evaluate its safety, tolerability, pharmacokinetics and pharmacodynamics in adults with mild traumatic brain injury. It is investigational and has not been approved for treating these conditions.
ONP-002 is developed by Oragenics Inc., which trades under the ticker OGEN. Oragenics is the sponsor of the clinical program for ONP-002 in mild traumatic brain injury and concussion.
ONP-002 is in Phase 2 development. The ongoing study is a Phase 2a pilot trial in adults with mild traumatic brain injury. ONP-002 is investigational and has not been approved by the FDA or any other regulator.
ONP-002 is being studied in one clinical trial, NCT06870240, titled a randomised, double-blind, placebo-controlled Phase 2a pilot study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ONP-002 in adults with mild traumatic brain injury. The trial plans to enroll 40 participants in Australia and is not yet recruiting.
Yes. ONP-002 is also known as a neurosteroid enantiomer. Searches for that alternative name refer to the same Oragenics Inc. (OGEN) investigational small molecule being studied in Phase 2 for mild traumatic brain injury and concussion.