Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Neurosteroid enantiomer · 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...
Neurosteroid enantiomer, also known as ONP-002, is an investigational small molecule being developed for the treatment of mild traumatic brain injury and concussion. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Neurosteroid enantiomer is a neurosteroid enantiomer, a class of compounds that modulate brain function. As a neurosteroid, it is designed to act on the central nervous system, though the specific molecular target has not been disclosed in available information.
Neurosteroid enantiomer is being developed by Oragenics Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol OGEN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with mild traumatic brain injury.
Neurosteroid enantiomer is currently in Phase 2 clinical development. It is being studied in a Phase 2a pilot trial, which is a randomized, double-blind, placebo-controlled study designed to evaluate the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics in adults with mild traumatic brain injury.
Neurosteroid enantiomer is being evaluated in one clinical trial, identified as NCT06870240. This is a Phase 2a pilot study in Australia that is not yet recruiting participants. The trial aims to enroll 40 adults with mild traumatic brain injury and will assess the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics.
Yes, Neurosteroid enantiomer is also known as ONP-002. The drug is being developed by Oragenics Inc. under the name ONP-002, and it is currently in Phase 2 clinical trials for the treatment of mild traumatic brain injury and concussion.