Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RG7314 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching to RG7314 in each stage (Stage I, II, III and IV) for 12 weeks. |
| RG7314 | EXPERIMENTAL | Participants will receive RG7314 orally at a dose of 1.5 mg/day in Stage I, 4 mg/day in Stage II, 10 mg/day in Stage III and 1.5 mg/day or 10 mg/day in Stage IV for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo will be administered in different stages of the study for 12 weeks. |
| RG7314 | DRUG | RG7314 will be administered orally at a dose of 1.5 mg/day in Stage I, 4 mg/day in Stage II, 10 mg/day in Stage III and 1.5 mg/day or 10 mg/day in Stage IV for 12 weeks. |
Inclusion Criteria: * Participants meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for ASD and Tenth Revision of the International Classification of Diseases and Related Health Problems (ICD-10) criteria for Autism diagnosis * SRS-2 (T-score) greater than ...
RG7314 is an investigational small molecule being studied for the treatment of Autism Spectrum Disorder (ASD). It is being developed by Roche Holding AG (RHHBY) and is currently in Phase 2 clinical development. The drug is intended for adult male patients with ASD.
The specific molecular target of RG7314 has not been disclosed in available information. The drug is a small molecule being investigated for its efficacy and safety in individuals with Autism Spectrum Disorder, but its mechanism of action is not publicly detailed.
RG7314 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The company is conducting clinical trials to evaluate the drug's potential in treating Autism Spectrum Disorder.
RG7314 is currently in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug is still investigational and has not been approved by regulatory authorities for any use.
RG7314 has been studied in one completed clinical trial with the identifier NCT01793441. This Phase 2 study, titled 'A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders (ASD),' enrolled 223 male participants aged 18 years and older in the United States.
RG7314 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Autism Spectrum Disorder. The completed Phase 2 trial (NCT01793441) was designed to assess efficacy and safety, but the drug has not yet received regulatory approval.