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Brilaroxazine

Phase 3

Schizophrenia | Small molecule | Psychiatry |Reviva Pharmaceuticals Holdings, Inc.|Last Updated: Dec 18, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment690

FDA Designations

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Clinical trial landscape

Brilaroxazine · 1 trial · 1 indication

Phase 3 1
NCT05184335Safety and Efficacy of Brilaroxazine (RP5063) in SchizophreniaSchizophrenia
RECRUITING690 Analytics
PHASE3RECRUITING
Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia
SchizophreniaUnlock trial analytics

Study Design & Arms

Interventions

NameTypeDescription
BrilaroxazineDRUGRP5063, a new chemical entity (NCE), is a novel multimodal neuromodulator intended for treating schizophrenia and comorbid conditions. This drug is an investigational drug and has not been approved for treatment or marketing. RP5063 belongs to a class of third generation antipsychotics called Dopamine-Serotonin System Stabilizers. The chemical name of the RP5063 active pharmaceutical ingredient (API) is 6-(4-(4-(2,3-dichlorophenyl)-piperazin-1-yl)-butoxy)-2H-benzo\[b\]\[1,4\]oxazin-3(4H)-one hydrochloride.
PlaceboOTHERRP5063 matching Placebo
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Frequently asked questions about Brilaroxazine

What is Brilaroxazine used for?

Brilaroxazine is an investigational small molecule being developed for the treatment of schizophrenia. It is currently in Phase 3 clinical development and has not been approved by the FDA. The drug is being studied in patients with schizophrenia to evaluate its safety and efficacy.

Who makes Brilaroxazine?

Brilaroxazine is being developed by Reviva Pharmaceuticals Holdings, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol RVPH. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with schizophrenia.

What phase is Brilaroxazine in?

Brilaroxazine is currently in Phase 3 clinical development for the treatment of schizophrenia. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is actively recruiting participants to assess the drug's safety and efficacy.

What clinical trials is Brilaroxazine in?

Brilaroxazine is being evaluated in a Phase 3 clinical trial with the identifier NCT05184335, titled 'Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia.' This trial is currently recruiting and aims to enroll approximately 690 participants with schizophrenia.

Is Brilaroxazine the same as RP5063?

Yes, Brilaroxazine is also known as RP5063. The ongoing Phase 3 clinical trial for schizophrenia, identified as NCT05184335, explicitly refers to the drug as Brilaroxazine (RP5063), confirming that these names refer to the same investigational compound.