Drug Profile

PRV 002

Alternative Names: ONP-002; PRV-002

Latest Information Update: 22 Aug 2025

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At a glance

Originator Prevacus
Developer Oragenics Inc
Class Anti-inflammatories; Neuroprotectants; Small molecules; Steroids
Mechanism of Action Antioxidants

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity Yes

Highest Development Phases

Phase I Traumatic brain injuries

Most Recent Events

11 Aug 2025 Oragenics plans to submit IND application to US FDA for Phase IIb clinical trial in Traumatic brain injuries in Q3-Q4 of 2025
11 Aug 2025 Oragenics secures Human Research Ethics Committee (HREC) approval in Australia before August 2025
11 Aug 2025 Oragenics plans a phase IIa trial for Traumatic brain injuries (In infants, In children) in Australia and New Zealand (Intranasal) in the third quarter of 2025 (NCT06870240)

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