FDA Events for Virios Therapeutics (VIRI)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Virios Therapeutics (VIRI).
Over the past two years, Virios Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
IMC-2. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
IMC-2 - FDA Regulatory Timeline and Events
IMC-2 is a drug developed by Virios Therapeutics for the following indication: Long-COVID.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IMC-2
- Announced Date:
- July 23, 2024
- Indication:
- Long-COVID
Announcement
Virios Therapeutics announced that the Bateman Horne Center ("BHC") has completed enrollment in its investigator-initiated, proof of concept LC study.,
AI Summary
Virios Therapeutics announced that the Bateman Horne Center has completed enrollment in its investigator-initiated, proof-of-concept study for Long-COVID (LC). This study is a randomized, double-blind, placebo-controlled trial that tests a combination of valacyclovir and celecoxib (IMC-2) to treat LC symptoms such as fatigue, pain, and orthostatic symptoms. The study follows previous positive findings where patients experienced improvements compared to a control group. Virios projects that the top line data from the study will be available in October 2024. This research aims to understand if targeting activated herpes viruses, which may worsen LC symptoms, can help millions of people suffering from LC. The study is significant because there is currently no FDA-approved treatment for LC symptoms, and a successful outcome could pave the way for a new treatment to relieve ongoing health issues in affected patients.
Read Announcement- Drug:
- IMC-2
- Announced Date:
- July 23, 2024
- Estimated Event Date Range:
- October 1, 2024 - October 31, 2024
- Target Action Date:
- October 01, 2024
- Indication:
- Long-COVID
Announcement
Virios Therapeutics, announced that Top line data from this study are projected to be released in October 2024.
AI Summary
Virios Therapeutics, a development-stage biotechnology company, announced that the top line data from its investigator-initiated proof-of-concept study for Long-COVID are projected to be released in October 2024. This randomized, double-blind, placebo-controlled study evaluates the combination of valacyclovir and celecoxib, which may help reduce fatigue and other troublesome symptoms in Long-COVID patients. The study builds on earlier research suggesting that reactivation of dormant herpes viruses, such as Epstein-Barr virus, might contribute to chronic symptoms like fatigue and cognitive issues among affected patients. By investigating this antiviral strategy, Virios Therapeutics is aiming to address a significant unmet need, as there are currently no FDA-approved treatments for Long-COVID. The upcoming data release in October 2024 is highly anticipated and could provide valuable insights into the potential of antiviral therapy to offer new relief for millions struggling with Long-COVID.
Read Announcement
Virios Therapeutics FDA Events - Frequently Asked Questions
As of now, Virios Therapeutics (VIRI) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Virios Therapeutics (VIRI) has reported FDA regulatory activity for IMC-2.
The most recent FDA-related event for Virios Therapeutics occurred on July 23, 2024, involving IMC-2. The update was categorized as "Enrollment Update," with the company reporting: "Virios Therapeutics announced that the Bateman Horne Center ("BHC") has completed enrollment in its investigator-initiated, proof of concept LC study.,"
Currently, Virios Therapeutics has one therapy (IMC-2) targeting the following condition: Long-COVID.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:VIRI) was last updated on 7/12/2025 by MarketBeat.com Staff
