Trial Profile
A first adequate and well-controlled clinical Phase III Study of IMC-1 for the Treatment of Fibromyalgia
Status:
Planning
Phase of Trial:
Phase III
Latest Information Update: 17 Aug 2023
Price :
$35
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At a glance
- Drugs Celecoxib/famciclovir (Primary)
- Indications Fibromyalgia
- Focus Registrational; Therapeutic Use
- Sponsors Virios Therapeutics
- 10 Aug 2023 According to a Virios Therapeutics media release, the Company submitting a final Phase 3 program outline and associated Phase 3 study protocols for FDA review, this year.According to a Virios Therapeutics media release, the Company submitting a final Phase 3 program outline and associated Phase 3 study protocols for FDA review, this year.
- 09 Aug 2023 According to a Virios Therapeutics media release, the company plans to begin enrollment in the first fibromyalgia Phase 3 safety and efficacy study in mid-2024.
- 15 May 2023 According to a Virios Therapeutics media release, tThe proposed phase 3 program consist of four primary components: two adequate and well-controlled clinical studies, one of which would be a full factorial design with each of the individual components of IMC-1 (famciclovir and celecoxib) as separate comparator arms, a long-term safety trial, and a pharmacokinetic/food effect study.