Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ampligen · 1 trial · 2 indications
| Name | Type | Description |
|---|---|---|
| Ampligen | DRUG | - |
Inclusion Criteria: 1. A diagnosis of CFS, as defined by the Center for Disease Control (1988 CDC case definition) \> 12 months (Appendix D). 2. Age Range: \> 18 years old, \< 60 years old. 3. Males or non-pregnant, non-lactating females: Females must be of non-child bearing potential (either post-...
Ampligen is an investigational small molecule being developed for Chronic Fatigue Syndrome, also known as Myalgic Encephalomyelitis. It is a Phase 3 drug candidate studied in a completed clinical trial with 234 participants. Ampligen has received Orphan Drug and Fast Track designations from the FDA.
Ampligen is being developed by AIM ImmunoTech Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol AIM. The company conducted a Phase 3 clinical trial of Ampligen for Chronic Fatigue Syndrome, which has been completed.
Ampligen is in Phase 3 clinical development for Chronic Fatigue Syndrome. It is an investigational drug, not yet approved by the FDA. The Phase 3 trial, NCT00215800, has been completed, and the drug has received Orphan Drug and Fast Track designations.
Ampligen has one completed Phase 3 clinical trial, NCT00215800, titled 'The Study of the Safety and Efficacy of Ampligen in Chronic Fatigue Syndrome.' The trial enrolled 234 participants aged 18 years and older with Chronic Fatigue Syndrome or Myalgic Encephalomyelitis. The study was randomized and double-blind.
Ampligen is not FDA approved. It is an investigational drug in Phase 3 clinical development for Chronic Fatigue Syndrome. The FDA has granted Ampligen Orphan Drug and Fast Track designations, which are intended to expedite development and review of promising therapies.
Ampligen is also known as rintatolimod. It is a small molecule drug candidate developed by AIM ImmunoTech Inc. for Chronic Fatigue Syndrome. In clinical trials, it has been studied as a treatment for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis.