simufilam
simufilam: developed by 1 company · 5 clinical trials tracked.
simufilam evidence translation
What we can confirm
5 tracked trials
What it means
What to watch
Prepared research question
How could simufilam → FLNA affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence2 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Development Pipeline (2)
| Company | Phase |
|---|---|
| Filana Therapeutics Inc. (FLNA) Alzheimer Disease; Alzheimer's Disease; Absorption | Phase 3 |
| Filana Therapeutics Inc. (FLNA) Alzheimer Disease; Alzheimer's Disease; Absorption | Phase 3 |
Clinical Trials (5)
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Simufilam Following a Single Oral Dose in Healthy Male Subjects
Primary endpoint: AUC of total radioactivity, parent drug and metabolite(s) in plasma.
An Open-label, Long-term Extension Study to Evaluate the Safety and Tolerability of Simufilam 100 mg Tablets in Participants With Mild to Moderate Alzheimer's Disease
Primary endpoint: Number of Participants With Adverse Events
An Open-Label Extension of the PTI-125-04 Study Evaluating the Safety and Long-Term Treatment of Simufilam in Mild-to-Moderate Alzheimer's Disease Patients
Primary endpoint: Adverse Event Monitoring
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 76-week Study Evaluating the Safety and Efficacy of Two Doses of Simufilam in Subjects With Mild-to-Moderate Alzheimer's Disease
Primary endpoint: Change From Baseline in the 12-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12)
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Study Evaluating the Safety and Efficacy of Simufilam 100 mg Tablets in Subjects With Mild-to-Moderate Alzheimer's Disease
Primary endpoint: Change From Baseline in the 12-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12)
Frequently asked questions
Who is developing simufilam?
simufilam is being developed by Filana Therapeutics Inc..
How many clinical trials involve simufilam?
BioSniper tracks 5 clinical trials involving simufilam.