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Filana Therapeutics (FLNA) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Simufilam | Hepatic Insufficiency | Phase I | Completed | A Pharmacokinetic Study of Simufilam in Subjects With Impaired Hepatic Function | Apr 25, 2024 | ― |
| Simufilam | Absorption, Metabolism, Excretion | Phase I | Completed | Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Simufilam Following a Single Oral Dose in Healthy Male Subjects | Dec 22, 2023 | ― |
| Simufilam | Alzheimer Disease | Phase III | Terminated | Open-label Extension for Phase 3 Clinical Trials of Simufilam | Oct 07, 2022 | ― |
| Simufilam | Alzheimer's Disease | Phase II | Terminated | Open-Label Extension of the PTI-125-04 Study in Mild-to-Moderate Alzheimer's Disease | Apr 04, 2022 | ― |
| Simufilam | Alzheimer Disease | Phase III | Terminated | Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease | Aug 09, 2021 | ― |
| Simufilam | Alzheimer Disease | Phase III | Completed | Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease | Jul 29, 2021 | ― |
| Simufilam 100 Mg Oral Tablet | Alzheimer Disease | Phase II | Completed | Simufilam (PTI-125), 100 mg, for Mild-to-moderate Alzheimer's Disease Patients | May 11, 2020 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Simufilam | Phase I | Hepatic Insufficiency | Completed | A Pharmacokinetic Study of Simufilam in Subjects With Impaired Hepatic Function | Apr 25, 2024 | ― |
| Simufilam | Phase I | Absorption, Metabolism, Excretion | Completed | Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Simufilam Following a Single Oral Dose in Healthy Male Subjects | Dec 22, 2023 | ― |
| Simufilam | Phase III | Alzheimer Disease | Terminated | Open-label Extension for Phase 3 Clinical Trials of Simufilam | Oct 07, 2022 | ― |
| Simufilam | Phase II | Alzheimer's Disease | Terminated | Open-Label Extension of the PTI-125-04 Study in Mild-to-Moderate Alzheimer's Disease | Apr 04, 2022 | ― |
| Simufilam | Phase III | Alzheimer Disease | Terminated | Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease | Aug 09, 2021 | ― |
| Simufilam | Phase III | Alzheimer Disease | Completed | Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease | Jul 29, 2021 | ― |
| Simufilam 100 Mg Oral Tablet | Phase II | Alzheimer Disease | Completed | Simufilam (PTI-125), 100 mg, for Mild-to-moderate Alzheimer's Disease Patients | May 11, 2020 | ― |
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Filana Therapeutics, Inc. (FLNA) have in its pipeline
Filana Therapeutics FLNA is currently developing the following drugs: Simufilam, Simufilam 100 Mg Oral Tablet. These drug candidates are in various stages of clinical development as the company works toward FDA approval.