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Cassava Sciences (SAVA)
:SAVA
Simufilam
Hepatic Insufficiency
Phase I
Completed
A Pharmacokinetic Study of Simufilam in Subjects With Impaired Hepatic Function
Apr 25, 2024
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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
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Simufilam
Alzheimer Disease
Phase III
Terminated
Open-label Extension for Phase 3 Clinical Trials of Simufilam
Oct 07, 2022
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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
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Simufilam
Alzheimer Disease
Phase III
Terminated
Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease
Aug 09, 2021
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Simufilam
Alzheimer Disease
Phase III
Completed
Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease
Jul 29, 2021
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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
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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
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 Cassava Sciences (SAVA) have in its pipeline
SAVA is currently developing the following drugs: Simufilam, Simufilam, Simufilam. These drug candidates are in various stages of clinical development as the company works toward FDA approval.