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Stoke Therapeutics Inc (STOK)
NASDAQ:STOK
Sham Comparator, Zorevunersen
Dravet Syndrome
Phase III
Recruiting
A Double-blind Study Evaluating the Efficacy, Safety, and Tolerability of Zorevunersen in Patients With Dravet Syndrome
Mar 06, 2025
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Stk-001
Dravet Syndrome
Phase II
Active Not Recruiting
An Open-Label Extension Study of STK-001 for Patients With Dravet Syndrome
Feb 02, 2021
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Stk-001 - Single Ascending Doses, Stk-001 - Multiple Ascending Doses
Dravet Syndrome
Phase I/II
Completed
An Open-Label Study to Investigate the Safety of Single and Multiple Ascending Doses in Children and Adolescents With Dravet Syndrome
Jun 08, 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 Stoke Therapeutics Inc (STOK) have in its pipeline
STOK is currently developing the following drugs: Sham Comparator, Zorevunersen, Stk-001, Stk-001 - Single Ascending Doses, Stk-001 - Multiple Ascending Doses. These drug candidates are in various stages of clinical development as the company works toward FDA approval.