Spn-817
Focal Onset Seizures
Phase II
Recruiting
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Aug 19, 2025
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Spn-817
Focal Onset Seizures
Phase II
Recruiting
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults with Focal Onset Seizures
Jan 16, 2025
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Nv-5138
Major Depressive Disorder
Phase II
Completed
Open-Label of SPN-820 in Adults With Major Depressive Disorder
Jan 23, 2024
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Spn-812
Attention-Deficit/Hyperactivity Disorder
Phase IV
Active Not Recruiting
Open-label Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD and Mood Symptoms
Dec 15, 2023
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Brexanolone
Tinnitus
Phase II
Completed
An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus
Dec 01, 2022
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Sage-718
Alzheimer's Disease, Mild Cognitive Impairment, Mild Dementia
Phase II
Completed
A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)
Nov 09, 2022
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Sage-718
Huntington Disease
Phase II
Completed
28-Day Study of SAGE-718 on Functioning Capacity in Participants With Huntington's Disease
Apr 27, 2022
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Sage-718
Parkinson Disease, Cognitive Dysfunction
Phase II
Completed
A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive Impairment
Apr 01, 2022
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Sage-718
Huntington's Disease
Phase II
Completed
A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)
Oct 25, 2021
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Nv-5138
Treatment Resistant Depression
Phase II
Completed
Phase 2 Study of NV-5138 in Adults With Treatment Resistant Depression
Sep 23, 2021
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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 Supernus Pharmaceuticals (S49) have in its pipeline
S49 is currently developing the following drugs: Spn-817, Spn-817, Nv-5138. These drug candidates are in various stages of clinical development as the company works toward FDA approval.