COMPANY

Supernus Pharmaceuticals

HQ: Rockville, MD source · supernus.com ↗ · Mid-Atlantic

FDA-approved therapeutic company Clinical Phase 3

Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Supernus Pharmaceuticals develops and commercializes medicines in neurology and psychiatry, and several product candidates in its pipeline are in early-to-late-stage clinical testing. From company website Source · checked 2026-10-19

Supernus completed its acquisition of Sage Therapeutics on July 31, 2025. From SEC filing Source · Source · 2026-10-12

Sources for this description (2)

Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.
- “We are a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.” https://www.supernus.com/about-us (2026-10-19)
Supernus Pharmaceuticals develops and commercializes medicines in neurology and psychiatry, and several product candidates in its pipeline are in early-to-late-stage clinical testing.
- “At Supernus, we strive to be a leader in the CNS industry by developing and commercializing new medicines in neurology and psychiatry.” https://www.supernus.com/about-us (2026-10-19)
- “Several product candidates in our pipeline are in early-to-late-stage clinical testing and moving toward being commercially available to patients.” https://www.supernus.com/about-us (2026-10-19)

Keywords: neuroscience therapeutics commercial-stage Attention-Deficit/Hyperactivity Disorder Parkinson Disease Postpartum Depression Super-Refractory Status Epilepticus Cognitive Dysfunction Attention Deficit Hyperactivity Disorder Focal Onset Seizures Huntington's Disease Huntington Disease Mild Dementia ADHD Epilepsy Epileptic Seizures Major Depressive Disorder Migraine Disorders Headache Disorders Attention Deficit Disorder With Hyperactivity Conduct Disorder Tinnitus Post Partum Depression Alzheimer Disease Severe Postpartum Depression Mild Cognitive Impairment Alzheimer's Disease Impulsive Aggression Idiopathic Parkinson Disease Focal Impaired Awareness Seizures SPN-817 SPN-812 SAGE-718 SPN-810 SAGE-547 Brexanolone

Location: Rockville, MD · source · Oct 15, 2026

Profile checked Oct 10, 2026

64Trials (company is sponsor)

Timeline

Jan 19, 2026 Trial start Phase 2: Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder source ↗
Jul 30, 2025 Trial start Phase 2: SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures source ↗
Mar 31, 2025 Trial start —: Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States: source ↗
Dec 30, 2024 Trial start 2: RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures source ↗
Mar 25, 2024 Trial start Phase 4: Open-label Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD and Mood Symptoms source ↗
Mar 19, 2024 Trial start Phase 4: Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD source ↗
May 23, 2023 Trial start Phase 4: Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women source ↗
May 10, 2023 Trial start Phase 2: An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus source ↗
Feb 7, 2023 Trial start Phase 2: Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy source ↗
Dec 14, 2022 Trial start Phase 3: A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease source ↗
Nov 29, 2022 Trial start Phase 2: A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD) source ↗
Jun 6, 2022 Trial start Phase 2: A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive Impairment source ↗
May 26, 2022 Trial start Phase 2: 28-Day Study of SAGE-718 on Functioning Capacity in Participants With Huntington's Disease source ↗
Jan 26, 2022 Trial start Phase 2: A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD) source ↗
Nov 11, 2021 Trial start Phase 1: Mass Balance Study of NV-5138 in Healthy Male Subjects source ↗
Oct 19, 2021 Trial start Early phase 1: Evaluating the Safety and Relative Bioavailability of Three SPN-817 Treatments (A, B and C) in Healthy Adult Subjects source ↗
Oct 8, 2021 Trial start Phase 4: A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting source ↗
Sep 21, 2021 Trial start Phase 1: Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants source ↗
Jul 27, 2021 Trial start Phase 4: Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD source ↗
Dec 7, 2020 Trial start Phase 2: A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD) source ↗
Jul 31, 2020 Trial start Phase 2: A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI) source ↗
Jul 14, 2020 Trial start Phase 4: Therapy for Migraine Prevention in Children 6-11 Years of Age source ↗
Jan 23, 2020 Trial start Phase 3: Open-label Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD source ↗
Nov 20, 2019 Trial start Phase 3: Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD source ↗
May 30, 2019 Trial start Phase 2: Exploratory fMRI Study on the Treatment for Impulsive Aggression in Children With ADHD source ↗

Showing 25 of 48 dated events.

Upcoming milestones

Dec 30, 2026 (ESTIMATED) · Phase 1/Phase 2 · BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures · NCT03474770
Dec 31, 2026 (ESTIMATED) · Phase 2 · Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder · NCT07226661
2027-08 (ESTIMATED) · 2 · RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures · NCT06798896
Aug 1, 2027 (ESTIMATED) · · Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States: · NCT07219927
Dec 31, 2027 (ESTIMATED) · Phase 2 · Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy · NCT05518578
Dec 31, 2027 (ESTIMATED) · Phase 2 · SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures · NCT07141329
2028-01 (ESTIMATED) · Phase 4 · Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD · NCT04781140

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) Showing 50 of 64

Record	Title	Phase	Status	Start	Primary completion
NCT04781140	Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD	Phase 4	Recruiting	Mar 19, 2024	2028-01 (estimated)
NCT06798896	RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures	2	Recruiting	Dec 30, 2024	2027-08 (estimated)
NCT02736656	Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule)	Phase 3	Active, not recruiting	Feb 2, 2016	2026-09 (estimated)
NCT05518578	Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy	Phase 2	Recruiting	Feb 7, 2023	Dec 31, 2027 (estimated)
NCT06185985	Open-label Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD and Mood Symptoms	Phase 4	Completed	Mar 25, 2024	Dec 3, 2024 (actual)
NCT07226661	Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder	Phase 2	Recruiting	Jan 19, 2026	Dec 31, 2026 (estimated)
NCT04050293	Therapy for Migraine Prevention in Children 6-11 Years of Age	Phase 4	Terminated	Jul 14, 2020	Mar 1, 2023 (actual)
NCT05655520	A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease	Phase 3	Terminated	Dec 14, 2022	Jan 20, 2025 (actual)
NCT00626236	Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems	2	Completed	Oct 21, 2008	Sep 23, 2009 (actual)
NCT07219927	Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States:	Not listed	Recruiting	Mar 31, 2025	Aug 1, 2027 (estimated)
NCT02942004	A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)	Phase 3	Completed	Aug 1, 2016	Sep 24, 2017 (actual)
NCT02477618	A Study With SAGE-547 for Super-Refractory Status Epilepticus	Phase 3	Completed	2015-06	Jul 18, 2017 (actual)
NCT07141329	SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures	Phase 2	Recruiting	Jul 30, 2025	Dec 31, 2027 (estimated)
NCT03771586	A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics of SAGE-718 Using a Ketamine Challenge in Healthy Subjects	Phase 1	Completed	Sep 24, 2018	Dec 17, 2018 (actual)
NCT03787758	A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Patients With Huntington's Disease - Part B	Phase 1	Completed	Feb 28, 2019	Oct 7, 2019 (actual)
NCT05049343	Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants	Phase 1	Completed	Sep 21, 2021	Nov 20, 2021 (actual)
NCT03770780	A Study to Assess the Electrophysiology, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Response Using Magnetic Resonance Imaging of SAGE-718 Using a Ketamine Challenge in Healthy Subjects	Phase 1	Completed	Nov 12, 2018	Mar 8, 2019 (actual)
NCT03844906	A Study to Assess Electrophysiology, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of SAGE-718 Using Ketamine Challenge in Healthy Subjects	Phase 1	Completed	Dec 27, 2018	Mar 18, 2019 (actual)
NCT05358821	28-Day Study of SAGE-718 on Functioning Capacity in Participants With Huntington's Disease	Phase 2	Completed	May 26, 2022	Feb 29, 2024 (actual)
NCT02942017	A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)	Phase 3	Completed	2016-07	Sep 17, 2017 (actual)
NCT05645432	An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus	Phase 2	Completed	May 10, 2023	Nov 21, 2023 (actual)
NCT03665038	A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)	Phase 3	Completed	Sep 7, 2018	Jan 8, 2021 (actual)
NCT04602624	A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)	Phase 2	Completed	Dec 7, 2020	Sep 28, 2021 (actual)
NCT04476017	A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)	Phase 2	Completed	Jul 31, 2020	Mar 25, 2022 (actual)
NCT03924492	Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression	Not listed	Approved for marketing	Not listed	Not listed
NCT05059600	A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting	Phase 4	Completed	Oct 8, 2021	Jul 14, 2022 (actual)
NCT02614547	A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression	Phase 2	Completed	Dec 15, 2015	Jun 22, 2016 (actual)
NCT05107128	A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)	Phase 2	Completed	Jan 26, 2022	Sep 4, 2024 (actual)
NCT02433314	An Open Label, Expanded Access Protocol With SAGE-547 for Super-Refractory Status Epilepticus	Not listed	No longer available	Not listed	Not listed
NCT05619692	A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)	Phase 2	Completed	Nov 29, 2022	Jun 5, 2024 (actual)
NCT02285504	Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression	Phase 2	Completed	Jan 7, 2015	Jun 5, 2015 (actual)
NCT02052739	Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus	Phase 1/Phase 2	Completed	Mar 21, 2014	May 3, 2015 (actual)
NCT05318937	A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive Impairment	Phase 2	Completed	Jun 6, 2022	Jan 17, 2024 (actual)
NCT03638466	Exploratory fMRI Study on the Treatment for Impulsive Aggression in Children With ADHD	Phase 2	Terminated	May 30, 2019	Nov 7, 2019 (actual)
NCT01107496	Evaluation of Immediate-Release Viloxazine in Adults With ADHD	Phase 1/Phase 2	Completed	2010-06	2010-12 (actual)
NCT06259331	Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women	Phase 4	Completed	May 23, 2023	Sep 20, 2023 (actual)
NCT02691182	Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4)	Phase 3	Terminated	2016-04	2021-05 (actual)
NCT04786990	Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD	Phase 4	Completed	Jul 27, 2021	May 23, 2023 (actual)
NCT03597503	Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment	Phase 3	Terminated	Jul 31, 2018	Jan 22, 2020 (actual)
NCT02618434	Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)	Phase 3	Completed	Feb 16, 2016	Nov 15, 2019 (actual)
NCT04143217	Open-label Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD	Phase 3	Completed	Jan 23, 2020	Jul 26, 2022 (actual)
NCT02618408	Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1)	Phase 3	Completed	Jan 25, 2016	Sep 4, 2019 (actual)
NCT03944785	Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)	Not listed	Completed	Nov 30, 2017	Dec 23, 2019 (actual)
NCT05102552	Evaluating the Safety and Relative Bioavailability of Three SPN-817 Treatments (A, B and C) in Healthy Adult Subjects	Early phase 1	Completed	Oct 19, 2021	Mar 25, 2022 (actual)
NCT03474770	BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures	Phase 1/Phase 2	Active, not recruiting	Apr 10, 2018	Dec 30, 2026 (estimated)
NCT04016779	Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD	Phase 3	Completed	Nov 20, 2019	Oct 10, 2020 (actual)
NCT05384977	Mass Balance Study of NV-5138 in Healthy Male Subjects	Phase 1	Completed	Nov 11, 2021	Dec 9, 2021 (actual)
NCT02633527	Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD	Phase 2	Completed	Feb 1, 2016	Jul 25, 2016 (actual)
NCT03247543	Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Children With ADHD	Phase 3	Completed	Oct 31, 2017	Oct 17, 2018 (actual)
NCT03247556	Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Adolescents With ADHD	Phase 3	Completed	Nov 20, 2017	Feb 14, 2019 (actual)