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SPN-812

Phase 3

ADHD | Small molecule | Psychiatry |Supernus Pharmaceuticals, Inc.|Last Updated: Jul 15, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials4
Total Enrollment1,397

FDA Designations

No designations recorded

Clinical trial landscape

SPN-812 · 8 trials · 3 indications

Phase 3 7Phase 2 1
NCT04143217Open-label Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHDAttention-Deficit/Hyperactivity Disorder
COMPLETED159 Analytics
NCT04016779Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHDAttention-Deficit/Hyperactivity Disorder (ADHD)
COMPLETED374 Analytics
NCT03247556Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Adolescents With ADHDADHD
COMPLETED297 Analytics
NCT03247517Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Adolescents With ADHDADHD
COMPLETED310 Analytics
NCT03247543Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Children With ADHDADHD
COMPLETED313 Analytics
NCT03247530Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Children With ADHDADHD
COMPLETED477 Analytics
NCT02736656Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule)Attention-Deficit/Hyperactivity Disorder
ACTIVE NOT_RECRUITING1,400 Analytics
PHASE3COMPLETED
Open-label Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD
Attention-Deficit/Hyperactivity DisorderUnlock trial analytics
PHASE3COMPLETED
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD
Attention-Deficit/Hyperactivity Disorder (ADHD)Unlock trial analytics
PHASE3COMPLETED
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Adolescents With ADHD
ADHDUnlock trial analytics
PHASE3COMPLETED
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Adolescents With ADHD
ADHDUnlock trial analytics
PHASE3COMPLETED
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Children With ADHD
ADHDUnlock trial analytics
PHASE3COMPLETED
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Children With ADHD
ADHDUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule)
Attention-Deficit/Hyperactivity DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Adverse Events
Up to 156 weeks

The percent of subjects who took at least one dose of SPN-812 (Safety Population; N) and who reported at least one Adverse Event (n). The percent is calculated by dividing "the number of subjects who reported at least one Adverse Event (n)" by "the number of subjects in the Safety Population (N)" and multiplying the product by 100. The higher the percentage, the higher the incidence in the Safety Population

Efficacy of SPN-812 on Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) as Assessed by the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score
Baseline and Week 6

The Primary Endpoint was the change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total score at Week 6. The AISRS is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The AISRS consists of 18 items that directly correspond to the 18 symptoms of ADHD per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The scale is subdivided into two subscales: Inattention (9 items) and Hyperactivity/Impulsivity (9 items). The clinician/investigator rates the subject on each item using a 4-point scale, where 0=none, 1=mild, 2=moderate, and 3=severe. A Total score is calculated by summating the ratings of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). A lower change from baseline AISRS Total score (\<0) represents a better outcome.

Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)
Baseline and Week 7 (End of Study)

The Primary Endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 7 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). A Total score is calculated by adding the responses of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). Lower change from baseline scores (\<0) represent a better outcome.

Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale, 5th Edition (ADHD-RS-5)
Baseline and Week 6 (End of Study)

The Primary Endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 6 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). A Total score is calculated by adding the responses of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). Lower change from baseline scores (\<0) represent a better outcome.

The Efficacy of SPN-812 on the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV)
Baseline to Week 8 (End of Study)

The Primary Endpoint was the change from baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV) Total score at Week 8 (End of Study). The ADHD-RS-IV is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). A Total score is calculated by adding the responses of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). Lower change from baseline scores (\<0) represent a better outcome.

Secondary Endpoints

The Effect of SPN-812 on Overall ADHD Symptoms as Measured by the Adult ADHD Investigator Symptom Rating Scale (AISRS)
Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124
The Effect of SPN-812 on Global Assessment of ADHD Symptom Severity as Measured by the Clinical Global Impression - Severity of Illness (CGI-S)
Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124
The Effect of SPN-812 on Clinical Global Impression - Severity of Illness (CGI-S) Responder Rate
Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Open-Label TreatmentEXPERIMENTALSPN-812 Open-Label Treatment 200mg to 600mg SPN-812 once daily for up to 156 weeks
PlaceboPLACEBO_COMPARATORPlacebo, qd, oral capsule
SPN-812EXPERIMENTALSPN-812, qd, oral capsule
400mg SPN-812EXPERIMENTAL400mg SPN-812, qd, oral capsule
600mg SPN-812EXPERIMENTAL600mg SPN-812, qd, oral capsule
200mg SPN-812EXPERIMENTAL200mg SPN-812, qd, oral capsule
100mg SPN-812EXPERIMENTAL100mg SPN-812, qd, oral capsule
300mg SPN-812EXPERIMENTAL300mg SPN-812, qd, oral capsule

Interventions

NameTypeDescription
SPN-812DRUGSPN-812 200 to 600 mg/day
PlaceboDRUGPlacebo will be administered once daily
400mg SPN-812DRUG400mg SPN-812 was administered once daily and compared to Placebo
600mg SPN-812DRUG600mg SPN-812 was administered once daily and compared to Placebo
200mg SPN-812DRUG200mg SPN-812 was administered once daily and compared to placebo
100mg SPN-812DRUG100mg SPN-812 was administered once daily and compared to placebo
300mg SPN-812DRUG300mg SPN-812 was administered once daily and compared to placebo
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites38

\*Please note, Inclusion/Exclusion Criterion "A" applies to subjects who completed Study 812P306 and enrolled in Study 812P311 on either the same day or up to 7 days after the end of Study 812P306. Inclusion/Exclusion Criterion "B" applies to subjects who completed Study 812P306, but enrolled in stu...

Countries:United States
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Competitive Landscape -ADHD 3 trials

CompanyTickerTrialsLead PhaseDrugs
Supernus Pharmaceuticals, Inc.SUPN1PHASE3SPN-812
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Recent Changes (Last 90 Days)

LOWJul 15, 2026NCT02736656lastUpdatePostDate: changed
LOWJul 15, 2026NCT02736656lastUpdatePostDate: changed

Frequently asked questions about SPN-812

What is SPN-812 used for?

SPN-812 is an investigational small molecule being developed for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). It is being studied in children, adolescents, and adults with ADHD. The drug is formulated as an extended-release capsule and is currently in Phase 3 clinical development.

Who makes SPN-812?

SPN-812 is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company listed on NASDAQ under the ticker symbol SUPN. The company is conducting clinical trials of SPN-812 in the United States across multiple age groups with ADHD.

What phase is SPN-812 in?

SPN-812 is in Phase 3 clinical development for ADHD. It is an investigational drug and has not been approved by the FDA. The Phase 3 program includes completed trials in adolescents, children, and adults with ADHD, evaluating the efficacy and safety of the extended-release capsule.

What clinical trials is SPN-812 in?

SPN-812 has been studied in four clinical trials, all completed. These include NCT02633527 in children (Phase 2), NCT03247517 in adolescents (Phase 3), NCT03247543 in children (Phase 3), and NCT04016779 in adults (Phase 3). All trials were conducted in the United States and were randomized, double-blind, and placebo-controlled.

Is SPN-812 the same as viloxazine?

SPN-812 is viloxazine extended-release capsule. The drug is being developed as a treatment for ADHD. Clinical trials have evaluated SPN-812 in children aged 6 years and older, adolescents aged 12 years and older, and adults aged 18 years and older with ADHD.