Sunosi

(Solriamfetol)

ApprovedSmall molecule

AAxsome Therapeutics, Inc.

Sunosi is one of 200 small molecule programs targeting Eating Disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

199

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Eating DisorderActive, not recruiting

Attention Deficit Hyperactivity DisorderActive, not recruiting

Obstructive Sleep ApneaActive, not recruiting

InsomniaActive, not recruiting

Idiopathic HypersomniaActive, not recruiting

Multiple SclerosisActive, not recruiting

Chronic Fatigue SyndromeActive, not recruiting

HypersomniaActive, not recruiting

Eating DisorderApproved

Active, not recruiting

Attention Deficit Hyperactivity DisorderPhase 2/Phase 3

Active, not recruiting

Obstructive Sleep ApneaPhase 3

Active, not recruiting

InsomniaApproved

Active, not recruiting

Idiopathic HypersomniaPhase 2

Active, not recruiting

Multiple SclerosisPhase 2

Active, not recruiting

Chronic Fatigue SyndromeApproved

Active, not recruiting

HypersomniaPhase 2

Active, not recruiting

Competition

Competitive Landscape

560 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

Sunosi

AAxsome Therapeutics, Inc.

Approved

1 2

Betaseron

Bayer

Preclinical

16 3

Tysabri

Biogen

Preclinical

14 4

Avonex

EMD Serono

Preclinical

22 5

Campath

GGenzyme, a Sanofi Company

Preclinical

12 6

Flomax

Sanofi

Preclinical

1 7

Novantrone

Pred Forte

Myfortic

Circadin

NNeurim Pharmaceuticals Ltd.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

AIN

NCT06568367

Q1 2027

Phase 2Recruiting

Multiple Sclerosis

NCT06170970

Q2 2027

Phase 2Not yet recruiting

Idiopathic Hypersomnia

NCT06590662

Q4 2028

Phase 3Recruiting

Depression

NCT07484217

Clinical

Trials by Indication[1]

Eating Disorder2 trials

Solriamfetol in Binge Eating Disorder

Unknown status·LLindner Center of HOPE·Phase 4·NCT04602936·64 enrolled

Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol

Recruiting·AAxsome Therapeutics, Inc.·Phase 3·NCT06413433·450 enrolled

Depression2 trials

Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol

Completed·AAxsome Therapeutics, Inc.·Phase 3·NCT06360419·346 enrolled

Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol

Recruiting·AAxsome Therapeutics, Inc.·Phase 3·NCT07484217·508 enrolled

Multiple Sclerosis1 trial

Solriamfetol for the Treatment of Multiple Sclerosis Fatigue

Recruiting·JJohns Hopkins University·Phase 2·NCT06170970·46 enrolled

Hypersomnia1 trial

RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)

Active, not recruiting·—·Phase 2·NCT06404099·361 enrolled

Sleep1 trial

RECOVER-SLEEP: Platform Protocol

Completed·—·Phase 2·NCT06404086·830 enrolled

10 more indications

Randomized1 trial

Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study

Completed·AAxsome Therapeutics, Inc.·Phase 4·NCT04789174·59 enrolled

Idiopathic Hypersomnia1 trial

Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.

Not yet recruiting·UUniversity Hospital, Montpellier·Phase 2·NCT06590662·60 enrolled

AIN1 trial

Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)

Recruiting·AAxsome Therapeutics, Inc.·Phase 3·NCT06568367·520 enrolled

Efficacy and Safety1 trial

A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)

Completed·AAxsome Therapeutics, Inc.·Phase 3·NCT05972044·516 enrolled

Insomnia1 trial

Solriamfetol and CBT-I in Patients With Insomnia Disorder

Active, not recruiting·UUniversity of Pennsylvania·Phase 4·NCT05838430·60 enrolled

Single Dose1 trial

Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration

Completed·AAxsome Therapeutics, Inc.·Phase 1·NCT05008341·6 enrolled

Excessive Sleepiness1 trial

Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder

Terminated·—·Phase 4·NCT04788953·84 enrolled

Chronic Fatigue Syndrome1 trial

A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Completed·RRochester Center for Behavioral Medicine·Phase 4·NCT04622293·44 enrolled

Attention Deficit Hyperactivity Disorder1 trial

A Controlled Study of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD) in Adults

Completed·MMassachusetts General Hospital·Phase 2/3·NCT04839562·66 enrolled

Obstructive Sleep Apnea1 trial

A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Solriamfetol in the Treatment of Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea (OSA)

Completed·IIgnis Therapeutics (Suzhou) Limited·Phase 3·NCT06103825·204 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 17, 2019

SUNOSI

NDA NDA211230

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Solriamfetol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Solriamfetol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Solriamfetol. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA211230). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Sunosi. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Axsome Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AAxsome Therapeutics, Inc.

Patent Landscape[5]

Patent Cliff

Jun 11, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9604917Jun 7, 2026

12209059Jun 7, 2026

10351517Jun 7, 2026

11753368Jun 7, 2026

8877806Jun 7, 2026

37 more patents

8440715Jun 11, 2031

10512609Sep 5, 2037

10195151Sep 5, 2037

12390419Sep 5, 2037

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11998639Sep 5, 2037

10959976Jun 1, 2038

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11872204Dec 30, 2042

12263145Dec 30, 2042

Sunosi

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q4 2028

Trials by Indication[1]

Eating Disorder2 trials

Depression2 trials

Multiple Sclerosis1 trial

Hypersomnia1 trial

Sleep1 trial

Randomized1 trial

Idiopathic Hypersomnia1 trial

AIN1 trial

Efficacy and Safety1 trial

Insomnia1 trial

Single Dose1 trial

Excessive Sleepiness1 trial

Chronic Fatigue Syndrome1 trial

Attention Deficit Hyperactivity Disorder1 trial

Obstructive Sleep Apnea1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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