Sunosi

(Solriamfetol)

ApprovedSmall molecule

AAxsome Therapeutics, Inc.

Sunosi is one of 98 small molecule programs targeting Eating Disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Eating DisorderActive, not recruiting

InsomniaActive, not recruiting

Idiopathic HypersomniaNot yet recruiting

Multiple SclerosisRecruiting

ADHDEnrolling by invitation

Excessive SleepinessTerminated

Binge Eating DisorderRecruiting

Chronic Fatigue SyndromeCompleted

Eating DisorderApproved

Active, not recruiting

InsomniaApproved

Active, not recruiting

Idiopathic HypersomniaPhase 2

Not yet recruiting

Multiple SclerosisPhase 2

Recruiting

ADHDPhase 3

Enrolling by invitation

Excessive SleepinessApproved

Terminated

Binge Eating DisorderPhase 3

Recruiting

Chronic Fatigue SyndromeApproved

Completed

Competition

Competitive Landscape

138 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

Sunosi

AAxsome Therapeutics, Inc.

Approved

1 2

Rinvoq

AbbVie

Phase 3

1 3

Cytoxan

BBaxter Healthcare Corporation

Phase 3

9 4

Questran

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

2 5

Vumerity

Biogen

Phase 3

5 6

Clemastine Fumarate

Novartis

Phase 3

2 7

Mayzent

Novartis

Phase 3

2 8

Activated Charcoal

Sanofi

Phase 3

1 9

Antihistamine

Arrowhead Pharmaceuticals

Phase 3

2 10

Recombinant Zoster Vaccine

MMAXVAX Biotechnology Limited Liability Company

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Binge Eating Disorder

NCT06413433

Phase 3Recruiting

Excessive Sleepiness

NCT06568367

Q1 2027

Phase 2Recruiting

Multiple Sclerosis

NCT06170970

Q2 2027

Phase 2Not yet recruiting

Idiopathic Hypersomnia

NCT06590662

Q4 2028

Phase 3Recruiting

Major Depressive Disorder

NCT07484217

Clinical

Trials by Indication[1]

Excessive Sleepiness2 trials

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

Terminated·—·Phase 4·NCT04788953·84 enrolled

A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated With Shift Work Disorder

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

Binge Eating Disorder2 trials

An Open-Label and Double-Blind, Randomized Withdrawal Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Adults With Binge Eating Disorder

Enrolling by invitation·AAxsome Therapeutics, Inc.·Phase 3·NCT06878976·236 enrolled

A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED)

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

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

Hypersomnia1 trial

RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)

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

12 more indications

Depression1 trial

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

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

Multiple Sclerosis1 trial

Solriamfetol for the Treatment of Multiple Sclerosis Fatigue

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

Eating Disorder1 trial

Solriamfetol in Binge Eating Disorder

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

Sleep1 trial

RECOVER-SLEEP: Platform Protocol

Completed·—·Phase 2·NCT06404086·830 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

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

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

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

Major Depressive Disorder1 trial

A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

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

ADHD1 trial

An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

Enrolling by invitation·AAxsome Therapeutics, Inc.·Phase 3·NCT07773883·300 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 17, 2019

SUNOSI

NDA NDA211230

Sources

References

[1]
ClinicalTrials.gov — 19 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

11439597Sep 5, 2037

11998639Sep 5, 2037

10959976Jun 1, 2038

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11560354Mar 6, 2039

11986455Mar 19, 2040

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12318362Mar 19, 2040

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11850226Mar 19, 2040

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11986454Mar 19, 2040

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12036194Dec 30, 2042

11779554Dec 30, 2042

11771666Dec 30, 2042

11771667Dec 30, 2042

11793776Dec 30, 2042

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]

Excessive Sleepiness2 trials

Binge Eating Disorder2 trials

Obstructive Sleep Apnea1 trial

Randomized1 trial

Hypersomnia1 trial

Depression1 trial

Insomnia1 trial

Single Dose1 trial

Multiple Sclerosis1 trial

Eating Disorder1 trial

Sleep1 trial

Idiopathic Hypersomnia1 trial

Chronic Fatigue Syndrome1 trial

Efficacy and Safety1 trial

Attention Deficit Hyperactivity Disorder1 trial

Major Depressive Disorder1 trial

ADHD1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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