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Clinical trials
catalyst calendar across sponsors →Studies where AXSM is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
36 interventional · 1 observational · 12 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| SUNOSI® (Solriamfetol) Pregnancy RegistryNCT06413420observationalLong-term Safety | — | Recruiting | Drug: Sunosi (solriamfetol), Other prescription wake-promoting medications or stimulants · Other: No treatment | Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring | 1,731 | Sep 2029 | ≤ 1,138 d | 2024-05-14 |
| Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using SolriamfetolNCT07484217Time from randomization to relapse of depressive symptomsRandomized · Double-masked · Treatment | Phase 3 | Recruiting | Drug: Solriamfetol 150 MG, Placebo | Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms | 508 | Dec 2028 | ≤ 865 d | 2026-07-24 |
| A Study to Assess the Efficacy and Safety of Solriamfetol in Children With ADHDNCT07717879ADHD-RS-5 Total Score, Change from Baseline to Week 6Randomized · Double-masked · Treatment | Phase 3 | Recruiting | Drug: Solriamfetol Dose A, Solriamfetol Dose B, Placebo | ADHD | 468 | 2028-06-30 | in 681 d | 2026-07-21 |
| A Study to Assess the Efficacy and Safety of Solriamfetol in Adolescents With ADHDNCT07717892ADHD-RS-5 Total Score, Change from Baseline to Week 6Randomized · Double-masked · Treatment | Phase 3 | Recruiting | Drug: Solriamfetol Dose A, Solriamfetol Dose B, Placebo | ADHD | 468 | 2028-06-30 | in 681 d | 2026-07-21 |
| Open-Label Safety Study of AXS-14 in Subjects With FibromyalgiaNCT07637162Long-term SafetyOpen-label · Treatment | Phase 3 | Enrolling by invitation | Drug: AXS-14 (esreboxetine) | Fibromyalgia | 300 | May 2028 | ≤ 651 d | 2026-07-24 |
| Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research DesignNCT07398417Time from randomization to loss of therapeutic responseRandomized · Double-masked · Treatment | Phase 3 | Recruiting | Drug: AXS-14 (Esreboxetine), Placebo | Fibromyalgia | 620 | Mar 2028 | ≤ 590 d | 2026-07-24 |
| A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating DisorderNCT06878976Time from randomization to relapse of binge eating in the RW segmentRandomized · Double-masked · Treatment | Phase 3 | Enrolling by invitation | Drug: Solriamfetol, Placebo | Binge-Eating Disorder | 236 | Dec 2027 | ≤ 499 d | 2026-08-11 |
| A Study to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in AdultsNCT077666554-Week Continuous Smoking Abstinence RateRandomized · Double-masked · Treatment | Phase 3 | Recruiting | Drug: AXS-05 (dextromethorphan-bupropion), Bupropion, Placebo | Smoking Cessation | 705 | Dec 2027 | ≤ 499 d | 2026-08-14 |
| An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHDNCT07773883Treatment-Emergent Adverse Events (TEAEs)Non-randomized · Open-label · Treatment | Phase 3 | Enrolling by invitation | Drug: Solriamfetol | ADHD | 300 | Dec 2027 | ≤ 499 d | 2026-08-19 |
| Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using SolriamfetolNCT06413433Change from Baseline to Week 12 in number of binge eating episodesRandomized · Double-masked · Treatment | Phase 3 | Recruiting | Drug: Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo | Binge-Eating Disorder | 450 | Dec 2026 | ≤ 134 d | 2026-07-28 |
| Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)NCT06568367Change from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT).Randomized · Double-masked · Treatment | Phase 3 | Recruiting | Drug: Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo | Excessive Sleepiness, Shift-work Disorder | 520 | Dec 2026 | ≤ 134 d | 2026-07-24 |
| A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive SymptomsNCT06223880Time from randomization to relapse of depressive symptomsRandomized · Triple-masked · Treatment | Phase 4 | Recruiting | Drug: AXS-05, Bupropion | Major Depressive Disorder | 350 | Mar 2026 | — | 2025-01-23 |
| An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension StudyNCT06736509results2026-06-25Long-Term SafetyOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Study AXS-05-AD-305 was terminated due to completion of overall program objectives. | Drug: AXS-05 (dextromethorphan-bupropion) | Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, Psychomotor | 139 | 2025-02-17actual | — | 2026-06-25 |
| A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)NCT05972044Change from Baseline to Week 6 in the AISRS total scoreRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo | ADHD | 516 | 2025-02-07actual | — | 2026-02-10 |
| Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using SolriamfetolNCT06360419Montgomery-Åsberg Depression Rating Scale (MADRS)Randomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Solriamfetol 300 mg, Placebo | Major Depressive Disorder | 346 | 2024-12-31actual | — | 2026-01-05 |
| A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease AgitationNCT04947553Long-term SafetyRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: AXS-05 (dextromethorphan-bupropion), Placebo | Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, Psychomotor | 456 | 2024-12-03actual | — | 2025-12-08 |
| Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE)NCT05550207Percentage of subjects with headache pain reliefOpen-label · Treatment | Phase 3 | Completed | Drug: AXS-07 (meloxicam-rizatriptan) | Migraine | 100 | 2024-11-27actual | — | 2025-12-02 |
| A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease AgitationNCT05557409results2026-08-13Cohen-Mansfield Agitation Inventory (CMAI)Randomized · Triple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: AXS-05, Placebo | Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation | 408 | 2024-11-21actual | — | 2026-08-13 |
| A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)NCT05113745Long-term safety as measured by the incidence of treatment-emergent adverse eventsRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: AXS-12 (reboxetine), Placebo | Narcolepsy, Cataplexy, Excessive Daytime Sleepiness | 68 | 2024-11-15actual | — | 2025-11-13 |
| A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With NarcolepsyNCT05059223Frequency of cataplexy attacksRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: AXS-12 (reboxetine), Placebo | Narcolepsy, Cataplexy, Excessive Daytime Sleepiness | 90 | 2024-03-15actual | — | 2026-05-28 |
| Assessing Clinical Outcomes in Alzheimer's Disease AgitationNCT04797715Time from randomization to relapse of agitation symptomsRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: AXS-05, Placebo | Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation,Psychomotor | 178 | 2022-11-21actual | — | 2023-11-29 |
| Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled StudyNCT04789174results2026-01-26Change From Baseline in the Average of the DSST RBANS Scores at the End of Each Double-blind Treatment PeriodRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: Solriamfetol, Placebo | Excessive Daytime Sleepiness, Obstructive Sleep Apnea, Impaired Cognitive Function | 59 | 2022-09-19actual | — | 2026-01-26 |
| Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral AdministrationNCT05008341Maximum Concentration (Cmax) of Solriamfetol in Breast Milk and PlasmaOpen-label · Treatment | Phase 1 | Completed | Drug: Solriamfetol 150 mg Oral Tablet | Narcolepsy, Obstructive Sleep Apnea, Excessive Daytime Somnolence, Excessive Sleepiness, Postpartum | 6 | 2022-04-15actual | — | 2023-04-14 |
| Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)NCT04634669results2026-01-28Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: This study was terminated once overall program objectives were met. | Drug: AXS-05 (dextromethorphan-bupropion) | Treatment Resistant Depression, Major Depressive Disorder | 181 | 2022-02-18actual | — | 2026-01-28 |
| An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent PatientsNCT04971291Montgomery-Åsberg Depression Rating Scale (MADRS) total scoreRandomized · Double-masked · Treatment | Phase 2 | Unknown status | Drug: AXS-05, Bupropion SR | Major Depressive Disorder, Treatment Resistant Depression | 312 | Jul 2021 | — | 2021-07-26 |
| Mechanistic Evaluation of Response in TRD (MERIT)NCT04608396RelapseRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: AXS-05, Placebo | Treatment Resistant Depression, Major Depressive Disorder | 44 | 2021-07-30actual | — | 2022-07-12 |
| A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow LesionsNCT02746068Change in patient reported pain intensityRandomized · Double-masked · Treatment | Phase 3 | Unknown status | Drug: AXS-02, Placebo | Osteoarthritis, Knee | 346 | Dec 2020 | — | 2019-01-10 |
| Open-Label Safety Study of AXS-05 in Subjects With DepressionNCT04039022results2022-10-12Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: AXS-05 (dextromethorphan and bupropion) oral tablets | Major Depressive Disorder, Treatment Resistant Depression, Depression | 876 | 2020-10-23actual | — | 2022-10-12 |
| Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)NCT04068051results2023-10-10Long-term Safety of Chronic Intermittent Use of AXS-07Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: AXS-07 | Migraine | 706 | 2020-09-22actual | — | 2023-10-10 |
| Addressing Dementia Via Agitation-Centered EvaluationNCT03226522results2023-09-13Change in CMAI Total ScoreRandomized · Triple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2/3 | Completed | Drug: AXS-05, Bupropion, Placebo | Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation,Psychomotor | 366 | 2020-04-17actual | — | 2023-09-13 |
| A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive DisorderNCT02741791Montgomery-Åsberg Depression Rating Scale (MADRS) total scoreRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: AXS-05, Bupropion | Treatment Resistant Major Depressive Disorder | 312 | 2020-03-20actual | — | 2021-03-24 |
| Initiating Early Control of Migraine Pain and Associated SymptomsNCT04163185results2026-01-28Percentage of Subjects Achieving Headache Pain Freedom at Hour 2Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: AXS-07 (MoSEIC meloxicam and rizatriptan), Placebo | Migraine | 302 | 2020-03-16actual | — | 2026-01-28 |
| Maximizing Outcomes in Treating Acute MigraineNCT03896009results2023-08-24Percentage of Subjects Reporting Headache Pain FreedomRandomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: AXS-07 (MoSEIC meloxicam and rizatriptan), Meloxicam, Rizatriptan, Placebo | Migraine | 1,594 | 2019-12-10actual | — | 2023-08-24 |
| Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)NCT03881852results2023-08-24Change From Baseline in the Weekly Average Total Number of Cataplexy AttacksRandomized · Triple-masked · TreatmentStudy Protocol and Statistical Analysis Plan: Study Protocol and SAP ↗ · Statistical Analysis Plan: SAP only ↗ | Phase 2 | Completed | Drug: AXS-12 (Reboxetine), Placebo | Narcolepsy, Cataplexy Narcolepsy, Excessive Sleepiness | 21 | 2019-11-27actual | — | 2026-06-15 |
| A Trial of AXS-05 in Patients With Major Depressive DisorderNCT04019704results2022-10-12Change in MADRS Total Score From Baseline to Week 6Randomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: AXS-05, Placebo | Depression, Major Depressive Disorder | 327 | 2019-11-26actual | — | 2022-10-12 |
| CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1NCT02504008Change in patient reported pain intensityRandomized · Double-masked · Treatment | Phase 3 | Unknown status | Drug: AXS-02 (oral zoledronate), Placebo | Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy | 190 | Jan 2019 | — | 2018-03-23 |
| Assessing Symptomatic Clinical Episodes in DepressionNCT03595579results2021-09-24MADRS Score - Overall Change From BaselineRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: AXS-05, Bupropion | Major Depressive Disorder | 97 | 2019-01-07actual | — | 2021-09-24 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19