Developer · AXSM · United States
Axsome Therapeutics, Inc.
Axsome Therapeutics is a U.S. biopharmaceutical company developing and commercializing novel therapies for central nervous system (CNS) conditions, including its marketed products Auvelity (AXS-05) for major depressive disorder and Sunosi (solriamfetol) for excessive daytime sleepiness.
Pipeline (4)
- NarcolepsyFiled (NDA)Active
- FibromyalgiaPhase 3Recruiting
- Binge eating disorderPhase 3Recruiting
- Excessive daytime sleepinessApprovedApproved
- Major depressive disorderPhase 3Recruiting
- Attention-deficit/hyperactivity disorderPhase 3Active
- Tobacco use disorderPhase 2Active
- Agitation in Alzheimer's diseaseApprovedApproved
Deals & partnerships
- AXS-12 (reboxetine)Licensor Pfizer Inc.
- AXS-14 (esreboxetine)Licensor Pfizer Inc.
- Solriamfetol (Sunosi)Licensor Jazz Pharmaceuticals plc
- Mar 28, 2022Licensing dealAxsome acquires Sunosi (solriamfetol) from Jazz PharmaceuticalsAxsome acquired Sunosi (solriamfetol), an approved dual-acting dopamine and norepinephrine reuptake inhibitor for excessive daytime sleepiness, from Jazz Pharmaceuticals for $53M upfront plus royalties. U.S. acquisition completed May 9, 2022; ex-U.S. rights followed.
- Jan 13, 2020Licensing dealAxsome in-licenses Pfizer esreboxetine candidate (AXS-14)As part of the same January 13, 2020 exclusive U.S. license agreement with Pfizer, Axsome obtained AXS-14 (esreboxetine), a late-stage Phase 3 candidate for fibromyalgia.
- Jan 13, 2020Licensing dealAxsome in-licenses Pfizer reboxetine data and IP (AXS-12)Axsome entered an exclusive U.S. license agreement with Pfizer for reboxetine clinical/nonclinical data and IP — the basis of AXS-12 (reboxetine), a selective norepinephrine reuptake inhibitor developed for narcolepsy. Combined reboxetine/esreboxetine terms: $8M Axsome stock, $3M cash upfront, up to $323M milestones, tiered royalties.
Catalysts · 5 upcoming · 8 reported
- 2H 2026Anticipated
Solriamfetol (Sunosi)forBinge eating disorderTopline data
ENGAGE Phase 3 (solriamfetol in binge eating disorder) topline results anticipated in the second half of 2026.
- PDUFA May 1, 2027Anticipated
AXS-12 (reboxetine)forNarcolepsyRegulatory
FDA PDUFA target action date for the AXS-12 NDA in cataplexy in narcolepsy
- 2027Anticipated
Solriamfetol (Sunosi)forExcessive daytime sleepinessTopline data
SUSTAIN Phase 3 (solriamfetol for excessive sleepiness in shift work disorder) topline anticipated in 2027.
- 1H 2028Anticipated
AXS-14 (esreboxetine)forFibromyalgiaTopline data
Topline results anticipated from the pivotal Phase 3 FORWARD trial (NCT07398417) of AXS-14 (esreboxetine) in fibromyalgia; randomized-withdrawal primary endpoint is time to loss of therapeutic response.
- 2029Anticipated
Solriamfetol (Sunosi)forMajor depressive disorderTopline data
CLARITY Phase 3 (MDD with EDS) topline anticipated after a ~December 2028 primary completion.
Recently reported
- 2026-08-14met
AXS-05 (dextromethorphan-bupropion)forTobacco use disorderRegistry results
Pivotal Phase 3 smoking-cessation trial of AXS-05 (NCT07766655) registered and recruiting
- 2026-05-04met
AXS-12 (reboxetine)forNarcolepsyRegulatory
AXS-12 NDA for cataplexy in narcolepsy submitted to the FDA (announced May 4, 2026)
- 2026-04-30met
AXS-05 (dextromethorphan-bupropion)forAgitation in Alzheimer's diseaseRegulatory
FDA approves AUVELITY (AXS-05) for agitation associated with dementia due to Alzheimer's disease — first non-antipsychotic approved
- 2025-04-08met
AXS-05 (dextromethorphan-bupropion)forAgitation in Alzheimer's diseaseTopline data
Phase 3 AXS-05 AD-agitation program complete: ACCORD-2 relapse-prevention positive (HR 0.276, P=.001); ADVANCE-2 supportive but missed primary endpoint
- 2025-04-01missed
Solriamfetol (Sunosi)forMajor depressive disorderTopline data
PARADIGM Phase 3 missed its primary MADRS endpoint in the overall MDD population; signal seen in the severe-EDS subgroup.
- 2025-03-25met
Solriamfetol (Sunosi)forAttention-deficit/hyperactivity disorderTopline data
FOCUS Phase 3 of solriamfetol in adult ADHD met its primary AISRS endpoint and key secondary endpoints (150 mg).
- 2024-11-26met
AXS-12 (reboxetine)forNarcolepsyTopline data
Long-term Phase 3 ENCORE trial met its randomized-withdrawal primary endpoint: patients switched to placebo had significantly greater worsening of cataplexy than those continuing AXS-12 (p=0.017), with significant worsening of cognition (p=0.011) and overall narcolepsy (p=0.024).
- 2024-03-25met
AXS-12 (reboxetine)forNarcolepsyTopline data
Phase 3 SYMPHONY trial met its primary endpoint: AXS-12 significantly reduced weekly cataplexy attacks vs placebo at Week 5 (rate ratio 0.49, p=0.018), with cataplexy remission in 33% vs 9.5% and improved EDS severity.
Recent activity
- Aug 14, 2026ReadoutAXS-05 (dextromethorphan-bupropion)·Tobacco use disordermetPivotal Phase 3 smoking-cessation trial of AXS-05 (NCT07766655) registered and recruitingsource ↗
- May 4, 2026ReadoutAXS-12 (reboxetine)·NarcolepsymetAXS-12 NDA for cataplexy in narcolepsy submitted to the FDA (announced May 4, 2026)source ↗
- Apr 30, 2026ReadoutAXS-05 (dextromethorphan-bupropion)·Agitation in Alzheimer's diseasemetFDA approves AUVELITY (AXS-05) for agitation associated with dementia due to Alzheimer's disease — first non-antipsychotic approvedsource ↗
- Feb 24, 2026Phase changeSolriamfetol (Sunosi)·Major depressive disorderPhase 3Axsome initiated the CLARITY Phase 3 randomized-withdrawal trial (NCT07484217) of solriamfetol 150 mg in MDD with EDS symptoms; first patient dosed. MDD program continues, focused on the EDS subpopulation.source ↗
- Feb 23, 2026Phase changeAXS-05 (dextromethorphan-bupropion)·Tobacco use disorderPhase 2Per the Q4/full-year 2025 business update, Axsome plans to initiate a pivotal Phase 2/3 trial of AXS-05 in smoking cessation in Q2 2026 (not yet initiated).source ↗
- Jan 14, 2026Phase changeAXS-14 (esreboxetine)·FibromyalgiaPhase 3Axsome initiated the pivotal Phase 3 FORWARD trial (NCT07398417) in fibromyalgia; study start 2026-01-14 (actual), first patient dosed announced 2026-01-15. Randomized-withdrawal design (12-week open-label AXS-14, then 1:1 AXS-14 8 mg QD vs placebo); primary endpoint time to loss of therapeutic response.source ↗
- Dec 31, 2025Phase changeAXS-12 (reboxetine)·NarcolepsyFiled (NDA)Axsome announced FDA pre-NDA meeting minutes confirming its regulatory data package would be sufficient to support an NDA for AXS-12 for cataplexy in narcolepsy; company guided to completing the NDA submission in January 2026. AXS-12 holds Orphan Drug Designation for narcolepsy. Formal NDA submission/acceptance and PDUFA date not yet confirmed in a press release as of 2026-06-25.source ↗
- Dec 30, 2025Phase changeAXS-05 (dextromethorphan-bupropion)·Agitation in Alzheimer's diseaseFiled (NDA)FDA accepted the sNDA for AXS-05 in AD agitation and granted Priority Review with a 30 April 2026 PDUFA date.source ↗
- Apr 8, 2025ReadoutAXS-05 (dextromethorphan-bupropion)·Agitation in Alzheimer's diseasemetPhase 3 AXS-05 AD-agitation program complete: ACCORD-2 relapse-prevention positive (HR 0.276, P=.001); ADVANCE-2 supportive but missed primary endpointsource ↗
- Apr 1, 2025ReadoutSolriamfetol (Sunosi)·Major depressive disordermissedPARADIGM Phase 3 missed its primary MADRS endpoint in the overall MDD population; signal seen in the severe-EDS subgroup.source ↗
- Mar 25, 2025ReadoutSolriamfetol (Sunosi)·Attention-deficit/hyperactivity disordermetFOCUS Phase 3 of solriamfetol in adult ADHD met its primary AISRS endpoint and key secondary endpoints (150 mg).source ↗
- Feb 20, 2025Phase changeSolriamfetol (Sunosi)·Binge eating disorderPhase 3Axsome started an open-label, long-term safety and efficacy study of solriamfetol in BED (NCT06878976; solriamfetol 75/150/300 mg once daily for up to 52 weeks), supporting the ENGAGE program.source ↗
Trials recruiting · 5 recruiting of 17 sponsored
- Phase 3Solriamfetol (Sunosi)
A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms (CLARITY)
- Phase 3Solriamfetol (Sunosi)
An Open-Label Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Adults With Binge Eating Disorder
- Phase 3Solriamfetol (Sunosi)
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 (SUSTAIN)
- Phase 3Solriamfetol (Sunosi)
A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED) (ENGAGE)
Showing 4 of 5 recruiting trials.
Competitive landscape
Other companies developing against Axsome Therapeutics, Inc.'s targets or indications.
- Otsuka Pharmaceutical Co., Ltd.3 compoundsNETMajor depressive disorderAttention-deficit/hyperactivity disorder
- Avanir Pharmaceuticals1 compoundNMDA receptorAgitation in Alzheimer's disease
- Definium Therapeutics, Inc.1 compoundMajor depressive disorderAttention-deficit/hyperactivity disorder
- Gilgamesh Pharmaceuticals, Inc.2 compoundsNMDA receptorMajor depressive disorder
- Intra-Cellular Therapies, Inc.2 compoundsAgitation in Alzheimer's diseaseMajor depressive disorder
- Neumora Therapeutics, Inc.2 compoundsAgitation in Alzheimer's diseaseMajor depressive disorder
- Taisho Pharmaceutical Co., Ltd.2 compoundsNarcolepsyMajor depressive disorder
- Tonix Pharmaceuticals Holding Corp.1 compoundFibromyalgiaMajor depressive disorder
- Alkermes plc1 compoundNarcolepsy
- Alto Neuroscience, Inc.2 compoundsMajor depressive disorder
- Autobahn Therapeutics, Inc.1 compoundMajor depressive disorder
- Beckley Psytech Limited1 compoundMajor depressive disorder
