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.

axsome.com ↗

4compounds
8programs
8indications
Approvedlead asset

Phase distribution

  • Approved1
  • Filed (NDA)1
  • Phase 35
  • Phase 21

Modality

  • Small molecule 4

Mechanism focus

Pipeline (4)

Deals & partnerships

  • 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.Solriamfetol (Sunosi)source ↗
  • 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.AXS-12 (reboxetine)source ↗
  • 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.AXS-14 (esreboxetine)source ↗

Catalysts · 6 upcoming · 7 reported

Recently reported

Recent activity

  • 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 ↗
  • Nov 26, 2024ReadoutAXS-12 (reboxetine)·NarcolepsymetLong-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).source ↗
  • Aug 1, 2024Phase changeSolriamfetol (Sunosi)·Excessive daytime sleepinessPhase 3Axsome initiated the SUSTAIN Phase 3 trial of solriamfetol (150 mg / 300 mg once daily) for excessive sleepiness associated with shift work disorder (NCT06568367); announced in the company's August 5, 2024 Q2 2024 business update. CT.gov registers an actual study start of August 2024; trial recruiting. At initiation the company anticipated topline results in 2026.source ↗

Trials recruiting · 5 recruiting of 17 sponsored

  • Phase 3Solriamfetol (Sunosi)n=50813 sites · United States

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

    Major Depressive DisorderExcessive Daytime SleepinessNCT07484217 ↗

  • Phase 3Solriamfetol (Sunosi)n=30031 sites · United States

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

    Binge Eating DisorderNCT06878976 ↗

  • Phase 3Solriamfetol (Sunosi)n=52040 sites · United States, Canada

    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)

    Shift Work DisorderExcessive SleepinessNCT06568367 ↗

  • Phase 3Solriamfetol (Sunosi)n=45045 sites · United States

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

    Binge Eating DisorderNCT06413433 ↗

Showing 4 of 5 recruiting trials.

Competitive landscape

Other companies developing against Axsome Therapeutics, Inc.'s targets or indications.

Leadership & advisors (12)