Axsome Therapeutics Advances Solriamfetol into Phase 3 Trial for MDD with Excessive Daytime Sleepiness

Event summary

  • Axsome Therapeutics initiated the CLARITY Phase 3 trial for solriamfetol in treating MDD with excessive daytime sleepiness (EDS) symptoms on February 24, 2026.
  • The trial is a double-blind, placebo-controlled, multicenter randomized withdrawal study with primary endpoint measuring time to relapse of depressive symptoms.
  • Solriamfetol is a DNRI, TAAR1 agonist, and 5-HT1A agonist being developed for multiple CNS disorders, including ADHD, BED, and SWD.
  • MDD affects over 21 million adults in the U.S., with EDS symptoms present in approximately 50% of patients, currently lacking approved treatments.

The big picture

Axsome Therapeutics is expanding its portfolio in the CNS space by targeting a critical gap in MDD treatment, particularly for patients experiencing excessive daytime sleepiness. This Phase 3 trial positions solriamfetol as a potential first-in-class therapy, addressing a significant unmet need in a market with limited approved options. The success of this trial could further solidify Axsome's leadership in developing innovative treatments for complex neurological and psychiatric conditions.

What we're watching

Clinical Success
Whether solriamfetol demonstrates efficacy and safety in the Phase 3 trial to support potential FDA approval for MDD with EDS.
Market Opportunity
The pace at which Axsome can capture a significant share of the MDD market, particularly given the unmet need for treatments addressing EDS symptoms.
Pipeline Progress
How the outcomes of this trial may influence the development and strategic positioning of solriamfetol for other indications like ADHD and BED.