Last reviewed 2026-04-23 · How we verify

SPD476

SPD476 is a small molecule drug that targets the serotonin receptor.

SPD476 is a small molecule drug that targets the serotonin receptor. Used for Treatment-resistant depression.

At a glance

Mechanism of action

It works by selectively binding to the serotonin receptor, which helps to modulate various physiological processes. This mechanism of action is still being researched and its exact effects on the body are not yet fully understood.

Approved indications

• Treatment-resistant depression

Common side effects

• Nausea
• Headache
• Dizziness

Key clinical trials

• Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis. (PHASE3)
• Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis (PHASE1)
• Prevention of Recurrence of Diverticulitis (PHASE3)
• Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis (PHASE3)
• Prevention of Recurrence of Diverticulitis (PHASE3)
• Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 (PHASE2)
• Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis (PHASE3)
• Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis (PHASE3)

Primary sources

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