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SPD476 (2.4 g)
SPD476 is a monoamine oxidase inhibitor that increases levels of dopamine, norepinephrine, and serotonin in the central nervous system.
SPD476 is a monoamine oxidase inhibitor that increases levels of dopamine, norepinephrine, and serotonin in the central nervous system. Used for Major depressive disorder.
At a glance
| Generic name | SPD476 (2.4 g) |
|---|---|
| Also known as | Lialda, MMX™ mesalazine |
| Sponsor | Shire |
| Drug class | Monoamine oxidase inhibitor |
| Target | Monoamine oxidase (MAO) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry/Neurology |
| Phase | Phase 3 |
Mechanism of action
SPD476 works by inhibiting monoamine oxidase enzymes, which are responsible for breaking down neurotransmitters. By blocking this degradation, the drug increases synaptic concentrations of dopamine, norepinephrine, and serotonin, thereby enhancing monoaminergic neurotransmission. This mechanism is intended to improve symptoms in conditions characterized by monoamine deficiency.
Approved indications
- Major depressive disorder
Common side effects
- Hypertension
- Insomnia
- Headache
- Nausea
- Dizziness
Key clinical trials
- 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)
- 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)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |