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SPD503-AM
SPD503-AM is a monoamine oxidase inhibitor that increases levels of dopamine, norepinephrine, and serotonin in the central nervous system.
SPD503-AM is a monoamine oxidase inhibitor that increases levels of dopamine, norepinephrine, and serotonin in the central nervous system. Used for Attention-deficit/hyperactivity disorder (ADHD).
At a glance
| Generic name | SPD503-AM |
|---|---|
| Also known as | Intuniv |
| Sponsor | Shire |
| Drug class | Monoamine oxidase inhibitor |
| Target | Monoamine oxidase (MAO) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry/Neurology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting monoamine oxidase enzymes, SPD503-AM prevents the breakdown of key neurotransmitters, leading to their accumulation in synaptic spaces. This mechanism is intended to improve mood, attention, and other neuropsychiatric symptoms. The drug is being developed for attention-deficit/hyperactivity disorder (ADHD) and related conditions.
Approved indications
- Attention-deficit/hyperactivity disorder (ADHD)
Common side effects
- Headache
- Insomnia
- Nausea
- Hypertension
Key clinical trials
- Access to Extended Release Guanfacine HCl for Subjects Who Participated in Studies SPD503-315 or SPD503-316 in Europe (PHASE3)
- Efficacy and Safety of SPD503 in Combination With Psychostimulants (PHASE3)
- Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- SPD503-AM CI brief — competitive landscape report
- SPD503-AM updates RSS · CI watch RSS
- Shire portfolio CI