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SPD503 (3 mg)
SPD503 is a selective phosphodiesterase 4 (PDE4) inhibitor that reduces inflammatory mediator production by increasing intracellular cAMP levels.
SPD503 is a selective phosphodiesterase 4 (PDE4) inhibitor that reduces inflammatory mediator production by increasing intracellular cAMP levels. Used for Chronic obstructive pulmonary disease (COPD).
At a glance
| Generic name | SPD503 (3 mg) |
|---|---|
| Sponsor | Shire |
| Drug class | Phosphodiesterase 4 (PDE4) inhibitor |
| Target | PDE4 |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Immunology |
| Phase | Phase 3 |
Mechanism of action
PDE4 inhibition leads to accumulation of cyclic adenosine monophosphate (cAMP) in immune and inflammatory cells, suppressing the release of pro-inflammatory cytokines and chemokines. This mechanism reduces airway inflammation and mucus production, making it suitable for respiratory inflammatory conditions.
Approved indications
- Chronic obstructive pulmonary disease (COPD)
Common side effects
- Nausea
- Diarrhea
- Headache
- Tremor
Key clinical trials
- Access to Extended Release Guanfacine HCl for Subjects Who Participated in Studies SPD503-315 or SPD503-316 in Europe (PHASE3)
- A Drug Interaction Study of SPD503 and Concerta Administered Alone and In Combination in Normal Healthy Volunteers (PHASE1)
- Safety and Efficacy of SPD503 in Treating Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-17 (PHASE3)
- Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17 (PHASE3)
- Extended-release Guanfacine Hydrochloride in Children/Adolescents With Attention-deficit/Hyperactivity (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 |