Last reviewed · How we verify
SPD503 (2 mg)
SPD503 (2 mg) is a dopamine receptor agonist Small molecule drug developed by Shire. It is currently in Phase 3 development for Parkinson's disease.
SPD503 is a dopamine receptor agonist.
SPD503 is a small molecule with the synonym MG-S-2525, used in clinical trials for various conditions including Attention Deficit Disorder With Hyperactivity, Attention Deficit Hyperactivity Disorder (ADHD), Generalized Anxiety Disorder (GAD), and anxiety-related phobias. It has been studied in doses of 1 mg, 2 mg, and 3 mg in clinical trials.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | SPD503 (2 mg) |
|---|---|
| Sponsor | Shire |
| Drug class | dopamine receptor agonist |
| Target | Dopamine receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
It works by activating dopamine receptors in the brain, which helps to improve symptoms of certain conditions.
Approved indications
- Parkinson's disease
Common side effects
- Nausea
- Dizziness
- Headache
Key clinical trials
- A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD) (PHASE4)
- Access to Extended Release Guanfacine HCl for Subjects Who Participated in Studies SPD503-315 or SPD503-316 in Europe (PHASE3)
- Safety and Efficacy of SPD503 in Treating Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-17 (PHASE3)
- SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP) (PHASE2)
- Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17 (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 (2 mg) CI brief — competitive landscape report
- SPD503 (2 mg) updates RSS · CI watch RSS
- Shire portfolio CI
Frequently asked questions about SPD503 (2 mg)
What is SPD503 (2 mg)?
How does SPD503 (2 mg) work?
What is SPD503 (2 mg) used for?
Who makes SPD503 (2 mg)?
What drug class is SPD503 (2 mg) in?
What development phase is SPD503 (2 mg) in?
What are the side effects of SPD503 (2 mg)?
What does SPD503 (2 mg) target?
Related
- Drug class: All dopamine receptor agonist drugs
- Target: All drugs targeting Dopamine receptor
- Manufacturer: Shire — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Parkinson's disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing