Last reviewed 2026-05-29 · How we verify

SPD503 and VYVANSE

Shire · Phase 1 active Small molecule ✓ Verified May 2026

SPD503 and VYVANSE is a Small molecule drug developed by Shire. It is currently in Phase 1 development.

SPD503 and VYVANSE are medications that were studied in a clinical trial involving healthy participants to evaluate their pharmacokinetic interaction when administered alone and in combination. The study, NCT00919867, was conducted by Takeda to assess the effects of co-administering SPD503 and VYVANSE in normal healthy volunteers.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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 and VYVANSE
Sponsor	Shire
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers (PHASE1)

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 and VYVANSE CI brief — competitive landscape report
SPD503 and VYVANSE updates RSS · CI watch RSS
Shire portfolio CI

Frequently asked questions about SPD503 and VYVANSE

What is SPD503 and VYVANSE?

SPD503 and VYVANSE is a Small molecule drug developed by Shire.

Who makes SPD503 and VYVANSE?

SPD503 and VYVANSE is developed by Shire (see full Shire pipeline at /company/shire).

What development phase is SPD503 and VYVANSE in?

SPD503 and VYVANSE is in Phase 1.

Manufacturer: Shire — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing