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SPD476 (mesalazine)
SPD476 (mesalazine) is a Aminopeptidase N inhibitor Small molecule drug developed by Shire. It is currently in Phase 3 development for Ulcerative colitis, Crohn's disease.
SPD476 (mesalazine) works by inhibiting the enzyme aminopeptidase N to reduce inflammation in the gut.
SPD476 (mesalazine) works by inhibiting the enzyme aminopeptidase N to reduce inflammation in the gut. Used for Ulcerative colitis, Crohn's disease.
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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).
| 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 | SPD476 (mesalazine) |
|---|---|
| Sponsor | Shire |
| Drug class | Aminopeptidase N inhibitor |
| Target | Aminopeptidase N |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Mesalazine, the active ingredient in SPD476, is a locally acting anti-inflammatory agent that inhibits the enzyme aminopeptidase N, thereby reducing the production of pro-inflammatory peptides in the gut. This action helps to reduce inflammation and alleviate symptoms associated with inflammatory bowel disease.
Approved indications
- Ulcerative colitis
- Crohn's disease
Common side effects
- Diarrhea
- Nausea
- Headache
Key clinical trials
- Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis. (PHASE3)
- Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis (PHASE1)
- 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)
- Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 (PHASE2)
- 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)
- Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis (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:
- SPD476 (mesalazine) CI brief — competitive landscape report
- SPD476 (mesalazine) updates RSS · CI watch RSS
- Shire portfolio CI
Frequently asked questions about SPD476 (mesalazine)
What is SPD476 (mesalazine)?
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Who makes SPD476 (mesalazine)?
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What does SPD476 (mesalazine) target?
Related
- Drug class: All Aminopeptidase N inhibitor drugs
- Target: All drugs targeting Aminopeptidase N
- Manufacturer: Shire — full pipeline
- Therapeutic area: All drugs in Gastroenterology
- Indication: Drugs for Ulcerative colitis
- Indication: Drugs for Crohn's disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing