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SPD476 (4.8 g)
SPD476 (4.8 g) is a SGLT2 inhibitor Small molecule drug developed by Shire. It is currently in Phase 3 development for Type 2 diabetes. Also known as: Lialda, MMX™ mesalazine.
SPD476 is a small molecule drug that targets the SGLT2 receptor.
SPD476 is a medication being studied in clinical trials for the prevention of recurrence of diverticulitis, as well as for the treatment of colitis and ulcerative colitis. The medication has been tested in doses of 1.2g, 2.4g, and 4.8g in clinical trials.
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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 (4.8 g) |
|---|---|
| Also known as | Lialda, MMX™ mesalazine |
| Sponsor | Shire |
| Drug class | SGLT2 inhibitor |
| Target | SGLT2 |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
By inhibiting SGLT2, SPD476 reduces glucose reabsorption in the kidneys, leading to decreased blood glucose levels. This mechanism is particularly useful in the treatment of type 2 diabetes.
Approved indications
- Type 2 diabetes
Common side effects
- Nausea
- Diarrhea
- Vomiting
Key clinical trials
- Prevention of Recurrence of Diverticulitis (PHASE3)
- Prevention of Recurrence of Diverticulitis (PHASE3)
- 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)
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 (4.8 g) CI brief — competitive landscape report
- SPD476 (4.8 g) updates RSS · CI watch RSS
- Shire portfolio CI
Frequently asked questions about SPD476 (4.8 g)
What is SPD476 (4.8 g)?
How does SPD476 (4.8 g) work?
What is SPD476 (4.8 g) used for?
Who makes SPD476 (4.8 g)?
Is SPD476 (4.8 g) also known as anything else?
What drug class is SPD476 (4.8 g) in?
What development phase is SPD476 (4.8 g) in?
What are the side effects of SPD476 (4.8 g)?
What does SPD476 (4.8 g) target?
Related
- Drug class: All SGLT2 inhibitor drugs
- Target: All drugs targeting SGLT2
- Manufacturer: Shire — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes
- Also known as: Lialda, MMX™ mesalazine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing