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MMX Mesalamine
MMX Mesalamine is a 5-aminosalicylic acid (5-ASA) agent Small molecule drug developed by Shire. It is currently FDA-approved for Induction of remission of mild to moderate ulcerative colitis, Maintenance of remission of ulcerative colitis. Also known as: Lialda, SPD476, Lialda.
MMX Mesalamine is a delayed-release formulation of mesalamine that delivers the anti-inflammatory drug to the colon to reduce inflammation in inflammatory bowel disease.
MMX Mesalamine is a small molecule that inhibits arachidonate 5-lipoxygenase, an enzyme involved in the inflammatory process. It is used to prevent the recurrence of diverticulitis and has been studied in clinical trials for the treatment of ulcerative colitis and as a healthy control.
At a glance
| Generic name | MMX Mesalamine |
|---|---|
| Also known as | Lialda, SPD476, Lialda |
| Sponsor | Shire |
| Drug class | 5-aminosalicylic acid (5-ASA) agent |
| Target | Prostaglandin and leukotriene pathways (topical anti-inflammatory) |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology / Immunology |
| Phase | FDA-approved |
Mechanism of action
Mesalamine (5-aminosalicylic acid) is a topical anti-inflammatory agent that works by inhibiting prostaglandin and leukotriene production in the colon. The MMX formulation uses a multi-matrix system to delay drug release until it reaches the colon, maximizing local therapeutic effect while minimizing systemic exposure and side effects.
Approved indications
- Induction of remission of mild to moderate ulcerative colitis
- Maintenance of remission of ulcerative colitis
Common side effects
- Headache
- Abdominal pain
- Diarrhea
- Nausea
- Flatulence
Key clinical trials
- Sulfamethoxazole Drug Interaction Study With MMX® Mesalazine/Mesalamine (PHASE1)
- 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)
- Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC) (PHASE4)
- Prevention of Recurrence of Diverticulitis (PHASE3)
- Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine (PHASE1)
- Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/Mesalamine (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:
- MMX Mesalamine CI brief — competitive landscape report
- MMX Mesalamine updates RSS · CI watch RSS
- Shire portfolio CI
Frequently asked questions about MMX Mesalamine
What is MMX Mesalamine?
How does MMX Mesalamine work?
What is MMX Mesalamine used for?
Who makes MMX Mesalamine?
Is MMX Mesalamine also known as anything else?
What drug class is MMX Mesalamine in?
What development phase is MMX Mesalamine in?
What are the side effects of MMX Mesalamine?
What does MMX Mesalamine target?
Related
- Drug class: All 5-aminosalicylic acid (5-ASA) agent drugs
- Target: All drugs targeting Prostaglandin and leukotriene pathways (topical anti-inflammatory)
- Manufacturer: Shire — full pipeline
- Therapeutic area: All drugs in Gastroenterology / Immunology
- Indication: Drugs for Induction of remission of mild to moderate ulcerative colitis
- Indication: Drugs for Maintenance of remission of ulcerative colitis
- Also known as: Lialda, SPD476, Lialda
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing