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mesalazine (Asacol®)
mesalazine (Asacol®) is a 5-aminosalicylic acid (5-ASA) derivative Small molecule drug developed by Cardiff and Vale University Health Board. It is currently in Phase 3 development for Ulcerative colitis (induction and maintenance of remission), Crohn's disease (colonic involvement), Inflammatory bowel disease. Also known as: Mesalazine, Asacol.
Mesalazine is an anti-inflammatory agent that reduces inflammation in the colon by inhibiting prostaglandin and leukotriene production.
Mesalazine (Asacol) is a small molecule inhibitor of the enzyme arachidonate 5-lipoxygenase, classified as an INHIBITOR. It is used to treat conditions such as ulcerative colitis, as indicated by clinical trials on ClinicalTrials.gov.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | mesalazine (Asacol®) |
|---|---|
| Also known as | Mesalazine, Asacol |
| Sponsor | Cardiff and Vale University Health Board |
| Drug class | 5-aminosalicylic acid (5-ASA) derivative |
| Target | Nuclear factor-kappa B (NF-κB); prostaglandin and leukotriene pathways |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology / Immunology |
| Phase | Phase 3 |
Mechanism of action
Mesalazine (5-aminosalicylic acid) acts locally in the gastrointestinal tract to suppress inflammatory mediators and reduce immune cell activation. It works primarily by inhibiting nuclear factor-kappa B (NF-κB) signaling and reducing production of pro-inflammatory cytokines, thereby decreasing mucosal inflammation in inflammatory bowel disease.
Approved indications
- Ulcerative colitis (induction and maintenance of remission)
- Crohn's disease (colonic involvement)
- Inflammatory bowel disease
Common side effects
- Headache
- Abdominal pain
- Diarrhea
- Nausea
- Rash
- Nephrotoxicity (rare)
Key clinical trials
- Mesalamine 4 gm/60 mL Rectal Enema (PHASE1)
- Additive Effect of Probiotics (Mutaflor®) in Patients With Ulcerative Colitis on 5-ASA Treatment. (PHASE4)
- Sulfamethoxazole Drug Interaction Study With MMX® Mesalazine/Mesalamine (PHASE1)
- Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine (PHASE1)
- Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/Mesalamine (PHASE1)
- Amoxicillin Drug Interaction Study With MMX® Mesalazine/Mesalamine (PHASE1)
- Study of the Effectiveness of ETIASA® (Sustained Release 5-Aminosalicylate) in Maintenance Treatment of Ulcerative Colitis (UC)
- Study of Pentasa® for Reducing Residual Systemic Immune Activation in Treated HIV Infection (PHASE1, PHASE2)
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:
- mesalazine (Asacol®) CI brief — competitive landscape report
- mesalazine (Asacol®) updates RSS · CI watch RSS
- Cardiff and Vale University Health Board portfolio CI
Frequently asked questions about mesalazine (Asacol®)
What is mesalazine (Asacol®)?
How does mesalazine (Asacol®) work?
What is mesalazine (Asacol®) used for?
Who makes mesalazine (Asacol®)?
Is mesalazine (Asacol®) also known as anything else?
What drug class is mesalazine (Asacol®) in?
What development phase is mesalazine (Asacol®) in?
What are the side effects of mesalazine (Asacol®)?
What does mesalazine (Asacol®) target?
Related
- Drug class: All 5-aminosalicylic acid (5-ASA) derivative drugs
- Target: All drugs targeting Nuclear factor-kappa B (NF-κB); prostaglandin and leukotriene pathways
- Manufacturer: Cardiff and Vale University Health Board — full pipeline
- Therapeutic area: All drugs in Gastroenterology / Immunology
- Indication: Drugs for Ulcerative colitis (induction and maintenance of remission)
- Indication: Drugs for Crohn's disease (colonic involvement)
- Indication: Drugs for Inflammatory bowel disease
- Also known as: Mesalazine, Asacol
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing