mesalazine (Asacol®) — Competitive Intelligence Brief

mesalazine (Asacol®) (mesalazine (Asacol®)) competitive landscape: 2 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: 5-aminosalicylic acid (5-ASA) derivative. Area: Gastroenterology / Immunology.

phase 3 5-aminosalicylic acid (5-ASA) derivative Nuclear factor-kappa B (NF-κB); prostaglandin and leukotriene pathways Gastroenterology / Immunology Small molecule

Target snapshot

mesalazine (Asacol®) (mesalazine (Asacol®)) — Cardiff and Vale University Health Board. Mesalazine is an anti-inflammatory agent that reduces inflammation in the colon by inhibiting prostaglandin and leukotriene production.

Comparator set (2 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
mesalazine (Asacol®) TARGET	mesalazine (Asacol®)	Cardiff and Vale University Health Board	phase 3	5-aminosalicylic acid (5-ASA) derivative	Nuclear factor-kappa B (NF-κB); prostaglandin and leukotriene pathways
Mesalazine tablets	Mesalazine tablets	AstraZeneca	phase 3	5-aminosalicylic acid (5-ASA) derivative	Prostaglandin and leukotriene synthesis inhibition; NF-κB pathway modulation
Delayed and extended release mesalazine	Delayed and extended release mesalazine	Shire	phase 3	5-aminosalicylic acid (5-ASA) derivative

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (5-aminosalicylic acid (5-ASA) derivative class)

1. AstraZeneca · 1 drug in this class
2. Cardiff and Vale University Health Board · 1 drug in this class
3. Shire · 1 drug in this class