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Mesalazine | CAS No: 89-57-6 | GMP-certified suppliers
A medication that treats mildly to moderately active ulcerative colitis and supports maintenance of remission in ulcerative colitis and Crohn’s ileocolitis for consistent therapeutic management.
Therapeutic categories
Agents causing hyperkalemiaAgents that produce hypertensionAminosalicylateAminosalicylic AcidsAnalgesicsAnalgesics, Non-Narcotic
Generic name
Mesalazine
Molecule type
small molecule
CAS number
89-57-6
DrugBank ID
DB00244
Approval status
Approved drug
ATC code
A07EC02
Primary indications
- Mesalazine is indicated for the treatment of mildly to moderately active ulcerative colitis in adults and patients 5 years or older
- Mesalazine is also indicated for the maintenance of remission of ulcerative colitis in adults and maintenance of remission of Crohn's ileocolitis
Product Snapshot
- Mesalazine is an oral and rectal small‑molecule anti‑inflammatory available in multiple controlled‑release tablets, capsules, granules, suspensions, foams, gels, enemas, and suppositories
- It is used for active management and maintenance of remission in ulcerative colitis and for maintenance of remission in Crohn’s ileocolitis
- It is approved in the US and Canada
Clinical Overview
Mesalazine (CAS 89-57-6) is an aminosalicylate anti‑inflammatory agent used in inflammatory bowel disease. It is indicated for the treatment of mildly to moderately active ulcerative colitis in adults and in pediatric patients from 5 years of age, as well as for maintenance of remission in ulcerative colitis and Crohn’s ileocolitis. Its therapeutic activity is localized primarily to the intestinal mucosa rather than mediated by systemic exposure.
Pharmacologically, mesalazine modulates inflammatory pathways relevant to chronic mucosal inflammation. It reduces prostaglandin formation through cyclooxygenase inhibition and interferes with leukotriene synthesis, contributing to reduced leukocyte recruitment. It also demonstrates free radical scavenging activity. Experimental data indicate additional effects on nuclear signaling, including inhibition of NF‑kB activation and potential activation of PPAR gamma receptors in colonic epithelium. Inhibition of inducible nitric oxide synthase has also been reported. Collectively, these mechanisms support its local anti‑inflammatory action in the colon.
Mesalazine shows limited systemic absorption, with topical luminal activity considered central to efficacy. Absorption and distribution vary by formulation, reflecting strategies designed to improve stability and enable targeted release. Historical approaches, such as pH‑dependent coatings and microgranule encapsulation, were introduced to address drug degradation before reaching the colon.
Safety considerations include known associations with nephrotoxicity, including interstitial nephritis, particularly with prolonged use. Hypersensitivity reactions and gastrointestinal intolerance may also occur. Because mesalazine is related structurally to salicylates, cross‑sensitivity should be considered. Drug interaction potential exists through transporter involvement, including OATP1B1, OATP1B3, and OATP2B1 substrates.
Notable usage contexts include established branded formulations such as Asacol and Pentasa, which differ in release characteristics but rely on the same active moiety.
For API procurement, emphasis should be placed on chemical stability, particle characteristics suitable for targeted oral formulations, and control of impurities relevant to aminosalicylic acid derivatives. Compliance with pharmacopeial specifications and demonstrated stability under manufacturing and storage conditions is essential.
Pharmacologically, mesalazine modulates inflammatory pathways relevant to chronic mucosal inflammation. It reduces prostaglandin formation through cyclooxygenase inhibition and interferes with leukotriene synthesis, contributing to reduced leukocyte recruitment. It also demonstrates free radical scavenging activity. Experimental data indicate additional effects on nuclear signaling, including inhibition of NF‑kB activation and potential activation of PPAR gamma receptors in colonic epithelium. Inhibition of inducible nitric oxide synthase has also been reported. Collectively, these mechanisms support its local anti‑inflammatory action in the colon.
Mesalazine shows limited systemic absorption, with topical luminal activity considered central to efficacy. Absorption and distribution vary by formulation, reflecting strategies designed to improve stability and enable targeted release. Historical approaches, such as pH‑dependent coatings and microgranule encapsulation, were introduced to address drug degradation before reaching the colon.
Safety considerations include known associations with nephrotoxicity, including interstitial nephritis, particularly with prolonged use. Hypersensitivity reactions and gastrointestinal intolerance may also occur. Because mesalazine is related structurally to salicylates, cross‑sensitivity should be considered. Drug interaction potential exists through transporter involvement, including OATP1B1, OATP1B3, and OATP2B1 substrates.
Notable usage contexts include established branded formulations such as Asacol and Pentasa, which differ in release characteristics but rely on the same active moiety.
For API procurement, emphasis should be placed on chemical stability, particle characteristics suitable for targeted oral formulations, and control of impurities relevant to aminosalicylic acid derivatives. Compliance with pharmacopeial specifications and demonstrated stability under manufacturing and storage conditions is essential.
Identification & chemistry
| Generic name | Mesalazine |
|---|---|
| Molecule type | Small molecule |
| CAS | 89-57-6 |
| UNII | 4Q81I59GXC |
| DrugBank ID | DB00244 |
Pharmacology
| Summary | Mesalazine exerts localized anti‑inflammatory activity in the intestinal mucosa by modulating arachidonic acid pathways, including inhibition of cyclooxygenase and lipoxygenase–derived mediators. It also influences key inflammatory signaling nodes such as NF‑κB, iNOS, and PPAR‑γ, reducing cytokine production, leukocyte recruitment, and oxidative stress. These combined actions support its therapeutic role in inflammatory bowel diseases. |
|---|---|
| Mechanism of action | Although the mechanism of action of mesalazine is not fully understood, it is believed to possess a topical anti-inflammatory effect on colonic epithelial cells.Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with chronic inflammatory bowel disease, and it is possible that mesalazine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon. Furthermore, mesalazine also has the potential to inhibit the activation of Nuclear Factor kappa B (NFkB) and consequently the production of key pro-inflammatory cytokines.It has been proposed that reduced expression of PPAR gamma nuclear receptors (gamma form of peroxisome proliferator-activated receptors) may be implicated in ulcerative colitis, and that mesalazine produces pharmacodynamic effects through direct activation of PPAR gamma receptors in the colonic/rectal epithelium.Other research also showed the potential involvement of inducible NO synthase (iNOS) and that mesalazine can inhibit this enzyme to amiliorate the enteropathy in inflammatory bowel diseases. Moreover, since increased leukocyte migration, abnormal cytokine production, increased production of arachidonic acid metabolites, particularly leukotriene B4, and increased free radical formation in the inflamed intestinal tissue are all present in patients with inflammatory bowel disease it is also believed that mesalazine has in-vitro and in-vivo pharmacological effects that inhibit leukocyte chemotaxis, decrease cytokine and leukotriene production and scavenge for free radicals. |
| Pharmacodynamics | Mesalazine is one of the two components of sulphasalazine, the other being sulphapyridine. It is the latter responsible for most of the side effects associated with sulphasalazine therapy, while mesalazine is known to be the active moiety in the treatment of ulcerative colitis . Mesalazine is thought to dampen the inflammatory process through its ability to inhibit prostaglandin synthesis, interfere with leukotriene synthesis, and consequent leukocyte migration as well as act as a potent scavenger of free radicals.Regardless of the mode of action, mesalazine appears to be active mainly topically rather than systemically. Intraperitoneally administered mesalazine at 30 and 340 mg/kg daily had similar efficacy in attenuating colitis as prednisolone 4 to 550 mg/kg daily given intraperitoneally or sulphasalazine 0.34 to 5 mg/kg given orally in immune complex-induced colitis mice.Mesalazine at 5 mmol/L and sulphasalazine 1.5 mmol/L also reversed the increase in water and chloride secretion and decrease the sodium in dinitrochlorbenzene-induced colitis guinea pig. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Prostaglandin G/H synthase 2 | Humans | inhibitor |
| Prostaglandin G/H synthase 1 | Humans | inhibitor |
| Arachidonate 5-lipoxygenase | Humans | inhibitor |
ADME / PK
| Absorption | Depending on the formulation administered, prescribing information for orally administered delayed-released tablets of 2.4g or 4.8g of mesalazine given once daily for 14 days to healthy volunteers was to found to be about 21% to 22% of the administered dose [FDA Label] while prescribing information for an orally administered controlled-release capsule formulation suggests 20% to 30% of the mesalazine in the formulation is absorbed.In contrast, when mesalamine is administered orally as an unformulated 1-g aqueous suspension, mesalazine is approximately 80% absorbed. |
|---|---|
| Half-life | For the delayed-release formulation, after intravenous administration, the elimination half-life of mesalamine is reported to be approximately 40 minutes. After oral dosing, the median terminal half life values for mesalamine are usually about 25 hours, but are variable, ranging from 1.5 to 296 hours. There is a large inter-subject and intra-subject variability in the plasma concentrations of mesalamine and N-acetyl-5-aminosalicylic acid and in their terminal half-lives following the administration of mesalazine.For the extended-release formulation, following single and multiple doses of mesalazine, the mean half-lives were 9 to 10 hours for 5-ASA, and 12 to 14 hours for N-Ac-5-ASA. The mean elimination half-life was 5 hours (CV=73%) for 5-ASA and 5 hours (CV=63%) for N-acetyl-5-ASA in patients taking 500 mg mesalazine as a rectal suppository every 8 hours for 6 days.For the rectal enema suspension formulation, the elimination half-life was 0.5 to 1.5 hours for 5-ASA and 5 to 10 hours for N-acetyl-5-ASA. |
| Protein binding | In an in vitro study, at 2.5 mcg/mL, mesalamine and N-Ac-5-ASA are 43±6% and 78±1% bound, respectively, to plasma proteins. Protein binding of N-Ac-5-ASA does not appear to be concentration dependent at concentrations ranging from 1 to 10 mcg/mL. |
| Metabolism | Mesalazine is metabolized both pre-systemically by the intestinal mucosa and systemically in the liver to N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA) principally by NAT-1. Some acetylation also occurs through the action of colonic bacteria. |
| Route of elimination | Elimination of mesalazine is mainly via the renal route following metabolism to N-acetyl-5-aminosalicylic acid (acetylation) . However, there is also limited excretion of the parent mesalazine drug in the urine. After the oral administration of the extended-release formulation of mesalazine, of the approximately 21% to 22% of the drug absorbed, less than 8% of the dose was excreted unchanged in the urine after 24 hours, compared with greater than 13% for N-acetyl-5-aminosalicylic acid. When given the controlled-release formulation, about 130 mg free mesalazine was recovered in the feces following a single 1-g dose, which was comparable to the 140 mg of mesalazine recovered from the molar equivalent sulfasalazine tablet dose of 2.5 g F3001]. Elimination of free mesalazine and salicylates in feces increased proportionately with the dose given. N-acetylmesalazine was the primary compound excreted in the urine (19% to 30%) following the controlled-release dosing. In patients with ulcerative proctitis treated with mesalamine 500 mg as a rectal suppository every 8 hours for 6 days, 12% or less of the dose was eliminated in urine as unchanged 5-ASA and 8% to 77% was eliminated as N-acetyl-5-ASA following the initial dose. At steady state, 11% or less of the dose was eliminated in the urine as unchanged 5-ASA and 3% to 35% was eliminated as N-acetyl-5-ASA. |
| Volume of distribution | For the extended-release formulation, mesalazine has a Vd of 18 L, confirming minimal extravascular penetration of systemically available drug.For the delayed-release formulation, the apparent volume of distribution was estimated to be 4.8 L. |
| Clearance | The mean (SD) renal clearance in L/h for mesalazine following the single dose administration of mesalazine delayed-release tablets 4.8g under fasting conditions to young and elderly subjects were documented as 2.05 ± 1.33 in young subjects aged 18 to 35 years old, 2.04 ± 1.16 in elderly subjects aged 65 to 75 years old and 2.13 ± 1.20 in elderly subjects older than 75 years. |
Formulation & handling
- Oral products rely on pH‑dependent or time‑controlled release to limit upper‑GI absorption and deliver the small, hydrophilic API to the distal gut.
- High aqueous solubility and low logP support suspension, enema, foam, and gel formats for rectal delivery, with attention to preventing oxidation and maintaining uniform dispersion.
- Solid oral forms require coatings or matrix technologies that withstand gastric conditions and release in the intestine; handling is straightforward for a stable crystalline solid.
Regulatory status
| Lifecycle | In Canada the API is in a fully mature post‑patent market, as relevant protections expired by 2021, while in the United States limited exclusivity remains in place until 2027. Overall, the product shows advanced lifecycle maturity with only the US market retaining active patent coverage. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Mesalazine is supplied by multiple originator and established pharmaceutical companies, with a broad network of repackagers, indicating a mature and diversified manufacturing base. Branded products such as Apriso and Asacol are well established in the US and Canada, reflecting sustained market presence. Several key patents have already expired, and only one extends to 2027 in the US, suggesting that generic competition is already significant and likely to continue expanding as protections lapse. |
|---|
Safety
| Toxicity | Mesalazine caused no increase in the incidence of neoplastic lesions over controls in a two-year study of Wistar rats fed up to 320 mg/kg/day of mesalazine admixed with diet (about 1.7 times the recommended human intra-rectal dose of CANASA, based on body surface area). Mesalazine was not mutagenic in the Ames test, the mouse lymphoma cell (TK+/-) forward mutation test, or the mouse micronucleus test. No effects on fertility or reproductive performance of the male and female rats were observed at oral mesalamine doses up to 320 mg/kg/day (about 1.7 times the recommended human intra-rectal dose of mesalazine, based on body surface area). Mesalazine is an aminosalicylate, and symptoms of salicylate toxicity include nausea, vomiting and abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms (headache, dizziness, confusion, seizures). Severe salicylate intoxication may lead to electrolyte and blood pH imbalance and potentially to other organ involvement (e.g., renal and liver). There is no specific antidote for mesalamine overdose; however, conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage and may include gastrointestinal tract decontamination to prevent further absorption. Correct fluid and electrolyte imbalance by the administration of appropriate intravenous therapy and maintain adequate renal function. Mesalazine is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Evaluate renal function in all patients prior to initiation and periodically while on Asacol HD therapy. Monitor patients with known renal impairment or a history of renal disease or taking nephrotoxic drugs for decreased renal function and mesalamine-related adverse reactions. |
|---|
High Level Warnings:
- High-dose studies show no carcinogenic, mutagenic, or fertility effects in rodents, but salicylate‑class toxicities can occur at excessive exposure, including gastrointestinal, neurologic, and respiratory manifestations
- Severe salicylate intoxication may involve electrolyte and acid–base disturbances with potential renal and hepatic involvement
- No compound‑specific antidote is identified
Mesalazine is a type of Aminosalicylates
Aminosalicylates are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the treatment of various inflammatory bowel diseases (IBDs), including ulcerative colitis and Crohn's disease. These compounds exhibit anti-inflammatory properties that target the gastrointestinal tract, helping to alleviate symptoms and manage these chronic conditions effectively.
Aminosalicylates function by inhibiting the production of inflammatory mediators, such as prostaglandins and leukotrienes, which play a significant role in triggering inflammation in the gut. By reducing the levels of these compounds, aminosalicylates aid in the suppression of inflammation, leading to symptom relief and promoting mucosal healing.
Commonly prescribed aminosalicylates include mesalazine (also known as mesalamine), olsalazine, and sulfasalazine. These medications are available in various formulations, including oral tablets, capsules, and rectal suppositories or enemas. The choice of formulation depends on the severity and location of the disease within the gastrointestinal tract.
The use of aminosalicylates has been shown to effectively induce and maintain remission in patients with IBDs. They are generally well-tolerated, with few reported side effects. However, as with any medication, individuals may experience mild adverse reactions, such as nausea, abdominal discomfort, or headaches.
In conclusion, aminosalicylates are a crucial class of pharmaceutical APIs utilized in the treatment of inflammatory bowel diseases. Their anti-inflammatory properties and targeted action on the gastrointestinal tract make them valuable therapeutic options for managing these chronic conditions. Proper usage of aminosalicylates, as directed by healthcare professionals, can significantly improve the quality of life for individuals living with IBDs.
Mesalazine (Aminosalicylates), classified under Anti-inflammatory Agents
Anti-inflammatory agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used to treat various inflammatory conditions. These agents play a vital role in alleviating pain, reducing swelling, and controlling inflammation in the body. They are widely employed in the management of diverse medical conditions, including arthritis, autoimmune disorders, asthma, and skin conditions like dermatitis.
Anti-inflammatory APIs primarily function by inhibiting the production of specific enzymes called cyclooxygenases (COX) and lipoxygenases (LOX). These enzymes are responsible for the synthesis of pro-inflammatory molecules known as prostaglandins and leukotrienes, respectively. By suppressing the activity of COX and LOX, anti-inflammatory agents effectively curtail the production of these inflammatory mediators, thereby mitigating inflammation.
Common examples of anti-inflammatory APIs include non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, aspirin, and naproxen. These agents exhibit analgesic, antipyretic, and anti-inflammatory properties. Another group of anti-inflammatory APIs includes corticosteroids, such as prednisone and dexamethasone, which are synthetic hormones that modulate the body's immune response to control inflammation.
In conclusion, anti-inflammatory agents are a vital category of pharmaceutical APIs widely used to manage inflammation-related disorders. They target enzymes involved in the synthesis of pro-inflammatory molecules, effectively reducing pain and swelling. NSAIDs and corticosteroids are commonly prescribed anti-inflammatory APIs due to their efficacy in controlling inflammation.
Mesalazine API manufacturers & distributors
Compare qualified Mesalazine API suppliers worldwide. We currently have 28 companies offering Mesalazine API, with manufacturing taking place in 12 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| ACE Japan | Producer | Japan | Japan | CoA | 76 products |
| ALP PHARM | Producer | China | China | CoA, USDMF | 33 products |
| Bayer | Producer | Germany | Unknown | CEP, CoA, GMP | 42 products |
| BEC Chemicals | Producer | India | India | CEP, CoA, FDA, GMP, ISO9001, USDMF, WC, WHO-GMP | 2 products |
| Cambrex, Karlskoga | Producer | Sweden | Sweden | CEP, CoA, FDA, GMP | 8 products |
| Chemi S.p.A. | Producer | Italy | Italy | CEP, CoA, FDA, GMP, USDMF | 18 products |
| Corden Pharma | Producer | Germany | Italy | CEP, CoA, FDA, GMP, USDMF | 45 products |
| Divis Labs. | Producer | India | India | CEP, CoA, FDA, GMP, ISO9001, Other, JDMF, USDMF, WC | 47 products |
| Dr. Sahu's Laboratories | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, MSDS | 70 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Italy | CoA, GMP, ISO9001, MSDS, WC | 170 products |
| Erregierre | Producer | Italy | Italy | CEP, CoA, FDA, GMP, JDMF, USDMF | 44 products |
| Ferring Therapeutics | Producer | India | India | CoA, WC | 1 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Infar, S.A. | Producer | Spain | Spain | CoA, GMP | 7 products |
| Ipca Labs. | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 69 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lupin | Producer | India | India | CoA, GMP, USDMF, WC | 155 products |
| Maithri Drugs | Producer | India | India | CEP, CoA, GMP, USDMF, WC | 12 products |
| PharmaZell | Producer | Germany | Germany, India | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GDP, GMP, JDMF, KDMF, MSDS, USDMF, WC, WHO-GMP | 31 products |
| PLIVA | Producer | Czech Republic | Czech Republic | CEP, CoA | 31 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Signa | Producer | Mexico | Mexico | CoA, USDMF | 42 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001 | 762 products |
| Sun Pharma | Producer | India | India | CEP, CoA, JDMF, USDMF, WC | 219 products |
| Syntese | Producer | Denmark | Denmark | CEP, CoA, GMP | 1 products |
| Wanbury | Producer | India | India | CoA, USDMF | 15 products |
| Zhejiang Chengyi | Producer | China | China | CoA, WC | 5 products |
| Zhejiang Hengkang Pharmac... | Producer | China | China | BSE/TSE, cDMF, CEP, CoA, EDMF/ASMF, FDA, GMP, JDMF, KDMF, MSDS, USDMF, WC | 31 products |
When sending a request, specify which Mesalazine API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Mesalazine API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Mesalazine API
Sourcing
What matters most when sourcing GMP-grade Mesalazine?
When sourcing GMP‑grade Mesalazine, the key considerations are compliance with US and Canadian regulatory and GMP requirements and verification that the supplier operates within an established, qualified manufacturing network. The mature and diversified supply base requires confirming traceability through repackagers and originators. It is also important to ensure the intended use does not conflict with the remaining US patent protection that extends to 2027 for specific products.
Which documents are typically required when sourcing Mesalazine API?
Request the core API documentation set: CoA (27 companies), GMP (19 companies), CEP (16 companies), USDMF (15 companies), FDA (12 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Mesalazine API?
Known or reported manufacturers for Mesalazine: Duchefa Farma B.V., Global Pharma Tek, SETV Global, Dr. Sahu's Laboratories, LGM Pharma, PharmaZell, Zhejiang Hengkang Pharmaceutical Co. Ltd. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Mesalazine API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Mesalazine manufacturers?
Audit reports may be requested for Mesalazine: 9 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Mesalazine API on Pharmaoffer?
Reported supplier count for Mesalazine: 27 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Mesalazine API?
Production countries reported for Mesalazine: India (11 producers), Italy (4 producers), China (3 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Mesalazine usually hold?
Common certifications for Mesalazine suppliers: CoA (27 companies), GMP (19 companies), CEP (16 companies), USDMF (15 companies), FDA (12 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Mesalazine (CAS 89-57-6) used for?
Mesalazine is used to treat mildly to moderately active ulcerative colitis in adults and children from 5 years of age and to maintain remission in ulcerative colitis. It is also used for maintenance therapy in Crohn’s ileocolitis. Its effect is localized to the intestinal mucosa, where it reduces inflammatory mediator production and modulates pathways involved in chronic mucosal inflammation.
Which therapeutic class does Mesalazine fall into?
Mesalazine belongs to the following therapeutic categories: Agents causing hyperkalemia, Agents that produce hypertension, Aminosalicylate, Aminosalicylic Acids, Analgesics. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Mesalazine mainly prescribed for?
The primary indications for Mesalazine: Mesalazine is indicated for the treatment of mildly to moderately active ulcerative colitis in adults and patients 5 years or older, Mesalazine is also indicated for the maintenance of remission of ulcerative colitis in adults and maintenance of remission of Crohn's ileocolitis. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Mesalazine work?
Although the mechanism of action of Mesalazine is not fully understood, it is believed to possess a topical anti-inflammatory effect on colonic epithelial cells.Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with chronic inflammatory bowel disease, and it is possible that Mesalazine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.
Furthermore, Mesalazine also has the potential to inhibit the activation of Nuclear Factor kappa B (NFkB) and consequently the production of key pro-inflammatory cytokines.It has been proposed that reduced expression of PPAR gamma nuclear receptors (gamma form of peroxisome proliferator-activated receptors) may be implicated in ulcerative colitis, and that Mesalazine produces pharmacodynamic effects through direct activation of PPAR gamma receptors in the colonic/rectal epithelium.Other research also showed the potential involvement of inducible NO synthase (iNOS) and that Mesalazine can inhibit this enzyme to amiliorate the enteropathy in inflammatory bowel diseases.
Moreover, since increased leukocyte migration, abnormal cytokine production, increased production of arachidonic acid metabolites, particularly leukotriene B4, and increased free radical formation in the inflamed intestinal tissue are all present in patients with inflammatory bowel disease it is also believed that Mesalazine has in-vitro and in-vivo pharmacological effects that inhibit leukocyte chemotaxis, decrease cytokine and leukotriene production and scavenge for free radicals.
What should someone know about the safety or toxicity profile of Mesalazine?
Mesalazine is generally well tolerated, but it can cause nephrotoxicity, including interstitial nephritis, particularly with long‑term use. Hypersensitivity reactions and gastrointestinal intolerance may occur, and cross‑sensitivity should be considered due to its salicylate structure. At excessive exposure, salicylate‑class toxicities may develop, with gastrointestinal, neurologic, respiratory, electrolyte, and acid–base disturbances, and possible renal or hepatic involvement; no specific antidote is identified. Limited systemic absorption reduces systemic toxicity, but monitoring renal function is an important safety measure.
What are important formulation and handling considerations for Mesalazine as an API?
Important considerations include selecting a release system that limits upper‑GI absorption and targets drug delivery to the distal intestine, such as pH‑dependent coatings or time‑controlled matrices. The API’s high aqueous solubility and low logP support suspensions and rectal formulations, which require measures to prevent oxidation and maintain uniform dispersion. Solid oral dosage forms need coatings that remain intact in gastric conditions. Handling is uncomplicated due to the stable crystalline nature of the API.
Is Mesalazine a small molecule?
Mesalazine is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Mesalazine?
Oral Mesalazine requires protection from gastric conditions because targeted delivery to the distal intestine depends on pH‑dependent or time‑controlled release systems. The API is a stable crystalline solid, but coatings or matrix technologies must remain intact in the upper GI tract to prevent premature absorption. Formulations also need to limit oxidation and maintain consistent release performance.
Regulatory
Where is Mesalazine approved or in use globally?
Mesalazine is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Mesalazine right now?
Mesalazine is regulated in both Canada and the United States, where it is approved for use under established national frameworks. The provided context does not indicate any active patent protections, suggesting it is treated as an established ingredient without referenced exclusivity barriers.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Mesalazine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Mesalazine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Mesalazine included in the PRO Data Insights coverage?
PRO Data Insights coverage for Mesalazine: 1506 verified transactions across 220 suppliers and 131 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Mesalazine?
Market report availability for Mesalazine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
