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mesalamine granules
mesalamine granules is a aminosalicylate Small molecule drug developed by Dr. Falk Pharma GmbH. It is currently in Phase 3 development for Mild to moderate ulcerative colitis, Moderate to severe ulcerative colitis. Also known as: Salofalk granules, Mesalazine, Rowasa.
Mesalamine works by releasing aminosalicylates in the colon to reduce inflammation and prevent symptoms of ulcerative colitis.
Mesalamine works by releasing aminosalicylates in the colon to reduce inflammation and prevent symptoms of ulcerative colitis. Used for Mild to moderate ulcerative colitis, Moderate to severe ulcerative colitis.
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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 | mesalamine granules |
|---|---|
| Also known as | Salofalk granules, Mesalazine, Rowasa |
| Sponsor | Dr. Falk Pharma GmbH |
| Drug class | aminosalicylate |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Mesalamine is a type of aminosalicylate that is released in the colon, where it reduces inflammation and prevents symptoms of ulcerative colitis. This is achieved by inhibiting the production of pro-inflammatory mediators and reducing the adhesion of leukocytes to the intestinal mucosa.
Approved indications
- Mild to moderate ulcerative colitis
- Moderate to severe ulcerative colitis
Common side effects
- Diarrhea
- Nausea
- Abdominal pain
- Headache
- Fatigue
Key clinical trials
- Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome (PHASE2)
- Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC) (PHASE3)
- Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC) (PHASE3)
- Study of the Effectiveness of ETIASA® (Sustained Release 5-Aminosalicylate) in Maintenance Treatment of Ulcerative Colitis (UC)
- Mesalamine Pellet to Maintain Remission of Mild to Moderate Ulcerative Colitis (PHASE3)
- Mesalamine Pellet Formulation to Maintain Remission of Mild to Moderate Ulcerative Colitis (PHASE3)
- Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea (PHASE2)
- PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers (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:
- mesalamine granules CI brief — competitive landscape report
- mesalamine granules updates RSS · CI watch RSS
- Dr. Falk Pharma GmbH portfolio CI
Frequently asked questions about mesalamine granules
What is mesalamine granules?
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Is mesalamine granules also known as anything else?
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Related
- Drug class: All aminosalicylate drugs
- Manufacturer: Dr. Falk Pharma GmbH — full pipeline
- Therapeutic area: All drugs in Gastroenterology
- Indication: Drugs for Mild to moderate ulcerative colitis
- Indication: Drugs for Moderate to severe ulcerative colitis
- Also known as: Salofalk granules, Mesalazine, Rowasa
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing