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Tofacitinib plus mesalamine
Tofacitinib plus mesalamine is a JAK inhibitor plus aminosalicylate Small molecule drug developed by Post Graduate Institute of Medical Education and Research, Chandigarh. It is currently FDA-approved for Ulcerative colitis.
Tofacitinib inhibits JAK kinases to reduce inflammatory signaling, while mesalamine acts as a topical anti-inflammatory in the colon.
Tofacitinib plus mesalamine is being studied as a treatment for ulcerative colitis and other inflammatory bowel diseases. A clinical trial, NCT06625450, is comparing the effectiveness of tofacitinib alone versus tofacitinib in combination with mesalamine for maintaining remission in ulcerative colitis.
At a glance
| Generic name | Tofacitinib plus mesalamine |
|---|---|
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh |
| Drug class | JAK inhibitor plus aminosalicylate |
| Target | JAK1/JAK3 (tofacitinib); unclear specific target for mesalamine (likely prostaglandin-related) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
Tofacitinib is a JAK inhibitor that suppresses T-cell activation and pro-inflammatory cytokine production systemically. Mesalamine (5-aminosalicylic acid) provides local anti-inflammatory effects in the intestinal mucosa. The combination targets both systemic and local inflammation in inflammatory bowel disease.
Approved indications
- Ulcerative colitis
Common side effects
- Infections (upper respiratory, urinary tract)
- Headache
- Diarrhea
- Nausea
- Elevated cholesterol
- Elevated liver enzymes
Key clinical trials
- Determination of the Optimal Treatment Target in Ulcerative Colitis (PHASE4)
- Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib (PHASE4)
- TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS (PHASE4)
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:
- Tofacitinib plus mesalamine CI brief — competitive landscape report
- Tofacitinib plus mesalamine updates RSS · CI watch RSS
- Post Graduate Institute of Medical Education and Research, Chandigarh portfolio CI
Frequently asked questions about Tofacitinib plus mesalamine
What is Tofacitinib plus mesalamine?
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What does Tofacitinib plus mesalamine target?
Related
- Drug class: All JAK inhibitor plus aminosalicylate drugs
- Target: All drugs targeting JAK1/JAK3 (tofacitinib); unclear specific target for mesalamine (likely prostaglandin-related)
- Manufacturer: Post Graduate Institute of Medical Education and Research, Chandigarh — full pipeline
- Therapeutic area: All drugs in Immunology / Gastroenterology
- Indication: Drugs for Ulcerative colitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing