Sulindac (Clinoril)

Other Medications · Approved since 1978

US Off-label EU EMA Approved ES Hospital use off-label in CRC Oral 7 Clinical Trials
COX-1 COX-2

Description

Sulindac is a nonsteroidal anti-inflammatory drug (NSAID) that has demonstrated chemopreventive properties in colorectal cancer prevention, particularly in patients with familial adenomatous polyposis (FAP) and those at high risk for developing colorectal adenomas. This medication is used off-label for chemoprevention to reduce the formation and growth of colorectal polyps and adenomas. Sulindac is often combined with eflornithine (DFMO) in clinical protocols for enhanced polyp prevention in high-risk populations.

Mechanism of Action

Sulindac works primarily through inhibition of cyclooxygenase (COX) enzymes, particularly COX-2, which reduces prostaglandin synthesis and inflammation in the colorectal mucosa. The drug's chemopreventive effects are attributed to its ability to induce apoptosis in precancerous cells, inhibit angiogenesis, and reduce inflammatory pathways that promote adenoma formation and progression to malignancy.

Molecular Targets

Side Effects

Gastrointestinal upset Nausea Abdominal pain Diarrhea Dizziness Headache Fluid retention Elevated liver enzymes

Not all side effects are listed. Side effects vary by individual. Always consult your oncologist.

Clinical Trials

NCT01483144 Phase 3
Archived
Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)
United States, Belgium, Canada, Germany, Netherlands, Spain, United Kingdom
NCT01349881 Phase 3
Active, not recruiting
S0820, Adenoma and Second Primary Prevention Trial
United States
NCT01856322 Phase 2
Archived
Surgery Plus Sulindac or Surgery Alone for Advanced Colorectal Cancer
United States
NCT01187901 Phase 2
Archived
A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients
United States
NCT00335504 Phase 2
Archived
Atorvastatin Calcium, Oligofructose-Enriched Inulin, or Sulindac in Preventing Cancer in Patients at Increased Risk of Developing Colorectal Neoplasia
United States
NCT00176618 Not Applicable
Archived
The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon
United States
View all 7 clinical trials →