Sulindac has been evaluated across numerous clinical trials spanning Phase I through Phase III, investigating monotherapy and combination regimens for chemoprevention and disease intervention. These studies encompass oncology and non-oncology conditions, including adenomatous polyposis coli, colorectal cancer, head and neck squamous cell carcinoma, breast cancer, acute myeloid leukemia, and fragile X syndrome. Sponsored by academic institutions and biopharmaceutical entities—including the National Cancer Institute, Massachusetts General Hospital, and Cancer Prevention Pharmaceuticals Inc.—trial statuses range from active and completed to terminated or withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT01349881 | ACTIVE_NOT_RECRUITING | Colorectal Neoplasms |
SWOG Cancer Research Network |
2013-08-23 | PHASE3 |
| NCT04207944 | ACTIVE_NOT_RECRUITING | IPMN; IPMN, Pancreatic |
Duke University |
2020-07-10 | PHASE2 |
| NCT04542135 | COMPLETED | Breast Cancer |
Alison Stopeck |
2020-11-20 | PHASE2 |
| NCT04823052 | WITHDRAWN | Fragile X Syndrome |
Healx Limited |
2022-05-25 | PHASE2 |
| NCT00299195 | COMPLETED | Leukoplakia, Oral; Benign Neoplasms |
Memorial Sloan Kettering Cancer Center |
2006-02-23 | |
| NCT01761877 | COMPLETED | Inflammation; Cancer; Pain; Hypertension |
Stony Brook University |
2012-12 | PHASE2 |
| NCT01483144 | COMPLETED | Familial Adenomatous Polyposis |
Cancer Prevention Pharmaceuticals, Inc. |
2013-10 | PHASE3 |
| NCT01636128 | WITHDRAWN | Focus of Study: Drug Response Biomarkers, Chemoprevention, Neoplasms |
Cancer Prevention Pharmaceuticals, Inc. |
2014-03 | PHASE2 |
| NCT01856322 | TERMINATED | Colorectal Cancer; Liver Metastasis; Colorectal Adenocarcinoma |
National Cancer Institute (NCI) |
2013-04 | PHASE2 |
| NCT01515137 | COMPLETED | Head and Neck Squamous Cell Carcinoma |
University of Pittsburgh |
2005-11 | PHASE1 |
| NCT01187901 | COMPLETED | Adenomatous Polyposis Coli |
University of Utah |
2010-04 | PHASE2 |
| NCT01636128 | Withdrawn | Focus of Study: Drug Response Biomarkers Chemoprevention Neoplasms |
Cancer Prevention Pharmaceuticals Inc.|University of Arizona |
2014-03 | Phase 2 |
| NCT01843179 | WITHDRAWN | Acute Myeloid Leukemia |
Massachusetts General Hospital |
2014-01 | PHASE2 |
| NCT01843179 | Withdrawn | Acute Myeloid Leukemia |
Massachusetts General Hospital |
2014-01 | Phase 2 |
| NCT01245816 | WITHDRAWN | Familial Adenomatous Polyposis |
Cancer Prevention Pharmaceuticals, Inc. |
2011-03 | PHASE3 |
| NCT00392665 | TERMINATED | Squamous Cell Carcinoma of the Head and Neck (SCCHN) |
Massachusetts General Hospital |
2006-10 | PHASE2 |
| NCT00841204 | COMPLETED | Precancerous Condition |
National Cancer Institute (NCI) |
2009-02 | PHASE2 |
| NCT00755976 | COMPLETED | Melanoma (Skin) |
Cancer Trials Ireland |
2007-08 | PHASE2 |
| NCT00368927 | COMPLETED | Precancerous Condition; Stage I Non-small Cell Lung Cancer; Tobacco Use Disorder |
National Cancer Institute (NCI) |
2006-08 | PHASE2 |
| NCT00068419 | COMPLETED | Desmoid Tumor |
Children's Oncology Group |
2004-02 | PHASE2 |
| NCT00335504 | COMPLETED | Colon Cancer; Precancerous Condition; Rectal Cancer |
National Cancer Institute (NCI) |
2006-03 | PHASE2 |
| NCT00118365 | COMPLETED | Precancerous Condition |
National Cancer Institute (NCI) |
1998-07 | PHASE3 |
| NCT00245024 | COMPLETED | Breast Cancer |
National Cancer Institute (NCI) |
2005-11 | PHASE1 |
| NCT00176618 | TERMINATED | Aberrant Crypt Foci |
University of Medicine and Dentistry of New Jersey |
2004-04 | |
| NCT00392665 | Terminated | Squamous Cell Carcinoma of the Head and Neck (SCCHN) |
Massachusetts General Hospital|Dana-Farber Cancer Institute|Emory University|University of North Carolina Chapel Hill|Genentech Inc.|OSI Pharmaceuticals |
2006-10 | Phase 2 |
| NCT00003365 | TERMINATED | Colorectal Cancer |
University of Medicine and Dentistry of New Jersey |
1996-08 | |
| NCT00062023 | TERMINATED | Colorectal Cancer |
M.D. Anderson Cancer Center |
2003-06 | PHASE2 |
| NCT00039520 | COMPLETED | Breast Cancer |
Fox Chase Cancer Center |
2002-01 | PHASE2 |
| NCT00319007 | UNKNOWN | Adenomatous Polyposis Coli |
Radboud University Medical Center |
2006-04 | PHASE2 |
| NCT00343629 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
Mayo Clinic |
2006-04 |
(data from https://clinicaltrials.gov, updated on 2026-04-02)
Check the
Sulindac
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.