Drugs / Sulindac

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) CLINORIL 1978-09-27 fda.gov

Trials 20 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT01515137 Nov 2005 → Sep 2014 head and neck squamous cell carcinoma University of Pittsburgh Completed No outcome recorded
Phase 1 NCT00245024 Nov 2005 → Aug 2007 breast cancer National Cancer Institute (NCI) Completed No outcome recorded
Phase 211 trials
Phase 2 NCT04207944 Jul 2020 → Jul 2026 overdue pancreatic intraductal papillary-mucinous neoplasm Duke University Active not recruiting No outcome recorded
Phase 2 NCT01636128 Mar 2014 → Mar 2016 Cancer Prevention Pharmaceuticals, Inc. Withdrawn No outcome recorded
Phase 2 NCT01843179 Jan 2014 acute myeloid leukemia Massachusetts General Hospital Withdrawn No outcome recorded
Phase 2 NCT01761877 Dec 2012 → Feb 2019 cancer, hypertensive disorder Stony Brook University Completed No outcome recorded
Phase 2 NCT00841204 Feb 2009 → Feb 2011 precancerous condition National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT00755976 Aug 2007 → May 2010 cutaneous melanoma Cancer Trials Ireland Completed No outcome recorded
Phase 2 NCT00368927 Aug 2006 → May 2010 nicotine dependence, non-small cell lung carcinoma, precancerous condition National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT00319007 Apr → Dec 2006 classic or attenuated familial adenomatous polyposis Radboud University Medical Center Unknown No outcome recorded
Phase 2 NCT00335504 Mar 2006 → Apr 2009 colon carcinoma, precancerous condition, rectal carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT00068419 Feb 2004 → Apr 2010 desmoid tumor Children's Oncology Group Completed No outcome recorded
Phase 33 trials
Phase 3 NCT01349881 Aug 2013 → Sep 2027 expected colorectal neoplasm SWOG Cancer Research Network Active not recruiting No outcome recorded
Phase 3 NCT01245816 Mar 2011 → May 2013 classic familial adenomatous polyposis Cancer Prevention Pharmaceuticals, Inc. Withdrawn No outcome recorded
Phase 3 NCT00118365 Jul 1998 → Aug 2008 precancerous condition National Cancer Institute (NCI) Completed No outcome recorded
Phase not applicable4 trials
NCT00343629 Apr 2006 → Oct 2007 cancer of unknown primary site Mayo Clinic Completed No outcome recorded
NCT00299195 Feb 2006 → Jan 2020 benign neoplasm, oral mucosa leukoplakia Memorial Sloan Kettering Cancer Center Completed No outcome recorded
NCT00176618 Apr 2004 → Jun 2007 University of Medicine and Dentistry of New Jersey Terminated No outcome recorded
NCT00003365 Aug 1996 → Jul 2006 colorectal cancer University of Medicine and Dentistry of New Jersey Terminated No outcome recorded
Also used as a comparator or background therapy in 6 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 26 trials
Phase 2 NCT04823052 Comparator May → Oct 2022 fragile X syndrome Healx Limited Withdrawn No outcome recorded
Phase 2 NCT04542135 Comparator Nov 2020 → Apr 2025 breast cancer Alison Stopeck Completed No outcome recorded
Phase 2 NCT01856322 Comparator Apr 2013 → Jan 2015 colorectal adenocarcinoma, metastasis from malignant tumor of colon National Cancer Institute (NCI) Terminated No outcome recorded
Phase 2 NCT01187901 Comparator Apr 2010 → Jun 2014 classic or attenuated familial adenomatous polyposis University of Utah Completed No outcome recorded
Phase 2 NCT00392665 Comparator Oct 2006 → Aug 2012 head and neck squamous cell carcinoma Massachusetts General Hospital Terminated No outcome recorded

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 27 sources stand behind the page.

FieldValueCited text
Known as Sulindac “Erlotinib (150 mg PO QD) plus sulindac (150 mg PO BID) (Arm A)” NCT01515137
25

NCT00319007

NCT00068419

NCT01843179

NCT00062023

NCT01856322

NCT00392665

NCT04207944

NCT01636128

NCT00245024

NCT01187901

NCT00368927

NCT04823052

NCT01761877

NCT00039520

NCT00841204

NCT00118365

NCT01349881

NCT00343629

NCT00299195

NCT00003365

NCT00335504

NCT00176618

NCT01245816

NCT04542135

NCT00755976

Known as Arthrocine ChEMBL registry synonym — accepted as the source's own label CHEMBL15770
Known as Artribid ChEMBL registry synonym — accepted as the source's own label CHEMBL15770
Known as Clinoril ChEMBL registry synonym — accepted as the source's own label CHEMBL15770
Known as HLX-0201 “Sulindac (HLX-0201) Capsule” NCT04823052
Known as MK-231 ChEMBL registry synonym — accepted as the source's own label CHEMBL15770
Known as NSC-757344 ChEMBL registry synonym — accepted as the source's own label CHEMBL15770
Known as Sulindaco ChEMBL registry synonym — accepted as the source's own label CHEMBL15770
Action Inhibit “Sulindac may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.” NCT00068419
Modality Small molecule “Sulindac is a non-steroidal, anti-inflammatory indene derivative designed for the treatment of arthritic conditions.” NCT01187901
Route Oral oral sulindac twice a day” NCT00003365