dolcanatide (SLX-G1039) / Bausch Health - LARVOL DELTA

Phase I double-blind, placebo-controlled trial of dolcanatide (SP-333) 27 mg to explore colorectal bioactivity in healthy volunteers. (PubMed, Cancer Biol Ther) - "Previous studies revealed that linaclotide, an oral GUCY2C agonist formulated for gastric release, did not persist to activate guanylyl cyclase signaling in the distal rectum. These data reveal that the enhanced stability of dolcanatide, with persistence along the rostral-caudal axis of the small and large intestine, is inadequate to regulate GUCY2C across the colorectum to prevent tumorigenesis. These results highlight the importance of developing a GUCY2C agonist for cancer prevention formulated for release and activity targeted to the colorectum."

Clinical • Journal • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers (clinicaltrials.gov) - P1; N=27; Completed; Sponsor: National Cancer Institute (NCI); Active, not recruiting ➔ Completed; Trial completion date: Apr 2022 ➔ May 2021

Trial completion • Trial completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers (clinicaltrials.gov) - P1; N=27; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Trial completion date: Apr 2021 ➔ Apr 2022

Clinical • Trial completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Synergy Pharmaceuticals announces SP-333 data presentation at the 17th Neurogastroenterology & Motility Scientific Meeting (Synergy Press Release) - "Synergy Pharmaceuticals...today announced a poster presentation on SP-333...will be featured at the 17th Neurogastroenterology & Motility Scientific Meeting being held September 20-22, 2013 at the Hyatt Regency Resort & Spa in Huntington Beach, California. Poster: SP-333, a GC-C agonist, ameliorates GI inflammation via a cyclic GMP mediated mechanism to downregulate IKK and NF-KappaB (106)."

Anticipated conference • Inflammatory Bowel Disease

Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC) (clinicaltrials.gov) - P2; N=260; Completed; Sponsor: Synergy Pharmaceuticals Inc.; Active, not recruiting ➔ Completed

Trial completion • Biosimilar • CNS Disorders • Demo Pain • Oncology • Pain

Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers (clinicaltrials.gov) - P1; N=27; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Trial completion date: Apr 2020 ➔ Apr 2021

Clinical • Trial completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers (clinicaltrials.gov) - P1; N=27; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Trial completion date: Apr 2019 ➔ Apr 2020

Clinical • Trial completion date

Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers (clinicaltrials.gov) - P1; N=27; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Active, not recruiting; Trial primary completion date: Apr 2019 ➔ Jan 2019

Clinical • Enrollment closed • Trial primary completion date