Dolcanatide

Dolcanatide is our second lead product candidate currently being explored for ulcerative colitis. Dolcanatide is designed to replicate the activity of uroguanylin, a naturally occurring human gastrointestinal peptide, with enhanced resistance to standard digestive breakdown by proteases in the intestine.

In January 2016, we announced positive proof-of-concept with dolcanatide in a phase 1b trial evaluating 28 patients with mild-to-moderate ulcerative colitis. We are planning to meet with regulatory agencies to discuss next steps in development for dolcanatide in mild-to-moderate ulcerative colitis.

In November 2014, we reported successful proof-of-concept with dolcanatide in a double-blind, placebo-controlled phase 2 trial in 289 patients with opioid induced constipation ("OIC"), showing the utility of our uroguanylin based GI platform in OIC. We are considering OIC as a potential life cycle growth opportunity for TRULANCE™ (plecanatide). 

Learn more information about our dolcanatide clinical trials here.

Uroguanylin Analog
Discovery Phase 1 Phase 2 Phase 3 NDA Filings Market
Dolcanatide (SP-333)
OIC Phase 2 Phase completed for OIC
Phase 2 Phase completed for OIC
Phase 2 Phase completed for OIC
Phase 2 Phase completed for OIC
Phase 2 Phase completed for OIC
Phase 2 Phase completed for OIC
UC Phase 1b Phase completed for UC
Phase 1b Phase completed for UC
Phase 1b Phase completed for UC
Phase 1b Phase completed for UC
Phase 1b Phase completed for UC
Phase 1b Phase completed for UC

Status of Dolcanatide Clinical Programs

  • Positive proof-of-concept study in patients with opioid-induced constipation (OIC) completed in November 2014
  • Positive proof-of-concept study in patients with ulcerative colitis (UC) completed in January 2016

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