TrulanceChronic idiopathic constipation
Development and Regulatory status
Jan 17. Approved in US
Jan 16: Filed in the US.
Jul 15: Synergy announced plans to file an NDA in January 2016
Jun 15: Synergy plans to file plecanatide for FDA approval using pooled data from 2 studies in Q4 2015
May 13: PIII programme to start 2H 2013
PII/III US study to start Oct 11
Jan 11: A PII/III study is planned to start 2Q 2011
Trial or other data
Feb 17: Results of (NCT01982240) published in American Journal of Gastroenterology .
May 16: Synergy announces positive data from two phase III trials (n=2683) showing that treatment of chronic idiopathic constipation with plecanatide met the primary endpoint and demonstrated statistical significance in the proportion of patients who achieved a complete spontaneous bowel movement (p<0.004) 
Jul 15: Synergy announces positive top-line results from the pivotal PIII study (NCT02122471) evaluating the efficacy and safety of plecanatide 3mg and 6mg daily in 1337 adult pts with CIC. Both doses met the primary endpoint (proportion of durable overall responders) over 12 weeks vs. placebo. The durable response rate was 20% in patients taking 3mg and 6mg vs. 12.8% in placebo (p=0.004 for both doses vs. placebo). Both doses also showed statistically significant improvement for the secondary endpoint; Bristol Stool Form Scale (BSFS) scores compared to placebo (mean increase of 1.49 in 3mg and 1.5 in 6mg compared to 0.87 in placebo; p<0.001). Plecanatide was safe and well tolerated at both doses; the most common adverse event was diarrhoea. 20 pts (1.4%) in the trial experienced serious adverse events but there was no imbalance across treatment groups in either incidences or individual serious adverse events and discontinuations due to diarrhoea were infrequent 
Jun 15: Synergy announce PIII trial in more than 1,300 adults with CIC. Both doses of plecanatide significantly beat placebo in eliciting durable overall responses, which are defined by the FDA as at least three spontaneous bowel movements a week and a net increase of one bowel movement compared to baseline for 9 of the study´s 12 weeks. The durable response rate was 21% for patients taking 3 mg of Synergy´s drug and 19.5% for those getting twice that, each beating placebo´s 10.2%. Plecanatide also came through on its secondary endpoint of stool consistency, with each dose clocking a statistically significant improvement in Bristol Stool Form Scale scores compared to placebo. There was no imbalance of serious side effects between the three treatment groups, and rates of discontinuation were low for both plecanatide doses. Top-line data from a second study is expected in the next few weeks 
Mar 15: Three PIII studies are on-going but have completed recruitment. All are due to complete in 2015 
Apr 14: NCT02122471 is a, randomized, 12-week, double-blind, placebo-controlled study to assess the safety and efficacy of plecanatide (3 and 6mg) in 1350 patients with chronic idiopathic constipation. The primary outcome is the proportion of patients who are overall responders ( defined as a weekly responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks. A weekly responder is defined as a patient who has ≥ 3 Complete Spontaneous Bowel Movements (CSBMs) per week and an increase from baseline of ≥1 CSBM for that week). The study starts Apr 14 and is due to complete Aug 15 
Nov 13: The first of two planned PIII clinical trials in adult patients with chronic idiopathic constipation (CIC) has started. This pivotal trial is a randomised, double-blind RCT (n=1350)which compares a 12-week, dose-ranging regimen of plecanatide (3.0 and 6.0mg) against placebo in adult patients with CIC in the US and Canada. The primary endpoint of the study is the proportion of patients who are overall responders for the 12-week treatment period.