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Trulance Approval History

FDA Approved: Yes (First approved January 19, 2017)
Brand name: Trulance
Generic name: plecanatide
Dosage form: Tablets
Company: Synergy Pharmaceuticals Inc.
Treatment for: Constipation, Chronic, Irritable Bowel Syndrome

Trulance (plecanatide) is a guanylate cyclase-C agonist for the treatment of chronic idiopathic constipation, and irritable bowel syndrome with constipation (IBS-C).

Development History and FDA Approval Process for Trulance

DateArticle
Jan 25, 2018Approval Synergy Pharmaceuticals Announces FDA Approval of Trulance (plecanatide) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in Adults
Jan 19, 2017Approval FDA Approves Trulance (plecanatide) for Chronic Idiopathic Constipation
Dec  9, 2016Synergy Pharmaceuticals Announces Positive Results in First Phase 3 Trial of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IBS-C)
Jul 15, 2016Synergy Pharmaceuticals Provides Update on Ongoing FDA Review of Plecanatide CIC NDA and IBS-C Clinical Development Program
Apr 19, 2016Synergy Pharmaceuticals Announces Acceptance of NDA for Plecanatide, a Novel Uroguanylin Analog, in Chronic Idiopathic Constipation
Jan 29, 2016Synergy Pharmaceuticals Files NDA for Plecanatide in Chronic Idiopathic Constipation
Jun 23, 2015Synergy Pharmaceuticals Initiates Second Phase 3 Clinical Trial of Plecanatide in Patients with IBS with Constipation
Oct 21, 2014Synergy Pharmaceuticals Presents Positive Phase 2b Study Results for Plecanatide in IBS with Constipation
May 21, 2013Synergy Pharmaceuticals Presents Plecanatide Results From a Large Multicenter Clinical Study at Late-Breaking Abstract Session During Digestive Disease Week 2013
Jan  2, 2013Synergy Announces Positive Results From Plecanatide Phase IIb/III Trial in Patients With Chronic Idiopathic Constipation
Oct  6, 2010Synergy Pharmaceuticals Announces Positive Phase IIa Results with Plecanatide to Treat Chronic Constipation

Further information

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