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