Linaclotide

For constipation (IBS-C). Sold as Linzess. Every FDA application for this active ingredient: 1 branded and 3 generic.

As of Nov 14, 2026, FDA lists 4 applications for Linaclotide (sold as Linzess), first approved Aug 30, 2012, with 5 new uses approved and 0 published complete response letters.

First approved: Aug 30, 2012
Applications: 4
New uses approved: 5
Complete response letters: 0
Medicare spending, 2025: $2.35B
First approved in the EU: Nov 26, 2012
First approved in Japan: Dec 19, 2016

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Linzess	Part D	$2.35B	+18%	692,734

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

LINZESS 145 MCG CAPSULE: $9.02 per unitBrand · -50% in a year
LINZESS 290 MCG CAPSULE: $9.01 per unitBrand · -50% in a year
LINZESS 72 MCG CAPSULE: $9.01 per unitBrand · -50% in a year

Approvals in the EU (EMA)

First approved in the EU 3 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Constella, new substanceAbbVie Deutschland GmbH & Co. KG · Nov 26, 2012

Approvals in Japan (PMDA)

First approved in Japan 52 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

LinzessA drug with a new additional indication for the treatment of chronic constipation (excluding constipation due to organic diseases). · Astellas Pharma Inc. · Aug 21, 2018
Linzess, new ingredientA drug with a new active ingredient indicated for the treatment of irritable bowel syndrome with constipation. · Astellas Pharma Inc. · Dec 19, 2016

Clinical Trials

6 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


MRI Parameters as Biomarkers in Cystic Fibrosis (FEMPTO)Cystic Fibrosis (CF) · University of Nottingham	Not applicable	Not yet recruiting	Aug 21, 2026
Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic FibrosisCystic Fibrosis (CF) · University of Nottingham	Early phase 1	Recruiting	May 6, 2026
"Efficacy and Safety of Linaclotide in Chronic Constipation"Chronic Idiopathic Constipation, Irritable Bowel Syndrome (IBS-C) · Md Mehedi Shahriar	Phase 4	Not yet recruiting	Feb 25, 2026
A Study of Virtual Reality and Linaclotide for IBS-CIrritable Bowel Syndrome With Constipation · Mayo Clinic	Not applicable	Recruiting	Apr 3, 2023
Linaclotide in Treating Patients With Stages 0-3 Colorectal CancerColorectal Adenoma, Stage 0 Colorectal Cancer AJCC v8 · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University	Phase 2	Active, not recruiting	Jan 8, 2019
Efficacy of Linaclotide in Type II Diabetics With Chronic ConstipationChronic Constipation, Diabete Mellitus · Texas Tech University Health Sciences Center, El Paso	Phase 4	Active, not recruiting	Apr 18, 2017

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Aug 30, 2012	LinzessNDA 202811 · New molecular entity	Abbvie	19	Marketed
Feb 9, 2021	LinaclotideANDA 209564	Mylan	3	Discontinued
Feb 7, 2023	LinaclotideANDA 209611	Aurobindo Pharma	0	Discontinued
Sep 24, 2026	LinaclotideANDA 211255	Actavis Labs Fl	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA