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Linzess · pharmadog

pharmadog
drugs
Linzess

drug

patient view →

linaclotide

Marketedupdated 2mo ago

by $ABBV AbbVie Inc.

Approved

community read0 votes

Protein drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 3 investigational indications.

all catalysts(19)

approval · 19

LINZESS (LINACLOTIDE) — FDA approval

LINZESS (LINACLOTIDE) — FDA approval

LINZESS (LINACLOTIDE) — FDA approval

LINZESS (LINACLOTIDE) — FDA approval

LINZESS (LINACLOTIDE) — FDA approval

LINZESS (LINACLOTIDE) — FDA approval

LINZESS (LINACLOTIDE) — FDA approval

LINZESS (LINACLOTIDE) — FDA approval

LINZESS (LINACLOTIDE) — FDA approval

LINZESS (LINACLOTIDE) — FDA approval

LINZESS (LINACLOTIDE) — FDA approval

LINZESS (LINACLOTIDE) — FDA approval

LINZESS (LINACLOTIDE) — FDA approval

LINZESS (LINACLOTIDE) — FDA approval

LINZESS (LINACLOTIDE) — FDA approval

LINZESS (LINACLOTIDE) — FDA approval

LINZESS (LINACLOTIDE) — FDA approval

LINZESS (LINACLOTIDE) — FDA approval

LINZESS (LINACLOTIDE) — FDA approval

view all 19 catalysts →

News(0)

no news has mentioned this drug yet

brand

Linzess

generic

linaclotide

MOA

12.1 Mechanism of Action Linaclotide is structurally related to human guanylin and uroguanylin and functions as a guanylate cyclase-C (GC-C) agonist. Both linaclotide and its active metabolite bind to GC-C and act locally on the luminal surface of the intestinal epithelium. Activation of GC-C results in an increase in both intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP). Elevation in intracellular cGMP stimulates secretion of chloride and bicarbonate into the intestinal lumen, mainly through activation of the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel, resulting in increased intestinal fluid and accelerated transit. In animal models, linaclotide has been shown to both accelerate GI transit and reduce intestinal pain. In an animal model of visceral pain, linaclotide reduced abdominal muscle contraction and decreased the activity of pain-sensing nerves by increasing extracellular cGMP.

indication

Constipation

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 31m ago

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$ABBV254.76-2.42%

Patent cliff

source: FDA Orange Book

first barrier falls

Aug 30, 2026

54 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (30)

Feb 16, 2034patentUS 9708371*PED
Feb 16, 2034patentUS 9708371*PED
Feb 16, 2034patentUS 9708371*PED
Aug 16, 2033formulationUS 9708371
Aug 16, 2033formulationUS 9708371
Aug 16, 2033formulationUS 9708371
Apr 30, 2032patentUS 8748573*PED
Apr 30, 2032patentUS 8748573*PED
Apr 30, 2032patentUS 8802628*PED
Apr 30, 2032patentUS 8802628*PED
Feb 11, 2032patentUS 10675325*PED
Feb 11, 2032patentUS 10702576*PED
Oct 30, 2031method-of-use (U-1515)US 8748573
Oct 30, 2031method-of-use (U-4345)US 8748573
Oct 30, 2031formulationUS 8802628
Oct 30, 2031formulationUS 8802628
Aug 17, 2031patentUS 8933030*PED
Aug 17, 2031patentUS 8933030*PED
Aug 17, 2031patentUS 8933030*PED
Aug 11, 2031formulationUS 10675325
Aug 11, 2031method-of-use (U-3644)US 10702576
Feb 17, 2031formulationUS 89330304.6y
Feb 17, 2031formulationUS 89330304.6y
Feb 17, 2031formulationUS 89330304.6y
Feb 28, 2027patentUS 7304036*PED236d
Feb 28, 2027patentUS 7304036*PED236d
Feb 28, 2027patentUS 7304036*PED236d
Aug 30, 2026compositionUS 730403654d
Aug 30, 2026compositionUS 730403654d
Aug 30, 2026compositionUS 730403654d

FDA exclusivities (4)

May 4, 2029PEDPediatric (6mo bonus)2.8y
Nov 4, 2028NPPNew Product (3y)2.3y
Jun 12, 2026I-921Indication (3y)
Jun 12, 2026I-921Indication (3y)

$ABBV254.76-2.42%

$ABBV254.76-2.42%

$ABBV254.76-2.42%

$ABBV254.76-2.42%

$ABBV254.76-2.42%

$ABBV254.76-2.42%

$ABBV254.76-2.42%

$ABBV254.76-2.42%

$ABBV254.76-2.42%

$ABBV254.76-2.42%

$ABBV254.76-2.42%

$ABBV254.76-2.42%

$ABBV254.76-2.42%

$ABBV254.76-2.42%

$ABBV254.76-2.42%

$ABBV254.76-2.42%

$ABBV254.76-2.42%

$ABBV254.76-2.42%

🐶 often sniffed alongside

top 3

tagApproval76 co-mentions · 19 sources
drugLINZESS76 co-mentions · 19 sources
tagSmall Molecule38 co-mentions · 19 sources

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Trials studying linaclotide

phase2A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotidecompletedn=19
phase3A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipationcompletedn=123
phase3Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)completedn=438
—Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)completedn=2,475
phase3A Study of Oral Dosing of ASP0456 in Patients With Chronic Constipationcompletedn=186
phase2A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndromecompletedn=559
phase3Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndromecompletedn=500