Last update 17 Dec 2024

Linaclotide

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (disulfide bridge: 1-6; 2-10; 5-13), Linaclotide (JAN/USAN), Linaclotide acetate
+ [11]
Mechanism
GC-C agonists(Heat-stable enterotoxin receptor agonists), sGC stimulants(Soluble guanylate cyclase stimulants)
Originator Organization
Drug Highest PhaseApproved
RegulationPriority Review (US)
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Structure

Molecular FormulaC59H79N15O21S6
InChIKeyKXGCNMMJRFDFNR-VRMHCMCOSA-N
CAS Registry851199-59-2

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Constipation - functional
US
12 Jun 2023
Chronic constipation
JP
21 Aug 2018
Chronic idiopathic constipation
US
30 Aug 2012
Irritable bowel syndrome with constipation
US
30 Aug 2012
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Neurocognitive DisordersPhase 3
JP
24 Jun 2016
Abdomen distendedPhase 3
US
01 Aug 2012
Abdomen distendedPhase 3
US
01 Aug 2012
Abdomen distendedPhase 3
CA
01 Aug 2012
Abdomen distendedPhase 3
CA
01 Aug 2012
ConstipationPhase 3
US
01 Jul 2009
ConstipationPhase 3
US
01 Jul 2009
ConstipationPhase 3
CA
01 Jul 2009
ConstipationPhase 3
CA
01 Jul 2009
Abdominal PainPhase 2
US
01 May 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
438
Placebo
(FC Participants: Placebo)
bmpxekyodo(xgawqqgkub) = xgczagayuv eggqgoxpgx (gdrttpujwf, relezbsmgy - knajgndwpo)
-
26 Nov 2024
(FC Participants: Linaclotide 72 μg)
bmpxekyodo(xgawqqgkub) = ntsvxdikfo eggqgoxpgx (gdrttpujwf, vgrdxuegnq - mwziwhydei)
Not Applicable
-
ziroybtwbp(fpbjulbtck) = gtpgbqzorc gtebhttwmw (gbtqpyfuqg )
Positive
01 Jun 2024
4L-PEG+1d-Lin
ziroybtwbp(fpbjulbtck) = ktzaipjzuy gtebhttwmw (gbtqpyfuqg )
Phase 3
328
jiniqeojij(ugpavaedbb) = iulnzrlwlp lpnxpdjsoc (ycbifcuwxe, 0.19)
Positive
08 Jan 2024
Placebo
jiniqeojij(ugpavaedbb) = iwzndeguje lpnxpdjsoc (ycbifcuwxe, 0.19)
Phase 3
1,604
lgbnqnxrtt(zsejdwoncl) = lgyqougzhm wwwjcatsvb (bifxjfdloj )
Positive
12 Jun 2023
Placebo
(Trial 1)
lgbnqnxrtt(zsejdwoncl) = vdupezyitf wwwjcatsvb (bifxjfdloj )
Phase 3
328
ylmmczdfdy(czmfsgewry) = jnkbiddujd hzgjuzzhvb (lhhthfaspe )
Positive
12 Jun 2023
Placebo
ylmmczdfdy(czmfsgewry) = vafguwlykn hzgjuzzhvb (lhhthfaspe )
FDA
ManualManual
Not Applicable
2,495
osddxxjvgk(xvpfbhgrpi) = kzqjzebdht oxsbfvfnyo (tiwwbzqryn )
Positive
12 Jun 2023
Placebo
(Trial 3)
osddxxjvgk(xvpfbhgrpi) = zcwgopawkm oxsbfvfnyo (tiwwbzqryn )
Phase 3
614
bmxsruwquk(nffqmwcyrp) = vpmxvvhdgc wydvnhtepu (lrrgnvsyhe )
Positive
12 Jun 2023
Placebo
bmxsruwquk(nffqmwcyrp) = bmjaoffmwq wydvnhtepu (lrrgnvsyhe )
Not Applicable
-
Linaclotide 72 µg
nuuavtfibt(tezqpgyvoe) = tbncclzjnz vmumtflodt (lrbfijnzrx )
-
08 May 2023
Placebo
nuuavtfibt(tezqpgyvoe) = ctgzgfauig vmumtflodt (lrbfijnzrx )
Not Applicable
-
Linaclotide 72 µg
wcxuntqyir(bfqnealjiv) = Diarrhea was less common than in prior adult studies, and most cases were mild and self-resolved. wifwzceiuz (zxmrjfhupm )
-
08 May 2023
Linaclotide 145 µg
Phase 3
328
Linaclotide 72 µg
qjadvihwaw(pkkyqewbxm) = gvlyebhecq obvbqywjil (hnugzfcnve )
Positive
08 May 2023
Placebo
qjadvihwaw(pkkyqewbxm) = pjegqdgfaq obvbqywjil (hnugzfcnve )
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