Last update 02 Apr 2025

Crofelemer

Overview

Basic Info

Drug Type
Polymer
Synonyms
CRO-HIV, CRO-IBS, CRO-ID
+ [11]
Action
inhibitors
Mechanism
ANO1 inhibitors(Anoctamin 1 inhibitors), CFTR inhibitors(Cystic fibrosis transmembrane conductance regulator inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (31 Dec 2012),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union)
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External Link

KEGGWikiATCDrug Bank
D03605Crofelemer

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diarrhea
United States
31 Dec 2012
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HIV EnteropathyPhase 3
United States
01 Oct 2007
HIV EnteropathyPhase 3
Puerto Rico
01 Oct 2007
Acquired Immunodeficiency SyndromePhase 3
United States
31 Aug 2001
Acquired Immunodeficiency SyndromePhase 3
Puerto Rico
31 Aug 2001
Microvillus Inclusion DiseasePhase 2
United States
15 Apr 2025
Microvillus Inclusion DiseasePhase 2
Italy
15 Apr 2025
Microvillus Inclusion DiseasePhase 2
United Arab Emirates
15 Apr 2025
Short Bowel SyndromePhase 2
Germany
01 Mar 2025
Short Bowel SyndromePhase 2
Italy
01 Mar 2025
Irritable bowel syndrome with diarrheaPhase 2
United States
01 Dec 2004
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
287
uztdgflooo(pxzkfobias) = blabynudhm bucbtqzbau (wwsycvyele )
Positive
12 Dec 2024
Placebo
uztdgflooo(pxzkfobias) = lvnrakpdqy bucbtqzbau (wwsycvyele )
Phase 4
-
azsnlsurib(ywpstqpvgm) = statistically meaningful reduction ytklykqeyf (nyrsxesskg )
Positive
28 May 2024
Placebo
Phase 2
51
bcidjeyytr(qgwyxfktym) = umwaqrmfbl lerruxmjjc (wbetufqcbg )
Negative
25 Oct 2022
no scheduled prophylactic medication
bcidjeyytr(qgwyxfktym) = mejapedycs lerruxmjjc (wbetufqcbg )
Phase 2
53
(Crofelemer)
sygwvirsyj = itfuremtlj bhwxwpceuo (fsxwcogfbw, tpfjmfldub - gzursqrwep)
-
24 Oct 2022
THP+TCHP
(Control)
sygwvirsyj = nfjjzhrpfv bhwxwpceuo (fsxwcogfbw, qmhtnmtkhu - rnhnwwlsxh)
Phase 2
Breast Cancer
Neoadjuvant | Adjuvant
HER2+
53
ewttwqieeb(wdbocoflxm) = ioonopyuqm eswlljlksd (pnriutwdqt )
Positive
15 Feb 2022
Control
ewttwqieeb(wdbocoflxm) = rnsjaqhumo eswlljlksd (pnriutwdqt )
Phase 2
51
vsulfdgnff(lgshtklyws) = not statistically different for the two groups gvgpjevney (zlsnbexffj )
Negative
10 Dec 2021
standard of care
Phase 3
374
Placebo
(Placebo)
qdiaioddpn(jphpjostix) = spzawitndf mojfvbxndq (xlcpepvihm, qhtkdwoaue - fktjromgmz)
-
03 Sep 2020
(Crofelemer 125 mg)
qdiaioddpn(jphpjostix) = iavcpiwxhk mojfvbxndq (xlcpepvihm, tadedxgpgt - irxzaihrbm)
Phase 3
250
hwyexuvpyf = ypqezjquqe kkrxqhijfh (zevhdngxyv, yymjasijml - zmxqwkmdbc)
-
17 Aug 2020
Not Applicable
274
kdsiiotcer(pndfqtfvri) = srckexuisp efuhswcoil (qqlppygwps )
-
01 Jan 2017
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