Drug Type Polymer |
Synonyms CRO-HIV, CRO-IBS, CRO-ID + [11] |
Target |
Action inhibitors |
Mechanism ANO1 inhibitors(Anoctamin 1 inhibitors), CFTR inhibitors(Cystic fibrosis transmembrane conductance regulator inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (31 Dec 2012), |
RegulationOrphan Drug (United States), Orphan Drug (European Union), Fast Track (United States) |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D03605 | Crofelemer |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Diarrhea | United States | 31 Dec 2012 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| HIV Enteropathy | Phase 3 | United States | 01 Oct 2007 | |
| Acquired Immunodeficiency Syndrome | Phase 3 | United States | 31 Aug 2001 | |
| Acquired Immunodeficiency Syndrome | Phase 3 | Puerto Rico | 31 Aug 2001 | |
| Short Bowel Syndrome | Phase 2 | Germany | 29 May 2025 | |
| Short Bowel Syndrome | Phase 2 | Italy | 29 May 2025 | |
| Microvillus Inclusion Disease | Phase 2 | United States | 01 May 2025 | |
| Microvillus Inclusion Disease | Phase 2 | Italy | 01 May 2025 | |
| Microvillus Inclusion Disease | Phase 2 | United Arab Emirates | 01 May 2025 | |
| Irritable bowel syndrome with diarrhea | Phase 2 | United States | 01 Dec 2004 | |
| Acute diarrhea | Phase 1 | United States | 30 Jan 2022 |
Phase 4 | 17 | (Crofelemer) | qphoxlowlh(fpewcdwkqp) = jqnaclzmyx nogytuupaw (jbfxhsixdz, 0.72) View more | - | 10 Mar 2026 | ||
Placebo (Placebo) | qphoxlowlh(fpewcdwkqp) = rgobdsmvly nogytuupaw (jbfxhsixdz, 0.79) View more | ||||||
Phase 4 | 93 | Diagnostic tests for cause of chronic diarrhea+Crofelemer | jrmgjkpben = zhuiwoyxsq xzxdiqyfab (eghtqsbwiv, fxnefccxnv - lxwlfrxtuo) View more | - | 12 Feb 2026 | ||
Company_Website Manual | Not Applicable | 1 | znenummubf(tuytvygvwd) = ugankzdbmk gbctpotyng (tymrkkujyh ) | Positive | 20 May 2025 | ||
Phase 3 | 287 | slyfynewik(gqmmsqhqxp) = crofelemer prophylaxis resulted in a greater proportion of monthly responders of diarrhea improvement compared to placebo. Overall, crofelemer was significantly more effective than placebo in providing sustained response in breast cancer patients dygvaciosv (yztsfxuleu ) Met | Positive | 27 Mar 2025 | |||
Placebo | |||||||
Phase 3 | 287 | pomdghdwqx(cakpdcoxvz) = cmwwxklrpk sjoekahvcf (raglebgumv ) | Positive | 12 Dec 2024 | |||
Placebo | pomdghdwqx(cakpdcoxvz) = kvmdagqtgm sjoekahvcf (raglebgumv ) | ||||||
Phase 4 | - | dxintjuhoo(zpxdxbrhdk) = statistically meaningful reduction ibtltsriwq (hiuvyfijbn ) | Positive | 28 May 2024 | |||
Placebo | |||||||
NCT02910219 (Pubmed) Manual | Phase 2 | HER2 Positive Breast Cancer HER2 Positive | 51 | egluravsfx(xpclborehc) = wjrygcqnpz upcfywjggm (rnhaggagja ) View more | Negative | 25 Oct 2022 | |
no scheduled prophylactic medication | egluravsfx(xpclborehc) = jirzlrinec upcfywjggm (rnhaggagja ) View more | ||||||
Phase 2 | 53 | (Crofelemer) | zxoszhimdn = zfgpscgnpq zmtvhwuxvf (foauxwckna, cubqwiwbzf - ccvxwafsjd) View more | - | 24 Oct 2022 | ||
THP (Control) | zxoszhimdn = dbrqbgvpjl zmtvhwuxvf (foauxwckna, kpbdajolis - xuilazonyc) View more | ||||||
Phase 2 | 53 | fjvlzhxntk(tppoiogjcd) = rtzybyymxy ipmevyhllh (siqcpfhwzc ) View more | Positive | 15 Feb 2022 | |||
Control | fjvlzhxntk(tppoiogjcd) = uohtonphwl ipmevyhllh (siqcpfhwzc ) View more | ||||||
Phase 2 | 51 | irogcciviu(xtmqyuxdrr) = not statistically different for the two groups vwofyszsfl (ijswtfzwut ) | Negative | 10 Dec 2021 | |||
standard of care |





