Drugs / Crofelemer
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | MYTESI | — | 2012-12-31 | fda.gov ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06326645 | Mar 2025 → Feb 2026 overdue | short bowel syndrome | Lindsey Russell, MD | Recruiting | No outcome recorded |
| Phase 24 trials · 2 missed | ||||||
| Phase 2 | NCT06904872 | May 2025 → Mar 2027 expected | malabsorption syndrome, short bowel syndrome | Napo Therapeutics, S.p.A. | Recruiting | No outcome recorded |
| Phase 2 | NCT02910219 | Jan 2017 → Nov 2020 | breast cancer | Sandra Swain | Completed | Missed primary |
| Phase 2 | NCT00461526 | Oct 2006 → Dec 2007 | irritable bowel syndrome | Bausch Health Americas, Inc. | Completed | Missed primary |
| Phase 2 | NCT00101725 | Dec 2004 → Nov 2005 | colonic disorder, diarrheal disease, irritable bowel syndrome | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06721871 | May 2025 → Dec 2026 expected | microvillus inclusion disease | Napo Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT04538625 | Oct 2020 → Aug 2023 | chemotherapy-induced toxicity | Napo Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01374490 | Jun 2011 → Oct 2012 | HIV enteropathy | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00547898 | Oct 2007 → Jan 2011 | HIV enteropathy | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00002408 | — | HIV infectious disease, diarrheal disease | Shaman Pharmaceuticals | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT04486326 | Aug 2020 → Sep 2022 | diarrheal disease | Beth Israel Deaconess Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04192487 | Oct 2019 → Aug 2021 | AIDS, HIV enteropathy | Napo Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT03898856 | Apr 2019 → Jan 2025 | chronic diarrheal disease | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT00002310 | — | HIV infectious disease, herpes simplex infectious disease | Shaman Pharmaceuticals | Completed | No outcome recorded |
| — | NCT00002186 | — | HIV infectious disease, herpes simplex infectious disease | Shaman Pharmaceuticals | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT03094052 Background | Oct 2018 → Oct 2022 | HER2 positive breast carcinoma, breast adenocarcinoma | University of California, San Francisco | Completed | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-07-25 | RedHill Biopharma Limited | RedHill Biopharma Initiates Co-Promotion of HIV/AIDS Anti-Diarrheal Drug Mytesi® redhillbio.com ↗ |
| 2018-06-28 | RedHill Biopharma Limited | RedHill Biopharma Announces U.S. Co-Promotion Agreement with Napo Pharmaceuticals for HIV/AIDS Anti-Diarrheal Drug Mytesi® redhillbio.com ↗ |
| 2018-06-28 | RedHill Biopharma Limited | RedHill Announces U.S. Co-Promotion Agreement with Napo Pharmaceuticals for HIV/AIDS Anti-Diarrheal Drug Mytesi redhillbio.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | crofelemer | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00461526 ↗ |
| Known as | Fulyzaq | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108184 ↗ |
| Known as | Mytesi | “Crofelemer 125 MG [Mytesi]” NCT04538625 ↗ |
| Known as | MytesiTM | “It is an FDA approved treatment for HIV-diarrhea (MytesiTM).” NCT06326645 ↗ |
| Known as | NP-303 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108184 ↗ |
| Known as | Provir | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108184 ↗ |
| Known as | SP-303 | “A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired...” NCT00002408 ↗ |
| Known as | TRN-002 | “This study is designed to evaluate the safety and effectiveness of an investigational drug, TRN-002 (crofelemer) to relieve the symptoms of diarrhea-predominant irritable bowel...” NCT00101725 ↗ |
| Known as | Virend | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108184 ↗ |
| Action | Inhibit | “inhibits luminal chloride efflux by blocking the calcium activated chloride channel (CaCC) and cystic fibrosis transmembrane regulator (CFTR) chloride channels” NCT02910219 ↗1“Anoctamin-1 blocker” CHEMBL2108184 ↗ |
| Modality | Small molecule | — CHEMBL2108184 ↗ |
| Route | Oral | “Orally Administered SP-303” NCT00002408 ↗ |
| Target | ANO1 | “Anoctamin-1 blocker” CHEMBL2108184 ↗ |
| Target | CFTR | “Crofelemer is a novel anti-diarrheal drug that reduces intestinal chloride ion and fluid secretion. It is an FDA approved treatment for HIV-diarrhea (MytesiTM). Its...” NCT06326645 ↗ |