Drugs / RBX2660
RBX2660
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03378167 | Dec 2018 → Sep 2023 | Crohn disease, colitis | McMaster Children's Hospital | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03367910 | Feb 2018 → Dec 2021 | urinary tract infection | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1/2 | NCT03439982 | Apr 2016 → Aug 2019 | hepatic encephalopathy | University of Alberta | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT02589847 | Oct 2015 → Jun 2017 | Clostridium difficile colitis | Rebiotix Inc. | Completed | Met primary |
| Phase 2 | NCT01925417 | Aug 2013 → Mar 2014 | Clostridium difficile colitis | Rebiotix Inc. | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT05831189 | Apr 2023 → Jan 2025 | Clostridium difficile colitis | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03931941 | Jul 2019 → Jul 2023 | Clostridium difficile colitis | Rebiotix Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03244644 | Jul 2017 → Apr 2020 | Clostridium difficile colitis | Rebiotix Inc. | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT02299570 Comparator | Dec 2014 → Jan 2016 | Clostridium difficile colitis | Rebiotix Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2025-05-26 | Lumen Bioscience, Inc. | Results Reviewing Real-World Safety and Efficacy Data on C. difficile Therapy Rebyota By John Parkinson lumen.bio ↗ |
| 2023-05-08 | Ferring Pharmaceuticals | Results Four Analyses of Data for REBYOTA™ (fecal microbiota, live – jslm), the First FDA-Approved Microbiome-Based Treatment for the Prevention of Recurrent C. difficile Infection, Presented at DDW 2023 ferring.com ↗
The analyses reviewed the safety of REBYOTA (previously known as RBX2660) in patients with inflammatory bowel disease, as well as safety and efficacy in immunocompromised patients and when administered by colonoscopy. |
| 2022-11-30 | Ferring Pharmaceuticals | Regulatory Ferring receives U.S. FDA approval for REBYOTA™ (fecal microbiota, live-jslm) – A novel first-in-class microbiota-based live biotherapeutic ferring.com ↗
Ferring receives U.S. FDA approval for REBYOTA™ (fecal microbiota, live-jslm) – A novel first-in-class microbiota-based live biotherapeutic |
| 2022-11-07 | Ferring Pharmaceuticals | Results Pivotal Phase 3 Efficacy and Safety Data for Ferring’s RBX2660 Published in Drugs ferring.com ↗
The model-estimated treatment success rate at eight weeks for RBX2660 was 70.6% versus 57.5% for placebo, with a 99.1% posterior probability that RBX2660 was superior to placebo in reducing rCDI after standard-of-care antibiotic treatment. |
| 2022-09-22 | Ferring Pharmaceuticals | Regulatory Ferring Receives Positive Vote from U.S. FDA Advisory Committee for RBX2660 ferring.com ↗
Ferring Pharmaceuticals today announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the U.S. Food and Drug Administration (FDA) issued a positive vote for RBX2660, an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrence of C. difficile infection (CDI) after antibiotic treatment. |
| 2022-05-24 | Ferring Pharmaceuticals | Results Ferring Presents New Analyses of Efficacy, Safety and Microbiome Composition Data at DDW 2022 for RBX2660 its Investigational Microbiota-Based Live Biotherapeutic ferring.com ↗
In the analysis, participants who received RBX2660 demonstrated greater treatment success compared to placebo (68.3% vs. 55.0%, respectively; P=0.012). |
| 2021-05-22 | Ferring Pharmaceuticals | Results Ferring and Rebiotix Present Positive Interim Phase 3 Results from Open-Label Study of Investigational Microbiota-based Live Biotherapeutic RBX2660 at Digestive Disease Week® (DDW) ferring.com ↗
Interim analysis of the Phase 3 PUNCH™ CD3-Open-Label Study (OLS) showed positive efficacy and consistent safety with RBX2660 for up to six months in patients with recurrent Clostridioides difficile ( difficile) infection, adding to robust evidence of largest clinical development program in microbiome-based therapeutic |
| 2021-05-21 | Ferring Pharmaceuticals | Results Ferring and Rebiotix Present Landmark Phase 3 Data Demonstrating Superior Efficacy of Investigational RBX2660 Versus Placebo to Reduce Recurrence of C. difficile Infection ferring.com ↗
Ferring Pharmaceuticals and Rebiotix, a Ferring Company, today presented results from the pivotal Phase 3 PUNCH™ CD3 clinical trial, demonstrating superior efficacy and consistent safety of single-dose RBX2660 in reducing recurrence of Clostridioides difficile infection (CDI) over placebo. |
| 2020-05-06 | Ferring Pharmaceuticals | Results Rebiotix and Ferring announce world’s first with positive preliminary pivotal Phase 3 data for investigational microbiome-based therapy RBX2660 ferring.com ↗
Today, Rebiotix and Ferring Pharmaceuticals announced positive preliminary findings from their ongoing pivotal Phase 3 trial of the investigational microbiome-based treatment, RBX2660. |
All press releases naming this drug 15 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RBX2660 | “A Prospective Single Center Open Label Trial of RBX2660 (Microbiota Suspension) in the Management of Hepatic Encephalopathy” NCT03439982 ↗8“Fecal microbiota enema (RBX2660) infused via colonoscope x 1 + oral microbiota capsules (RBX7455) x 6 weeks.” NCT03378167 ↗ “150mL of FMT product RBX2660 delivered via enema” NCT03367910 ↗ |
| Known as | fecal microbiota, live-jslm | “Fecal microbiota, live-jslm (REBYOTA®; RBL, previously RBX2660), is the first microbiota-based live biotherapeutic approved by the US Food and Drug Administration to prevent...” PMID 39006315 ↗ Jun 2024 |
| Known as | Microbiota Suspension | “A Prospective Single Center Open Label Trial of RBX2660 (Microbiota Suspension) in the Management of Hepatic Encephalopathy” NCT03439982 ↗ |
| Known as | RBL | “Fecal microbiota, live-jslm (REBYOTA®; RBL, previously RBX2660), is the first microbiota-based live biotherapeutic approved by the US Food and Drug Administration to prevent...” PMID 39006315 ↗ Jun 2024 |
| Known as | REBYOTA | “Fecal microbiota, live-jslm (REBYOTA®; RBL, previously RBX2660), is the first microbiota-based live biotherapeutic approved by the US Food and Drug Administration to prevent...” PMID 39006315 ↗ Jun 2024 |
| Action | Restore | “Microbiota restoration can prevent Clostridioides difficile infection (CDI) recurrences.” PMID 33593430 ↗ Feb 2021 |
| Modality | Other / unclassified | “a microbiota-based investigational therapeutic” PMID 33593430 ↗ Feb 2021 |
| Route | Other | “RBX2660 administered via enema.” PMID 26565008 ↗ Nov 2015 |