Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Low Dose Rifaximin · 1 trial · 1 indication
Maximum observed plasma concentration
| Arm | Type | Description |
|---|---|---|
| Low Dose Rifaximin ER | EXPERIMENTAL | twice daily |
| Low Dose Rifaximin DER | EXPERIMENTAL | twice daily |
| High Dose Rifaximin ER | EXPERIMENTAL | twice daily |
| High Dose Rifaximin DER | EXPERIMENTAL | twice daily |
| Placebo | PLACEBO_COMPARATOR | twice daily |
| Name | Type | Description |
|---|---|---|
| Low Dose Rifaximin ER | DRUG | Low Dose Rifaximin Extended Release Twice Daily |
| Low Dose Rifaximin DER | DRUG | Low Dose Rifaximin Delayed Extended Release Twice Daily |
| High Dose Rifaximin ER | DRUG | High Dose Rifaximin Extended Release Twice Daily |
| High Dose Rifaximin DER | DRUG | High Dose Rifaximin Delayed Extended Release Twice Daily |
| Placebo | DRUG | Placebo Twice Daily |
Inclusion Criteria: 1. ability and willingness to sign a written informed consent form. 2. between the ages of 18 to 70 years old (inclusive) at the time of consent. 3. SCD of any genotype (HbSS, HbSC, HbS β-thalassemia). If the subject's genotype has not been previously documented, genotyping will...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 5 | PHASE3 | Etavopivat Low dose |
| Novartis AG Sponsored ADR | NVS | 4 | PHASE3 | Crizanlizumab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE3 | PCV21, 20vPCV |
| Vertex Pharmaceuticals Incorporated | VRTX | 3 | PHASE3 | CTX001 |
| Agios Pharmaceuticals, Inc. | AGIO | 2 | PHASE2 | Mitapivat |
| Pfizer Inc. | PFE | 1 | PHASE2 | Osivelotor |
| Bristol-Myers Squibb Company | BMY | 1 | PHASE1 | BMS-986470, Famotidine, Pantoprazole |
| Fulcrum Therapeutics, Inc. | FULC | 1 | PHASE2 | Pociredir |
| Beam Therapeutics, Inc. | BEAM | 2 | PHASE1 | BEAM-101 |
| Editas Medicine, Inc. | EDIT | 2 | PHASE1 | EDIT-301 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-3405 |
| Illumina, Inc. | ILMN | 1 | - | Undisclosed |
Low Dose Rifaximin is an investigational small molecule being studied for gastrointestinal conditions including non-constipation irritable bowel syndrome, diarrhea, irritable bowel syndrome with diarrhea, and Clostridium infections. It is developed by Bausch Health Companies Inc. (BHC) and is currently in Phase 2 clinical development.
Low Dose Rifaximin is a rifamycin antibiotic that works by inhibiting bacterial RNA synthesis, thereby reducing intestinal bacterial overgrowth and altering the gut microbiome. This mechanism is thought to alleviate symptoms of irritable bowel syndrome with diarrhea and other gastrointestinal disorders.
Low Dose Rifaximin is being developed by Bausch Health Companies Inc., a company traded on the New York Stock Exchange under the ticker symbol BHC. The drug is currently in Phase 2 clinical trials for gastrointestinal indications.
Low Dose Rifaximin is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials are ongoing to evaluate its safety and efficacy for conditions such as irritable bowel syndrome with diarrhea.
Low Dose Rifaximin has completed four Phase 3 trials, including NCT00269399 comparing it to vancomycin for Clostridium difficile-associated diarrhea, NCT00328380 and NCT00742469 for prevention of travelers' diarrhea, and NCT01543178 for irritable bowel syndrome with diarrhea re-treatment. These trials enrolled a total of 2,583 participants.
Low Dose Rifaximin is a formulation of rifaximin, the active ingredient in Xifaxan. The clinical trial NCT00269399 compared Xifaxan to vancomycin for Clostridium difficile-associated diarrhea, indicating that Low Dose Rifaximin is related to the Xifaxan brand.