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Rifaximin SSD
Rifaximin SSD is a Rifamycin antibiotic Small molecule drug developed by Bausch Health Americas, Inc.. It is currently in Phase 3 development for Traveler's diarrhea (approved indication for rifaximin), Hepatic encephalopathy (approved indication for rifaximin), Irritable bowel syndrome with diarrhea (IBS-D) — Phase 3 pipeline indication.
Rifaximin SSD is a non-absorbed antibiotic that inhibits bacterial RNA polymerase to reduce pathogenic gut bacteria.
Rifaximin SSD is a small molecule that inhibits bacterial DNA-directed RNA polymerase, classified as an inhibitor. It has been studied in clinical trials for various conditions, including dementia, liver cirrhosis, and hepatic encephalopathy, among others.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Rifaximin SSD |
|---|---|
| Sponsor | Bausch Health Americas, Inc. |
| Drug class | Rifamycin antibiotic |
| Target | Bacterial RNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Rifaximin is a rifamycin-class antibiotic that acts locally in the gastrointestinal tract without systemic absorption. The SSD formulation (likely a sustained-release or modified delivery form) targets bacterial RNA polymerase to inhibit bacterial protein synthesis. This mechanism reduces pathogenic bacterial populations in the gut, potentially benefiting conditions driven by dysbiosis or bacterial overgrowth.
Approved indications
- Traveler's diarrhea (approved indication for rifaximin)
- Hepatic encephalopathy (approved indication for rifaximin)
- Irritable bowel syndrome with diarrhea (IBS-D) — Phase 3 pipeline indication
Common side effects
- Abdominal pain
- Diarrhea
- Nausea
- Headache
Key clinical trials
- Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis (PHASE3)
- Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis (PHASE3)
- Rifaximin SSD in Dementia Trial (PHASE1, PHASE2)
- Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE) (PHASE2)
- Pilot Study Of The Effect Of Rifaximin On B-Cell Dysregulation In Cirrhosis (NA)
- Dose-ranging Study of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications of Early Decompensated Liver Cirrhosis (PHASE2)
- Blood Lipopolysaccharide (LPS) Rifaximin Study (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Rifaximin SSD CI brief — competitive landscape report
- Rifaximin SSD updates RSS · CI watch RSS
- Bausch Health Americas, Inc. portfolio CI
Frequently asked questions about Rifaximin SSD
What is Rifaximin SSD?
How does Rifaximin SSD work?
What is Rifaximin SSD used for?
Who makes Rifaximin SSD?
What drug class is Rifaximin SSD in?
What development phase is Rifaximin SSD in?
What are the side effects of Rifaximin SSD?
What does Rifaximin SSD target?
Related
- Drug class: All Rifamycin antibiotic drugs
- Target: All drugs targeting Bacterial RNA polymerase
- Manufacturer: Bausch Health Americas, Inc. — full pipeline
- Therapeutic area: All drugs in Gastroenterology
- Indication: Drugs for Traveler's diarrhea (approved indication for rifaximin)
- Indication: Drugs for Hepatic encephalopathy (approved indication for rifaximin)
- Indication: Drugs for Irritable bowel syndrome with diarrhea (IBS-D) — Phase 3 pipeline indication
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing