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Rifaximine

Ain Shams University · Phase 2 active Small molecule ✓ Verified May 2026

Rifaximine is a Small molecule drug developed by Ain Shams University. It is currently in Phase 2 development for Diarrhea due to E. Coli, Hepatic encephalopathy, Irritable bowel syndrome with diarrhea. Also known as: Targaxan.

Rifaximin is a non-absorbable, broad-spectrum antibiotic that inhibits bacterial DNA-directed RNA polymerase, a bacterial enzyme involved in RNA synthesis. It is primarily used to treat non-infectious gastrointestinal diseases, including irritable bowel syndrome, and has been licensed in over 30 countries for various conditions such as diverticular disease, bloating, and functional bowel disorder.

Likelihood of approval
17.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Anti-infectives pathway favourability +2.0pp
    Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2031–2034 —
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 nameRifaximine
Also known asTargaxan
SponsorAin Shams University
TargetNuclear receptor subfamily 1 group I member 2, Bacterial DNA-directed RNA polymerase
ModalitySmall molecule
Therapeutic areaInfectious Disease
PhasePhase 2

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Rifaximine

What is Rifaximine?

Rifaximine is a Small molecule drug developed by Ain Shams University, indicated for Diarrhea due to E. Coli, Hepatic encephalopathy, Irritable bowel syndrome with diarrhea.

What is Rifaximine used for?

Rifaximine is indicated for Diarrhea due to E. Coli, Hepatic encephalopathy, Irritable bowel syndrome with diarrhea.

Who makes Rifaximine?

Rifaximine is developed by Ain Shams University (see full Ain Shams University pipeline at /company/ain-shams-university).

Is Rifaximine also known as anything else?

Rifaximine is also known as Targaxan.

What development phase is Rifaximine in?

Rifaximine is in Phase 2.

What does Rifaximine target?

Rifaximine targets Nuclear receptor subfamily 1 group I member 2, Bacterial DNA-directed RNA polymerase.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing