(Clarithromycin + clofazimine + rifabutin) is under clinical development by RedHill Biopharma and currently in Phase III for Crohn’s Disease (Regional Enteritis). According to GlobalData, Phase III drugs for Crohn’s Disease (Regional Enteritis) have a 65% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how (Clarithromycin + clofazimine + rifabutin)’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

(Clarithromycin + clofazimine + rifabutin) overview

RHB-104, a fixed dose combination of rifabutin, clarithromycin and clofazimine is under development for the treatment of Crohn’s disease caused by Mycobacterium avium paratuberculosis (MAP). The drug is administered orally as a capsule. Rifabutin is an antibiotic that targets DNA-dependent RNA polymerase activity in susceptible cells. Clarithromycin binds to the 50S ribosomal subunit and targets RNA-dependent protein synthesis in susceptible organisms. Clofazimine inhibits mycobacterial growth and binds preferentially to mycobacterial DNA. It was also under development for the treatment of rheumatoid arthritis, psoriasis, type 1 diabetes, systemic lupus erythematosus and relapsing remitting multiple sclerosis (RRMS).

RedHill Biopharma overview

RedHill Biopharma (RedHill) is a specialty biopharmaceutical company that develops and commercializes therapeutics for gastrointestinal (GI) diseases and cancer. The company’s commercial product portfolio consists of branded prescription drugs including a combination of omeprazole, amoxicillin and rifabutinomeprazole; naloxegol; and rifamycin. It is investigating its pipeline candidates for the treatment of Crohn’s disease, non-tuberculous mycobacterial infection (NTM) infections, gastroenteritis, gastritis, irritable bowel syndrome with diarrhea (IBS-D), bowel cleanser, cancer and novel coronavirus disease (COVID-19). The company has a subsidiary in the US. RedHill is headquartered in Tel Aviv, Israel.

For a complete picture of (Clarithromycin + clofazimine + rifabutin)’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.