Rifaximin is under clinical development by Alfasigma and currently in Phase III for Collagenous Colitis. According to GlobalData, Phase III drugs for Collagenous Colitis does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Rifaximin LoA Report. Buy the report here.

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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.

Rifaximin overview

Rifaximin (Xifaxan / Normix / Spiraxin / Normiks / Refero / Targaxan / Tixteller / Zaxine / Faxinorm / Xifaxanta / Redactiv / Tixtar / Rifacol / Rifxima / Alpha Normix Forte / Flonorm / Ticstar / Tixta) is a non-aminoglycoside semi-synthetic antibiotic acts as anti-bacterial agent. It is formulated as tablets, film coated tablets, suspension and granules for oral route of administration and ointment and cream for topical application. It is indicated for the treatment of patients with travellers’ diarrhoea (TD) caused by noninvasive strains of Escherichia coli and reduction in risk of overt hepatic encephalopathy. Xifaxanta tablets are indicated for the treatment of travellers' diarrhoea that is not associated with any of fever, bloody diarrhoea, eight or more unformed stools in the previous 24 h and occult blood or leucocytes in the stool. Zaxine is indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients greater than18 years of age, adjunct in the treatment of hyperammonemia, and also indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

The drug candidate is under development for the treatment of Crohn's disease, collagenous colitis, chronic intestinal pseudo-obstruction, Alzheimer's disease, sickle cell disease and symptoms of gastrointestinal distress and pulmonary compromise associated with COVID-19 infection caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and for nonalcoholic fatty liver disease.

It was under development for the treatment of irritable bowel syndrome, decompensated cirrhosis and bacterial vaginosis.

Alfasigma overview

Alfasigma is a manufacturer and supplier of pharmaceutical products. The company offers prescription and over-the-counter drugs for the treatment of gastrointestinal disorders, drugs for diabetes and vascular diseases, nutraceuticals and medical foods. It also produces medicines to treat cardiology, orthopedics, rheumatology and broncho-pneumology indications. Alfasigma is investigating drugs against gastroenterology, vascular disease and neuroscience disorders. The company operates a contract manufacturing office in Alanno, Pescara, Italy. It has an operational presence in Belgium, China, Czech Republic, France, India, Mexico, Netherlands, Poland, Portugal, Romania, Russia, Slovak Republic, Spain, Switzerland, Tunisia and the US. Alfasigma is headquartered in Bologna, Emilia-Romagna, Italy.

For a complete picture of Rifaximin’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.