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Rifaximin - Alfasigma

Drug Profile

Rifaximin - Alfasigma

Alternative Names: Dermodis; EIR formulation of rifaximin - Salix Pharmaceuticals; Flonorm; L-105; Lumenax; Normix; RedActive®; Rifacol; Rifaxidin®; Rifaximin soluble solid dispersion tablet; Rifaximin SSD; Rifaximin-a 550mg; rifaximin-alpha; Rifxima; SLX-G1043; SLX-G1063; SLX-L1042; SLX-L1044; Spiraxin; Targaxan 550; Tixtar; Xifaxan; Xifaxan 550mg; XIFAXAN550; Xifaxanta; Zaxine

Latest Information Update: 25 Apr 2024

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At a glance

  • Originator Alfa Wassermann SpA
  • Developer Alfa Wassermann SpA; Alfasigma; ASKA Pharmaceutical; Bausch Health Companies; Lupin; Norgine; Salix Pharmaceuticals; University of Washington; Yokohama City University
  • Class Anti-infectives; Anti-inflammatories; Antianaemics; Antibacterials; Antidiarrhoeals; Hepatoprotectants; Irritable bowel syndrome therapies; Rifamycins; Skin disorder therapies; Small molecules
  • Mechanism of Action DNA-directed RNA polymerase inhibitors; Transcription factor inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Hepatic encephalopathy; Sickle cell anaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Diverticulitis; Hepatic encephalopathy; Hyperammonaemia; Intestinal infections; Irritable bowel syndrome; Skin and soft tissue infections; Traveller's diarrhoea
  • Phase III Crohn's disease; Liver disorders
  • Phase II Intestinal obstruction; Rosacea; Sickle cell anaemia
  • Phase Unknown COVID 2019 infections
  • No development reported Unspecified
  • Discontinued Bacterial vaginosis; Clostridium difficile infections; Pouchitis; Shigella infections

Most Recent Events

  • 25 Apr 2024 Bausch Health Companies plans to submit NDA for Liver disorders (prevention of complications of decompensated cirrhosis) in 2026
  • 05 Apr 2024 United States District Court for the District of New Jersey dismisses lawsuit filed by Bausch Health Companies and Salix Pharmaceuticals against Amneal Pharmaceuticals for alleged patent infringement over generic XIFAXAN® (rifaximin) 550 mg tablets
  • 21 Mar 2024 Bausch Health Americas completes enrollment in phase III trial in Hepatic encephalopathy (Prevention) in Puerto Rico, Canada, Australia, USA (PO) (NCT05071716)
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