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Crofelemer - Napo Pharmaceuticals

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Drug Profile

Crofelemer - Napo Pharmaceuticals

Alternative Names: CRO-HIV; CRO-IBS; CRO-ID; CRO-PED; Fulyzaq; Mytesi; Provir; SP 303; TRN-002- Napo Pharmaceuticals; Virend

Latest Information Update: 27 May 2026

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At a glance

  • Originator Shaman Pharmaceuticals
  • Developer Napo Pharmaceuticals; Salix Pharmaceuticals; Shaman Pharmaceuticals
  • Class Antidiarrhoeals; Biopolymers; Chromans; Flavonoids; Irritable bowel syndrome therapies; Phytotherapies; Small molecules
  • Mechanism of Action Chloride channel antagonists
  • Orphan Drug Status

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

    Yes - Diarrhoea; Short bowel syndrome
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Diarrhoea
  • Phase II Irritable bowel syndrome; Short bowel syndrome
  • No development reported Inflammatory bowel diseases
  • Discontinued Herpes simplex virus infections; Influenza virus infections

Most Recent Events

  • 31 Dec 2025 Napo plans to pursue Breakthrough Therapy Designation for Crofelemer from the US FDA, prior to December 2025
  • 01 May 2025 Phase-II clinical trials in Diarrhoea (In infants, In children, In adolescents) in USA, United Arab Emirates (PO) (NCT06721871)
  • 01 Apr 2025 apo Therapeutics plans a phase II trial for Short bowel syndrome in Germany and Italy (PO, solution) (NCT06904872)

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