Drug Profile


Alternative Names: Mucosta; OPC-12759; OPC-12759E; OPC759; Pramipide; Proamipide

Latest Information Update: 13 Sep 2017

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At a glance

  • Originator Otsuka Pharmaceutical
  • Developer Acucela; Otsuka Pharmaceutical
  • Class Amino acids; Antiulcers; Cytoprotectives; Eye disorder therapies; Quinolones; Small molecules
  • Mechanism of Action Oxygen radical formation antagonists; Oxygen radical scavengers; Prostaglandin agonists
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Dry eyes; Gastric ulcer; Gastritis
  • Phase II Stomatitis
  • Discontinued Cancer; Diabetes mellitus; Keratoconjunctivitis; NSAID-induced ulcer; Ulcerative colitis; Xerostomia

Most Recent Events

  • 31 Mar 2017 Rebamipide is still in phase III trials for Dry eyes in Japan (Ophthalmic,Drops,Multi dose) (Otsuka pipeline, March 2017)
  • 06 Jan 2017 Otsuka Pharmaceutical completes a phase II trial in Dry eyes (Neoadjuvant therapy) in Japan (Ophthalmic,Drops,Unit dose) (UMIN000016986)
  • 10 Jun 2016 Otsuka Pharmaceutical initiates a clinical pharmacological trial for Dry eyes in Japan (Ophthalmic) (UMIN000022629)
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