Using existing compounds in an innovative way offers many advantages.

What can be new?

• New:
  Clinical application or indication, method of use, (synergistic) combination of compounds, treatment regimen, route of administration, package, formulation, new or improved route of synthesis or combinations of these.
• Not new:
  Compounds used (drugs approved for human use or biological compounds/hormones that occur in the human naturally, but may have never been considered as a drug for human use).
• Always new:
  Formulation (e.g. dose, combination of drugs, pharmaceutical formulation).

Advantages

• Established safety record for the approved dose range and route of administration (in case of existing drugs).

• Cost effective because less safety data are required for final clinical development.
• Low attrition rate.
• Fast drug development focused on clinical phase II.
• Diminished development risk.
• Fast and easy registration and approval procedures expected due to established safety of the compound(s) and/or drug(s) used.
• Long remaining patent life of 12-15 years after marketing approval by authorities.

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