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An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease.or example, orphan drug regulations generally acknowledge the fact that it may not be possible to test 1,000 patients in a phase III clinical trial, as fewer than that number may be afflicted with the disease in question.
What is an Orphan Disease? An orphan disease is a disease which affects a relatively small number of individuals and for which no drug therapy has been developed because the small market would make the research and the drug unprofitable. Diseases are classified as orphan when they affect fewer than 200,000 people.