Illness or its symptoms treated in a new way
Drug development is done in global collaboration with external experts, healthcare professionals, and health and marketing authorities.
Target identification and validation
Identification of a drug target in the human body – most commonly a protein or gene – and conducting validation experiments to show therapeutic effect on development of an illness or on symptoms.
Drug molecule identification
Selection of suitable drug molecules for further research from up to thousands of potential molecules.
Lead molecule optimisation
Lead molecules modified,tested and improved. Aim is to identify a few molecules with best possible efficacy and safety as drug candidates.
Confirmation that molecules are sufficiently safe for testing in humans: In vitro in test tubes and cell culture, and in vivo in laboratory animal tests.
Clinical trial authorization application
Clinical trial of a drug requires authorisation from authorities. Early research has taken 3-5 years.
Phase I: about 1 year
• First tests on humans: 20–100 healthy volunteer Participants in clinical trial
• Oncology drug clinical trials start directly with patients
• Tests the safety and behaviour of a drug in the body
• Only about one in ten molecules that enter clinical trials becomes a finished drug
Phase II: 1-3 years
• Drug tested the first time on actual Patients in clinical trial. Trial size 100–500 patients.
• Consistency of effects and the original idea confirmed
• Safety and behaviour of a drug in the body studied
Phase III: 2-4 years
• Aim is to confirm efficacy and safety of a drug with clinically and statistically significant number of patients
• Hundreds of trial clinics around the world. Trial size 1,000–5,000 patients.
Marketing authorization application: about 1 year
Approval of drug by authorities can be sought based on pre-clinical and clinical results.
New drug available for use in patients
Total costs of developing a new drug up to EUR 2* billion.
*Includes costs of unsuccessful projects.
Developing an idea into a finished drug takes 10-15 years.
Phase IV: Drug safety follow-up
Data collected on use and possible adverse effects of a drug throughout its entire lifespan.