The development of new drugs is a long and difficult process. Fewer than one or two compounds in 10,000 tested actually make it through to being licensed treatments with many being rejected on safety, efficacy or quality grounds. On average it will take 10-15 years for a new compound to get from the test-tube into the medicine cabinet. It is important to remember that not all the treatments currently being developed or tested will receive a license or be approved for use in the NHS.

What does the drug development process involve?

Drug development process
Phase I: The first step in testing a new drug is to determine the safety of single doses in a small number of healthy volunteers.
Phase IIIf the treatment proves to be safe, studies begin to determine the effectiveness of the drug in people with the condition to be treated. 
Phase IIIIf a drug shows effectiveness, a larger study is conducted in hundreds of people.
Licensing: Data from all of these three phases is presented to the regulatory authorities.
NHS appraisal: Once a new medicine has been licensed, drugs may need to be appraised by NICE for England and Wales and SMC for Scotland.

Drugs in the pipeline for relapsing remitting MS

Drug in development

Status

ATX-MS-1467 Phase II
Daclizumab NHS appraisal
Laquinimod Phase III
Ocrelizumab Licensing
Ofatumumab Phase II

Drugs in the pipeline for secondary progressive MS

Drug in development

Status

Amiloride Phase II
Fluoxetine Phase II
Ibudilast Phase II
Masitinib Phase II
MD1003 (Biotin) Licensing
Opicinumab (Anti-LINGO-1, BIIB033) Phase II
Riluzole Phase II
Siponimod Phase III

Drugs in the pipeline for primary progressive MS

Drug in development

Status

Ibudilast Phase II
Idebenone Phase II
Laquinimod Phase II
Masitinib Phase III
MD1003 (Biotin) Licensing
Ocrelizumab Licensing
Opicinumab (Anti-LINGO-1, BIIB033) Phase II

Last updated: 10 February 2017
This page will be reviewed within three years