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
Ofatumumab Phase II
Ocrelizumab Phase III
Laquinimod Phase III
Daclizumab NHS appraisal

Drugs in the pipeline for secondary progressive MS

Drug in development

Status

Opicinumab (Anti-LINGO-1, BIIB033) Phase II
Masitinib Phase II
MD1003 (Biotin) Phase III
Natalizumab Phase III
Siponimod Phase III

Drugs in the pipeline for primary progressive MS

Drug in development

Status

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

Last updated: 6 July 2016
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