Medicines on the horizon

It can take many years for new medicines to become available. This is because they go through thorough testing to make sure they’re effective and safe. It takes a long time to develop new medicines. We describe the main stages below.

Preclinical tests

When a new medicine is developed, it first goes through lots of testing in the lab to find out how it works. This is called preclinical testing. It helps scientists work out what the medicine is likely to do in people.

Clinical trials

If a medicine is successful in preclinical testing, it must then be tested in people. These tests are called clinical trials. Early-stage clinical trials involve a small number of people. They check that the medicine is safe and find out the best dose to use. If early-stage trials are successful, the medicine is then tested in larger clinical trials to make sure it works and is safe.

Licensing

If a medicine is successful in large clinical trials, the company that makes it applies for a product licence. To do this, they submit evidence that the medicine is safe and effective to a regulatory authority. In the UK, this is the Medicines & Healthcare products Regulatory Agency (MHRA). The MHRA decides if the medicine should be approved for use in the UK.

A product licence covers the use of a medicine for a particular illness. This means that some medicines might be approved only for Crohn’s and some only for Colitis. Some might be approved for both. A medicine that is approved for one condition at first could get approval for the other at a later date.

NHS assessment

If a medicine is approved for use in the UK, it is then assessed to decide if it should be made available on the NHS.

• The National Institute for Health and Care Excellence (NICE) is the organisation that decides whether treatments should be available on the NHS in England. Wales and Northern Ireland usually follow NICE decisions too.
• The Scottish Medicines Consortium (SMC) is the organisation that decides for Scotland.

Only medicines approved by NICE or the SMC can be prescribed on the NHS. NICE can begin looking at some drugs while they are still at the licensing stage, to help speed up the process. Once a medicine is approved by NICE it must be made available within 90 days of the final decision.

If a medicine is not successful at any stage of the development process, it cannot move to the next stage. Many medicines never become available.

What is it?

Obefazimod is a new type of medicine that is under investigation for the treatment of Ulcerative Colitis and Crohn’s Disease. It works by triggering your body to produce more of a molecule called miR-124. This molecule helps to control inflammation in your body.

How do you have it?

Obefazimod is as a tablet that you take once a day.

Who might it be used to treat?

Obefazimod has been successful in large clinical trials in adults with moderately to severely active Ulcerative Colitis.

It is also being tested to see if it is suitable as a treatment in people with Crohn’s Disease.

What stage of development is it at?

Late-stage clinical trials have been completed for obefazimod in Ulcerative Colitis. The company who makes the medicine plan to submit an application for a product license in the US by the end of 2026.

It is also in earlier stage clinical trials for Crohn’s Disease.

When might it be available?

We do not know yet if, or when obefazimod will be available in the UK. Once a product license has been submitted in the US, an application in the UK may follow. If this is successful, it will then be assessed to decide if it should be made available on the NHS.

Research aims to improve the lives of people living with Crohn’s or Colitis. One day, it may even find a cure. But good quality research can only happen when people with Crohn’s or Colitis are involved. Being involved in research may also open up opportunities for your own care, such as access to different treatments or closer monitoring.

Ask your IBD team about any possible opportunities to get involved in research.

Find out more about research opportunities.