It takes a long time to develop new medicines. It is also very expensive.

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.

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.

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 Ulcerative 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.

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 reach the clinic.

Upadacitinib is now approved for NHS use for people with Crohn's or Ulcerative Colitis. We have more details in our full information on upadacitinib.

What is it?

Risankizumab is a type of biologic medicine. It sticks to a protein called IL-23. Your immune system naturally makes IL-23 to help you fight infections. But it can also cause inflammation. Risankizumab blocks the effects of IL-23. This reduces gut inflammation.

The brand name for risankizumab is Skyrizi.

How do you have it?

You have your first three doses of rizankizumab through a drip into a vein. You have one dose every 4 weeks. This aims to get your Crohn’s or Colitis under control (induction treatment).

After this, you have rizankizumab as an injection under your skin. You have the injection every 12 weeks. The injections aim to keep your Crohn’s or Colitis under control (maintenance treatment).

Who might it be used to treat?

For Crohn's

Risankizumab is approved for NHS use throughout the UK as a treatment for Crohn’s. We have more details in our full information on risankizumab.

For Colitis

Risankizumab is being assessed for people with Ulcerative Colitis, but this is at an earlier stage of development.

What stage of development is it at?

Risankizumab has completed large clinical trials in over 16s with moderately or severely active Ulcerative Colitis. The developers have announced that these trials were successful, but the full results have not been published yet.

Risankizumab is not yet approved in the UK to treat Ulcerative Colitis. If it is approved for use in the UK, it will also be assessed to decide if it should be available on the NHS. This process has already started.

When might it be available?

NICE have announced that they will be assessing risankizumab to decide if it should be available on the NHS in England for people with Ulcerative Colitis. Wales and Northern Ireland usually follow NICE decisions too.

Risankizumab is not yet being assessed by the SMC to decide if it should be available for people with Ulcerative Colitis on the NHS in Scotland. We do not know yet when this might happen.

What is it?

Mirikizumab is a type of biologic medicine. It sticks to a protein called IL-23. Your immune system naturally makes IL-23 to help you fight infections. But it can also cause inflammation. Mirikizumab blocks the effects of IL-23. This reduces gut inflammation.

The brand name for mirikizumab is Omvoh.

How do you have it?

You have your first three doses of mirikizumab through a drip into a vein. You have one dose every 4 weeks. This aims to get your Colitis under control (induction treatment).

After this, you have mirikizumab as an injection under your skin. The injections aim to keep your Colitis under control (maintenance treatment).

Who might it be used to treat?

Mirikizumab has been recommended as a treatment for some people with moderate or severe active Ulcerative Colitis. It is recommended for adults who are not suitable for treatment with an anti-TNF medicine (such as infliximab or adalimumab). This could be because they do not respond to an anti-TNF medicine. Or they may have had to stop taking an anti-TNF medicine due to side effects.

The company that makes mirikizumab also plans to apply for it to be assessed as a Crohn's treatment. This has not happened yet.

What stage of development is it at?

For Ulcerative Colitis

Mirikizumab has been accepted throughout the UK as a treatment option for some people with Ulcerative Colitis.

For Crohn's

The company that makes mirikizumab plans to apply for it to be assessed as a treatment for Crohn's. This is expected to take place in 2024.

When might it be available?

For Ulcerative Colitis

Both NICE and the SMC have recommended mirikizumab as a treatment for some people with Ulcerative Colitis. It is available in England, Scotland, Wales and Northern Ireland.

For Crohn's

The company that makes mirikizumab plans to apply for it to be assessed as a treatment for Crohn's. This is expected to take place in 2024.

What is it?

Etrasimod is a type of medicine called an S1P receptor modulator. It sticks to a protein on some white blood cells. This stops the white blood cells travelling into your gut, where they can cause inflammation.

The brand name for etrasimod is Velsipity.

How do you have it?

You have etrasimod as tablets that you take once a day.

Who might it be used to treat?

Etrasimod is being assessed for people with Crohn’s. This assessment is still in development. It has already been approved as a treatment for some adults with Ulcerative Colitis.

We have more information on the approval of etrasimod as a treatment for Ulcerative Colitis in our news item on NICE's decision.

What stage of development is it at?

Etrasimod has been approved by NICE for use by some adults with Ulcerative Colitis. It is being assessed to see whether it is suitable as a treatment for Crohn’s. This assessment is at the clinical trial stage.

When might it be available?

We do not yet know when etrasimod’s assessment as a treatment for Crohn’s will be complete. But as it is currently at the clinical trial stage, this is likely to take some time.  

Etrasimod is now available on the NHS in England for people with Ulcerative Colitis. Wales and Northern Ireland usually follow NICE decisions too.

It is not yet being assessed by the SMC to decide if it should be available on the NHS in Scotland. We do not know yet when this might happen.