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 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.

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 Colitis.

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

What stage of development is it at?

Etrasimod has been approved in the UK to treat some people aged 16 or over with 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 has been approved throughout the UK for use as an NHS treatment for some people aged 16 years and older with moderately to severely active Colitis.

What is it?

Guselkumab is a type of biologic medicine. Biologic medicines are made by a biological process rather than a chemical one. They’re produced in a lab using living cells.  

Guselkumab works by blocking a protein called IL-23. Your immune system naturally makes IL-23 to help you fight infections. But it can sometimes also cause inflammation. By blocking IL-23, guselkumab reduces gut inflammation.

The brand name for guselkumab is Tremfya.

How do you have it?

Guselkumab can be given through a drip into a vein and as an injection under the skin.

Who might it be used to treat?

Guselkumab has been successful in large clinical trials in adults with moderately to severely active Crohn’s and moderately to severely active Colitis.

What stage of development is it at?

NICE is currently in the early stages of assessing guselkumab for the treatment of moderately to severely active Crohn’s and Colitis in England. Wales and Northern Ireland usually follow NICE decisions too.

For Crohn's

Guselkumab is being assessed for use in England as a treatment for people with moderately to severely active Crohn’s who:

• Cannot have standard treatments or other biological treatments
• Have not responded to standard treatments or other biological treatments

For Colitis

Guselkumab is being assessed for use in England as a treatment for people with moderately to severely active Colitis who:

• Cannot have standard treatments, other biological treatments or a JAK inhibitor
• Have not responded to standard treatments, other biological treatments or a JAK inhibitor
• Have stopped responding to standard treatments, biological treatments or a JAK inhibitor

When might it be available?

NICE have not said when they expect to make a decision. The assessment process usually takes up to a year. 

Guselkumab is not yet being assessed by the SMC to decide if it should be available for people with Crohn's or 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. Biologic medicines are made by a biological process rather than a chemical one. They’re produced in a lab using living cells.

Mirikizumab works by sticking 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 moderately or severely active 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.

Mirankizumab is being assessed by NICE for use in England as a treatment for people with Crohn’s. This process is in its very early stages. Wales and Northern Ireland usually follow NICE decisions too.

What stage of development is it at?

For Colitis

Mirikizumab has been accepted throughout the UK as a treatment option for some people with Colitis. We have more details in our full information on mirikizumab.

For Crohn's

NICE is assessing mirankizumab for use as a treatment for people with Crohn’s in England.

When might it be available?

For Colitis

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

For Crohn's

NICE is currently in the early stages of assessing mirikizumab for the treatment of Crohn’s in England. They have not said when they expect to make a decision. The assessment process usually takes up to a year. Wales and Northern Ireland usually follow NICE decisions too.

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

What is it?

Risankizumab is a type of biologic medicine. Biologic medicines are made by a biological process rather than a chemical one. They’re produced in a lab using living cells.

Risankizumab works by sticking 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 risankizumab 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 risankizumab 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 recommended as a treatment option for adults with moderate to severely active Crohn’s who:

• Cannot take an anti-TNF medicine
• Have not responded well enough to another biologic medicine
• Have stopped responding to another biologic medicine
• Have had to stop another biologic medicine because of bad side effects

Risankizumab is used to treat over 16s in England and Wales with moderate to severely active Crohn’s. In Northern Ireland it is used to treat over 18s, although it can sometimes be given to 16- and 17-year-olds if biologic medicines are not suitable.

For Colitis

Risankizumab is recommended as a treatment option for adults with moderate to severely active Ulcerative Colitis who:

• Cannot take an anti-TNF medicine
• Have not responded well enough to an anti-TNF medicine
• Have stopped responding to an anti-TNF medicine
• Have had to stop taking an anti-TNF medicine because of bad side effects

What stage of development is it at?

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 has been approved by NICE for NHS use in England for people with Ulcerative Colitis. Wales and Northern Ireland usually follow NICE decisions too.

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

When might it be available?

Both NICE and the SMC have recommended risankizumab as a treatment for some people with Crohn’s. It is available on the NHS in England, Scotland, Wales and Northern Ireland.

NICE has recommended risankizumab as a treatment for some people with Ulcerative Colitis. It is available on the NHS in England, Wales and Northern Ireland.

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.