Relugolix
What is relugolix?
Relugolix (Orgovyx®) is a new type of hormone therapy used to treat some men with prostate cancer. It is not an extra treatment to take with your current hormone therapy. It works in the same way as other types of hormone therapy, but it can be taken as tablets instead of injections.
Prostate cancer cells usually need testosterone to grow. Hormone therapy works by lowering the level of testosterone in the body. This means that less testosterone reaches the cancer cells, which usually shrinks the cancer and slows its growth.
Hormone therapy can’t cure your cancer on its own. But it can help keep it under control and delay symptoms.
Who can have relugolix?
If you have localised or locally advanced prostate cancer
Relugolix may be a treatment option, alongside radiotherapy, if you have:
- localised prostate cancer that has a high risk of spreading, or
- locally advanced prostate cancer.
Both these types of prostate cancer have a Cambridge Prognostic Group (CPG) score of 4 or 5. For more information on CPG scores, visit What do my test results mean?
Relugolix may also be given as a first step before radiotherapy. You may hear this called neoadjuvant treatment (a type of treatment that comes before your main treatment).
If you have advanced prostate cancer
Relugolix may also be a treatment option if you have advanced hormone-sensitive prostate cancer. This mean your cancer is likely to respond (if you are newly diagnosed and yet to start hormone therapy) or still responding to hormone therapy treatment.
Availability
Relugolix is available throughout the UK. Speak to your doctor about whether it would be suitable for you.
Other treatment options
If you can’t have relugolix or you decide it isn’t right for you, there are other treatment options. Speak to your doctor about the treatments available for localised prostate cancer, locally advanced prostate cancer or advanced prostate cancer.
Will having relugolix affect my treatment options later on?
If you have relugolix to treat your prostate cancer and then it becomes less effective, you will have the option of trying other treatments. Speak to your healthcare team or read more about treatment options after your first hormone therapy. You can also talk things through with our Specialist Nurses.
What does relugolix treatment involve?
Relugolix is usually taken as one tablet a day.
On the first day, you should take three tablets. This is called a loading dose.
The tablet should be swallowed whole with some liquid, either with food or between meals. Try to take the tablet at the same time each day.
Unlike with some other hormone therapies, you will not need to take anti-androgen tablets when you first start taking relugolix. Anti-androgens block testosterone from reaching cancer cells, but you don’t need to take them with relugolix because it doesn’t cause a sudden increase in testosterone when you first start taking it.
Always follow the instructions you have been given by your healthcare team. Ask them to explain anything if you are unsure.
Other health problems and medicines
Before taking relugolix, tell your doctor if you have:
- a heart rhythm problem (such as arrhythmia)
- a history of cardiovascular disease (such as heart attack or stroke)*
- kidney or liver problems
- osteoporosis (weakened bones).
*You may still be offered relugolix if you've had these problems (see section below).
You should tell your doctor about any other health problems you have as well, even if they're not on this list.
Cardiovascular disease
Hormone therapy can increase your risk of developing a health problem that affects your heart or blood vessels (such as diabetes, heart attack or stroke), especially if you have a history of these problems.
But hormone therapy may be the best treatment for your prostate cancer. And if you have a history of cardiovascular disease, relugolix may be more suitable for you than other types of hormone therapy. This is because it may have a reduced risk of cardiovascular side effects compared with other hormone therapies. But more research is needed to know for sure.
Other medicines and relugolix
Tell your doctor about any other medicines you’re taking or have taken recently, including herbal supplements. Some medicines can affect how well relugolix works.
Your doctor may change your dose of relugolix, or the times when you take your other medicines, if you’re on medication for any of the following health conditions:
- chest pain (angina)
- a heart rhythm problem (such as arrhythmia)
- high blood pressure (hypertension).
Relugolix needs to be taken at a different dose if you are taking apalutamide (Erleada®), which is another hormone therapy used to treat prostate cancer. Other prostate cancer treatments are not affected.
What are the side effects?
Like all treatments, relugolix can cause side effects. Before you start relugolix, your doctor or nurse will explain the possible side effects. They affect each person differently, and you’re unlikely to get all the possible side effects. But knowing what to expect and how to manage them can help you feel more prepared and in control.
The side effects of relugolix are similar to the side effects of other hormone therapies, and are mainly caused by changing testosterone levels. After you stop taking relugolix, they should go away after a few months.
The most common side effects are:
- constipation
- diarrhoea*
- extreme tiredness (fatigue)
- hot flushes
- muscle and joint pain or stiffness.
*Speak to your doctor if you have had diarrhoea for more than two days, as it may affect how well relugolix works.
Relugolix is a new medicine so we don’t have as much information about the side effects as we do for most other medicines. If you have any side effects, please report them to the Yellow Card reporting scheme. This helps doctors to understand the less common side effects that may be caused by new treatments.
Tell your doctor or healthcare team if you have any side effects, as they may be able to help you manage them. You can also speak to our Specialist Nurses.
Contraception and fertility
If your partner is pregnant, or if there is a chance they could become pregnant, use a condom together with another form of contraception when having sex. You should do this while you’re taking relugolix, and for two weeks after taking your last tablet. This is because relugolix could harm the baby.
Relugolix might affect your fertility while you’re taking it. Speak with your doctor if you are worried about this.
Dealing with side effects
Living with prostate cancer and managing side effects can impact not only your physical but also your emotional health. Men on hormone therapy in particular may experience changes in their mood, energy levels, self-esteem and body image. This is normal. Give yourself time to deal with your feelings. It’s important to look after your emotional and mental wellbeing. Remember, you are not alone. There is support available.
Find out more about how hormone therapy affects you.
What happens next?
You will continue taking relugolix unless it stops working or you start having serious side effects.
While you’re taking relugolix, you will have appointments at the hospital to check how well your treatment is working. How often you have these appointments will depend on your hospital.
At these appointments, you will have several tests. What tests you have, and how often you have them, will depend on your hospital. Your healthcare team will discuss this with you. The tests may include:
- a prostate specific antigen (PSA) blood test
- blood tests to check for any problems with your kidneys or liver
- blood pressure tests.
Your doctor will use your PSA level and results from any other tests, along with information about how you’re feeling, to check how well the treatment is working.
Tell your doctor or nurse about any side effects you’re having, as there may be ways of managing these.
If your PSA level falls, this usually suggests your treatment is working. How quickly the PSA level falls, and how low it goes, will vary from person to person.
What if my PSA level doesn’t fall?
In some men, the PSA level won’t fall. This doesn’t necessarily mean relugolix isn’t working. But your doctor may ask about any symptoms you’re having, such as urinary problems or bone pain.
You may be sent for further scans, which could include an MRI scan, a bone scan or a computerised tomography (CT) scan to see if your cancer has spread.
If your doctor is concerned your cancer is growing, they will talk to you about other treatment options.
If the scans show your cancer hasn’t spread, then you may be offered another hormone therapy to take alongside relugolix. If your cancer has spread, you may be offered chemotherapy or another type of hormone therapy to take with relugolix.
If you are concerned, speak to your doctor or healthcare team. You can also speak to our Specialist Nurses for information and support.
Dealing with prostate cancer
Being diagnosed and living with prostate cancer can change how you think and feel about life. If you or your loved one is dealing with prostate cancer, it’s normal to feel scared, stressed or even angry. Lots of men with prostate cancer can get these kinds of thoughts and feelings. But there is no ‘right’ way to feel and everyone reacts in their own way. You may find it helpful to read our information on living with advanced prostate cancer. Our Wellbeing Hub has information to support you in looking after your emotional, mental and physical wellbeing.
If you are close to someone with prostate cancer, find out more about how you can support them and where to get more information.
Questions you may want to ask your doctor or nurse
- Is relugolix a suitable treatment for me, and why?
- What treatments can I have instead of relugolix?
- If I get side effects, are there ways to manage them?
- If I go on relugolix, what tests will I have to monitor my prostate cancer, and how often will I have them?
- Can I have other treatments alongside relugolix?
- What will happen if my PSA level continues to rise while I’m on relugolix?
- What other treatments might be suitable if my cancer becomes advanced?
- What treatments might be suitable if my advanced prostate cancer stops responding to hormone therapy?
References and reviewers
Created: January 2025 | Due for review: January 2028.
- Accord-UK Ltd. Summary of Product Characteristics (SmPC - Orgovyx® 120 mg film-coated tablets, Relugolix 120 mg film-coated tablets (Great Britain). 2024.
- Cirne F, Aghel N, Petropoulos JA, Klotz L, Lenihan DJ, Saad F, et al. The cardiovascular effects of gonadotropin-releasing hormone antagonists in men with prostate cancer. Eur Heart J - Cardiovasc Pharmacother. 2022 May 5;8(3):253–62.
- Cornford P, van den Bergh RCN, Briers E, De Santis M, Gillessen S, Henry AM, et al. EAU - EANM - ESTRO - ESUR - ISUP - SIOG Guidelines on Prostate Cancer. European Association of Urology; 2024.
- Dearnaley DP, Saltzstein DR, Sylvester JE, Karsh L, Mehlhaff BA, Pieczonka C, et al. The Oral Gonadotropin-releasing Hormone Receptor Antagonist Relugolix as Neoadjuvant/Adjuvant Androgen Deprivation Therapy to External Beam Radiotherapy in Patients with Localised Intermediate-risk Prostate Cancer: A Randomised, Open-label, Parallel-group Phase 2 Trial. Eur Urol. 2020 Aug 1;78(2):184–92.
- National Institute for Health and Care Excellence. Prostate cancer: diagnosis and management [Internet]. 2021 [cited 2022 Dec 19]. Available from: https://www.nice.org.uk/guidance/ng131
- National Institute for Health and Care Excellence. Relugolix for treating hormone-sensitive prostate cancer. 2024.
- Saad F, Shore ND. Relugolix: a novel androgen deprivation therapy for management of patients with advanced prostate cancer. Ther Adv Med Oncol. 2021 Mar 24;13:1758835921998586.
- Scottish Medicines Consortium. relugolix (Orgovyx) [Internet]. Scottish Medicines Consortium. 2024 [cited 2024 Oct 3]. Available from: https://scottishmedicines.org.uk/medicines-advice/relugolix-orgovyx-full-smc2678/
- Shirley M. Relugolix: A Review in Advanced Prostate Cancer. Target Oncol. 2023 Mar;18(2):295–302.
- Shore ND, Saad F, Cookson MS, George DJ, Saltzstein DR, Tutrone R, et al. Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer. N Engl J Med. 2020 Jun 4;382(23):2187–96.
- Tombal B, Collins S, Morgans AK, Hunsche E, Brown B, Zhu E, et al. Impact of Relugolix Versus Leuprolide on the Quality of Life of Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study. Eur Urol. 2023 Dec 1;84(6):579–87.
- Johann de Bono, Head of Division of Clinical Studies, Royal Marsden NHS Foundation Trust
- Hilary Glen, Consultant Medical Oncologist, Beatson West of Scotland Cancer Centre
- Will Ince, Consultant Oncologist, Cambridge University Hospitals NHS Foundation Trust
- Joe O'Sullivan, Professor of Radiation Oncology, Queen's University Belfast and Consultant Prostate Oncologist, The Northern Ireland Cancer Centre
- Our volunteers.