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For US Healthcare Professionals

Results from the ENSPRYNG clinical trials

Experiencing a relapse can be challenging, so it’s important to find a treatment that may help reduce the risk of future relapses.

Clinical study 1: ENSPRYNG alone
Clinical study 2: ENSPRYNG + IST
Possible side effects

ENSPRYNG was studied in two clinical trials

Two clinical trials were conducted to determine the effectiveness of ENSPRYNG, taken alone or with immunosuppressive therapy (IST), in lowering the risk of relapse in adults with AQP4+ NMOSD. Both trials also measured how many people were relapse-free at specific points along the treatment journey.

Across both, there were:

A diverse group of patients from around the world, inclusive of Black, White, Asian, and American Indian populations

A balanced number of patients in age, AQP4-IgG status, and severity of disease

Both men and women, with a larger proportion of women

In Study 1, ENSPRYNG alone was compared to placebo

In order to qualify for Study 1 and be randomly chosen to receive ENSPRYNG or placebo, 95 adults were tested to see if they were AQP4- or AQP4+. People who had recently taken other treatments before the trial started weren’t included. Sixty-four of the 95 people tested AQP4+ and out of those 64 people, 41 received ENSPRYNG and 23 received placebo.

Infographic showing at 96 weeks, ENSPRYNG reduced relapse risk by 74%.

In Study 2, ENSPRYNG plus IST was compared to placebo plus IST

In order to qualify for Study 2 and be randomly chosen to receive ENSPRYNG plus IST or placebo plus IST, 76 adults were tested to see if they were AQP4- or AQP4+. Only people who were taking certain ISTs (eg, azathioprine, mycophenolate mofetil, or oral corticosteroids) before the trial started were included. Fifty-two of the 76 people tested AQP4+ and out of those 52 people, 26 received ENSPRYNG plus IST and 26 received placebo plus IST.

Chart comparing the effect of ENSPRYNG on relapse reduction.

Why choose ENSPRYNG?

Now that you know ENSPRYNG has been proven to reduce risk of relapse, learn about side effects that may occur.

View Safety Information
NEXT: ENSPRYNG Side Effects

Important Safety Information & Indication

What is ENSPRYNG?

ENSPRYNG is a prescription medicine used to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who are aquaporin-4 (AQP4) antibody positive. It is not known if ENSPRYNG is safe and effective in children.

Who should not receive ENSPRYNG?

Do not take ENSPRYNG if you:

  • are allergic to ENSPRYNG or any of the ingredients in ENSPRYNG.
  • have an active hepatitis B infection.
  • have active or untreated inactive (latent) tuberculosis.
What is the most important information I should know about ENSPRYNG?

ENSPRYNG may cause serious side effects including:

  • Infections. ENSPRYNG can increase your risk of serious infections, some of which can be life-threatening. Talk to your healthcare provider if you are being treated for an infection, or call them right away if you think you have signs of an infection, with or without a fever, such as:
    • chills, feeling tired, muscle aches, cough that will not go away or a sore throat
    • skin redness, swelling, tenderness, pain or sores on your body
    • diarrhea, belly pain, or feeling sick
    • burning when you urinate or urinating more often than usual

Your healthcare provider will check if you have an infection and treat it if needed before you start or continue to take ENSPRYNG.

  • Your healthcare provider should test you for hepatitis and tuberculosis (TB) before you start taking ENSPRYNG.
  • All required vaccinations should be completed before starting ENSPRYNG. People using ENSPRYNG should not be given ‘live’ or ‘live-attenuated’ vaccines. ‘Live’ or ‘live-attenuated’ vaccines should be given at least 4 weeks before you start ENSPRYNG. Your healthcare provider may recommend that you get a ‘non-live’ (inactivated) vaccine, such as some of the seasonal flu vaccines. If you plan to get a ‘non-live’ (inactivated) vaccine, it should be given, whenever possible, at least 2 weeks before you start ENSPRYNG.
  • Increased liver enzymes.
    Your healthcare provider should order blood tests to check your liver enzymes before and while you are taking ENSPRYNG. Your healthcare provider will tell you how often you will need to have these blood tests. Make sure you get all of your follow-up blood tests as ordered by your healthcare provider. Your healthcare provider will tell you if you need to wait to start ENSPRYNG if your liver enzymes are increased.
  • Low neutrophil count.
    ENSPRYNG can cause a decrease in your neutrophil counts in your blood. Neutrophils are white blood cells that help the body fight off bacterial infections. Your healthcare provider should order blood tests to check your neutrophil count while you are taking ENSPRYNG.
  • Serious allergic reactions.
    Serious allergic reactions that may be life-threatening have happened with other medicines like ENSPRYNG. Tell your healthcare provider before taking your next dose if you had hives, rash, or flushing after your injection. Seek medical attention right away if you have any symptoms of a serious allergic reaction, such as:
    • shortness of breath or trouble breathing
    • dizziness or feeling faint
    • swelling of your lips, face, or tongue
    • moderate or severe stomach (abdominal) pain or vomiting
    • chest pain    

Before you take ENSPRYNG, tell your healthcare provider about all of your medical conditions, including if you:

  • have or think you have an infection. See "What is the most important information I should know about ENSPRYNG?"
  • have liver problems.
  • have ever had hepatitis B or are a carrier of the hepatitis B virus.
  • have had or have been in contact with someone with tuberculosis.
  • have had a recent vaccination or are scheduled to receive any vaccination.
  • are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if ENSPRYNG will harm your unborn baby.
    • Pregnancy Registry: There is a registry for pregnant women who take ENSPRYNG. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking ENSPRYNG, talk to your healthcare provider about how you can join this pregnancy registry, or you may contact the registry at 1-833-277-9338 to enroll.
  • are breastfeeding or plan to breastfeed. It is not known if ENSPRYNG passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take ENSPRYNG.

Tell your healthcare provider about all the medicines you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the most common side effects of ENSPRYNG?
The most common side effects of ENSPRYNG include:

  • sore throat, runny nose (nasopharyngitis)
  • rash
  • fatigue
  • extremity pain
  • headache
  • upper respiratory tract infection
  • nausea
  • inflammation of the stomach lining (gastritis)
  • joint pain (arthralgia)

These are not all the possible side effects of ENSPRYNG.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.

For more information, call 1-844-NSPRYNG.

For additional safety information, please see the full Prescribing Information and Medication Guide.

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