Rystiggo (rozanolixizumab)
An approved treatment for Myasthenia Gravis.
The same compound appears under different names depending on the context. Here is how to identify Rozanolixizumab wherever you encounter it, plus the key facts at a glance.
- Generic name
- Rozanolixizumab
- Brand name
- Rystiggo
- Development code
- UCB7665
- Drug class
- FcRn inhibitor
- Manufacturer
- UCB
- How it's taken
- Given by a healthcare provider as a subcutaneous infusion into the lower belly using an infusion pump, at up to 20 mL per hour.
An FcRn inhibitor for adults with generalized myasthenia gravis who test positive for either AChR or MuSK antibodies, given as an infusion under the skin. It is not approved for children or for people who test negative for both antibodies.
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Where Rozanolixizumab fits
Subcutaneous FcRn blocker for generalized MG, the second in this drug class. Provides an alternative to efgartigimod with a different dosing schedule.
How Rozanolixizumab works
Like efgartigimod, rozanolixizumab blocks the FcRn receptor to accelerate the breakdown of IgG antibodies, including the pathogenic antibodies that attack the neuromuscular junction in myasthenia gravis. This leads to a rapid reduction in harmful antibody levels and improvement in muscle strength.
Mechanism: FcRn inhibitor that reduces pathogenic IgG antibodies in myasthenia gravis
Side effects and safety
Headache (including severe headache) is the most common side effect. Infections, diarrhea, fever, allergic-type reactions, and nausea also occur. Lowering IgG increases infection risk, and rare serious cases of aseptic meningitis (a non-infectious swelling of the brain lining) have been reported. Headaches typically decrease with subsequent dosing cycles.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Rozanolixizumab
Given by a healthcare provider as a subcutaneous infusion into the lower belly using an infusion pump, at up to 20 mL per hour. The dose is 3 to 6 mL depending on body weight. Dosed weekly for 6 weeks per treatment cycle, with cycles repeated as needed based on clinical response.
Availability and cost
Only available as the brand-name product.
FcRn blocker administered as subcutaneous infusion. Second FcRn-targeted therapy for MG, contributing to a growing competitive class.
Help paying for Rystiggo
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Commercially insured patients may pay as little as $0 per dose. Medicare, Medicaid, TRICARE, VA and other government plans excluded.
For: private insurance · source - Infusion cost help
Copay program terms include support for administration costs, except for residents of Massachusetts, Minnesota and Rhode Island.
For: private insurance · source - Free medicine program
Rystiggo Patient Assistance Program: eligible patients may get Rystiggo at no cost for up to 12 months. Contact ONWARD for criteria.
The official page does not say who qualifies. Ask the program. · source - Insurance and case manager help
Dedicated Care Coordinator reviews coverage and financial options, even if uninsured; infusion finder.
For: no insurance · source
Good to know: Phone is 1-844-ONWARD-1. Free-drug eligibility criteria not listed on the page.
- From a charity · NORD RareCareMyasthenia Gravis Medical Assistance fundOpen
Pays for: Medical and medication costs.
The foundation says: “Accepting new applications and re-enrollments for current year” - From a charity · NORD RareCareMyasthenia Gravis Premium Copay Assistance fundOpen
Pays for: Insurance premiums and copays.
The foundation says: “Accepting new applications and re-enrollments for current year” - From a charity · TotalAssist (formerly PAN Foundation)Myasthenia Gravis fundOpen
Pays for: Out-of-pocket costs for approved medications, up to $10,000 per year. Requires Medicare, Medicaid or TRICARE.
- From a charity · The Assistance FundMyasthenia Gravis fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “WAITLIST — Accepting Waitlist Patients. TAF is currently accepting requests to join the enrollment waitlist for this program. Waitlists a…”
Clinical trial results
MycarinG Phase 3 trial showed significant improvement in daily activities and muscle strength across both AChR+ and MuSK+ patients. First FcRn inhibitor approved for both antibody subtypes.
Development history
Approved by FDA in June 2023. Notable as the first FcRn inhibitor approved for both AChR-positive and MuSK-positive generalized myasthenia gravis, broadening treatment eligibility.
Explore Myasthenia Gravis trials
Other Myasthenia Gravis treatments
Rozanolixizumab in Trial Friend News and Guides
Common questions about Rozanolixizumab
▸What is Rozanolixizumab (Rystiggo)?
An FcRn inhibitor for adults with generalized myasthenia gravis who test positive for either AChR or MuSK antibodies, given as an infusion under the skin. It is not approved for children or for people who test negative for both antibodies.
▸How does Rozanolixizumab work?
Like efgartigimod, rozanolixizumab blocks the FcRn receptor to accelerate the breakdown of IgG antibodies, including the pathogenic antibodies that attack the neuromuscular junction in myasthenia gravis. This leads to a rapid reduction in harmful antibody levels and improvement in muscle strength.
▸What are the side effects of Rozanolixizumab?
Headache (including severe headache) is the most common side effect. Infections, diarrhea, fever, allergic-type reactions, and nausea also occur. Lowering IgG increases infection risk, and rare serious cases of aseptic meningitis (a non-infectious swelling of the brain lining) have been reported. Headaches typically decrease with subsequent dosing cycles.
▸How is Rozanolixizumab taken?
Given by a healthcare provider as a subcutaneous infusion into the lower belly using an infusion pump, at up to 20 mL per hour. The dose is 3 to 6 mL depending on body weight. Dosed weekly for 6 weeks per treatment cycle, with cycles repeated as needed based on clinical response.
▸Is Rozanolixizumab FDA approved?
Yes, Rozanolixizumab (Rystiggo) is FDA approved (2023) for the treatment of Myasthenia Gravis.
▸What is Rystiggo used for?
Rystiggo (rozanolixizumab-noli) is approved to treat generalized myasthenia gravis (gMG) in adults.
About the disease: Myasthenia gravis is an autoimmune disease in which antibodies interfere with the signal between nerves and muscles, causing weakness that gets worse with activity.
Who qualifies: Rystiggo is only for people who test positive for either acetylcholine receptor (AChR) antibodies or muscle-specific tyrosine kinase (MuSK) antibodies.
Not approved for: Children or people who test negative for both antibodies.
Source: FDA label for Rystiggo, DailyMed, effective 2026-01-20
▸How does Rystiggo work? What is its mechanism of action?
Rystiggo is a lab-made antibody that blocks the neonatal Fc receptor (FcRn).
What FcRn does: FcRn normally rescues IgG antibodies from being broken down and recycles them back into the blood, which keeps antibody levels high.
Effect of blocking it: Blocking FcRn lets the body clear IgG faster, so levels of all IgG antibodies fall, including the harmful AChR and MuSK antibodies that attack the nerve-to-muscle connection. In the main trial, total IgG and the disease-causing antibodies dropped in a similar pattern after treatment.
Drug class: FcRn blocker (also called FcRn inhibitor). Chemically it is a humanized IgG4 monoclonal antibody, meaning a single type of antibody engineered to look mostly human.
Source: FDA label for Rystiggo, DailyMed, effective 2026-01-20
▸Is Rystiggo an IV infusion?
No, Rystiggo is given as a subcutaneous infusion, which means it is slowly pumped into the fatty tissue under the skin rather than into a vein.
How it is given: A healthcare provider places a small needle in the lower right or lower left belly below the navel and uses an infusion pump at a rate of up to 20 mL per hour.
Site rotation: The infusion site is rotated each time.
Monitoring: You are watched during the infusion and for 15 minutes afterward for signs of an allergic reaction.
Source: FDA label for Rystiggo, DailyMed, effective 2026-01-20
▸How is Rystiggo dosed?
The dose depends on body weight, given as 1 infusion a week for 6 weeks per treatment cycle.
Dose by weight: People under 50 kg get 420 mg (3 mL), people 50 kg to under 100 kg get 560 mg (4 mL), and people 100 kg and above get 840 mg (6 mL).
Cycles: A treatment cycle is 1 infusion a week for 6 weeks. Your doctor decides when to start the next cycle based on how you are doing, but starting a new cycle sooner than 63 days from the start of the previous one has not been studied.
Missed dose: It can be given up to 4 days late, and then the original schedule continues.
Cycles per year: In the extension study, people started an average of 4 cycles a year.
Source: FDA label for Rystiggo, DailyMed, effective 2026-01-20
▸What are the side effects of Rystiggo?
The most common side effects in the main trial were headache, infections, diarrhea and fever.
Main trial: In 133 people on Rystiggo versus 67 on placebo, the most common side effects were headache (44% vs 19%), any infection (23% vs 19%), diarrhea (20% vs 13%), fever (17% vs 2%), allergic-type reactions (11% vs 5%), nausea (10% vs 8%), reactions at the infusion site (8% vs 3%), abdominal pain (8% vs 6%) and joint pain (7% vs 3%).
Severe headache: Occurred in 5.3% of people on Rystiggo and none on placebo.
Infections: Across all studies, the most frequent infections were upper respiratory infections (17%), COVID-19 (14%), urinary tract infections (9%) and herpes simplex (6%), and serious infections occurred in 4%.
Since approval: Shingles (herpes zoster) has been reported.
Source: FDA label for Rystiggo, DailyMed, effective 2026-01-20
▸What are the risks of Rystiggo for myasthenia gravis?
The label has no contraindications, but it carries 3 main warnings.
Infections: Because Rystiggo lowers IgG, it can raise the risk of infection, so treatment is delayed if you have an active infection, and live vaccines are not recommended during treatment.
Aseptic meningitis: Serious cases of aseptic meningitis (swelling of the lining around the brain that is not caused by an infection) have been reported, including 1 person with gMG in the trials who was hospitalized.
Allergic reactions: Reactions including angioedema (swelling under the skin) and rash occurred within 1 day to 2 weeks of a dose.
Deaths in studies: Across the studies, 3 people died of pneumonia, 2 from COVID-19 and 1 from an unknown cause.
Source: FDA label for Rystiggo, DailyMed, effective 2026-01-20
▸Can Rystiggo cause liver damage?
The current FDA label does not list liver injury as a warning or as a side effect seen in the trials.
Lab findings: The label also does not include liver-related lab abnormalities in its side effect table.
What to do: If you have a liver condition or notice symptoms such as yellowing of the skin or eyes, tell your doctor, since the label does not describe how Rystiggo behaves in people with liver disease.
Source: FDA label for Rystiggo, DailyMed, effective 2026-01-20
▸Can Rystiggo be used by someone with kidney disease?
The label does not address kidney disease and does not give dosing instructions for people with reduced kidney function.
What the label says: Rystiggo is a large antibody protein, and the label does not describe any kidney-related side effects from the trials.
What to do: Your neurologist and kidney specialist would need to weigh this together, since there is no label guidance either way.
Source: FDA label for Rystiggo, DailyMed, effective 2026-01-20
▸Does Rystiggo help with myasthenia gravis fatigue?
Fatigue was not measured as a separate outcome in the main trial, and it is not listed in the label's side effect table.
What was measured: The MG-ADL score, a 0 to 24 scale covering 8 daily activities such as talking, chewing, swallowing, breathing and getting up from a chair, where higher scores mean more impairment.
Result: People on Rystiggo improved by 3.4 points at day 43 compared with 0.8 points on placebo.
Muscle weakness: Measured by the QMG scale, it also improved more on Rystiggo.
Source: FDA label for Rystiggo, DailyMed, effective 2026-01-20
▸What did the Rystiggo clinical trial show?
In the MycarinG trial, Rystiggo improved daily activity and muscle strength scores significantly more than placebo across both antibody subtypes.
Trial design: The MycarinG study (Study 1, NCT03971422) enrolled 200 adults with gMG, 89.5% with AChR antibodies and 10.5% with MuSK antibodies, and compared 6 weekly infusions of Rystiggo with placebo.
Daily activities: At day 43, the MG-ADL daily activities score fell by 3.4 points on Rystiggo versus 0.8 points on placebo, a difference of 2.6 points.
Muscle strength: The QMG score (0 to 39, higher is worse) fell by 5.4 points at the lower dose and 6.7 points at the higher dose versus 1.9 points on placebo.
Significance: Both results were statistically significant (p below 0.001). It was the first pivotal trial to show an FcRn blocker works across both antibody subtypes.
Source: FDA label for Rystiggo, DailyMed, effective 2026-01-20
▸Who makes Rystiggo, and when did the FDA approve it?
Rystiggo is made by UCB, Inc., and the FDA approved it in June 2023.
Development code: UCB7665.
Why it was notable: It was the first FcRn blocker approved for both AChR-positive and MuSK-positive generalized myasthenia gravis, which widened eligibility compared with earlier targeted drugs that covered AChR-positive patients only.
Latest label change: The most recent major change to the prescribing information, an update to the preparation and administration instructions, was made in August 2025.
Source: FDA label for Rystiggo, DailyMed, effective 2026-01-20
▸How much does Rystiggo cost, and is there payment assistance?
The FDA label does not list a price, and Trial Friend does not have a verified cost figure.
What affects cost: Rystiggo is a specialty biologic given by a healthcare provider, so your out-of-pocket cost depends on your insurance and site of care.
Assistance: UCB's ONWARD program provides a dedicated Care Coordinator, a review of your insurance coverage, copay assistance for eligible people and symptom tracking tools.
What to do: Ask your care team or contact ONWARD directly to find out what you qualify for.
▸Is there a generic Rystiggo?
No, Rystiggo is a biologic antibody made in living cells, so an exact generic is not possible.
Biosimilars: The equivalent for biologics is a biosimilar, and none has been approved for rozanolixizumab.
Availability: Rystiggo remains available only as the brand product from UCB.
▸Is there an alternative to Rystiggo? What drugs are like it?
The closest alternative is efgartigimod, another FcRn blocker that also lowers IgG.
Schedule: The 2 drugs use different schedules, since Rystiggo is given weekly for 6-week cycles, while efgartigimod uses 4-week cycles.
Route: Rystiggo is subcutaneous only, while efgartigimod has both IV and subcutaneous options.
Antibody type: Rystiggo was the first FcRn blocker approved for MuSK-positive patients as well as AChR-positive patients, so antibody type may affect which drug your neurologist suggests.
Drug interactions: Rystiggo can reduce the effectiveness of other antibody-based drugs and immunoglobulin products (such as IVIG) that also bind FcRn, so your doctor may need to monitor those or choose one approach.
▸Is Rystiggo approved for fibromyalgia?
No, the only FDA-approved use of Rystiggo is generalized myasthenia gravis in adults who are AChR or MuSK antibody positive.
Fibromyalgia: It is not approved for fibromyalgia, and the label contains no data on fibromyalgia or any other condition.
What that means: If you have seen it mentioned alongside fibromyalgia, that is not a use the FDA has reviewed.
Source: FDA label for Rystiggo, DailyMed, effective 2026-01-20
▸What does Rystiggo look like, and how is it stored?
Rystiggo is a clear to slightly cloudy liquid that ranges from colorless to pale brownish yellow, kept refrigerated in its carton.
Vial sizes: Single-use glass vials of 280 mg (2 mL), 420 mg (3 mL), 560 mg (4 mL) and 840 mg (6 mL) at 140 mg per mL.
Refrigeration: Vials are kept at 36°F to 46°F (2°C to 8°C) in the original carton to protect them from light, and they must not be frozen or shaken.
Room temperature: A vial can sit at room temperature up to 77°F (25°C) for a single period of up to 20 days, but once it has been at room temperature it cannot go back in the refrigerator.
Before use: The provider lets the vial warm for about 30 minutes before use and must start the infusion within 4 hours of puncturing it.
Source: FDA label for Rystiggo, DailyMed, effective 2026-01-20