Danielle is a nurse and fantasy author who went through 9 neurologists before a single fiber EMG, a nerve and muscle test that can show myasthenia gravis when blood tests come back empty, confirmed her diagnosis. She has no detectable myasthenia gravis antibodies, which makes her seronegative. When she asked for an FcRn blocker, one of the newest kinds of myasthenia gravis drug, her insurer denied it, and the Myasthenia Gravis Foundation of America, telling her story in February 2025, noted that the treatment was not FDA approved for seronegative disease. She started IVIG instead (MGFA, 2025).
On May 8, 2026, the FDA expanded Vyvgart to every adult with generalized myasthenia gravis, whatever their antibody test shows (argenx, May 2026). For that one drug, the approval gap Danielle ran into is closed. The other 6 targeted drugs still require a positive AChR or MuSK antibody test, and this guide lays out who qualifies for each one, how each is given, what each costs under Medicare, and which 2 drugs are next in line at the FDA.
Every FDA-Approved Myasthenia Gravis Drug by Antibody Type and Age
The first targeted drug for generalized myasthenia gravis arrived in October 2017, when the FDA approved Soliris (eculizumab) for adults with AChR antibodies. Today the list of 7 splits into 3 families. Complement inhibitors (Soliris, Ultomiris and Zilbrysq) block C5, a protein that helps the immune system punch holes in the muscle side of the nerve-muscle connection. FcRn blockers (Vyvgart, Rystiggo and Imaavy) make the body break down its IgG antibodies faster, harmful ones included. Uplizna, the newest, removes the B cells that make those antibodies in the first place.
| Drug | Type | Approved for | How it is given | How often |
|---|---|---|---|---|
| Soliris (eculizumab), plus biosimilars Bkemv and Epysqli | C5 complement inhibitor | AChR-positive adults; Soliris also AChR-positive children 6 and older | IV infusion | Weekly for the first 5 doses, then every 2 weeks (adult schedule) |
| Ultomiris (ravulizumab) | C5 complement inhibitor | AChR-positive adults | IV infusion | Loading dose, then every 8 weeks |
| Zilbrysq (zilucoplan) | C5 complement inhibitor | AChR-positive adults | Injection under the skin you can give yourself after training | Every day |
| Vyvgart and Vyvgart Hytrulo (efgartigimod) | FcRn blocker | All adults with generalized MG, any antibody result | IV infusion (Vyvgart) or injection under the skin (Hytrulo), including a prefilled syringe for home use | Weekly for 4 weeks per cycle, with cycles repeated based on symptoms |
| Rystiggo (rozanolixizumab) | FcRn blocker | AChR-positive or MuSK-positive adults | Infusion under the skin given by a health care provider | Weekly for 6 weeks per cycle |
| Imaavy (nipocalimab) | FcRn blocker | AChR-positive or MuSK-positive patients 12 and older | IV infusion | Loading dose, then every 2 weeks |
| Uplizna (inebilizumab) | CD19 B-cell depleting antibody | AChR-positive or MuSK-positive adults | IV infusion of about 90 minutes | 2 doses 2 weeks apart, then every 6 months |
The complement drugs are approved only for AChR-positive disease because AChR antibodies do much of their damage by switching on complement at the junction between nerve and muscle, while MuSK antibodies mostly work another way. The FcRn blockers and Uplizna act further upstream, on the antibodies themselves or the cells that make them, and their labels reach further as a result. Soliris also has 2 biosimilars, Bkemv and Epysqli, which added AChR-positive myasthenia gravis in adults to their labels in late 2024 but are not approved for children with the disease (FDA labels, 2024 to 2026).
Uplizna, the Twice-a-Year Option Approved in December 2025
The FDA approved Uplizna for generalized myasthenia gravis on December 11, 2025, for adults with AChR or MuSK antibodies. In its 238-person MINT trial, MG-ADL scores (a 0 to 24 rating of how much the disease gets in the way of talking, chewing, swallowing, breathing and daily tasks) improved by 4.2 points on Uplizna and 2.2 points on placebo at week 26, even as patients on steroids tapered toward 5 mg of prednisone a day starting at week 4 (Amgen, December 2025). After 2 starting infusions, Uplizna is given every 6 months, the least frequent schedule on the list. Before the first dose, the label requires screening for hepatitis B and tuberculosis and a check of antibody levels, and the most common side effects in the myasthenia gravis trial were headache and infusion reactions (Uplizna prescribing information, September 2026).
Seronegative Myasthenia Gravis Now Has 1 Approved Targeted Drug
About 20% of people with generalized myasthenia gravis have no detectable AChR antibodies. Some of them carry MuSK or LRP4 antibodies instead, and about 10% of all patients have none of the 3, a group called triple seronegative (argenx, May 2026). Until May 2026, none of the targeted drugs was approved for anyone outside the AChR and MuSK groups.
The trial that changed that, ADAPT SERON, enrolled 119 adults whose tests showed no AChR antibodies. After 4 weekly doses, MG-ADL scores on Vyvgart had improved by 3.35 points from where they started, and the difference from placebo had less than a 1 in 100 chance of being a fluke (argenx, May 2026).
“gMG patients who do not have detectable AChR-Ab have been left behind”
Allison Foss, Executive Director, Myasthenia Gravis Association, in argenx's May 2026 announcement
Trials have been slower to open up. On September 30, 2026, Trial Friend read the posted eligibility rules of every open drug trial on ClinicalTrials.gov that lists myasthenia gravis as a condition, 73 in all, counting drug, antibody and cell therapy studies and leaving out observational, device and exercise studies. In 48 of them, the rules require a positive antibody test, and 22 accept only AChR-positive patients. Only 5 clearly allow people without a positive antibody test.
- 30%AChR-positive only
- 22%AChR or MuSK positive
- 14%Any positive myasthenia antibody, including LRP4
- 7%People without a positive test allowed
- 27%Antibody status not stated in the rules
Of those 5 trials, 3 have US sites. MyClad is a Phase 3 trial of a new formulation of oral cladribine, the drug in the multiple sclerosis pill Mavenclad (NCT06463587). MyVision is a Phase 3 trial of Rystiggo in ocular myasthenia gravis, the form limited to the eyes and eyelids (NCT07463521). RESET-MG is an early-stage CAR-T cell therapy study from Cabaletta Bio, with 17 sites, all in the United States (NCT06359041). The 20 trials that do not mention antibody status in their posted rules may still take seronegative patients, and the study team is the one to ask. Trial Friend's myasthenia gravis trial list shows each study's sites and contacts.
IV Infusion or a Shot at Home: How Each Myasthenia Gravis Drug Fits Into a Week
The schedules differ more than the results do. An adult on Soliris spends an infusion appointment every 2 weeks for as long as the drug keeps working, someone on Ultomiris goes every 8 weeks, and someone on Uplizna twice a year. Zilbrysq runs the other way, with a small injection under the skin every day, given at home after training (Zilbrysq prescribing information). The FcRn blockers mostly come in cycles, with Vyvgart given weekly for 4 weeks and Rystiggo weekly for 6, then repeated when symptoms return. Imaavy is the exception in its class, with an IV dose every 2 weeks and no breaks between cycles. Since April 10, 2025, Vyvgart Hytrulo has also come in a prefilled syringe that patients or caregivers can inject at home after instruction (argenx, April 2025).
The complement inhibitors share a requirement the others do not. Because blocking C5 raises the risk of meningococcal infection, a rare but fast-moving bacterial infection, all 3 carry a boxed warning and are available only through restricted safety programs called REMS, and patients need meningococcal vaccines at least 2 weeks before the first dose unless waiting would be riskier (Soliris, Ultomiris and Zilbrysq prescribing information). The FcRn blockers carry no boxed warning, though lowering IgG raises the risk of ordinary infections, and Rystiggo's label warns about aseptic meningitis, an inflammation of the lining around the brain and spinal cord that is not caused by an infection. Our Rystiggo guide covers the FcRn side effects in more detail.
What Myasthenia Gravis Drugs Cost, and Why Medicare Part B vs Part D Matters
The list prices UCB and argenx publish show the scale. UCB lists Zilbrysq at $1,164.21 for the 23 mg syringe, one of 3 weight-based daily doses (UCB, prices as of January 2026), which works out to about $425,000 for a year at that dose. In its September 2025 price disclosure, argenx lists one Vyvgart Hytrulo prefilled syringe at $16,732, and a 4-week cycle uses 4 of them, about $67,000 at list price. List prices come before insurer discounts and rebates, and what a patient pays depends mostly on which part of Medicare, or which insurance plan, the drug runs through.
Picture a 68-year-old retired teacher with AChR-positive myasthenia gravis who has Original Medicare and no supplemental plan. If her neurologist picks a drug given in a clinic, such as Ultomiris, Soliris, Imaavy or Uplizna, it is usually billed under Medicare Part B. Part B charges 20% coinsurance after a $283 deductible in 2026, and Original Medicare has no yearly limit on what she pays out of pocket (Medicare.gov). On a drug with a six-figure yearly price, 20% can mean tens of thousands of dollars. A drug she injects herself at home, such as Zilbrysq, is usually covered under her Part D drug plan instead, where out-of-pocket costs stop at $2,100 for the year in 2026 and $2,400 in 2027 (Medicare.gov).
Insurers add their own rules on top. A study of US commercial and Medicaid coverage policies reviewed in 2023 found that 95.2% of eculizumab policies, 91.3% of efgartigimod policies and 85.7% of ravulizumab policies for myasthenia gravis required step therapy, meaning a patient had to try other treatments first (Levine et al., Journal of Neuromuscular Diseases, 2026). Danielle's denial turned on the label, while step therapy rules turn on the order in which treatments were tried. Our guide to appealing an insurance denial walks through both kinds.
Help exists on both sides. Each drugmaker runs a support program, and for commercially insured patients most offer copay help that can bring the cost to as little as $0. For people on Medicare, charity funds matter more. When Trial Friend last checked on September 28, 2026, the TotalAssist myasthenia gravis fund was open to people with Medicare, Medicaid or TRICARE, with grants of up to $10,000; NORD's 2 myasthenia gravis programs and The Assistance Fund's program were open; and Good Days' fund was closed. The patient assistance finder lists each program with its current status.
Cemdisiran and Gefurulimab: Myasthenia Gravis Drugs Awaiting FDA Decisions
Cemdisiran, with an FDA decision due in November 2026
Regeneron's cemdisiran is a small interfering RNA, or siRNA, that tells the liver to make less C5 in the first place. It is injected under the skin every 12 weeks, 4 times a year, and the FDA accepted it under Priority Review with a target action date in November 2026 for adults with AChR-positive generalized myasthenia gravis (Regeneron, June 2026). In its Phase 3 trial, NIMBLE, MG-ADL scores improved 2.3 points more than on placebo at week 24, results published in The Lancet in April 2026 (Regeneron, April 2026). If approved, it would be the first siRNA treatment for myasthenia gravis. The cemdisiran decision page will show the outcome when it comes.
Gefurulimab, under FDA review with no public date
AstraZeneca's gefurulimab, approved in Japan as Klygefa, is a C5 blocker built from a nanobody, an antibody fragment about a tenth the size of a full antibody, and designed as a once-weekly self-injection with an autoinjector. In the 260-patient PREVAIL trial in AChR-positive adults, it improved MG-ADL scores by 1.6 points more than placebo at week 26. Europe's drug advisory committee, the CHMP, recommended approval on September 18, 2026, and AstraZeneca says the US application is under review without giving a decision date (AstraZeneca, September 2026).
Further out, argenx has reported positive results for Vyvgart Hytrulo in ocular myasthenia gravis, and several Phase 3 trials with US sites are enrolling, including telitacicept (UPSTREAM MG, NCT06456580), IMVT-1402 (NCT07039916) and claseprubart (EMERGE, NCT07647510). Johnson & Johnson is also running EPIC, an open-label Phase 3 trial comparing Imaavy directly with Vyvgart in AChR-positive adults (NCT07217587).
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Myasthenia Gravis Treatment Questions People Ask
Which myasthenia gravis drugs work for seronegative MG?
Since May 8, 2026, Vyvgart and Vyvgart Hytrulo (efgartigimod) are approved for all adults with generalized myasthenia gravis, including people with no detectable AChR, MuSK or LRP4 antibodies. They are the only targeted drugs with that approval. Older treatments such as pyridostigmine, steroids, immune suppressants and IVIG are also used, and a few trials allow seronegative patients, including MyClad, MyVision and RESET-MG in the United States.
What can I use instead of Soliris for myasthenia gravis?
Soliris (eculizumab) has 2 biosimilars, Bkemv and Epysqli, approved for AChR-positive adults with generalized myasthenia gravis. Other complement inhibitors are Ultomiris, an IV infusion every 8 weeks, and Zilbrysq, a daily self-injection. Outside that class, the FcRn blockers Vyvgart, Rystiggo and Imaavy and the B-cell drug Uplizna are approved for AChR-positive adults as well. Switching is a decision for your neurologist and your insurer.
Is there a myasthenia gravis drug you can take at home?
Yes. Zilbrysq (zilucoplan) is a daily injection under the skin that AChR-positive adults can give themselves after training. Vyvgart Hytrulo also comes in a prefilled syringe, approved in April 2025, that patients or caregivers can inject at home in 4-week cycles. The other targeted drugs are given as infusions in a clinic or by a health care provider.
Which myasthenia gravis drugs are approved for children?
Only 2 targeted drugs are approved for children with generalized myasthenia gravis. Soliris is approved for AChR-positive patients 6 and older, and Imaavy for AChR-positive or MuSK-positive patients 12 and older. Children's trials of Uplizna, Zilbrysq, Vyvgart Hytrulo, Imaavy in younger children and gefurulimab are enrolling.
When will the FDA decide on cemdisiran for myasthenia gravis?
Regeneron says the FDA accepted cemdisiran under Priority Review with a target action date in November 2026, for adults with AChR-positive generalized myasthenia gravis. Regeneron has not published the exact day. Cemdisiran is injected under the skin every 12 weeks.
Does Medicare cover myasthenia gravis drugs?
Yes, through different parts. Drugs given in a clinic or by a health care provider, such as Soliris, Ultomiris, Imaavy, Uplizna and Rystiggo, are usually billed under Part B, with 20% coinsurance and no yearly out-of-pocket limit in Original Medicare unless you have Medigap or a Medicare Advantage plan. Drugs you inject at home, such as Zilbrysq, are usually covered under Part D, where out-of-pocket costs are capped at $2,100 in 2026 and $2,400 in 2027. Drugmaker copay cards cannot be used with Medicare.
What does MG-ADL mean in myasthenia gravis trials?
MG-ADL stands for Myasthenia Gravis Activities of Daily Living. Patients rate 8 everyday functions from 0 to 3 each: talking, chewing, swallowing, breathing, brushing teeth or combing hair, getting up from a chair, double vision and drooping eyelids. The total runs from 0 to 24, lower is better, and a drop of 2 points or more is usually counted as an improvement patients notice.
The table in this guide will change. Cemdisiran's decision is due in November, gefurulimab is under review, and the children's trials listed above will decide whether more of these drugs reach patients under 18. Trial Friend's myasthenia gravis alerts send an email when the FDA decides on a myasthenia gravis drug on our calendar or when a new myasthenia gravis trial opens.