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Updated May 2026 · ClinicalTrials.gov

Phase 3 Myasthenia Gravis Trials

15 Phase 3 trials for Myasthenia Gravis, the final stage before a treatment can be submitted for FDA approval.

15 Phase 3 clinical trials for Myasthenia Gravis are registered on ClinicalTrials.gov. Phase 3 is the final stage of testing before a treatment can be submitted for FDA approval, and the trials below come directly from the federal registry. Always talk to your doctor before contacting a study site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

What Phase 3 Means for Myasthenia Gravis

Phase 3 trials are the largest and most expensive stage of clinical research before potential FDA approval. For Myasthenia Gravis, a Phase 3 protocol typically enrolls several hundred to several thousand patients across many medical centers, randomizes participants between the investigational treatment and either a placebo or current standard of care (where ethically appropriate), and tracks them for months or years to confirm that the treatment is both effective and safe in a real-world patient population.

15 Phase 3 trials for Myasthenia Gravis are currently registered. Conditions in this range often have a focused research agenda with a small number of late-stage candidates, frequently targeting a specific subpopulation or stage of the disease.

Novartis Pharmaceuticals (2), Janssen Research & Development, LLC (2), Alexion Pharmaceuticals, Inc. (1) lead the Phase 3 Myasthenia Gravis sponsor list. The blend of industry, academic, and government sponsors on a condition's Phase 3 list is a useful signal of how broadly the research community is engaged with the disease.

Phase 3 Myasthenia Gravis Trials on ClinicalTrials.gov

RECRUITINGPhase 3NCT06607627

PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis

The primary objective of this study is to assess the pharmacokinetics and pharmacodynamics of gefurulimab in pediatric participants with AChR+ gMG for the duration of the study.

Sponsor: Alexion Pharmaceuticals, Inc.Enrolling: 1213 locations
RECRUITINGPhase 3NCT06799247

Investigating an mRNA CAR T-cell Therapy, Known as Descartes-08, as a Potential Approach to Treat Myasthenia Gravis

The AURORA Study is evaluating the safety, tolerability, and efficacy of an investigational mRNA CAR T-cell therapy known as Descartes-08 in adults with acetylcholine receptor...

Sponsor: Cartesian TherapeuticsEnrolling: 10020 locations
RECRUITINGPhase 3NCT07249632

A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG)

This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Telitacicept for the treatment of Ocular...

Sponsor: RemeGen Co., Ltd.Enrolling: 1201 location
RECRUITINGPhase 3NCT06517758

A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants...

The study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate efficacy, safety and tolerability of iptacopan in patients with AChR+ gMG...

Sponsor: Novartis PharmaceuticalsEnrolling: 14620 locations
RECRUITINGPhase 3NCT06744920

A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With...

A study to evaluate the efficacy, safety and tolerability of Remibrutinib versus placebo in adult patients with Generalized Myasthenia Gravis who are on stable, standard-of-care...

Sponsor: Novartis PharmaceuticalsEnrolling: 18020 locations
RECRUITINGPhase 3NCT07215949

Zilucoplan for Severe gMG Exacerbations

This is an open-label, multicenter, interventional phase 3b study in participants with AChR+ gMG and severe exacerbation that require hospitalization. Patients will receive...

Sponsor: Miriam FreimerEnrolling: 151 location
RECRUITINGPhase 3NCT06463587

Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized...

The purpose of this clinical study is to determine the efficacy and safety of a new oral cladribine formulation in participants with Generalized Myasthenia Gravis (gMG) in...

Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyEnrolling: 26420 locations
RECRUITINGPhase 3NCT06765161

Efgartigimod in IVIG Dependent Myasthenia Gravis Patients

This study is an open label, single center, prospective, 26 weeks study with descriptive analysis where IVIG is replaced by efgartigimod therapy. MG-ADL and MGQOL evaluations will...

Sponsor: Clinique Neuro-OutaouaisEnrolling: 301 location
RECRUITINGPhase 3NCT06342544

Immediate Corticosteroid Therapy and Rituximab to Prevent Generalization in Ocular Myasthenia: a PROBE Multicenter...

Myasthenia is an autoimmune disease causing dysfunction of the neuromuscular junction, resulting in fluctuating and variable muscle weakness. In the initial phase of the disease,...

Sponsor: Fondation Ophtalmologique Adolphe de RothschildEnrolling: 12811 locations
RECRUITINGPhase 3NCT05868837

Rituximab EfFicacy IN MyasthEnia Gravis (REFINE)

The primary objective of this phase III trial is to investigate if Rituximab can reduce patients' functional impairment caused by MG. The secondary objectives of this trial are to...

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCSEnrolling: 401 location
RECRUITINGPhase 3NCT07217587

Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis

The purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's...

Sponsor: Janssen Research & Development, LLCEnrolling: 1158 locations
RECRUITINGPhase 3NCT06587867

Seronegative Myasthenia Gravis - Efgartigimod IV

This is to study the efficacy, safety and tolerability of efgartigimod in patients with seronegative generalized myasthenia gravis. This is an open label study. There will be 30...

Sponsor: University Health Network, TorontoEnrolling: 301 location
RECRUITINGPhase 3NCT06456580

A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG)

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.

Sponsor: Vor BiopharmaEnrolling: 18020 locations
RECRUITINGPhase 3NCT07039916

Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis

The purpose of the study is to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.

Sponsor: Immunovant Sciences GmbHEnrolling: 23120 locations
RECRUITINGPhase 3NCT04951622

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). The purpose of the...

Sponsor: Janssen Research & Development, LLCEnrolling: 19920 locations

What Participation Looks Like

Phase 3 trials for Myasthenia Gravis typically enroll several hundred to several thousand participants across multiple sites. Participation involves a screening visit to confirm eligibility, randomization to either the investigational treatment or a comparator (often the current standard of care), regular study visits over months or years, and follow-up after the active treatment period. The protocols, time commitments, and visit schedules differ from trial to trial — read the per-trial page for the specifics before discussing participation with your doctor.

Each trial begins with informed consent and a screening visit, where the study team confirms eligibility against the inclusion and exclusion criteria. Randomization assigns participants to either the investigational treatment or a comparator. Standard-of-care portions of the protocol are typically billed to insurance; trial-specific procedures (extra imaging, biopsies, lab draws beyond standard care) are usually covered by the sponsor. Read each trial\'s detailed page for its specific time commitment and visit schedule.

Authoritative Resources for Myasthenia Gravis Trials

Verify any individual trial directly on ClinicalTrials.gov. For the federal context on how Phase 3 results feed into approval decisions, see the FDA drug approval process. For oncology-specific trial resources, the National Cancer Institute publishes patient-oriented overviews. For trials registered outside the U.S., the WHO ICTRP aggregates registries from around the world.

Frequently Asked Questions

What is a Phase 3 Myasthenia Gravis trial?

A Phase 3 trial is the final stage of clinical testing before a treatment can be submitted to the FDA for approval. For Myasthenia Gravis, Phase 3 studies typically enroll hundreds to thousands of patients across multiple medical centers, comparing the new treatment to the current standard of care or a placebo (where ethically appropriate). The goal is to confirm efficacy, monitor side effects in a larger population, and generate the evidence the FDA needs to make an approval decision.

How many Phase 3 Myasthenia Gravis trials are recruiting?

15 Phase 3 trials for Myasthenia Gravis are currently registered on ClinicalTrials.gov. Recruitment status varies by trial — some are actively enrolling, some have closed enrollment but are still in the active treatment phase, and some are completing follow-up. Click any trial below to see its current status, eligibility criteria, and contact information.

Who can participate in a Phase 3 Myasthenia Gravis trial?

Phase 3 eligibility depends entirely on the specific trial protocol. Each trial sets its own inclusion criteria (typically a confirmed diagnosis, certain disease stage or severity, age range) and exclusion criteria (often previous treatments, comorbidities, lab values that fall outside set ranges). The trial pages on this site translate the clinical eligibility criteria into plain English alongside the original text. Whether you fit any specific trial is a medical decision your doctor needs to confirm.

Is participating in a Phase 3 Myasthenia Gravis trial safe?

Phase 3 trials use treatments that have already passed Phase 1 (safety in small groups) and Phase 2 (initial efficacy and side-effect monitoring), so the safety profile is better understood than in earlier-phase studies. That said, side effects can still emerge in larger populations, and the trial protocol may require additional procedures (lab draws, imaging, biopsies) beyond standard care. The informed consent document for any specific trial details the known risks. Discuss those risks with your physician before deciding whether to participate.

Where does this trial data come from?

All trial data is sourced from the ClinicalTrials.gov API v2, the federal registry maintained by the National Library of Medicine at NIH. Under FDAAA 801, most U.S. drug and device trials must register on ClinicalTrials.gov, making it the most comprehensive source of trial information. Sponsors are required to update trial status within 30 days of a change, but delays occur — always confirm the current status with the trial site before traveling for screening.

How This Page Is Built

The trial list is filtered to ClinicalTrials.gov registrations whose phase field includes Phase 3 and whose condition list includes Myasthenia Gravis. Trial counts and the sponsor leaderboard are computed from the same record set. Plain-English eligibility translations on each linked trial page preserve the original clinical text alongside the accessible version. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2, maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData, Phase 3 Myasthenia Gravis list, May 2026. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · 15 Phase 3 trials tracked for Myasthenia Gravis.

The this entity category groups every U.S. clinical trials and research registries entity sharing this attribute. The list above is the data; the paragraphs below explain what the grouping means against the broader the NIH ClinicalTrials.gov registry distribution and how to read the relative rankings within the category.

For readers using this category as a starting point, the per-entity detail pages linked from the table above carry the underlying the NIH ClinicalTrials.gov registry data in full. The category-level view is the filter; the per-entity pages are the actual answer.