Myasthenia gravis is an autoimmune neuromuscular junction disorder causing fluctuating skeletal muscle weakness and fatigability, often affecting ocular, bulbar, and limb muscles. Disease results from autoantibodies that impair neuromuscular transmission.
A retrospective study found that myocarditis within the first month after immune checkpoint inhibitor initiation was linked to higher mortality risk. The analysis identified 4,635 cases in VigiBase.
Three FcRn inhibitors are approved for generalized myasthenia gravis, with a head-to-head trial of efgartigimod and nipocalimab underway. Emerging therapies including telitacicept, gefurulimab, and CAR-T cell therapy (KYV-101) show promise, while Immunovant's batoclimab failed TED trials.
BioNxt Solutions Inc. receives European Patent No. 4539857 for its proprietary sublingual cladribine oral thin film drug delivery technology, providing protection across up to 39 European Patent Convention states through at least June 14, 2043.
Amgen received FDA and European Commission approval for Uplizna to treat generalized myasthenia gravis in adults who are anti-AChR or anti-MuSK antibody positive, offering twice-yearly maintenance dosing after initial loading doses.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07478172 |
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease |
RECRUITING | NA |
| NCT07411963 |
Evaluation of the Condition of Patients Receiving EARLY Ravulizumab and Admitted in ICU for gMG Crisis |
RECRUITING | |
| NCT07392528 |
Universal Chimeric Antigen Receptor T-Cell （UCAR T-cell） Therapy Targeting CD19/ BCMA（QT-019C） in Patients With r/ r Neurological Autoimmune Diseases |
NOT_YET_RECRUITING | EARLY_PHASE1 |
| NCT07333196 |
Tongji NADs Cohort |
NOT_YET_RECRUITING | |
| NCT07319689 |
Predictors of Myasthenia Gravis Outcome Following Thoracoscopic Thymectomy: Comparative Study Between Thymomatous and Non-Thymomatous Patients |
COMPLETED | |
| NCT07304154 |
A Study Evaluating the Safety and Efficacy of KITE-363 in Relapsed/Refractory Autoimmune Neurologic Diseases |
RECRUITING | PHASE1 |
| NCT07294170 |
ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis |
RECRUITING | |
| NCT07291713 |
Psychological Health and Adverse Childhood Experiences in Myasthenia Gravis: Online Mental Health BMI Learning Program |
COMPLETED | NA |
| NCT07284420 |
ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod |
RECRUITING | PHASE2 |
| NCT07250750 |
A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis |
RECRUITING | PHASE1/PHASE2 |
