gMG stands for generalized myasthenia gravis, an autoimmune neuromuscular junction disorder causing fluctuating weakness beyond ocular muscles, including bulbar, limb, axial, and respiratory involvement. Disease severity can range from mild to life-threatening exacerbations. Management includes acetylcholinesterase inhibitors and immunomodulatory therapies.
argenx reported $1.3B in Q1 2026 global product net sales (63% YoY growth). The FDA PDUFA target date for seronegative gMG is May 10, 2026. Positive ADAPT OCULUS results support an oMG label expansion. Pipeline milestones include myositis readout in Q3 2026 and MMN readout in Q4 2026.
Regeneron said the Phase 3 NIMBLE trial of cemdisiran in generalized myasthenia gravis met primary and key secondary endpoints at week 24. The company said a U.S. regulatory application has been submitted and EU filings are planned for 2026.
Dianthus Therapeutics will host a conference call on March 9, 2026, to discuss interim responder analysis results from Part A of the Phase 3 CAPTIVATE trial of claseprubart in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
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 |
|---|---|---|---|
| NCT07596784 |
Efficacy and Safety of Ravulizumab in Chinese Adults Participants With Generalized Myasthenia Gravis (gMG) |
NOT_YET_RECRUITING | PHASE3 |
| NCT07595653 |
A Study to Evaluate the Impact of Efgartigimod on Overall Disease Experience of People Suffering From Generalized Myasthenia Gravis (gMG) in Italy |
RECRUITING | |
| NCT07294170 |
ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis |
RECRUITING | |
| 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 |
| NCT07221838 |
A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab |
RECRUITING | PHASE4 |
| NCT06607627 |
PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis |
RECRUITING | PHASE3 |
| NCT06298552 |
A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05644561 |
Evaluation of PK, PD, Efficacy, Safety, and Immunogenicity of IV Ravulizumab in Pediatric Participants With Generalized Myasthenia Gravis |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05374590 |
Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis |
ENROLLING_BY_INVITATION | PHASE2/PHASE3 |
| NCT04980495 |
An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis |
COMPLETED | PHASE3 |
