Chronic inflammatory demyelinating polyneuropathy (CIDP) is an immune-mediated neuropathy that damages peripheral nerve myelin, causing progressive weakness, sensory loss, and reduced reflexes.
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.
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.
Regulatory incentives for rare disease treatments, including market exclusivity and development subsidies, are spurring pharmaceutical innovation across the US, Europe, Japan, and Australia, with multiple companies advancing therapies for conditions affecting limited patient populations.
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).
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07478172 |
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease |
RECRUITING | NA |
| NCT07304154 |
A Study Evaluating the Safety and Efficacy of KITE-363 in Relapsed/Refractory Autoimmune Neurologic Diseases |
RECRUITING | PHASE1 |
| NCT07188844 |
An Open-Label Extension Study of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
ENROLLING_BY_INVITATION | PHASE2 |
| NCT07154524 |
Immunoadsorption for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
RECRUITING | |
| NCT07091630 |
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP |
RECRUITING | PHASE3 |
| NCT07072676 |
The Use of Assistive Gait Devices Can Reduce the Risk of Falls in Patients With Neuromuscular Diseases Following a Training Period. |
ENROLLING_BY_INVITATION | NA |
| NCT07032662 |
Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
RECRUITING | PHASE2 |
| NCT07027111 |
Safety, Tolerability, and Efficacy of NVG-2089 in Participants With CIDP |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT07006597 |
Vitaccess Real CIDP Registry |
NOT_YET_RECRUITING | |
| NCT06920004 |
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP |
RECRUITING | PHASE3 |
