Generalized Myasthenia Gravis

Neurology
29
Pipeline Programs
7
Companies
29
Clinical Trials
7 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
2
5
20
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
8100%
+ 20 programs with unclassified modality

On Market (2)

Approved therapies currently available

UP
RYSTIGGOApproved
rozanolixizumab
UCB Pharma
Neonatal Fc Receptor Blocker [EPC]subcutaneous2023
UP
ZILBRYSQApproved
zilucoplan
UCB Pharma
Complement Inhibitor [EPC]subcutaneous2023

Competitive Landscape

7 companies ranked by most advanced pipeline stage

UP
UCB PharmaBelgium - Brussels
12 programs
1
2
9
1
RozanolixizumabPhase 3Monoclonal Antibody1 trial
RozanolixizumabPhase 3Monoclonal Antibody1 trial
RozanolixizumabPhase 3Monoclonal Antibody1 trial
RozanolixizumabPhase 3Monoclonal Antibody1 trial
ZilucoplanPhase 31 trial
+7 more programs
Active Trials
NCT03315130Completed45Est. Nov 2020
NCT06055959Recruiting8Est. Dec 2026
NCT06149559Recruiting12Est. Aug 2026
+9 more trials
argenx
argenxBelgium - Zwijnaarde
10 programs
3
6
ARGX-113Phase 31 trial
ARGX-113Phase 31 trial
Efgartigimod IVPhase 31 trial
Efgartigimod IVPhase 31 trial
efgartigimod PH20 SCPhase 31 trial
+5 more programs
Active Trials
NCT04777734Approved For Marketing
NCT04833894Recruiting12Est. Mar 2027
NCT05374590Enrolling By Invitation12Est. Sep 2029
+7 more trials
Immunovant
ImmunovantDURHAM, NC
2 programs
2
Batoclimab 680 mg SC weeklyPhase 31 trial
IMVT-1402Phase 31 trial
Active Trials
NCT05403541Active Not RecruitingEst. Jan 2027
NCT07039916RecruitingEst. Dec 2028
Regeneron
RegeneronTARRYTOWN, NY
1 program
1
Pozelimab + CemdisiranPhase 31 trial
Active Trials
NCT05070858Active Not Recruiting288Est. Nov 2028
CP
Chugai PharmaJapan - Tokyo
1 program
1
SatralizumabPhase 3Monoclonal Antibody1 trial
Active Trials
NCT04963270Terminated188Est. Sep 2024
Vor Biopharma
Vor BiopharmaMA - Cambridge
1 program
1
TelitaciceptPhase 31 trial
Active Trials
NCT06456580Recruiting180Est. Jan 2029
Amgen
AmgenTHOUSAND OAKS, CA
1 program
1
InebilizumabPhase 2Monoclonal Antibody2 trials
Active Trials
NCT06987539Recruiting15Est. Mar 2030
NCT06212245Unknown33Est. Jun 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
AmgenInebilizumab
ImmunovantIMVT-1402
UCB PharmaZilucoplan
UCB Pharmarozanolixizumab
UCB PharmaZilucoplan
Vor BiopharmaTelitacicept
argenxEfgartigimod IV
UCB PharmaRozanolixizumab
UCB Pharmazilucoplan
ImmunovantBatoclimab 680 mg SC weekly
argenxEfgartigimod IV
RegeneronPozelimab + Cemdisiran
Chugai PharmaSatralizumab
argenxefgartigimod PH20 SC
argenxefgartigimod PH20 SC

Showing 15 of 28 trials with date data

Clinical Trials (29)

Total enrollment: 2,380 patients across 29 trials

NCT06212245AmgenInebilizumab

A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders

Start: Feb 2024Est. completion: Jun 202533 patients
Phase 4Unknown
NCT07039916ImmunovantIMVT-1402

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

Start: May 2025Est. completion: Dec 2028
Phase 3Recruiting
NCT06435312UCB PharmaZilucoplan

An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis

Start: Nov 2024Est. completion: Nov 20278 patients
Phase 3Enrolling By Invitation
NCT06540144UCB Pharmarozanolixizumab

An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis

Start: Oct 2024Est. completion: Aug 202712 patients
Phase 3Enrolling By Invitation
NCT06471361UCB PharmaZilucoplan

A Study to Evaluate the Safe and Effective Use of a Zilucoplan Auto-injector by Study Participants With Generalized Myasthenia Gravis

Start: Aug 2024Est. completion: Feb 202531 patients
Phase 3Completed
NCT06456580Vor BiopharmaTelitacicept

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

Start: Jul 2024Est. completion: Jan 2029180 patients
Phase 3Recruiting
NCT06298552argenxEfgartigimod IV

A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis

Start: Apr 2024Est. completion: Jun 2027119 patients
Phase 3Active Not Recruiting
NCT05681715UCB PharmaRozanolixizumab

A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)

Start: Apr 2023Est. completion: Apr 202462 patients
Phase 3Completed
NCT05514873UCB Pharmazilucoplan

An Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Zilucoplan in Participants With Generalized Myasthenia Gravis Who Were Previously Receiving Intravenous Complement Component 5 Inhibitors

Start: Oct 2022Est. completion: Oct 202426 patients
Phase 3Completed
NCT05403541ImmunovantBatoclimab 680 mg SC weekly

Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis

Start: Jun 2022Est. completion: Jan 2027
Phase 3Active Not Recruiting
NCT04980495argenxEfgartigimod IV

An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis

Start: Dec 2021Est. completion: Oct 202569 patients
Phase 3Completed
NCT05070858RegeneronPozelimab + Cemdisiran

A Study to Test How Safe Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Alone Are and How Well They Work in Adult Patients With Generalized Myasthenia Gravis

Start: Dec 2021Est. completion: Nov 2028288 patients
Phase 3Active Not Recruiting
NCT04963270Chugai PharmaSatralizumab

A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis

Start: Oct 2021Est. completion: Sep 2024188 patients
Phase 3Terminated
NCT04818671argenxefgartigimod PH20 SC

Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis

Start: Apr 2021Est. completion: Dec 2024184 patients
Phase 3Completed
NCT04735432argenxefgartigimod PH20 SC

Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis

Start: Feb 2021Est. completion: Dec 2021110 patients
Phase 3Completed
NCT04650854UCB PharmaRozanolixizumab

A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis

Start: Feb 2021Est. completion: Jan 2024165 patients
Phase 3Completed
NCT04225871UCB Pharmazilucoplan

Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis

Start: Dec 2019Est. completion: Jun 2026200 patients
Phase 3Active Not Recruiting
NCT04124965UCB PharmaRozanolixizumab

A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

Start: Oct 2019Est. completion: Sep 202171 patients
Phase 3Completed
NCT03971422UCB PharmaRozanolixizumab

A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

Start: Jun 2019Est. completion: Oct 2021200 patients
Phase 3Completed
NCT03770403argenxARGX-113

A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.

Start: Mar 2019Est. completion: Jun 2022151 patients
Phase 3Completed
NCT03669588argenxARGX-113

An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness

Start: Aug 2018Est. completion: Apr 2020167 patients
Phase 3Completed
NCT06055959UCB PharmaZilucoplan

A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis

Start: Oct 2024Est. completion: Dec 20268 patients
Phase 2/3Recruiting
NCT06392386argenxEfgartigimod PH20 SC

A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis

Start: Jun 2024Est. completion: Sep 202612 patients
Phase 2/3Recruiting
NCT06149559UCB Pharmarozanolixizumab

A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis

Start: Jun 2024Est. completion: Aug 202612 patients
Phase 2/3Recruiting
NCT05374590argenxEfgartigimod IV or Efgartigimod PH20 SC

Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis

Start: Aug 2022Est. completion: Sep 202912 patients
Phase 2/3Enrolling By Invitation
NCT04833894argenxEfgartigimod IV

Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis

Start: Oct 2021Est. completion: Mar 202712 patients
Phase 2/3Recruiting
NCT06987539AmgenInebilizumab

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG)

Start: Apr 2026Est. completion: Mar 203015 patients
Phase 2Recruiting
NCT03315130UCB Pharmazilucoplan

Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis

Start: Oct 2017Est. completion: Nov 202045 patients
Phase 2Completed
NCT04777734argenxefgartigimod

Efgartigimod Expanded Access for Generalized Myasthenia Gravis

N/AApproved For Marketing

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

20 late-stage (Phase 3) programs — potential near-term approvals
7 actively recruiting trials targeting 2,380 patients
7 companies competing in this space

Related Indications

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