Primary completion· ClinicalTrials.gov
An Open-Label Extension Study of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Batoclimab History and Updates
21 events · 2022 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
0
FDA Approvals
0
Label Revisions
21
Trial Milestones
0
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-08Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Batoclimab since 2022, drawn from openFDA, ClinicalTrials.gov, and PubMed.
All published updates (4)
2026
- Primary completionBatoclimab Phase 3 Thyroid Eye Disease Extension Study Completes Primary Phase· Apr 2, 2026
- Primary completionBatoclimab Phase 3 Trial for Thyroid Eye Disease Completes Primary Assessment· Feb 3, 2026
2025
- Primary completionBatoclimab Completes Phase 3 Trial for Thyroid Eye Disease· Nov 2, 2025
- Primary completionBatoclimab Phase 3 for Generalized Myasthenia Gravis Reaches Primary Completion· Jan 10, 2025
Upcoming & expected milestones
Past events
2026
Primary completion· ClinicalTrials.gov
Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
Primary completion· ClinicalTrials.gov
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
Primary completion· ClinicalTrials.gov
To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP
2025
Primary completion· ClinicalTrials.gov
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
Trial registered· ClinicalTrials.gov
An Open-Label Extension Study of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Trial started· ClinicalTrials.gov
An Open-Label Extension Study of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Primary completion· ClinicalTrials.gov
A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease
Primary completion· ClinicalTrials.gov
Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized My
2023
Trial registered· ClinicalTrials.gov
A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease
Trial started· ClinicalTrials.gov
A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease
Trial started· ClinicalTrials.gov
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
2022
Trial started· ClinicalTrials.gov
To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP
Trial started· ClinicalTrials.gov
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
Trial started· ClinicalTrials.gov
Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
Trial registered· ClinicalTrials.gov
To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP
Trial registered· ClinicalTrials.gov
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
Trial registered· ClinicalTrials.gov
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
Trial registered· ClinicalTrials.gov
Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
Trial started· ClinicalTrials.gov
Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized My
Trial registered· ClinicalTrials.gov
Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized My
Sources
FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.