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Empasiprubart IV
Empasiprubart IV is a FcRn antagonist Biologic drug developed by argenx. It is currently in Phase 3 development for Generalized myasthenia gravis (gMG), Other autoimmune conditions (under investigation). Also known as: ARGX-117.
Empasiprubart is a FcRn (neonatal Fc receptor) antagonist that reduces the recycling and extends the half-life of IgG antibodies, enhancing their therapeutic activity.
Empasiprubart IV is an antibody used in clinical trials to study its safety and efficacy in treating various conditions, including dermatomyositis, myositis, multifocal motor neuropathy, chronic inflammatory demyelinating polyneuropathy, and CIDP. It is administered intravenously as part of a phase 2 clinical trial.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Empasiprubart IV |
|---|---|
| Also known as | ARGX-117 |
| Sponsor | argenx |
| Drug class | FcRn antagonist |
| Target | FcRn (neonatal Fc receptor) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
By blocking FcRn-mediated recycling, empasiprubart increases IgG catabolism and prolongs circulating antibody half-lives, which can amplify the effects of endogenous or co-administered IgG-based therapeutics. This mechanism is designed to enhance immune responses in autoimmune and inflammatory conditions where increased antibody persistence is therapeutically beneficial.
Approved indications
- Generalized myasthenia gravis (gMG)
- Other autoimmune conditions (under investigation)
Common side effects
- Infection
- Infusion-related reactions
- Immunogenicity
Key clinical trials
- A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP (PHASE3)
- ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
- 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 (PHASE2)
- A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Empasiprubart IV CI brief — competitive landscape report
- Empasiprubart IV updates RSS · CI watch RSS
- argenx portfolio CI
Frequently asked questions about Empasiprubart IV
What is Empasiprubart IV?
How does Empasiprubart IV work?
What is Empasiprubart IV used for?
Who makes Empasiprubart IV?
Is Empasiprubart IV also known as anything else?
What drug class is Empasiprubart IV in?
What development phase is Empasiprubart IV in?
What are the side effects of Empasiprubart IV?
What does Empasiprubart IV target?
Related
- Drug class: All FcRn antagonist drugs
- Target: All drugs targeting FcRn (neonatal Fc receptor)
- Manufacturer: argenx — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Generalized myasthenia gravis (gMG)
- Indication: Drugs for Other autoimmune conditions (under investigation)
- Also known as: ARGX-117
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing