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ARGX-119 IV
ARGX-119 IV is a Monoclonal antibody Biologic drug developed by argenx. It is currently in Phase 2 development for Treatment of generalized myasthenia gravis.
ARGX-119 IV is a monoclonal antibody targeting CD70.
ARGX-119 is an antibody modality. It is also known by the synonyms 3B2G2M1-HLGG1 LALADELK and LALADELK.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | ARGX-119 IV |
|---|---|
| Sponsor | argenx |
| Drug class | Monoclonal antibody |
| Target | CD70 |
| Modality | Biologic |
| Therapeutic area | Autoimmune diseases |
| Phase | Phase 2 |
Mechanism of action
ARGX-119 IV works by binding to CD70, a protein involved in the activation of immune cells. This binding leads to the depletion of CD70-expressing immune cells, which are thought to contribute to autoimmune diseases. By reducing the activity of these cells, ARGX-119 IV aims to alleviate symptoms and slow disease progression.
Approved indications
- Treatment of generalized myasthenia gravis
Common side effects
- Infusion-related reactions
Key clinical trials
- A Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Intravenous Administration of ARGX-119 in Pediatric Participants Aged 5 to Less Than 18 Years With Spinal Muscular Atrophy (PHASE2)
- A Phase 1b Study to Investigate Safety and Tolerability of ARGX-119 in Adult Participants With DOK7-Congenital Myasthenic Syndromes (CMS) (PHASE1)
- A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-119 in Healthy Participants (PHASE1)
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:
- ARGX-119 IV CI brief — competitive landscape report
- ARGX-119 IV updates RSS · CI watch RSS
- argenx portfolio CI
Frequently asked questions about ARGX-119 IV
What is ARGX-119 IV?
How does ARGX-119 IV work?
What is ARGX-119 IV used for?
Who makes ARGX-119 IV?
What drug class is ARGX-119 IV in?
What development phase is ARGX-119 IV in?
What are the side effects of ARGX-119 IV?
What does ARGX-119 IV target?
Related
- Drug class: All Monoclonal antibody drugs
- Target: All drugs targeting CD70
- Manufacturer: argenx — full pipeline
- Therapeutic area: All drugs in Autoimmune diseases
- Indication: Drugs for Treatment of generalized myasthenia gravis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing