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ALX-0061
ALX-0061 is a IL-17 inhibitor Biologic drug developed by Ablynx, a Sanofi company. It is currently in Phase 2 development for Psoriasis, Ankylosing spondylitis. Also known as: Vobarilizumab.
ALX-0061 is a nanobody targeting IL-17A and IL-17F, which are pro-inflammatory cytokines involved in autoimmune diseases.
ALX-0061 is a nanobody targeting IL-17A and IL-17F, which are pro-inflammatory cytokines involved in autoimmune diseases. Used for Psoriasis, Ankylosing spondylitis.
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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. -
Big-pharma sponsor
+3.0pp
Ablynx, a Sanofi company is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | ALX-0061 |
|---|---|
| Also known as | Vobarilizumab |
| Sponsor | Ablynx, a Sanofi company |
| Drug class | IL-17 inhibitor |
| Target | IL-17A, IL-17F |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 2 |
Mechanism of action
By binding to both IL-17A and IL-17F, ALX-0061 inhibits their interaction with the IL-17 receptor, reducing inflammation and the associated symptoms in autoimmune conditions.
Approved indications
- Psoriasis
- Ankylosing spondylitis
Common side effects
- Infections
- Injection site reactions
Key clinical trials
- A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis (PHASE2)
- A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis (PHASE2)
- An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis (PHASE2)
- A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus (PHASE2)
- Study to Assess Safety and Efficacy of Anti-Interleukin 6-receptor (IL6R) Nanobody in Rheumatoid Arthritis (RA) Patients (PHASE1, PHASE2)
- ALX-0061 Phase I Bioavailability Study in Healthy Volunteers (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:
- ALX-0061 CI brief — competitive landscape report
- ALX-0061 updates RSS · CI watch RSS
- Ablynx, a Sanofi company portfolio CI
Frequently asked questions about ALX-0061
What is ALX-0061?
How does ALX-0061 work?
What is ALX-0061 used for?
Who makes ALX-0061?
Is ALX-0061 also known as anything else?
What drug class is ALX-0061 in?
What development phase is ALX-0061 in?
What are the side effects of ALX-0061?
What does ALX-0061 target?
Related
- Drug class: All IL-17 inhibitor drugs
- Target: All drugs targeting IL-17A, IL-17F
- Manufacturer: Ablynx, a Sanofi company — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Psoriasis
- Indication: Drugs for Ankylosing spondylitis
- Also known as: Vobarilizumab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing