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tocilizumab IV
tocilizumab IV is a IL-6 receptor antagonist Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 3 development. Also known as: RoActemra/Actemra.
Tocilizumab binds to IL-6 receptors, blocking interleukin-6 signaling and reducing inflammation.
Tocilizumab IV is an interleukin-6 receptor alpha subunit inhibitor, classified as an INHIBITOR drug modality. It is used to treat various conditions, including Diffuse Large B-Cell Lymphoma (DLBCL), and is being studied for its efficacy in Generalized Myasthenia Gravis, among other conditions.
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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). -
Big-pharma sponsor
+3.0pp
Hoffmann-La Roche 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 | 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 | tocilizumab IV |
|---|---|
| Also known as | RoActemra/Actemra |
| Sponsor | Hoffmann-La Roche |
| Drug class | IL-6 receptor antagonist |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Tocilizumab is a humanized monoclonal antibody that binds to both soluble and membrane-bound IL-6 receptors, inhibiting IL-6-mediated signaling. By blocking this pathway, it reduces the inflammatory cascade involved in autoimmune and inflammatory diseases.
Approved indications
Common side effects
Key clinical trials
- A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (PHASE1, PHASE2)
- Testing the Addition of the Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy for Recurrent Glioblastoma (PHASE2)
- ACTEMRA® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma (PHASE2)
- A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003) (PHASE1, PHASE2)
- A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma (PHASE1)
- A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma (PHASE1)
- A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma (PHASE1, PHASE2)
- A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (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:
- tocilizumab IV CI brief — competitive landscape report
- tocilizumab IV updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI
Frequently asked questions about tocilizumab IV
What is tocilizumab IV?
How does tocilizumab IV work?
Who makes tocilizumab IV?
Is tocilizumab IV also known as anything else?
What drug class is tocilizumab IV in?
What development phase is tocilizumab IV in?
Related
- Drug class: All IL-6 receptor antagonist drugs
- Manufacturer: Hoffmann-La Roche — full pipeline
- Also known as: RoActemra/Actemra
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing