Last reviewed · How we verify
Foralumab TZLS-401 100 µg
Foralumab TZLS-401 100 µg is a Anti-CD3 monoclonal antibody Small molecule drug developed by Tiziana Life Sciences LTD. It is currently in Phase 2 development.
Foralumab binds to CD3 on T cells, modulating immune responses through mucosal administration to induce regulatory T cells and reduce inflammation.
-
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).
| 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 | Foralumab TZLS-401 100 µg |
|---|---|
| Sponsor | Tiziana Life Sciences LTD |
| Drug class | Anti-CD3 monoclonal antibody |
| Modality | Small molecule |
| Phase | Phase 2 |
Mechanism of action
Foralumab is an anti-CD3 monoclonal antibody administered via the nasal route. This mucosal delivery is intended to activate regulatory immune pathways while avoiding systemic T cell depletion and cytokine release syndrome associated with intravenous anti-CD3 antibodies.
Approved indications
Common side effects
Key clinical trials
- Assessment of Foralumab Safety and Modulation of Microglial Activation in Alzheimer's Disease (PHASE2)
- Nasal Foralumab in Patients With Non-Active Secondary Progressive Multiple Sclerosis (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:
- Foralumab TZLS-401 100 µg CI brief — competitive landscape report
- Foralumab TZLS-401 100 µg updates RSS · CI watch RSS
- Tiziana Life Sciences LTD portfolio CI
Frequently asked questions about Foralumab TZLS-401 100 µg
What is Foralumab TZLS-401 100 µg?
How does Foralumab TZLS-401 100 µg work?
Who makes Foralumab TZLS-401 100 µg?
What drug class is Foralumab TZLS-401 100 µg in?
What development phase is Foralumab TZLS-401 100 µg in?
Related
- Drug class: All Anti-CD3 monoclonal antibody drugs
- Manufacturer: Tiziana Life Sciences LTD — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing