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Alentuzumab
Alentuzumab is a Small molecule drug developed by Gruppo Italiano Trapianto di Midollo Osseo. It is currently in Phase 2 development.
Alentuzumab is a medication used to treat various conditions, including Acute Myeloblastic Leukemia, Lymphoblastic Leukemia, Myelodysplasia, and Chronic Myeloid Leukemia, as well as Type 1 Diabetes Mellitus through islet transplantation. The exact mechanism of action of Alentuzumab is not specified in the provided facts, but it is listed as an intervention in clinical trials.
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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).
| 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 | Alentuzumab |
|---|---|
| Sponsor | Gruppo Italiano Trapianto di Midollo Osseo |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant (PHASE2, PHASE3)
- Steroid-free and Long-term Calcineurin-free Trial in Islet 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:
- Alentuzumab CI brief — competitive landscape report
- Alentuzumab updates RSS · CI watch RSS
- Gruppo Italiano Trapianto di Midollo Osseo portfolio CI
Frequently asked questions about Alentuzumab
What is Alentuzumab?
Who makes Alentuzumab?
What development phase is Alentuzumab in?
Related
- Manufacturer: Gruppo Italiano Trapianto di Midollo Osseo — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing