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U32 CAR-T
U32 CAR-T is a Small molecule drug developed by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd. It is currently in Phase 1 development.
U32 CAR-T is a small molecule intervention being studied in a clinical trial for Acute Myeloid Leukaemia. The clinical trial, identified as NCT07036250, is a single-arm, open-label study evaluating the safety, tolerability, and efficacy of U32 Injection in patients with Acute Myeloid Leukemia.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | U32 CAR-T |
|---|---|
| Sponsor | Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Clinical Study of U32 in Patients With Acute Myeloid Leukemia (PHASE1, 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:
- U32 CAR-T CI brief — competitive landscape report
- U32 CAR-T updates RSS · CI watch RSS
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd portfolio CI
Frequently asked questions about U32 CAR-T
What is U32 CAR-T?
Who makes U32 CAR-T?
What development phase is U32 CAR-T in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing