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XZP-3621
XZP-3621 is a Small molecule drug developed by Xuanzhu Biopharmaceutical Co., Ltd.. It is currently in Phase 3 development.
XZP-3621 is a small molecule being studied in a Phase 1 clinical trial for its absorption, metabolism, and excretion in humans. The study is investigating the mass balance, pharmacokinetics, and metabolism of XZP-3621 in healthy volunteers and patients with non-small cell lung cancer.
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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).
| 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 | XZP-3621 |
|---|---|
| Sponsor | Xuanzhu Biopharmaceutical Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- A Phase I Study of XZP-3621 in Chinese Patients With ALK or ROS1 Rearrangement Non-small Cell Lung Cancer (PHASE1)
- Food Effect and Mass Balance Study of XZP-3621 Tablets (PHASE1)
- A Study of the Absorption, Metabolism and Excretion of [14C]XZP-3621 in Human (PHASE1)
- Drug-drug Interaction Study of XZP-3621 Tablet (PHASE1)
- A Study of XZP-3621 in Chinese Patients With ALK Positive NSCLC (PHASE2)
- A Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib (PHASE3)
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:
- XZP-3621 CI brief — competitive landscape report
- XZP-3621 updates RSS · CI watch RSS
- Xuanzhu Biopharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about XZP-3621
What is XZP-3621?
Who makes XZP-3621?
What development phase is XZP-3621 in?
Related
- Manufacturer: Xuanzhu Biopharmaceutical Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing