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XZP-3287
XZP-3287 is a Small molecule drug developed by Sihuan Pharmaceutical Holdings Group Ltd.. It is currently in Phase 1 development.
XZP-3287 is a small molecule being studied in clinical trials for its effects on various conditions, including advanced breast cancer and metastasis solid tumors. A Phase I study is examining the pharmacokinetics of XZP-3287 in healthy subjects, specifically how food affects its absorption.
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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 | XZP-3287 |
|---|---|
| Sponsor | Sihuan Pharmaceutical Holdings Group Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer (PHASE3)
- A Phase I/II Study of XZP-3287 in Metastasis Solid Tumors (PHASE1, PHASE2)
- A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer (PHASE3)
- A Clinical Trial of XZP-3287 for Material Balance (PHASE1)
- Effect of Clarithromycin and Rifampicin on the Pharmacokinetics of XZP-3287 in Healthy Subjects (PHASE1)
- Effect of Food on the Pharmacokinetics of XZP-3287 in Healthy Subjects (PHASE1)
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-3287 CI brief — competitive landscape report
- XZP-3287 updates RSS · CI watch RSS
- Sihuan Pharmaceutical Holdings Group Ltd. portfolio CI
Frequently asked questions about XZP-3287
What is XZP-3287?
Who makes XZP-3287?
What development phase is XZP-3287 in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing