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XH-S004 tablet
XH-S004 tablet is a Small molecule drug developed by S-INFINITY Pharmaceuticals Co., Ltd. It is currently in Phase 1 development.
The XH-S004 tablet is a small molecule being studied in a Phase Ib clinical trial for its safety, tolerability, and pharmacokinetic characteristics in patients with Chronic Obstructive Pulmonary Disease (COPD). The trial is also evaluating the XH-S004 tablet in patients with Non-Cystic Fibrosis Bronchiectasis and in healthy adults.
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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 | XH-S004 tablet |
|---|---|
| Sponsor | S-INFINITY Pharmaceuticals Co., Ltd |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- The Phase Ib Clinical Trial of the XH-S004 Tablet in Patients With Chronic Obstructive Pulmonary Disease (COPD) to Evaluate Its Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamic Characteristics After Multiple Administrations (PHASE1)
- A Multicenter, Randomized, Double-blind, Placebo-controlled Parallel-group Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of XH-S004 Tablets in Patients With Non-cystic Fibrosis Bronchiectasis (PHASE2)
- A Phase I Study of XH-S004 in Healthy Volunteers (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:
- XH-S004 tablet CI brief — competitive landscape report
- XH-S004 tablet updates RSS · CI watch RSS
- S-INFINITY Pharmaceuticals Co., Ltd portfolio CI
Frequently asked questions about XH-S004 tablet
What is XH-S004 tablet?
Who makes XH-S004 tablet?
What development phase is XH-S004 tablet in?
Related
- Manufacturer: S-INFINITY Pharmaceuticals Co., Ltd — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing