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YZJ-1139 tablets
YZJ-1139 tablets is a Small molecule drug developed by Shanghai Haiyan Pharmaceutical Technology Co., Ltd.. It is currently in Phase 1 development.
YZJ-1139 tablets are being studied in a clinical trial for their effects on insomnia, central nervous system conditions, and hepatic impairment. The study is comparing the pharmacokinetics and pharmacodynamics of YZJ-1139 to those of zolpidem and a placebo.
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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 | YZJ-1139 tablets |
|---|---|
| Sponsor | Shanghai Haiyan Pharmaceutical Technology Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Safety and Efficacy Study of YZJ-1139 Tablets in Insomnia Disorder (PHASE3)
- PK/PD Study of YZJ-1139 (PHASE1)
- Safety and Efficacy Study of YZJ-1139 in Primary Chronic Insomnia Disorder (PHASE2)
- A Clinical Study to Evaluate the Drug Interaction Between YZJ-1139 Tablets and Escitalopram Oxalate Tablets (PHASE1)
- Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Severe Renal Impairment and Normal Renal Impairment (PHASE1)
- Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Mild, Moderate and Normal Hepatic Impairment (PHASE1)
- A Drug-drug Interaction Study of YZJ-1139 Tablets and Ticagrelor Tablets in Healthy Subjects (PHASE1)
- Safety and Efficacy Study of YZJ-1139 in Insomnia Disorder (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:
- YZJ-1139 tablets CI brief — competitive landscape report
- YZJ-1139 tablets updates RSS · CI watch RSS
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd. portfolio CI
Frequently asked questions about YZJ-1139 tablets
What is YZJ-1139 tablets?
Who makes YZJ-1139 tablets?
What development phase is YZJ-1139 tablets in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing