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injection ，CU-20401
injection ，CU-20401 is a Small molecule drug developed by Cutia Therapeutics（Wuxi）Co.,Ltd. It is currently in Phase 1 development. Also known as: test group administration.
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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 | injection ，CU-20401 |
|---|---|
| Also known as | test group administration |
| Sponsor | Cutia Therapeutics（Wuxi）Co.,Ltd |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Phase 2 Clinical Study of CU-20401 (PHASE2)
- A Phase 1 Clinical Study of CU-20401 in Chinese Healthy Population (PHASE1)
- A Clinical Study to Evaluate the Safety, Pharmacokinetic Profile and Efficacy of CU-20401 (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:
- injection ，CU-20401 CI brief — competitive landscape report
- injection ，CU-20401 updates RSS · CI watch RSS
- Cutia Therapeutics（Wuxi）Co.,Ltd portfolio CI
Frequently asked questions about injection ，CU-20401
What is injection ，CU-20401?
Who makes injection ，CU-20401?
Is injection ，CU-20401 also known as anything else?
What development phase is injection ，CU-20401 in?
Related
- Manufacturer: Cutia Therapeutics（Wuxi）Co.,Ltd — full pipeline
- Also known as: test group administration
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing