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LPM3770164 sustained release tablet
LPM3770164 sustained release tablet is a Small molecule drug developed by Luye Pharma Group Ltd.. It is currently in Phase 1 development. Also known as: LY03015.
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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 | LPM3770164 sustained release tablet |
|---|---|
| Also known as | LY03015 |
| Sponsor | Luye Pharma Group Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Safety and Efficacy of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia (PHASE1, PHASE2)
- Safety, Tolerability and Pharmacokinetic of Multiple-ascending Doses of LPM3770164 in Healthy Subjects (PHASE1)
- Effect of Food on the Pharmacokinetics of LPM3770164 Sustained-release Tablets (PHASE1)
- A Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 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:
- LPM3770164 sustained release tablet CI brief — competitive landscape report
- LPM3770164 sustained release tablet updates RSS · CI watch RSS
- Luye Pharma Group Ltd. portfolio CI
Frequently asked questions about LPM3770164 sustained release tablet
What is LPM3770164 sustained release tablet?
Who makes LPM3770164 sustained release tablet?
Is LPM3770164 sustained release tablet also known as anything else?
What development phase is LPM3770164 sustained release tablet in?
Related
- Manufacturer: Luye Pharma Group Ltd. — full pipeline
- Also known as: LY03015
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing