Last reviewed · How we verify
Placebo, extended-release microspheres
Placebo, extended-release microspheres is a Small molecule drug developed by Luye Pharma Group Ltd.. It is currently in Phase 3 development.
This drug is a placebo, meaning it has no active therapeutic effect.
Placebo is a type of extended-release microspheres used as a control intervention in clinical trials. It is not a drug with a known mechanism, but rather a neutral treatment used for comparison purposes in studies examining conditions such as tibial meniscus injuries and Parkinson's disease.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Placebo, extended-release microspheres |
|---|---|
| Sponsor | Luye Pharma Group Ltd. |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
As a placebo, it does not interact with any biological molecules or systems, and its effects are purely psychological or due to the natural course of the disease.
Approved indications
Common side effects
Key clinical trials
- Success of Long-acting Anti-inflammatories After Anterior Cruciate Ligament and Meniscal Injury (PHASE2)
- A Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD (PHASE3)
- A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003 (PHASE1)
- Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone (PHASE2, PHASE3)
- A Multiple Ascending Dose Study With LY03003 in Patients With Early-stage Parkinson's Disease (PHASE1)
- A Study of LY03003 in Patients With Early-stage Parkinson's Disease (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:
- Placebo, extended-release microspheres CI brief — competitive landscape report
- Placebo, extended-release microspheres updates RSS · CI watch RSS
- Luye Pharma Group Ltd. portfolio CI
Frequently asked questions about Placebo, extended-release microspheres
What is Placebo, extended-release microspheres?
How does Placebo, extended-release microspheres work?
Who makes Placebo, extended-release microspheres?
What development phase is Placebo, extended-release microspheres in?
Related
- Manufacturer: Luye Pharma Group Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing