Last reviewed · How we verify
LY03005 extended-release tablet
LY03005 extended-release tablet is a Dopamine D2 receptor antagonist (antipsychotic) Small molecule drug developed by Luye Pharma Group Ltd.. It is currently in Phase 3 development for Schizophrenia, Bipolar disorder. Also known as: Desvenlafaxine, 4-Methylbenzoate of desvenlafaxine hydrochloride.
LY03005 is a dopamine D2 receptor antagonist that blocks dopamine signaling in the central nervous system.
LY03005 extended-release tablet is being studied for the treatment of Major Depressive Disorder. The safety, tolerability, and pharmacokinetics of LY03005 extended-release tablet have been evaluated in a multiple ascending dose study in healthy subjects.
-
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). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| 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 | LY03005 extended-release tablet |
|---|---|
| Also known as | Desvenlafaxine, 4-Methylbenzoate of desvenlafaxine hydrochloride |
| Sponsor | Luye Pharma Group Ltd. |
| Drug class | Dopamine D2 receptor antagonist (antipsychotic) |
| Target | Dopamine D2 receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry/Neurology |
| Phase | Phase 3 |
Mechanism of action
LY03005 acts as a dopamine D2 receptor antagonist, reducing dopaminergic neurotransmission. The extended-release formulation provides sustained drug delivery over an extended period, allowing for once-daily or less frequent dosing. This mechanism is typical of antipsychotic medications used to manage psychotic symptoms and behavioral disturbances.
Approved indications
- Schizophrenia
- Bipolar disorder
Common side effects
- Extrapyramidal symptoms
- Akathisia
- Sedation
- Weight gain
- Hyperprolactinemia
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of Ansofaxine Hydrochloride Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD) (PHASE3)
- Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LY03005 Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD) (PHASE1)
- Multiple Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY03005 (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:
- LY03005 extended-release tablet CI brief — competitive landscape report
- LY03005 extended-release tablet updates RSS · CI watch RSS
- Luye Pharma Group Ltd. portfolio CI
Frequently asked questions about LY03005 extended-release tablet
What is LY03005 extended-release tablet?
How does LY03005 extended-release tablet work?
What is LY03005 extended-release tablet used for?
Who makes LY03005 extended-release tablet?
Is LY03005 extended-release tablet also known as anything else?
What drug class is LY03005 extended-release tablet in?
What development phase is LY03005 extended-release tablet in?
What are the side effects of LY03005 extended-release tablet?
What does LY03005 extended-release tablet target?
Related
- Drug class: All Dopamine D2 receptor antagonist (antipsychotic) drugs
- Target: All drugs targeting Dopamine D2 receptor
- Manufacturer: Luye Pharma Group Ltd. — full pipeline
- Therapeutic area: All drugs in Psychiatry/Neurology
- Indication: Drugs for Schizophrenia
- Indication: Drugs for Bipolar disorder
- Also known as: Desvenlafaxine, 4-Methylbenzoate of desvenlafaxine hydrochloride
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing