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Lesuride (LEVOSULPIRIDE)
Lesuride (generic name: LEVOSULPIRIDE) is a levosulpiride drug. It is currently in Phase 2 development.
Lesuride works by binding to dopamine D(2) receptors in the brain, which helps to regulate gut motility and secretion.
Lesuride, also known as Levosulpiride, is a small molecule drug that targets the D(2) dopamine receptor. It belongs to the levosulpiride class and is used to treat gastrointestinal disorders. However, its commercial status and approved indications are unclear. Further research is needed to determine its safety profile and potential side effects. As a result, it is not widely used in clinical practice.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | LEVOSULPIRIDE |
|---|---|
| Drug class | levosulpiride |
| Target | D(4) dopamine receptor, Myeloperoxidase, D(2) dopamine receptor |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 2 |
Mechanism of action
Imagine your brain is like a switchboard, and dopamine is a messenger that helps control how your gut moves and digests food. Lesuride helps to fine-tune this process by blocking or activating certain dopamine receptors, which can help alleviate symptoms of gastrointestinal disorders.
Approved indications
Common side effects
- Sopor
- Cerebellar syndrome
- Galactorrhoea
- Disorganised speech
- Drug interaction
- Serotonin syndrome
- Drug abuse
- Hyperprolactinaemia
Key clinical trials
- Effect of Levosulpiride on Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema (PHASE2)
- Constipation Bundle/Protocol and the Effect of Adherence in the Incidence of Constipation in Critically Ill Patients (NA)
- Helicobacter Pylori Eradication in Functional Dyspepsia (NA)
- Pharmacokinetic Study of Levosulpiride (PHASE1)
- A Study To Evaluate The Efficacy And Safety Of Intramuscular Levosulpiride In Patients With Agitation Of Schizophrenia (PHASE2,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:
- Lesuride CI brief — competitive landscape report
- Lesuride updates RSS · CI watch RSS
Frequently asked questions about Lesuride
What is Lesuride?
How does Lesuride work?
What is the generic name of Lesuride?
What drug class is Lesuride in?
What development phase is Lesuride in?
What are the side effects of Lesuride?
What does Lesuride target?
Related
- Drug class: All levosulpiride drugs
- Target: All drugs targeting D(4) dopamine receptor, Myeloperoxidase, D(2) dopamine receptor
- Therapeutic area: All drugs in Gastroenterology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing