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Libexin®
Libexin® is a Non-narcotic antitussive Small molecule drug developed by Dompé Farmaceutici S.p.A. It is currently in Phase 3 development for Dry cough and unproductive cough in various respiratory conditions. Also known as: prenoxdiazine.
Libexin is a non-narcotic antitussive agent that suppresses cough by acting as a local anesthetic on the respiratory mucosa and reducing airway irritation.
Libexin is a non-narcotic antitussive agent that suppresses cough by acting as a local anesthetic on the respiratory mucosa and reducing airway irritation. Used for Dry cough and unproductive cough in various respiratory conditions.
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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 | Libexin® |
|---|---|
| Also known as | prenoxdiazine |
| Sponsor | Dompé Farmaceutici S.p.A |
| Drug class | Non-narcotic antitussive |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Pulmonology |
| Phase | Phase 3 |
Mechanism of action
Libexin (prenoxdiazine) works through a combination of local anesthetic effects on the airways and central cough suppression without opioid activity. It reduces the sensitivity of cough receptors in the respiratory tract, thereby decreasing the cough reflex while maintaining normal airway clearance and respiratory function.
Approved indications
- Dry cough and unproductive cough in various respiratory conditions
Common side effects
- Drowsiness
- Dizziness
- Gastrointestinal upset
- Headache
Key clinical trials
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:
- Libexin® CI brief — competitive landscape report
- Libexin® updates RSS · CI watch RSS
- Dompé Farmaceutici S.p.A portfolio CI
Frequently asked questions about Libexin®
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Related
- Drug class: All Non-narcotic antitussive drugs
- Manufacturer: Dompé Farmaceutici S.p.A — full pipeline
- Therapeutic area: All drugs in Respiratory / Pulmonology
- Indication: Drugs for Dry cough and unproductive cough in various respiratory conditions
- Also known as: prenoxdiazine