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(-)-Dropropizine (LEVODROPROPIZINE)
(-)-Dropropizine (generic name: LEVODROPROPIZINE) is a levodropropizine drug. It is currently in Phase 3 development.
Levodropropizine is thought to work by modulating the activity of certain neurotransmitters in the nervous system.
(-)-Dropropizine is a small molecule with multiple synonyms, including DANKA, DIPROPIZINE, and DROPROPIZINE.
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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). -
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 | LEVODROPROPIZINE |
|---|---|
| Drug class | levodropropizine |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 3 |
Mechanism of action
Imagine your nervous system as a complex network of messengers that help your body respond to different stimuli. Levodropropizine is believed to affect the way these messengers work, which can help alleviate symptoms of certain respiratory conditions. However, the exact details of how it achieves this are still not fully understood.
Approved indications
Common side effects
- Headache
- Dry mouth
- Alanine aminotransferase increased
- Hypoaesthesia oral
- Nausea
- Dizziness
- Malaise
- Aspartate aminitransferase increased
- Haematuria
- Gastroduodenitis
- Abdominal pain
- Dysgeusia
Key clinical trials
- CHAO Tos: Codeina, HederA Helix, LevOdropropizina Para la TOS (PHASE4)
- Drug-Drug Interaction Between R1_PBK_M2301 and R2_PBK_M2301 in Healthy Adults (PHASE1)
- Evaluation of the Pharmacokinetics of "PBK_M2301" in Healthy Adults (PHASE1)
- Clinical Trial of Efficacy and Safety of Levopront® 30 mg/5 ml in Patients With Dry Cough (PHASE3)
- The Impact of Inhaled Furosemide and Perorally Administered Levodropropizine on Dyspnea in Patients With Respiratory Diseases (PHASE2,PHASE3)
- Phase III Study to Evaluate the Efficacy and Safety of HOB-048 CR Tab. in Comparison With HOB-048 Syrup in Patients With Cough Due to Acute or Chronic Bronchitis (PHASE3)
- Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine + Pseudoephedrine + Dropropizine in the Control of Cough and the Relief of Nasal Symptoms, Suffering From Non-productive Cough and Acute Rhinitis (PHASE3)
- Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2-12 Years Old,Suffering From Cough and Acute Rhinitis (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:
- (-)-Dropropizine CI brief — competitive landscape report
- (-)-Dropropizine updates RSS · CI watch RSS
Frequently asked questions about (-)-Dropropizine
What is (-)-Dropropizine?
How does (-)-Dropropizine work?
What is the generic name of (-)-Dropropizine?
What drug class is (-)-Dropropizine in?
What development phase is (-)-Dropropizine in?
What are the side effects of (-)-Dropropizine?
Related
- Drug class: All levodropropizine drugs
- Therapeutic area: All drugs in Neuroscience
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing