Last reviewed · How we verify
Catabex (DROPROPIZINE)
Catabex (generic name: DROPROPIZINE) is a dropropizine drug. It is currently in Phase 3 development for Non-productive cough.
Dropropizine works by modulating the cough reflex through its action on the central nervous system.
Catabex, also known as dropropizine, is a small molecule drug in the dropropizine class. It is used to treat non-productive cough, a condition characterized by a persistent cough without the production of mucus. The commercial status of Catabex is currently unknown, and it is not clear if it is patented or available as a generic medication. As a pharma professional, it is essential to consider the potential safety implications of Catabex, including any unknown side effects or interactions. Further research is needed to fully understand the pharmacology and clinical use of this medication.
-
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 | DROPROPIZINE |
|---|---|
| Drug class | dropropizine |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 3 |
Mechanism of action
Imagine your brain has a 'cough switch' that gets triggered when you need to cough to get rid of something in your throat. Dropropizine helps to adjust this switch so that it doesn't get triggered as easily, reducing the frequency and severity of non-productive coughs.
Approved indications
- Non-productive cough
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:
- Catabex CI brief — competitive landscape report
- Catabex updates RSS · CI watch RSS
Frequently asked questions about Catabex
What is Catabex?
How does Catabex work?
What is Catabex used for?
What is the generic name of Catabex?
What drug class is Catabex in?
What development phase is Catabex in?
What are the side effects of Catabex?
Related
- Drug class: All dropropizine drugs
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Non-productive cough
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing