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Ipratropium / Levosalbutamol Fixed Dose Combination
Ipratropium / Levosalbutamol Fixed Dose Combination is a Anticholinergic / Short-acting beta-2 agonist combination Small molecule drug developed by Neutec Ar-Ge San ve Tic A.Ş. It is currently in Phase 3 development for Chronic obstructive pulmonary disease (COPD), Asthma (acute bronchospasm relief).
This combination drug relaxes airway muscles through dual action: ipratropium blocks acetylcholine receptors to reduce bronchoconstriction, while levosalbutamol stimulates beta-2 adrenergic receptors to promote bronchodilation.
This combination drug relaxes airway muscles through dual action: ipratropium blocks acetylcholine receptors to reduce bronchoconstriction, while levosalbutamol stimulates beta-2 adrenergic receptors to promote bronchodilation. Used for Chronic obstructive pulmonary disease (COPD), Asthma (acute bronchospasm relief).
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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 | Ipratropium / Levosalbutamol Fixed Dose Combination |
|---|---|
| Sponsor | Neutec Ar-Ge San ve Tic A.Ş |
| Drug class | Anticholinergic / Short-acting beta-2 agonist combination |
| Target | Muscarinic acetylcholine receptors (ipratropium); Beta-2 adrenergic receptor (levosalbutamol) |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Pulmonology |
| Phase | Phase 3 |
Mechanism of action
Ipratropium is an anticholinergic agent that blocks muscarinic receptors in airway smooth muscle, preventing acetylcholine-induced bronchoconstriction. Levosalbutamol (the active R-enantiomer of albuterol) is a short-acting beta-2 agonist that binds to beta-2 adrenergic receptors, increasing intracellular cAMP and causing smooth muscle relaxation. Together, they provide complementary bronchodilation through different pathways.
Approved indications
- Chronic obstructive pulmonary disease (COPD)
- Asthma (acute bronchospasm relief)
Common side effects
- Tremor
- Headache
- Palpitations
- Dry mouth
- Nervousness
- Tachycardia
Key clinical trials
- Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients (PHASE3)
- Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination Nebuliser Solutions in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients (PHASE3)
- Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD (PHASE3)
- Outcomes and Costs Associated With Initiating Maintenance Treatment With Fluticasone Propionate 250mcg/Salmeterol Xinafoate 50mcg Combination (FSC) Versus Anticholinergics Including Tiotropium (TIO) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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:
- Ipratropium / Levosalbutamol Fixed Dose Combination CI brief — competitive landscape report
- Ipratropium / Levosalbutamol Fixed Dose Combination updates RSS · CI watch RSS
- Neutec Ar-Ge San ve Tic A.Ş portfolio CI
Frequently asked questions about Ipratropium / Levosalbutamol Fixed Dose Combination
What is Ipratropium / Levosalbutamol Fixed Dose Combination?
How does Ipratropium / Levosalbutamol Fixed Dose Combination work?
What is Ipratropium / Levosalbutamol Fixed Dose Combination used for?
Who makes Ipratropium / Levosalbutamol Fixed Dose Combination?
What drug class is Ipratropium / Levosalbutamol Fixed Dose Combination in?
What development phase is Ipratropium / Levosalbutamol Fixed Dose Combination in?
What are the side effects of Ipratropium / Levosalbutamol Fixed Dose Combination?
What does Ipratropium / Levosalbutamol Fixed Dose Combination target?
Related
- Drug class: All Anticholinergic / Short-acting beta-2 agonist combination drugs
- Target: All drugs targeting Muscarinic acetylcholine receptors (ipratropium); Beta-2 adrenergic receptor (levosalbutamol)
- Manufacturer: Neutec Ar-Ge San ve Tic A.Ş — full pipeline
- Therapeutic area: All drugs in Respiratory / Pulmonology
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD)
- Indication: Drugs for Asthma (acute bronchospasm relief)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing