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COPD Pharmacologic Substance
COPD Pharmacologic Substance is a Small molecule drug developed by Elpen Pharmaceutical Co. Inc.. It is currently in Phase 2 development.
Salmeterol-fluticasone is a pharmacologic substance used to treat conditions such as Chronic Obstructive Pulmonary Disease (COPD) and asthma, as indicated by ClinicalTrials.gov. It is a protein modality, according to ChEMBL, which suggests its mechanism of action involves interaction with proteins.
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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 | COPD Pharmacologic Substance |
|---|---|
| Sponsor | Elpen Pharmaceutical Co. Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting
- Venous Congestion And Cognitive Dysfunction After Cardiac Surgery
- Comparing Hydrocortisone and Prednisolone for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) (PHASE4)
- Montelukast in Parkinson Disease (PHASE2, PHASE3)
- Structured Review: To Optimise Management and Prevent Harm in COPD (NA)
- Daratumumab in STK11 Mutated NSCLC (PHASE2)
- Clinical Study on Guben Kechuan Granules Promoting Disease Recovery by Regulating Immune-Inflammatory Dysregulation in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease During the Peri-Discharge Period (NA)
- Probiotics in COPD: Effects on Symptoms, Lung Function, and Inflammation (NA)
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:
- COPD Pharmacologic Substance CI brief — competitive landscape report
- COPD Pharmacologic Substance updates RSS · CI watch RSS
- Elpen Pharmaceutical Co. Inc. portfolio CI
Frequently asked questions about COPD Pharmacologic Substance
What is COPD Pharmacologic Substance?
Who makes COPD Pharmacologic Substance?
What development phase is COPD Pharmacologic Substance in?
Related
- Manufacturer: Elpen Pharmaceutical Co. Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing