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Test 2 Montelukast
Test 2 Montelukast is a Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 1 development.
Montelukast is a small molecule that acts as a cysteinyl leukotriene receptor 1 antagonist. It is used to treat conditions such as asthma, as indicated by clinical trials.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Test 2 Montelukast |
|---|---|
| Sponsor | GlaxoSmithKline |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- PRISTINE - Personalised Approach to Improve aSThma prescrIbing iN childrEn (PHASE4)
- Establishment of a Diagnosis and Treatment System for Information Processing Damage in Children With OSAHS
- Bioequivalence Study of Montelukast, 5 mg Chewable Tablets (Pharmtechnology LLC, Belarus), and Singulair®, 5 mg Chewable Tablets (Merck Sharp & Dohme B.V., the Netherlands), in Healthy Volunteers Under Fasting Conditions (PHASE1)
- TEAM (Trial on Efficacy and Quality of Life Among Asthmatic Patient With Montelukast) (PHASE4)
- PK and Safety Study of HCP1102, HGP0813 and HGP1408 (PHASE1)
- Bioequivalence Study of Montelukast 10 mg Tablets (PHASE1)
- Bioequivalence Study of Montelukast 5 mg Chewable (PHASE1)
- Relative Bioavailability Study of Two Montelukast Sodium (GW483100) 5 Milligrams (mg) Chewable Tablets and One Reference Montelukast Sodium 5 mg Chewable Tablet in Healthy Adult Subjects (PHASE1)
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:
- Test 2 Montelukast CI brief — competitive landscape report
- Test 2 Montelukast updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Test 2 Montelukast
What is Test 2 Montelukast?
Who makes Test 2 Montelukast?
What development phase is Test 2 Montelukast in?
Related
- Manufacturer: GlaxoSmithKline — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing