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Montelukast or equivalent
Montelukast or equivalent is a Small molecule drug developed by Sanofi. It is currently in Phase 3 development.
Montelukast is a medication used to treat asthma, including persistent asthma and asthma in children, as well as asthma exacerbation. It has been studied as an add-on therapy to other treatments, such as inhaled corticosteroids, and compared to salmeterol in clinical trials.
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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). -
Big-pharma sponsor
+3.0pp
Sanofi 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 | 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 | Montelukast or equivalent |
|---|---|
| Sponsor | Sanofi |
| Modality | Small molecule |
| Phase | Phase 3 |
Approved indications
Common side effects
- Fatigue
- Muscle cramp
- Palpitations
- Cough
- Diarrhea
- Dizziness
- Dysphagia
- Dyspnea
- Lung infection
- Nausea
- Neutrophil count decreased
- Upper respiratory infection
Key clinical trials
- Daratumumab in STK11 Mutated NSCLC (PHASE2)
- A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (PHASE2)
- Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease (PHASE2)
- Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma (PHASE3)
- SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM (PHASE3)
- Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation (PHASE1, PHASE2)
- Asthma Research in Children and Adolescents
- A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma (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:
- Montelukast or equivalent CI brief — competitive landscape report
- Montelukast or equivalent updates RSS · CI watch RSS
- Sanofi portfolio CI
Frequently asked questions about Montelukast or equivalent
What is Montelukast or equivalent?
Who makes Montelukast or equivalent?
What development phase is Montelukast or equivalent in?
What are the side effects of Montelukast or equivalent?
Related
- Manufacturer: Sanofi — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing