Asset profile

Montelukast (Singulair)

Small molecule

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Approvedregulatory verdict

Evidence outlook

Approved: Asthma

Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.

track record: Reliable signal

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Competitive landscape

60 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Montelukast (Singulair): this drugApprovedSmall moleculeCysteinyl leukotriene receptor 1 (CysLT1)
Albuterol (Armstrong Albuterol HFA)ApprovedSmall moleculeBeta-2 adrenergic receptor
Albuterol / Budesonide (Airsupra)ApprovedCombinationBeta-2 adrenergic receptor, Glucocorticoid receptor, Glucocorticoid receptor / Beta-2 adrenergic receptor
Albuterol HFA (Armstrong's)ApprovedSmall moleculeBeta-2 adrenergic receptor
Albuterol HFA (Proventil HFA)ApprovedSmall moleculeBeta-2 adrenergic receptor
Albuterol Sulfate (Armstrong)ApprovedSmall moleculeBeta-2 adrenergic receptor
Albuterol Sulfate (Provenetil-HFA)ApprovedSmall moleculeBeta-2 adrenergic receptor
AminophyllineApprovedSmall moleculePhosphodiesterase (multi-subtype)
Beclomethasone (QVAR)ApprovedSmall moleculeGlucocorticoid receptor
Beclomethasone Dipropionate / Formoterol Fumarate / GlycopyrrolateApprovedSmall moleculeGlucocorticoid receptor / Beta-2 adrenergic receptor / Muscarinic M3 receptor (ICS/LABA/LAMA triple combination)
Benralizumab (Fasenra)ApprovedMonoclonal antibodyIL-5 receptor alpha, IL-5 receptor alpha (IL-5Rα / CD125); Fc region additionally engages FcγRIIIa on NK cells (ADCC), IL-5 receptor alpha (IL5RA) on eosinophils/basophils
Budesonide (Pulmicort)ApprovedSmall moleculeGlucocorticoid receptor agonist
Budesonide / Formoterol Fumarate (SYMBICORT)ApprovedCombinationGlucocorticoid receptor; Beta-2 adrenergic receptor
Budesonide / Glycopyrrolate / Formoterol Fumarate (Breztri Aerosphere)ApprovedSmall moleculeGlucocorticoid receptor; Muscarinic M3; Beta-2 adrenergic
Ciclesonide (Alvesco)ApprovedSmall moleculeGlucocorticoid receptor
DepemokimabApprovedMonoclonal antibodyIL-5

…and 45 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(18 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (2)
November 2026 (1)
Phase 2/3Parkinson DiseaseRecruiting
Est. primary completion 2026-11-20 · NCT06113640 · CT.gov ↗
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December 2026 (1)
Phase 4Multiple MyelomaRecruiting
Est. primary completion 2026-12-31 · NCT07101445 · CT.gov ↗
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2027 (11)
January 2027 (2)
Phase 2/3Dengue, Montelukast, TransaminasesRecruiting
Est. primary completion 2027-01 · NCT06747130 · CT.gov ↗
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Phase 2Plasma Cell Myeloma RefractoryRecruiting
Est. primary completion 2027-01-08 · NCT06356571 · CT.gov ↗
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February 2027 (4)
Phase 4Allergic Rhinitis (AR)Not yet recruiting
Est. primary completion 2027-02 · NCT07532993 · CT.gov ↗
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Phase 4AlbuminuriaRecruiting
Est. primary completion 2027-02 · NCT05498116 · CT.gov ↗
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Phase 2Multiple MyelomaActive not recruiting
Est. primary completion 2027-02-01 · NCT04268498 · CT.gov ↗
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Phase 3Myocardial Infarction (MI)Recruiting
Est. primary completion 2027-02-01 · NCT07320625 · CT.gov ↗
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May 2027 (1)
Phase 2Acute Myocardial Infarction (AMI)Recruiting
Est. primary completion 2027-05 · NCT07537868 · CT.gov ↗
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June 2027 (3)
Phase 1ACL Injury, Meniscus Tear, Post-traumatic OsteoarthritisRecruiting
Est. primary completion 2027-06 · NCT04572256 · CT.gov ↗
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Phase 1/2Bronchopulmonary Dysplasia (BPD), Premature Births, Critical IllnessRecruiting
Est. primary completion 2027-06-01 · NCT07101640 · CT.gov ↗
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Phase 2Bronchiolitis Obliterans Syndrome, Bronchiolitis Obliterans, Lung Diseases, Chronic Graft Versus Host DiseaseRecruiting
Est. primary completion 2027-06-30 · NCT05922761 · CT.gov ↗
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July 2027 (1)
Early phase / not applicablePost-acute Sequelae of SARS-COV-2 InfectionNot yet recruiting
Est. primary completion 2027-07 · NCT06597682 · CT.gov ↗
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2028 (1)
April 2028 (1)
Phase 1Gulf War SyndromeRecruiting
Est. primary completion 2028-04 · NCT05992311 · CT.gov ↗
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2029 (1)
March 2029 (1)
Phase 2Refractory Multiple Myeloma, Relapsed Multiple MyelomaRecruiting
Est. primary completion 2029-03-01 · NCT05896228 · CT.gov ↗
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2030 (2)
February 2030 (1)
Phase 1Type 2 DiabetesNot yet recruiting
Est. primary completion 2030-02 · NCT07409714 · CT.gov ↗
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October 2030 (1)
Phase 3Plasma Cell MyelomaActive not recruiting
Est. primary completion 2030-10-14 · NCT04270409 · CT.gov ↗
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2031 (1)
June 2031 (1)
Phase 4Diabetes, Kidney Disease, Vascular Disease, RetinopathyNot yet recruiting
Est. primary completion 2031-06-30 · NCT07685886 · CT.gov ↗
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See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (72)
Phase 2/3 (11)
Phase 2 (41)
Phase 1/2 (4)
Phase 1 (51)
Phase 4 (88)
Early phase / not applicable (37)
Used as active comparator (19)
Appears in other studies (5)