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montelukast

Generic: MONTELUKAST SODIUM·Brand: MONTELUKAST SODIUM, SINGULAIR, Singulair

montelukast: sourced relationships with 2 companies · 10 clinical trials tracked · 5 FDA decisions.

montelukast evidence translation

What we can confirm

5 FDA records · 10 tracked trials

What it means

More than one company relationship is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

What is verified about montelukast, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence5 indications · 1 study sponsors
Dated Pipeline Records (2)
CompanyDated record stage
DR REDDYS LABORATORIES LTD (RDY)
Reported 2012-08-06 · Current development: unknownSource
Approved
Teva Pharmaceutical Industries Limited (TEVA)
Reported 2012-08-03 · Current development: unknownSource
Approved
Clinical Trial Registry Records (10)

Prevent Allergic Reactions to Aphexda With Dexamethasone (PARADE)

NCT07101445Registry updated 2026-02-10·Phase 4
Recruiting

Primary endpoint: Incidence and severity of systemic reactions

InterventionalRandomizedtriple94 targetStarted 2025-09Completion 2027-121 site · United StatesEmory University

A Single-arm, Open-label, Phase 2 Study Evaluating Subcutaneous Administration of Isatuximab, Administered by an On Body Delivery System, in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)

NCT06356571Registry updated 2026-02-23·Phase 2·SNY
Recruiting

Primary endpoint: Overall response rate (ORR)

Interventionalopen64 targetStarted 2025-03Completion 2027-0734 sites · United StatesSanofi

An Open-Label, Phase 2 Study to Evaluate the Activity of Belumosudil in Subjects With New Onset and Incipient Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Cell Transplantation

NCT05922761Registry updated 2026-06-10·Phase 2
Recruiting

Primary endpoint: 24-week Overall Response Rate (ORR) [Cohort A]

Interventionalopen45 targetStarted 2024-05Completion 2027-126 sites · United StatesDana-Farber Cancer Institute

Phase 2, Single-Arm Study of Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma

NCT05896228Registry updated 2026-03-11·Phase 2
Recruiting

Primary endpoint: Rate of MRD-negativity: Iber-KDd Combination therapy.

Interventionalopen30 targetStarted 2024-02Completion 2031-031 site · United StatesBenjamin T Diamond, MD

A Phase 1 Clinical Trial in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of TERN-701, the Effects of Food, Acid-Reducing Agents, and Drug-Drug Interactions, and the Relative Bioavailability of New Tablet Formulations of TERN-701

NCT07838987Registry updated 2026-09-24·Phase 1
Completed

Primary endpoint: Number of Participants Who Experience a Treatment Emergent Adverse Event (AE)

InterventionalRandomizedopen196 enrolledStarted 2023-12Completion 2026-061 site · United StatesTerns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

A Study to Investigate Safety and Tolerability of Higher Infusion Rate to shORten the duraTion of FabrazymE Infusion

NCT06019728Registry updated 2025-10-21·Phase 4·SNY
Completed

Primary endpoint: Percent Reduction in Shortest Tolerated Infusion Duration From Pre-study Average of Recent 3 Infusions

Interventionalopen8 enrolledStarted 2023-11Completion 2024-105 sites · United StatesSanofi

Subcutaneous Methotrexate, Oral Dexamethasone or Oral Montelukast for the Prevention of Infusion Related Reaction Associated With Amivantamab, an EGFR-MET Bispecific Antibody, Among Post-osimertinib Treated EGFRm NSCLC; SKIPPirr, a Phase 2 Study

NCT05663866Registry updated 2026-09-25·Phase 2
Active, not recruiting

Primary endpoint: Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1

Interventionalopen68 enrolledStarted 2023-05Completion 2027-0936 sites · France, South Korea, Spain, Taiwan…Janssen Research & Development, LLC

A Randomized, Phase 2, Open Label Study Evaluating Subcutaneous Administration of Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)

NCT05704049Registry updated 2025-12-29·Phase 2·SNY
Active, not recruiting

Primary endpoint: Overall response rate (ORR) - Cohorts 1 to 3

InterventionalRandomizedopen118 targetStarted 2023-04Completion 2028-0523 sites · Australia, Brazil, China, Czechia…Sanofi

A Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

NCT05405166Registry updated 2025-11-14·Phase 3·SNY
Active, not recruiting

Primary endpoint: Overall Response Rate (ORR)

InterventionalRandomizedopen531 targetStarted 2022-06Completion 2027-0350 sites · Argentina, Australia, Brazil, Canada…Sanofi

Phase 2, Open-Label Randomized Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone vs Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

NCT04268498Registry updated 2026-03-24·Phase 2
Active, not recruiting

Primary endpoint: Rate of Minimal Residual Disease (MRD) Negativity

InterventionalRandomizedopen310 targetStarted 2020-02Completion 2027-027 sites · United StatesUniversity of Miami
FDA Decisions5 records
Approval(RDY)FDA ↗
ANDA202906UNKNOWNOralGranule
Approval(RDY)FDA ↗
ANDA201582Not ApplicableOralTablet
ANDA078723OralTablet, Chewable
ANDA078605OralTablet
ANDA090955OralGranule

Frequently asked questions

Which companies have sourced relationships with montelukast?

montelukast has dated SEC/FDA relationship records for DR REDDYS LABORATORIES LTD, Teva Pharmaceutical Industries Limited.

How many clinical trials involve montelukast?

BioSniper tracks 10 clinical trials involving montelukast.

What is montelukast's latest FDA decision?

The most recent tracked FDA decision for montelukast is Approval, dated September 17, 2012.