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TEV-56248

Phase 3

Asthma | Small molecule | Respiratory |Teva Pharmaceutical Industries Limited|Last Updated: May 4, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials2
Total Enrollment2,730
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06052267A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma ExacerbationsPHASE3 RECRUITING 2,700 — — Aug 30, 2023Oct 31, 2026May 4, 2026393 United States, Argentina +20
NCT06290102Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years OldPHASE1 COMPLETED 30 — — May 16, 2024Oct 7, 2024Aug 14, 202510 United States
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Study Endpoints
Primary Endpoints
Time to First Severe Clinical Asthma Exacerbation (CAE) with High Dose (HD) Fp/ABS eMDPI
Up to 42 months
Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp)
Up to 24 hours postdose
Maximum Observed Plasma Drug Concentration (Cmax) of Albuterol Sulfate(ABS)
Up to 24 hours postdose
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for Fp
Up to 24 hours postdose
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for ABS
Up to 24 hours postdose
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to 24 Hours Postdose (AUC0-24) of Fluticasone Propionate
Up to 24 hours postdose
AUC0-24 of Albuterol Sulfate
Up to 24 hours postdose
Time to Maximum Observed Plasma Drug Concentration (tmax) for Fp
Up to 24 hours postdose
Time to Maximum Observed Plasma Drug Concentration (tmax) for ABS
Up to 24 hours postdose
Terminal Phase (Apparent Elimination) Half-Life (t½) of Fp
Up to 24 hours postdose
Terminal Phase (Apparent Elimination) Half-Life (t½) of ABS
Up to 24 hours postdose
Last Measurable Concentration Above the Quantification Limit (Clast) of Fp
Up to 24 hours postdose
Last Measurable Concentration Above the Quantification Limit (Clast) of ABS
Up to 24 hours postdose
Time of Last Measurable Concentration (tlast) of Fp
Up to 24 hours postdose
Time of Last Measurable Concentration (tlast) of ABS
Up to 24 hours postdose
Secondary Endpoints
Time to first severe CAE with Low Dose (LD) Fp/ABS eMDPI
Up to 42 months
Annualized Severe CAE Rate
Up to 42 months
Total Annualized SCS Exposure Over the Treatment Period
Up to 42 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TEV-56248 Low DoseEXPERIMENTALInhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
TEV-56248 High DoseEXPERIMENTALInhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
Albuterol sulfateACTIVE_COMPARATORInhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
Sequence ABCEXPERIMENTAL -
Sequence BCAEXPERIMENTAL -
Sequence CABEXPERIMENTAL -
Sequence ACBEXPERIMENTAL -
Sequence BACEXPERIMENTAL -
Sequence CBAEXPERIMENTAL -
Interventions
NameTypeDescription
TEV-56248DRUGFluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.
Albuterol sulfateDRUGOral inhalation powder
Fp MDPIDRUGPharmaceutical form: Dry powder Route of administration: Oral inhalation
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Eligibility Criteria
Age Range4 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites393

Inclusion Criteria: * The participant has a documented diagnosis of asthma for at least 1 year according to the 2022 GINA guidelines. * The participant has a documented history of at least 1 severe clinical asthma exacerbation (CAE) ending within the past 12 month. * The participant is using any pr...

Countries:United StatesArgentinaAustraliaBulgariaCanadaCzechiaDenmarkGermanyGreeceHungaryIsraelItalyLatviaMexicoNew ZealandPolandRomaniaSerbiaSlovakiaSouth AfricaSouth KoreaSpain
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Competitive Landscape -Asthma 81 trials
CompanyTickerTrialsLead PhaseDrugs
Novartis AG Sponsored ADRNVS5PHASE3QVM149, Salmeterol Xinafoate / Fluticasone Propionate, Run-In Medication, QMF149, Budesonide
Teva Pharmaceutical Industries Limited Sponsored ADRTEVA4PHASE3Fp/ABS, ABS, Budesonide/Formoterol, TEV-56248, Albuterol
GSK plc Sponsored ADRGSK6PHASE3Depemokimab, FF/UMEC/VI, GSK5784283, Salbutamol HFA-152a, Salbutamol HFA-134a
Sanofi SA Sponsored ADRSNY8PHASE3Dupilumab, Dupilumab Prefilled Syringe, Amlitelimab, Lunsekimig, Short-Acting Beta Agonists
AstraZeneca PLCAZN29PHASE3Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, Mannitol
Generate Biomedicines, Inc.GENB3PHASE3GB-0895
Amgen Inc.AMGN2PHASE2Rocatinlimab, AMG 691
Pfizer Inc.PFE1PHASE2PF-07275315
Kymera Therapeutics, Inc.KYMR1PHASE2KT-621
Eli Lilly and CompanyLLY1PHASE2Brenipatide
Incyte CorporationINCY1PHASE2povorcitinib, ICS-LABA
Upstream Bio, Inc.UPB1PHASE2Verekitug
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE2ARO-RAGE
Apogee Therapeutics, Inc.APGE1PHASE1APG777
Celldex Therapeutics, Inc.CLDX1PHASE1CDX-622
Unity Health TorontoUBX1NAUndisclosed
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06052267studyFirstPostDate: changed