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Fp/ABS

Phase 3

Asthma | Small molecule | Respiratory |Teva Pharmaceutical Industries Limited|Last Updated: Mar 19, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment724

FDA Designations

No designations recorded

Clinical trial landscape

Fp/ABS · 1 trial · 1 indication

Phase 3 1
NCT06664619A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With AsthmaAsthma
RECRUITING724 Analytics
PHASE3RECRUITING
A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from Baseline forced expiratory volume in one second (FEV1) area under the effect curve over 4 weeks
Baseline, Week 4

Baseline values are averaged on day 1 to get a single value. Area under the effect curve will be calculated using measurements collected between zero and 6 hours after dosing. Baseline-adjusted post-dose FEV1 AUEC0-6h for visits on Day 1 and at Week 4 will be calculated using the trapezoidal rule.

Change from Baseline trough FEV1 at week 4
Baseline, Week 4

Secondary Endpoints

Time to 15% improvement from baseline FEV1 post-dose on day 1
Baseline to Post-dose on Day 1
Time to 12% improvement from baseline FEV1 post-dose on day 1
Baseline to Post-dose on Day 1
Duration of 15% increase in FEV1 from baseline post-dose on day 1
Baseline Pre-dose to Post-dose on Day 1
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Fp/ABS eMDPIEXPERIMENTALFluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module
Fp eMDPIACTIVE_COMPARATORFluticasone propionate (Fp) dry powder inhaler with an integrated electronic module (eMDPI)
ABS eMDPIACTIVE_COMPARATORAlbuterol sulfate (ABS) dry powder inhaler with an integrated electronic module (eMDPI)
Placebo eMDPIPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Fp/ABSDRUGInhalation powder
FPDRUGInhalation powder
ABSDRUGInhalation powder
PlaceboDRUGInhalation powder
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites138

Inclusion Criteria: * The participant has a diagnosis of asthma of at least 6 months duration. * Participants currently receive a beta-agonist (eg, salbutamol \[albuterol\] or ICS albuterol or ICS-formoterol) as rescue medication with or without asthma controller medication. * If female, a particip...

Countries:United StatesArgentinaBulgariaCzechiaGermanyIsraelMexicoPolandRomaniaSlovakiaTurkey (Türkiye)
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Frequently asked questions about Fp/ABS

What is Fp/ABS used for?

Fp/ABS is an investigational small molecule being developed for the treatment of asthma. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients 12 years and older with asthma.

What does Fp/ABS target?

Fp/ABS is a combination of fluticasone propionate and albuterol sulfate. Fluticasone propionate is a corticosteroid that reduces inflammation in the airways, while albuterol sulfate is a bronchodilator that relaxes muscles in the airways to improve breathing. The combination is designed to address both inflammation and bronchoconstriction in asthma.

Who makes Fp/ABS?

Fp/ABS is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker symbol TEVA. Teva is conducting clinical trials to evaluate the safety and efficacy of this drug candidate for the treatment of asthma.

What phase is Fp/ABS in?

Fp/ABS is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is designed to assess the efficacy and safety of the drug in patients with asthma.

What clinical trials is Fp/ABS in?

Fp/ABS is being evaluated in a Phase 3 clinical trial registered as NCT06664619. This is a randomized, double-blind, placebo-controlled study with an enrollment of 724 participants aged 12 years and older with asthma. The trial is currently recruiting and is being conducted in multiple countries including the United States, Argentina, Bulgaria, Czechia, Germany, Israel, Mexico, Poland, Romania, Slovakia, and Turkey.

Is Fp/ABS the same as fluticasone propionate/albuterol sulfate?

Yes, Fp/ABS is the abbreviation for fluticasone propionate and albuterol sulfate combination. This combination therapy is being developed by Teva Pharmaceutical Industries for the treatment of asthma. The drug is currently in Phase 3 clinical trials and has not yet been approved for use.