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Formoterol

Phase 4FDA approved

Asthma | Small molecule | Respiratory |Novartis AG|Trials Updated: May 19, 2023

Formoterol development status

FDA approval on record Feb 16, 2001
Approval holderNovartis
ApplicationNDA020831
Highest phase Phase 4 (NCT00134979)
Phase scored for NVSPhase 3
Registered trials 23 across 7 sponsors since Aug 2005

Formoterol target and mechanism

Molecular targetADRB2
Target classAgonist
ModalitySmall molecule

Also known as Formoterol fumarate

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment205

FDA Designations

No designations recorded

Formoterol clinical trials

Formoterol · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT00130351A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With AsthmaAsthma
COMPLETED155 Analytics
PHASE3COMPLETED
A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Device use: Patients were instructed to record the number appearing in the dose counter window after their dose on the diary card.
Safety: Assessed by adverse events, physical examinations, vital signs abnormalities, forced expiratory volume in 1 second (FEV1) and screening ECG.
• Efficacy assessed by 12 hour Area Under the Curve (AUC) of FEV1 (forced expiratory volume in 1 second, is a measure of how well the lungs are working)

Secondary Endpoints

• Efficacy assessed by forced expiratory volume in 1 second at pre-dose, 15, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 11 and 12 hours post dose
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Interventions

NameTypeDescription
formoterolDEVICE -
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Eligibility Criteria

Age Range5 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Patients who are capable of understanding the directions for device usage, evaluating device function and completing the patient diary * Patients who have a current diagnosis of asthma * Patients who have a documented forced expiratory volume at 1 second (FEV1) reversibility o...

Countries:United StatesGermany
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Frequently asked questions about Formoterol

What is formoterol used for in asthma?

Formoterol is a small molecule drug developed for the treatment of asthma. It is delivered by inhalation and is studied in patients with asthma, including adults and children. The clinical program includes a Phase 3 study in patients aged 5 years and older and a Phase 2 study in adults.

What does formoterol target?

Formoterol targets ADRB2, the beta-2 adrenergic receptor, and acts as an agonist at this receptor. This target class places formoterol among the beta-2 adrenergic receptor agonists used in respiratory medicine. Its activity at ADRB2 is the basis for its development in asthma.

Who makes formoterol?

Formoterol is developed by Novartis AG, which trades under the ticker NVS. Novartis is the company associated with the clinical development program for formoterol in asthma, including the Phase 3 and Phase 2 studies listed for the drug.

What phase is formoterol in?

Formoterol is in Phase 3 development for asthma. It is an investigational small molecule and is not described as approved. The program includes two completed trials, one Phase 3 and one Phase 2, with no active trials currently listed.

What clinical trials is formoterol in?

Formoterol has been studied in two completed trials. NCT00130351 was a 3-week Phase 3 study of patient use and functionality of formoterol in a novel inhalation device in asthma patients aged 5 years and older in the United States. NCT00443482 was a Phase 2 equivalence study of formoterol 12 and 24 µg delivered via two single dose dry powder inhalers in Germany.

Is formoterol the same as formoterol fumarate?

Yes, formoterol is also known as formoterol fumarate, and it has been referred to as formoterol (12 µg b.i.d.). These names refer to the same drug, a small molecule developed by Novartis AG for asthma. Searches using any of these names point to the same asset.