Last reviewed · How we verify

Budesonide / Formoterol 400/12

EMS · Phase 3 active Small molecule

Budesonide / Formoterol 400/12 is a Inhaled corticosteroid / long-acting beta-2 agonist combination Small molecule drug developed by EMS. It is currently in Phase 3 development for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.

Budesonide reduces airway inflammation via glucocorticoid receptor activation, while formoterol dilates airways by stimulating beta-2 adrenergic receptors.

Budesonide reduces airway inflammation via glucocorticoid receptor activation, while formoterol dilates airways by stimulating beta-2 adrenergic receptors. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.

At a glance

Generic nameBudesonide / Formoterol 400/12
SponsorEMS
Drug classInhaled corticosteroid / long-acting beta-2 agonist combination
TargetGlucocorticoid receptor; beta-2 adrenergic receptor
ModalitySmall molecule
Therapeutic areaRespiratory / Pulmonology
PhasePhase 3

Mechanism of action

Budesonide is an inhaled corticosteroid that suppresses inflammatory mediators and immune cell recruitment in the lungs. Formoterol is a long-acting beta-2 agonist that relaxes bronchial smooth muscle, improving airflow. Together, they provide both anti-inflammatory and bronchodilatory effects for sustained asthma and COPD control.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about Budesonide / Formoterol 400/12

What is Budesonide / Formoterol 400/12?

Budesonide / Formoterol 400/12 is a Inhaled corticosteroid / long-acting beta-2 agonist combination drug developed by EMS, indicated for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.

How does Budesonide / Formoterol 400/12 work?

Budesonide reduces airway inflammation via glucocorticoid receptor activation, while formoterol dilates airways by stimulating beta-2 adrenergic receptors.

What is Budesonide / Formoterol 400/12 used for?

Budesonide / Formoterol 400/12 is indicated for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.

Who makes Budesonide / Formoterol 400/12?

Budesonide / Formoterol 400/12 is developed by EMS (see full EMS pipeline at /company/ems).

What drug class is Budesonide / Formoterol 400/12 in?

Budesonide / Formoterol 400/12 belongs to the Inhaled corticosteroid / long-acting beta-2 agonist combination class. See all Inhaled corticosteroid / long-acting beta-2 agonist combination drugs at /class/inhaled-corticosteroid-long-acting-beta-2-agonist-combination.

What development phase is Budesonide / Formoterol 400/12 in?

Budesonide / Formoterol 400/12 is in Phase 3.

What are the side effects of Budesonide / Formoterol 400/12?

Common side effects of Budesonide / Formoterol 400/12 include Tremor, Headache, Palpitations, Oral candidiasis, Nervousness.

What does Budesonide / Formoterol 400/12 target?

Budesonide / Formoterol 400/12 targets Glucocorticoid receptor; beta-2 adrenergic receptor and is a Inhaled corticosteroid / long-acting beta-2 agonist combination.

Related