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long-acting beta2-agonist
long-acting beta2-agonist is a Long-acting beta2-agonist (LABA) Small molecule drug developed by National Heart, Lung, and Blood Institute (NHLBI). It is currently in Phase 3 development for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.
Long-acting beta2-agonists bind to beta2-adrenergic receptors on airway smooth muscle, causing prolonged relaxation and bronchodilation.
Long-acting beta2-agonists bind to beta2-adrenergic receptors on airway smooth muscle, causing prolonged relaxation and bronchodilation. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | long-acting beta2-agonist |
|---|---|
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Drug class | Long-acting beta2-agonist (LABA) |
| Target | Beta2-adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | Phase 3 |
Mechanism of action
Beta2-agonists activate beta2-adrenergic receptors, which increase intracellular cAMP levels and promote smooth muscle relaxation in the airways. Long-acting formulations provide sustained bronchodilation for 12-24 hours, making them suitable for maintenance therapy in chronic respiratory conditions. They are typically used in combination with inhaled corticosteroids for optimal asthma and COPD control.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Nervousness
- Palpitations
- Muscle cramps
- Tachycardia
Key clinical trials
- Phase 2 Study to Evaluate RPT193 in Adults With Moderate to Severe T2-high Asthma (PHASE2)
- A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation (PHASE4)
- Efficacy of Oral Nigella Sativa as Adjuvant Therapy in Children With Moderate Persistent Asthma (NA)
- A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype (PHASE3)
- A Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) With a Next-generation Propellant (NGP) With a Spacer, BGF MDI Hydrofluoroalkane (HFA) With a Spacer, as Well as BGF MDI NGP Without a Spacer (PHASE1)
- Oral Intake of Mg in Controlled Asthmatic Patients (PHASE2, PHASE3)
- A Study to Assess the Pharmacokinetics and Safety of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) With a Next-Generation Propellant (NGP) With a Spacer, BGF MDI Hydrofluoroalkane (HFA) With a Spacer, as Well as BGF MDI NGP Without a Spacer (PHASE1)
- To Evaluate the Efficacy and Safety of Inhaled Corticosteroids Combined With Bronchodilators and Programmed Death-ligand 1 (PD-L1) Inhibitor Plus Platinum-based Chemotherapy in Patients With Advanced Lung Squamous Cell Carcinoma Complicated With Chronic Obstructive Pulmonary Disease (COPD)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial 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:
- long-acting beta2-agonist CI brief — competitive landscape report
- long-acting beta2-agonist updates RSS · CI watch RSS
- National Heart, Lung, and Blood Institute (NHLBI) portfolio CI
Frequently asked questions about long-acting beta2-agonist
What is long-acting beta2-agonist?
How does long-acting beta2-agonist work?
What is long-acting beta2-agonist used for?
Who makes long-acting beta2-agonist?
What drug class is long-acting beta2-agonist in?
What development phase is long-acting beta2-agonist in?
What are the side effects of long-acting beta2-agonist?
What does long-acting beta2-agonist target?
Related
- Drug class: All Long-acting beta2-agonist (LABA) drugs
- Target: All drugs targeting Beta2-adrenergic receptor
- Manufacturer: National Heart, Lung, and Blood Institute (NHLBI) — full pipeline
- Therapeutic area: All drugs in Respiratory
- Indication: Drugs for Asthma maintenance therapy
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD) maintenance therapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing