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Procaterol, Salbultamol
Procaterol, Salbultamol is a Beta-2 adrenergic receptor agonist Small molecule drug developed by PT Otsuka Indonesia. It is currently in Phase 3 development for Asthma, Chronic obstructive pulmonary disease (COPD).
Procaterol is a beta-2 adrenergic receptor agonist, and Salbutamol is a beta-2 adrenergic receptor agonist.
Procaterol and Salbutamol are small molecule medications used to treat moderate acute asthma. They are administered via nebulization, with Procaterol being compared to Salbutamol in clinical trials for their efficacy in treating moderate acute asthma.
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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 | Procaterol, Salbultamol |
|---|---|
| Sponsor | PT Otsuka Indonesia |
| Drug class | Beta-2 adrenergic receptor agonist |
| Target | Beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | Phase 3 |
Mechanism of action
Procaterol and Salbutamol work by stimulating the beta-2 adrenergic receptors in the lungs, leading to bronchodilation and relief of bronchospasm. This results in improved lung function and symptoms in patients with asthma and chronic obstructive pulmonary disease (COPD).
Approved indications
- Asthma
- Chronic obstructive pulmonary disease (COPD)
Common side effects
- Tremors
- Nervousness
- Headache
- Palpitations
- Dizziness
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.
| 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:
- Procaterol, Salbultamol CI brief — competitive landscape report
- Procaterol, Salbultamol updates RSS · CI watch RSS
- PT Otsuka Indonesia portfolio CI
Frequently asked questions about Procaterol, Salbultamol
What is Procaterol, Salbultamol?
How does Procaterol, Salbultamol work?
What is Procaterol, Salbultamol used for?
Who makes Procaterol, Salbultamol?
What drug class is Procaterol, Salbultamol in?
What development phase is Procaterol, Salbultamol in?
What are the side effects of Procaterol, Salbultamol?
What does Procaterol, Salbultamol target?
Related
- Drug class: All Beta-2 adrenergic receptor agonist drugs
- Target: All drugs targeting Beta-2 adrenergic receptor
- Manufacturer: PT Otsuka Indonesia — full pipeline
- Therapeutic area: All drugs in Respiratory
- Indication: Drugs for Asthma
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing