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Budesonide inhalant
Budesonide inhalant is a Glucocorticoid Small molecule drug developed by Guangdong Hengrui Pharmaceutical Co., Ltd. It is currently in Phase 2 development for Asthma, Chronic obstructive pulmonary disease (COPD).
Glucocorticoid receptor agonist
Budesonide inhalant is a small molecule glucocorticoid receptor agonist used to treat conditions such as asthma, acute pharyngitis, and asthma-COPD overlap. It is classified as an agonist in the drug class and is administered via inhalation.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Budesonide inhalant |
|---|---|
| Sponsor | Guangdong Hengrui Pharmaceutical Co., Ltd |
| Drug class | Glucocorticoid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | Phase 2 |
Mechanism of action
Budesonide acts as a glucocorticoid receptor agonist, which reduces inflammation and immune responses.
Approved indications
- Asthma
- Chronic obstructive pulmonary disease (COPD)
Common side effects
- Oral thrush
- Headache
- Cough
Key clinical trials
- Clinical Study on the Efficacy and Safety of SHR-4597 Inhalant in Adult Patients With Asthma (PHASE2)
- Single-dose AQ001S PK Study in Healthy Volunteers (PHASE1)
- Inhaled Steroids for Acute Pharyngitis. (PHASE2, PHASE3)
- Effect of Symbicort on GR Localisation in Asthma (NA)
- Efficiency of Budesonide Combined With Formoterol and Tiotropium in the Treatment of Acute Exacerbation of ACO (NA)
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:
- Budesonide inhalant CI brief — competitive landscape report
- Budesonide inhalant updates RSS · CI watch RSS
- Guangdong Hengrui Pharmaceutical Co., Ltd portfolio CI
Frequently asked questions about Budesonide inhalant
What is Budesonide inhalant?
How does Budesonide inhalant work?
What is Budesonide inhalant used for?
Who makes Budesonide inhalant?
What drug class is Budesonide inhalant in?
What development phase is Budesonide inhalant in?
What are the side effects of Budesonide inhalant?
What does Budesonide inhalant target?
Related
- Drug class: All Glucocorticoid drugs
- Target: All drugs targeting Glucocorticoid receptor
- Manufacturer: Guangdong Hengrui Pharmaceutical Co., Ltd — 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