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Doxophylline
Doxophylline is a Small molecule drug developed by Universidad Autonoma de Nuevo Leon. It is currently in Phase 3 development. Also known as: There is no other intervention names.
Doxophylline is a small molecule used in the treatment of various respiratory conditions, including moderate to severe persistent bronchial asthma, chronic obstructive pulmonary disease, and asthma in children. It is typically administered orally in combination with other medications, such as inhaled budesonide and formoterol, as part of a treatment regimen.
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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 | Doxophylline |
|---|---|
| Also known as | There is no other intervention names |
| Sponsor | Universidad Autonoma de Nuevo Leon |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Effects of Oral Doxofylline and Procaterol on Chronic Obstructive Pulmonary Disease (PHASE4)
- Vmax Detection of Acupuncture-doxofylline as a Whole Probe of CYP1A in Vivo (NA)
- Efficacy and Safety Study of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet in the Treatment of Moderate-Severe COPD. (PHASE4)
- Effect of add-on Doxofylline on Lung Function in Stable COPD (PHASE4)
- Efficacy Of Doxophylline As A Sparing Treatment For Inhaled Corticosteroids In Mexican Children With Asthma (PHASE3)
- Controller Medications in the Management of Bronchial Asthma (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:
- Doxophylline CI brief — competitive landscape report
- Doxophylline updates RSS · CI watch RSS
- Universidad Autonoma de Nuevo Leon portfolio CI
Frequently asked questions about Doxophylline
What is Doxophylline?
Who makes Doxophylline?
Is Doxophylline also known as anything else?
What development phase is Doxophylline in?
Related
- Manufacturer: Universidad Autonoma de Nuevo Leon — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: There is no other intervention names
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing