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Ansimar (DOXOFYLLINE)
Ansimar (generic name: DOXOFYLLINE) is a doxofylline drug. It is currently in Phase 3 development.
Doxofylline works by stimulating the beta-2 adrenergic receptors in the lungs, causing bronchodilation.
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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 | DOXOFYLLINE |
|---|---|
| Drug class | doxofylline |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | Phase 3 |
Mechanism of action
Imagine your airways are like a narrow road that gets congested. Doxofylline helps to relax the muscles around the road, making it wider and easier to breathe. This makes it easier for air to flow in and out of the lungs.
Approved indications
Common side effects
- Pneumonia
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:
- Ansimar CI brief — competitive landscape report
- Ansimar updates RSS · CI watch RSS
Frequently asked questions about Ansimar
What is Ansimar?
How does Ansimar work?
What is the generic name of Ansimar?
What drug class is Ansimar in?
What development phase is Ansimar in?
What are the side effects of Ansimar?
Related
- Drug class: All doxofylline drugs
- Therapeutic area: All drugs in Respiratory
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing