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Alenia
Alenia is a Small molecule drug developed by Eurofarma Laboratorios S.A.. It is currently in Phase 3 development. Also known as: Formoterol/Budesonide.
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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 | Alenia |
|---|---|
| Also known as | Formoterol/Budesonide |
| Sponsor | Eurofarma Laboratorios S.A. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Study of Formoterol 6 mcg/Fluticasone 125 mcg by Eurofarma Laboratórios S.A. Versus Alenia® 6 mcg/200 mcg in Patients With Asthma (FORASMA) (PHASE3)
- Non-Inferiority,Combination Formoterol/FluticasonexAlenia®Formoterol/Budesonide for Asthma in Brazil (PHASE3)
- A Non-inferiority, Comparative Study Between Foraseq®, Eurofarma´s Formoterol/Budesonide and Alenia® in Asthma (PHASE3)
- A Multicenter, Randomized, Parallel, Two-period, Non-inferiority Study of EurofarmavsAlenia in Asthma and COPD Treatment (PHASE3)
- A Two Week Nitazoxanidebased Quadruple Regimen (PHASE3)
- Nitazoxanide Plus Lactulose Versus Lactulose Alone Treatment of Hepatic Encephalopathy (PHASE2, PHASE3)
- Study of Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori (PHASE3)
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:
- Alenia CI brief — competitive landscape report
- Alenia updates RSS · CI watch RSS
- Eurofarma Laboratorios S.A. portfolio CI
Frequently asked questions about Alenia
What is Alenia?
Who makes Alenia?
Is Alenia also known as anything else?
What development phase is Alenia in?
Related
- Manufacturer: Eurofarma Laboratorios S.A. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Formoterol/Budesonide
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing