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ambroxol BIH1526
ambroxol BIH1526 is a Mucolytic agent Small molecule drug developed by Sanofi. It is currently in Phase 3 development for Chronic obstructive pulmonary disease (COPD).
Ambroxol BIH1526 is a mucolytic agent that works by increasing the concentration of glutathione in the airways, which helps to break down and clear mucus.
Ambroxol BIH1526 is a mucolytic agent that works by increasing the concentration of glutathione in the airways, which helps to break down and clear mucus. Used for Chronic obstructive pulmonary disease (COPD).
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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). -
Big-pharma sponsor
+3.0pp
Sanofi is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | ambroxol BIH1526 |
|---|---|
| Sponsor | Sanofi |
| Drug class | Mucolytic agent |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | Phase 3 |
Mechanism of action
Ambroxol BIH1526 is a derivative of ambroxol, a compound that has been shown to increase the concentration of glutathione in the airways. Glutathione is an antioxidant that helps to protect the airways from damage and inflammation, and it also helps to break down and clear mucus. By increasing the concentration of glutathione, ambroxol BIH1526 helps to make it easier to breathe and to clear mucus from the airways.
Approved indications
- Chronic obstructive pulmonary disease (COPD)
Common side effects
- Nausea
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:
- ambroxol BIH1526 CI brief — competitive landscape report
- ambroxol BIH1526 updates RSS · CI watch RSS
- Sanofi portfolio CI
Frequently asked questions about ambroxol BIH1526
What is ambroxol BIH1526?
How does ambroxol BIH1526 work?
What is ambroxol BIH1526 used for?
Who makes ambroxol BIH1526?
What drug class is ambroxol BIH1526 in?
What development phase is ambroxol BIH1526 in?
What are the side effects of ambroxol BIH1526?
Related
- Drug class: All Mucolytic agent drugs
- Manufacturer: Sanofi — full pipeline
- Therapeutic area: All drugs in Respiratory
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing