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Acetylcystine
Acetylcystine is a Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development.
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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
GlaxoSmithKline 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 | Acetylcystine |
|---|---|
| Sponsor | GlaxoSmithKline |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- The Effect of NAC on Lung Function and CT Mucus Score (PHASE4)
- Behavioral Effects of Drugs (Inpatient): 43 (Opioids, Cocaine, n-Acetylcysteine) (EARLY_PHASE1)
- The Effects of Positive Airway Pressure on the Mucolytic Effects of NAC (TEAM) (PHASE4)
- NAC Effect on Iron Overload and Blood Transfusion in β-thalassemia Major (PHASE1)
- Clinical Trial of NAC in Asthma (PHASE4)
- Evaluation of Aerosolized Drugs Deposition During Mechanical Ventilation (NA)
- Warming Sensation and Tolerability Study of Acetylcysteine 2% Oral Solution for Productive Cough (PHASE3)
- Postoperative Nasal Irrigation Using Mucolytic Agents (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:
- Acetylcystine CI brief — competitive landscape report
- Acetylcystine updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Acetylcystine
What is Acetylcystine?
Who makes Acetylcystine?
What development phase is Acetylcystine in?
Related
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing