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Immediate-release Guaifenesin
Immediate-release Guaifenesin is a Expectorant Small molecule drug developed by Reckitt Benckiser LLC. It is currently in Phase 2 development for Acute bronchitis, Chronic bronchitis, Acute upper respiratory tract infections. Also known as: IR guaifenesin, IR GGE.
Guaifenesin is an expectorant that works by increasing the volume and reducing the viscosity of respiratory tract secretions.
Immediate-release Guaifenesin is a small molecule with an unknown mechanism of action. It is used to treat cough and has been studied in clinical trials under various conditions, including fasted and fed states.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Immediate-release Guaifenesin |
|---|---|
| Also known as | IR guaifenesin, IR GGE |
| Sponsor | Reckitt Benckiser LLC |
| Drug class | Expectorant |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | Phase 2 |
Mechanism of action
It does this by inhibiting the action of surfactant protein A, which normally helps to reduce the surface tension of pulmonary surfactant, thereby facilitating the clearance of mucus from the airways.
Approved indications
- Acute bronchitis
- Chronic bronchitis
- Acute upper respiratory tract infections
Common side effects
- Nausea
- Vomiting
- Diarrhea
Key clinical trials
- Bioequivalence Study Comparing Mucinex Extended-release 600 mg Tablets to Immediate-release Guaifenesin 600 mg in Healthy Volunteers (PHASE1)
- Mucinex® ER 600 mg Bi-layer Tablet Versus Guaifenesin Immediate Release (IR) 200 mg q4h (PHASE1)
- Study to Evaluate the Pharmacokinetics of Guaifenesin in Adults and Adolescents (PHASE1)
- Study to Characterize the Pharmacokinetics of 3 Marketed Products Containing 200 mg Guaifenesin in Healthy Volunteers. (PHASE1)
- Codeine Phosphate/Guaifenesin ER Tablet 30 mg/600 mg Steady State Clinical Study (PHASE1)
- Single Dose Trial of Extended Release Combination Tablet Codeine and Guaifenesin (PHASE1)
- Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections (PHASE2, PHASE3)
- Study of Count Coughs in Subjects With Acute Upper Respiratory Tract Infections (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:
- Immediate-release Guaifenesin CI brief — competitive landscape report
- Immediate-release Guaifenesin updates RSS · CI watch RSS
- Reckitt Benckiser LLC portfolio CI
Frequently asked questions about Immediate-release Guaifenesin
What is Immediate-release Guaifenesin?
How does Immediate-release Guaifenesin work?
What is Immediate-release Guaifenesin used for?
Who makes Immediate-release Guaifenesin?
Is Immediate-release Guaifenesin also known as anything else?
What drug class is Immediate-release Guaifenesin in?
What development phase is Immediate-release Guaifenesin in?
What are the side effects of Immediate-release Guaifenesin?
Related
- Drug class: All Expectorant drugs
- Manufacturer: Reckitt Benckiser LLC — full pipeline
- Therapeutic area: All drugs in Respiratory
- Indication: Drugs for Acute bronchitis
- Indication: Drugs for Chronic bronchitis
- Indication: Drugs for Acute upper respiratory tract infections
- Also known as: IR guaifenesin, IR GGE
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing