Data updated: May 26, 2026
XTRELUS (guaifenesin)
Respiratory
Approved 2018-04-25
1
Indication
--
Phase 3 Trials
8
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2018-04-25
- Routes
- ORAL
- Dosage Forms
- TABLET
XTRELUS Approval History
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2018 to 2025
What XTRELUS Treats
1 FDA approvalsOriginally approved for its first indication in 2018 .
- Other (1)
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01202279 Wait and See results posted | 2009-MUCD-001 | Ph 4 | completed | Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI |
| NCT01364467 results posted | HM13538 | Ph 2 | completed | The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
XTRELUS FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.