Data updated: May 26, 2026
CETYLEV (acetylcysteine)
Hepatology
Approved 2016-01-29
1
Indication
--
Phase 3 Trials
10
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2016-01-29
- Patent Cliff
- 2032
- Routes
- ORAL
- Dosage Forms
- TABLET, EFFERVESCENT
CETYLEV Approval History
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2016 to 2018
Mar 2018 SUPPL
Label · Labeling
Jul 2017 SUPPL
Label · Labeling
What CETYLEV Treats
1 FDA approvalsOriginally approved for its first indication in 2016 .
- Other (1)
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Clinical Trial Registry
17 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04918719 | 32358-01 | Ph 2 | completed | Intravenous N-Acetylcysteine for the Treatment of Acute Ischemic Stroke |
| NCT07414212 NADALS-001-ALS | NADALS-001-ALS-2021 2024-519857-13-00 | Ph 1, Ph 2 | recruiting | Evaluation of the Combined Therapy of EH-301 and N-acetylcysteine Together With Riluzole in Amyotrophic Lateral Sclerosis (ALS) |
| NCT02569957 results posted | 15P.404 JT 7408 | Ph 2 | terminated | Effect of Acetylcysteine With Topotecan Hydrochloride on the Tumor Microenvironment in Patients With Persistent or Recurrent High Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer |
| NCT05070650 | SAN-0657 | Ph 3 | withdrawn | Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold |
| NCT00558142 results posted | NAC0606 NRES reference: 07/MRE00/64, EudraCT reference: 2006 | Ph 4 | completed | Mechanisms for the Effect of Acetylcysteine on Renal Function After Exposure to Radiographic Contrast Material |
| NCT02788292 | 1021326 | Ph 4 | withdrawn | Effect of N-Acetylcysteine on Autologous Fat Graft Survival |
| NCT04123405 results posted | 2018-08-EFT-1 2019-000060-20 | Ph 3 | completed | Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis |
| NCT03177395 POP results posted | PP100-001 | Ph 1 | completed | PP100-01 (Calmangafodipir) for Overdose of Paracetamol |
| NCT02123511 results posted | MC13C2 NCI-2014-00865, Mod13-007632-07 | Ph 2 | completed | Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy |
| NCT02760901 | master | Ph 2 | completed | Evaluation of the Effect of Acetazolamide, Mannitol and N-acetylcysteine on Cisplatin-Induced Nephrotoxicity |
| NCT02080182 | NAC1165 | Ph 2 | completed | Effect of Acetylcysteine in Pediatric Acute Pyelonephritis. |
| NCT02723669 | AR10.001 | Ph 1 | completed | Relative Bioavailability of AR10 Compared to Reference Product |
| NCT02357303 | PortugueseOIC 001 | Ph 4 | completed | Simethicone and N-acetylcysteine in Upper Endoscopy - Prospective Double-blinded Randomized Controlled Trial |
| NCT02168387 results posted | Pro00026503 | Ph 4 | completed | Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient |
| NCT01050270 SNAP | CZB/4/722 2009-017800-10 | Ph 4 | completed | Scottish and Newcastle Anti-emetic Pre-treatment for Paracetamol Poisoning Study (SNAP) |
| NCT00996424 | 2009/464 | Ph 4 | terminated | The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function |
| NCT00736866 ACT | IEP- HCor 001/08 | Ph 3 | completed | The Acetylcysteine for Contrast-Induced Nephropathy Trial |
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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.
CETYLEV FDA Label Details
View full patent landscape →
3 OB patents · 1 families ·
9 international docs across 2 countries
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- • Cliff: 2032
- • 12 active patents
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.