TheraRadar
Data updated: Jun 28, 2026

CETYLEV (acetylcysteine) · ARBOR PHARMS LLC

Hepatology Approved 2016-01-29

CETYLEV is FDA-approved to treat 2 conditions (same as ACETYLCYSTEINE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
10
Years on Market

Details

Status
Discontinued
First Approved
2016-01-29
Patent Cliff
2032

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Routes
ORAL
Dosage Forms
TABLET, EFFERVESCENT

Companies

ARBOR PHARMS LLC
Active Ingredient: ACETYLCYSTEINE

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
Apr 2017 SUPPL
Label · Labeling
FDA Letter Label

What CETYLEV Treats

2 indications

CETYLEV is approved for 2 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Acetaminophen Overdose
  • Hepatic Injury

Same approved indications as ACETYLCYSTEINE (same active ingredient).

Source: FDA Label
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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NCT05070650 SAN-0657 Ph 3 withdrawn Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold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NCT02788292 1021326 Ph 4 withdrawn Effect of N-Acetylcysteine on Autologous Fat Graft Survival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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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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

Indications & Usage

FDA Label (PDF)

CETYLEV is FDA-approved to treat 2 conditions — same approved indications as ACETYLCYSTEINE.

View full patent landscape →
3 OB patents · 1 families · 9 international docs across 2 countries

CETYLEV Patents & Exclusivity

Latest Patent: May 2032

Patents (3 active)

US8747894 Expires May 8, 2032
US9561204 Expires May 8, 2032
US9427421 Expires May 8, 2032
Source: FDA Orange Book

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Revenue Insights

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Patent Timeline

  • • Cliff: 2032
  • • 12 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA207916 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.