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acetylcysteine · 1 trial · 1 indication
The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15. Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.
The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15. Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.
| Arm | Type | Description |
|---|---|---|
| Group A: 600 mg acetylcysteine | EXPERIMENTAL | one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
| Group B: 1200 mg acetylcysteine | EXPERIMENTAL | two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
| Group C: 2400 mg acetylcysteine | EXPERIMENTAL | four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily) |
| Group D: Placebo | PLACEBO_COMPARATOR | four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
| Name | Type | Description |
|---|---|---|
| acetylcysteine | DRUG | 600 mg tablet |
| Placebo | DRUG | Placebo to acetylcysteine |
Inclusion Criteria: 1. Male or female subjects aged between 14 and 75 years inclusive on the date of consent 2. Diagnosis of acute, uncomplicated rhinosinusitis defined at screening visit 1 and at Visit 2 as: 1. major symptom score (MSS) assessed by the patient ≥8 and ≤12 points for the followi...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE3 | Itepekimab |
| AstraZeneca PLC | AZN | 4 | PHASE3 | Tezepelumab |
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150, Standard therapy for INCS |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | - | Undisclosed |
Acetylcysteine is an investigational small molecule being studied for the treatment of acute uncomplicated rhinosinusitis. It is being developed by Novartis AG (NVS) and is currently in Phase 3 clinical development. The drug is intended to address symptoms of rhinosinusitis, though it is not yet approved for this indication.
Acetylcysteine is a small molecule developed by Novartis AG. Its specific molecular target has not been disclosed in the available information. The drug is being investigated for its efficacy and safety in treating acute uncomplicated rhinosinusitis, a condition involving inflammation of the nasal and sinus passages.
Acetylcysteine is being developed by Novartis AG, a multinational pharmaceutical company traded under the ticker NVS. The drug is currently in Phase 3 clinical trials for the treatment of acute uncomplicated rhinosinusitis. Novartis is conducting research to evaluate the drug's efficacy and safety in this patient population.
Acetylcysteine is in Phase 3 clinical development for the treatment of acute uncomplicated rhinosinusitis. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. A Phase 3 trial has been completed, and the drug is being evaluated for its efficacy and safety in this indication.
Acetylcysteine has one completed Phase 3 clinical trial registered under NCT04123405, titled 'Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis.' This randomized, double-blind, placebo-controlled trial enrolled 944 participants across Bulgaria, Germany, Moldova, and Russia. The study included individuals aged 14 years and older.
Acetylcysteine is the generic name for the compound commonly known as N-acetylcysteine. In the context of this clinical development program, it is being studied as a treatment for acute uncomplicated rhinosinusitis. The drug is being developed by Novartis AG and is currently in Phase 3 trials.