Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
N-acetylcysteine · 1 trial · 1 indication
Percentage of participants with dose reductions in N-Acetylcysteine and placebo cohorts during the 24-week treatment period.
Percentage of participants with early treatment discontinuations in N-Acetylcysteine and placebo cohorts during the 24-week treatment period.
An adverse event (AE) is defined as any untoward medical occurrence in a participant who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect.
| Arm | Type | Description |
|---|---|---|
| Matching Placebo | PLACEBO_COMPARATOR | - |
| N-Acetylcysteine | EXPERIMENTAL | - |
| Pirfenidone | OTHER | Background therapy |
| Name | Type | Description |
|---|---|---|
| Matching Placebo | DRUG | Matching Placebo, oral administration, three times daily for 24 weeks. |
| N-acetylcysteine | DRUG | N-acetylcysteine, 600 mg, oral administration, three times daily for 24 weeks. |
| Pirfenidone | DRUG | Pirfenidone, at least 1602 mg/day, oral administration, for 32 weeks, during the wash-out and screening period and for at least 8 weeks prior to randomization. |
Inclusion Criteria: * Clinical symptoms consistent with IPF of \>=3 months' duration (relative to Day 1) * Must have been on a dose of pirfenidone not less than 1602 mg/day for at least 8 weeks prior to randomization at Day 1 * Able to understand the importance of adherence to study treatment and t...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | BMS-986278 |
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Treprostinil |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | ABBV-142 |
| PureTech Health PLC Sponsored ADR | PRTC | 2 | PHASE3 | Deupirfenidone, Pirfenidone |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Contineum Therapeutics, Inc. Class A | CTNM | 1 | PHASE2 | PIPE-791 Dose A, PIPE-791 Dose B |
| Rein Therapeutics, Inc | RNTX | 1 | PHASE2 | LTI-03 |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | HEC585, Pirfenidone |
| Cumberland Pharmaceuticals Inc. | CPIX | 1 | PHASE2 | Ifetroban |
| Avalyn Pharma Inc | AVLN | 3 | PHASE2 | AP01 |
N-acetylcysteine is an investigational small molecule being studied for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a chronic and progressive lung disease. It is being evaluated in combination with pirfenidone to assess its safety and tolerability in patients with IPF.
N-acetylcysteine is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research to evaluate the drug's potential in treating Idiopathic Pulmonary Fibrosis.
N-acetylcysteine is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities for the treatment of Idiopathic Pulmonary Fibrosis. One Phase 2 trial has been completed.
N-acetylcysteine has been studied in one completed Phase 2 clinical trial, identified as NCT02707640. This trial assessed the safety and tolerability of N-acetylcysteine when administered with pirfenidone to participants with Idiopathic Pulmonary Fibrosis.
N-acetylcysteine is commonly known as NAC. It is a small molecule being investigated for Idiopathic Pulmonary Fibrosis, and it is being developed by Roche Holding AG. The drug is currently in Phase 2 clinical development.