7 completed, 2 unknown. 5 Phase 1, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 5 | Completed 5 |
| Phase 2 | 4 | Completed 2, Unknown 2 |
Follow cavosonstat: new trials by email Literature Review of cavosonstat trials Research Report on cavosonstat
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Cavosonstat Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD) placebo, Cavosonstat 5 mg, Cavosonstat 10 mg - Chronic Obstructive Pulmonary Disease (COPD) | Phase 2 | Unknown | GSNOR Therapeutics, Inc. | 108 | 2021-02-03 | 2020-10-23 |
| PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study MCT, Clazakizumab, Broncho-Vaxom - Asthma | Phase 2 | Completed | University of North Carolina, Chapel Hill | 950 | 2019-12-19 | 2026-04-01 |
| MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Cavosonstat (N91115) in Healthy Subjects (SNO-9) Cavosonstat, Placebo - Cystic Fibrosis | Phase 1 | Completed | Nivalis Therapeutics, Inc. | 32 | 2016-10-01 | 2017-01-31 |
| Study of Cavosonstat (N91115) in CF Patients Who Are Heterozygous for F508del-CFTR and a Gating Mutation and Being Treated With Ivacaftor Cavosonstat, Placebo - Cystic Fibrosis | Phase 2 | Unknown | Nivalis Therapeutics, Inc. | 19 | 2016-04-01 | 2016-11-21 |
| Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation Cavosonstat, Placebo - Cystic Fibrosis | Phase 2 | Completed | Nivalis Therapeutics, Inc. | 138 | 2015-11-01 | 2017-01-10 |
| A Drug-Drug Interaction Study of N91115 +/- Rifampin in Healthy Adult Subjects N91115, Rifampin - Drug Interaction Potentiation | Phase 1 | Completed | Nivalis Therapeutics, Inc. | 15 | 2015-06-01 | 2016-11-07 |
| Study of N91115 in Patients With Cystic Fibrosis Homozygous F508del-CFTR Mutation N91115 - Cystic Fibrosis | Phase 1 | Completed | Nivalis Therapeutics, Inc. | 51 | 2015-02-01 | 2016-11-07 |
| PK Study of N91115 in Cystic Fibrosis Patients N91115 - Cystic Fibrosis | Phase 1 | Completed | Nivalis Therapeutics, Inc. | 6 | 2014-10-01 | 2016-11-07 |
| MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects N91115, Placebo, Placebo-Day 1 only - Healthy | Phase 1 | Completed | Nivalis Therapeutics, Inc. | 49 | 2014-02-01 | 2016-12-21 |
Cystic Fibrosis (5) · Asthma (1) · Pulmonary Disease, Chronic Obstructive (1)
Nivalis Therapeutics, Inc. (7) · GSNOR Therapeutics, Inc. (1) · University of North Carolina, Chapel Hill (1)
United States (8)
Christopher Galloway, MD (2) · Scott Donaldson, MD (2) · Anastasia Ivanova, PhD (1) · James Chmiel, MD (1) · Robert Williams, MD (1) · Steven A Shoemaker, MD (1) · Steven Shoemaker, MD (1)
U24HL138998 (1)