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Clinical trials
catalyst calendar across sponsors →Studies where TRVI is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
16 interventional · 10 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) TabletsNCT07671911Relative Change from Baseline in 24-hour Cough Frequency at Week 26Randomized · Double-masked · Treatment | Phase 3 | Recruiting | Drug: NAL ER, Placebo | Idiopathic Pulmonary Fibrosis | 306 | Jun 2028 | ≤ 681 d | 2026-07-10 |
| The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)NCT07671924Relative Change From Baseline in 24-hour Cough Frequency at Week 6Randomized · Double-masked · Treatment | Phase 2 | Recruiting | Drug: NAL ER, Placebo | Refractory Chronic Cough | 100 | Sep 2027 | ≤ 407 d | 2026-08-10 |
| A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy ParticipantsNCT07487740Relative Bioavailability of NAL ERRandomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: NAL ER | Healthy Participants | 60 | Apr 2026 | — | 2026-03-23 |
| NAL ER IPF Respiratory Function and Safety StudyNCT07036029Respiratory Function and Safety Assessed by Number of Participants With Increase in End Tidal Partial Pressure of Carbon Dioxide by Capnography (PetCO2) of at Least 10 Millimetres of Mercury (mmHg) From Baseline, or PetCO2>55 mmHg, for at Least 1 MinuteOpen-label · Treatment | Phase 1 | Completed | Drug: NAL ER, Placebo | Idiopathic Pulmonary Fibrosis | 9 | 2026-06-30actual | — | 2026-08-03 |
| A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy ParticipantsNCT07015398Maximum Plasma Concentration (Cmax) of NAL ER, Pirfenidone, and NintedanibNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: NAL ER, Pirfenidone, Nintedanib | Healthy Participants | 132 | 2025-09-12actual | — | 2025-10-10 |
| Cough Reduction in IPF With Nalbuphine ERNCT05964335results2026-06-26Relative Change From Baseline in 24-hour Cough Frequency at Week 6Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: NAL ER, Placebo, NAL ER, NAL ER | Idiopathic Pulmonary Fibrosis | 165 | 2025-04-24actual | — | 2026-06-26 |
| Refractory Chronic Cough Improvement Via NAL ER (RIVER)NCT05962151results2026-03-30Relative Change From Baseline in 24-hour Cough Frequency at Day 21Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: NAL ER, Placebo | Refractory Chronic Cough | 66 | 2025-01-06actual | — | 2026-03-30 |
| A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of CoughNCT04030026results2025-05-29Number of Participants Who Experienced at Least One Treatment Emergent Adverse Events (TEAEs)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: NAL ER, Placebo | Idiopathic Pulmonary Fibrosis | 42 | 2022-05-27actual | — | 2025-05-29 |
| PRISM Study-Pruritus Relief Through Itch Scratch ModulationNCT03497975results2025-06-24Percentage of Participants With ≥ 4- Point Decrease in 7-day Average Worst Itch - Numerical Rating Scale (WI-NRS) up to Week 14Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Completed | Drug: Nalbuphine ER Tablets, Placebo Tablets | Prurigo Nodularis | 353 | 2022-05-10actual | — | 2025-06-24 |
| Study of Nalbuphine ER in Participants With Hepatic ImpairmentNCT04020016results2026-03-19Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL EROpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: Nalbuphine ER | Hepatic Impairment | 28 | 2020-02-05actual | — | 2026-03-19 |
| Oral Abuse Potential Study of NalbuphineNCT04018664results2020-08-31To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main Study (Part B).Non-randomized · Triple-masked · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: Nalbuphine HCl solution, Placebo solution | Nalbuphine, Opioid Abuse | 56 | 2018-12-03actual | — | 2025-05-21 |
| Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo NodularisNCT02174432results2020-10-23Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Completed | Drug: nalbuphine HCl ER | Prurigo Nodularis, Nodularis Prurigo, Prurigo | 36 | 2017-09-03actual | — | 2025-05-21 |
| Study of Nalbuphine HCl ER Tablets in Patients With Prurigo NodularisNCT02174419results2020-08-21Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating ScaleRandomized · Triple-masked · Treatment | Phase 2/3 | Completed | Drug: nalbuphine HCl ER tablets 90 mg BID, nalbuphine HCl ER tablets 180 mg BID, Placebo tablets BID | Prurigo Nodularis, Nodularis Prurigo, Prurigo, Pruritus | 62 | Aug 2016actual | — | 2025-05-21 |
| Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic PruritusNCT02143973results2020-09-07Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs)Open-label · Treatment | Phase 2/3 | Completed | Drug: nalbuphine HCl ER | Uremic Pruritus, Pruritus | 167 | Jan 2016actual | — | 2025-05-21 |
| Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic PruritusNCT02143648results2020-09-07Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating ScaleRandomized · Triple-masked · Treatment | Phase 2/3 | Completed | Drug: nalbuphine HCl ER tablets 60 mg BID, nalbuphine HCl ER tablets 120mg BID, Placebo tablets BID | Uremic Pruritus, Pruritus | 373 | Jul 2015actual | — | 2025-05-21 |
| Phase 1 Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic PruritusNCT02373215Steady state PK of nalbuphine HCl ER tablets as a function of doseNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Nalbuphine HCL ER | Uremic Pruritus | 22 | Nov 2013actual | — | 2025-05-22 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19