Cough Reduction in IPF With Nalbuphine ER

Phase 2 Completed 165 enrolled Trevi Therapeutics

RandomizedParallel-groupDouble-blindTreatment

Summary

The main purpose of the study is to evaluate the effect of NAL ER on 24-hour cough frequency using objective digital cough monitoring and to assess safety and tolerability of NAL ER.

Timeline

Start: 2024-02-06
Primary completion: 2025-04-24
Completion: 2025-04-24

Publications

Molyneaux PL, Mogulkoc N, Gunen H, Doboszynska A, Kreuter M, Neustifter B, Mathur V, Cassella J; CORAL Study Group. Oral Nalbuphine in Idiopathic Pulmonary Fibrosis-Associated Cough: The CORAL Randomized Clinical Trial. JAMA. 2026 Mar 24;335(12):1050-1059. doi: 10.1001/jama.2025.26179.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nalbuphine	Small molecule	27 mg	Oral
Subject	Nalbuphine	Small molecule	54 mg	Oral
Subject	Nalbuphine	Small molecule	108 mg	Oral

Cough Reduction in IPF With Nalbuphine ER

Summary

Timeline

Publications

Drugs

Indications