Haduvio (nalbuphine ER) / Trevi Therap, Endo - LARVOL DELTA

Quality of life outcomes assessed by the Leicester Cough Questionnaire in the Phase 2a RIVER trial of nalbuphine extended-release in refractory chronic cough (ERS 2026) - P2 | "Compared with PBO, NAL ER significantly improved patient-reported QoL in patients with RCC. Submitted on behalf of the RIVER study investigators."

HEOR • P2a data • Chronic Cough • Cough • Renal Cell Carcinoma • Respiratory Diseases

Nalbuphine extended-release for chronic cough in patients with idiopathic pulmonary fibrosis: assessment of quality of life using the Leicester Cough Questionnaire in the Phase 2b CORAL trial (ERS 2026) - P2 | "NAL ER 54 mg and 108 mg BID significantly improved cough-related QoL."

Clinical • HEOR • P2b data • Chronic Cough • Cough • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

PATIENT-REPORTED OUTCOMES SHOW EARLY AND SUSTAINED IMPROVEMENT FOLLOWING NALBUPHINE EXTENDED-RELEASE IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS EXPERIENCING CHRONIC COUGH (CHEST 2026) - No abstract available

Clinical • Patient reported outcomes • Chronic Cough • Cough • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Cough in Interstitial Lung Disease: Current Knowledge and Research Gaps. (PubMed, Pulm Ther) - "While antifibrotic therapies have shown limited and inconsistent effects on cough, recent randomized clinical trials provide encouraging evidence for low-dose morphine and extended-release nalbuphine in IPF-associated chronic cough. Several novel therapeutic strategies targeting neural and inflammatory pathways are currently under investigation. A better understanding of the mechanisms driving cough in ILD, together with standardized assessment tools and adequately powered clinical trials, will be essential to develop effective, disease-specific treatments for this disabling symptom."

Clinical • Journal • Review • Chronic Cough • Cough • Fibrosis • Gastroenterology • Gastroesophageal Reflux Disease • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Interstitial Lung Disease • Obstructive Sleep Apnea • Pneumonia • Pulmonary Disease • Respiratory Diseases • Rheumatology • Sarcoidosis • Sleep Disorder

Trevi Therapeutics Announces Upcoming Presentations at the European Respiratory Society (ERS) Congress 2026 (GlobeNewswire) - "Professor Marlies Wijsenbeek will give an oral presentation on the quality-of-life outcomes assessed by the LCQ from the Phase 2b CORAL trial of nalbuphine ER for the treatment of patients with IPF-related chronic cough. Dr. Imran Satia will give a poster presentation on the quality-of-life outcomes assessed by the LCQ from the Phase 2a RIVER trial of nalbuphine ER for the treatment of patients with RCC."

P2a data • P2b data • Patient reported outcomes • Chronic Cough • Idiopathic Pulmonary Fibrosis

A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: Trevi Therapeutics | Recruiting ➔ Completed

Trial completion

Trevi Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Updates (The Manila Times) - "The Company initiated the Phase 3 OCEAN-1 trial, the first of two parallel conducted Phase 3 trials in patients with IPF-related chronic cough, in the second quarter of 2026. Topline data from the 52-week fixed dosing OCEAN-1 trial is expected in the first half of 2028. The Company plans to initiate the 12-week fixed dosing OCEAN-2 trial, in the third quarter of 2026, with topline results expected in the second half of 2027."

New P3 trial • P3 data: top line • Trial status • Chronic Cough • Idiopathic Pulmonary Fibrosis

NAL ER IPF Respiratory Function and Safety Study (clinicaltrials.gov) - P1 | N=9 | Completed | Sponsor: Trevi Therapeutics | Recruiting ➔ Completed

Trial completion • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

The role of SLC24A5 (NCKX5) in human skin pigmentation: the importance of cation transport activity. (PubMed, J Mol Biol) - "Reconstitution with the A111 variant of NCKX5 restored eumelanin synthesis more effectively than the T111 variant, whereas the D383N variant failed to rescue pigmentation. Moreover, the addition of the lysosomotropic weak base NH4Cl to the growth medium, which neutralizes the acidic pH of intracellular organelles, markedly increased eumelanin content in depigmented cells lacking NCKX5, suggesting a link between NCKX5-mediated Ca2+ transport activity in the TGN and melanosomal pH regulation. We also discuss the many NCKX5 mutants that have been reported to affect pigmentation in both humans (Oculocutaneous albinism or OCA6) and animals in the context of their potential effects on NCKX5-mediated Ca2+ transport activity."

Journal • Melanoma • Oncology • Solid Tumor

OCEAN-1: Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets (clinicaltrials.gov) - P3 | N=306 | Recruiting | Sponsor: Trevi Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Cough • Cough • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

LAKE: The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC) (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Trevi Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases

LAKE: The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC) (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Trevi Therapeutics

New P2 trial • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases

OCEAN-1: Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets (clinicaltrials.gov) - P3 | N=306 | Not yet recruiting | Sponsor: Trevi Therapeutics

New P3 trial • Chronic Cough • Cough • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Trevi Therapeutics Announces Oral Presentation and Multiple Posters Accepted at the American Thoracic Society (ATS) 2026 International Conference (GlobeNewswire) - "Primary and subgroup analysis from the Phase 2b CORAL trial of nalbuphine ER for the treatment of patients with IPF-related chronic cough accepted for oral presentation, including key subgroup analyses by baseline cough count and background anti-fibrotic use; An exploratory post-hoc analysis of the effects of nalbuphine ER and placebo on cough bouts from the Phase 2b CORAL trial in patients with IPF-related chronic cough and the Phase 2a RIVER trial in patients with refractory chronic cough; Drug–drug interaction data from a Phase 1 study evaluating pharmacokinetics and safety following co-administration of nalbuphine ER with pirfenidone or nintedanib."

P1 data • P2b data • Retrospective data • Chronic Cough • Idiopathic Pulmonary Fibrosis

Modulation of mu-opioid pathway for the treatment of pruritus: a systematic review of 1,146 patients. (PubMed, J Dermatolog Treat) - "RCTs investigated oral or topical naltrexone, intravenous naloxone, nalmefene, and extended-release nalbuphine, with most demonstrating clinically meaningful reductions in pruritus intensity using validated itch scales. Non-randomized studies reported improvement across a wide range of dermatologic and systemic conditions, with adverse events generally mild and well tolerated. Overall, μ-opioid pathway modulators show promising efficacy with acceptable short-term safety across diverse pruritic conditions, although larger high-quality RCTs are required to define optimal dosing and support clinical translation."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Lichen Planus • Prurigo Nodularis • Pruritus • Renal Disease • Urticaria

Efficacy and safety of extended-release dinalbuphine sebacate in a multimodal analgesic regimen following cesarean section: A prospective observational study. (PubMed, Taiwan J Obstet Gynecol) - P | "Dinalbuphine sebacate is safe and effective for post-cesarean pain management when integrated into multimodal analgesic regimens."

Journal • Observational data • Pain

Potent acridone antimalarial against all three life stages of Plasmodium. (PubMed, Nat Commun) - "Attributes of lead candidate T111 include potent in vitro activity against cultured parasites, ex vivo activity against clinical isolates, oral single-dose cure in an asexual blood-stage rodent model, inhibition of sexual blood-stage parasites, activity against relapsing parasites in non-human primate liver cells, prevention of parasite development in mosquitoes, and synergy in combination with tafenoquine against blood- and liver-stage parasites. The safety profile of T111, including toxicology evaluations in rats, absence of hemolytic toxicity, and low genotoxicity and cardiotoxicity potential, demonstrates a favorable therapeutic index. Overall, T111 emerges as a promising candidate for treatment and prevention of malaria, with potential for single-dose cure of bloodstream infections, radical cure of liver infections, and interruption of transmission to mosquitoes."

Journal • Cardiovascular • Infectious Disease • Malaria

NAL ER IPF Respiratory Function and Safety Study (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Trevi Therapeutics | Trial completion date: Apr 2026 ➔ Jun 2026 | Trial primary completion date: Apr 2026 ➔ Jun 2026

Trial completion date • Trial primary completion date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Trevi Therapeutics

New P1 trial

Study of Nalbuphine ER in Participants With Hepatic Impairment (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Trevi Therapeutics | Active, not recruiting ➔ Completed | N=56 ➔ 28

Enrollment change • Trial completion • Hepatology

Trevi Therapeutics Announces Completion of End-of-Phase 2 Meeting with the FDA, Gaining Alignment for Its Development Program for Idiopathic Pulmonary Fibrosis-Related Chronic Cough (GlobeNewswire) - " At the meeting, the Company gained overall alignment on the plan for the remaining development program. The Company plans to conduct two pivotal Phase 3 clinical trials and obtained agreement on the remaining Phase 1 clinical studies that the Company expects to conduct to support the New Drug Application (NDA) submission. The Company plans to conduct the Phase 3 trials in parallel with each other and is on track to initiate the first Phase 3 trial in the second quarter of 2026 and the second Phase 3 trial in the second half of 2026."

FDA event • New P3 trial • Chronic Cough • Idiopathic Pulmonary Fibrosis

The Effect of Nalbuphine Extended-release Tablets on Breathlessness in Patients With Idiopathic Pulmonary Fibrosis Experiencing Chronic Cough From the Phase 2b CORAL Trial (ATS 2026) - No abstract available

Clinical • P2b data • Chronic Cough • Cough • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase 2b Trial (CORAL) of Nalbuphine Extended-release Tablets in Patients With Idiopathic Pulmonary Fibrosis Experiencing Chronic Cough: Primary and Subgroup Analyses (ATS 2026) - No abstract available

Clinical • P2b data • Chronic Cough • Cough • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Nalbuphine Extended Release Reduces Cough Bouts in Patients With Refractory Chronic Cough in the Phase 2a RIVER Trial (ATS 2026) - No abstract available

Clinical • P2a data • Chronic Cough • Cough • Respiratory Diseases

The Effect of Nalbuphine Extended Release on Cough Bouts in Patients With Idiopathic Pulmonary Fibrosis From a Phase 2b Randomized Clinical Trial (CORAL) (ATS 2026) - No abstract available

Clinical • P2b data • Cough • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases