FDA Events for Trevi Therapeutics (TRVI)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Trevi Therapeutics (TRVI).
Over the past two years, Trevi Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Haduvio. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Haduvio (nalbuphine ER). - FDA Regulatory Timeline and Events
Haduvio (nalbuphine ER). is a drug developed by Trevi Therapeutics for the following indication: IPF Chronic Cough.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Haduvio (nalbuphine ER).
- Announced Date:
- June 2, 2025
- Indication:
- IPF Chronic Cough
Announcement
Trevi Therapeutics, Inc. is pleased to announce today positive topline results from its Phase 2b CORAL trial of Haduvio for the treatment of chronic cough in patients with IPF (N=165).
AI Summary
Trevi Therapeutics, Inc. announced positive topline results from its Phase 2b CORAL trial evaluating Haduvio for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF). In the study of 165 patients, the primary endpoint was met with statistically significant reductions in 24‑hour cough frequency across all dose groups. Patients receiving the highest dose (108 mg twice daily) experienced a 60.2% reduction, translating to a 43.3% placebo-adjusted change from baseline. Improvements were notable as early as Week 2, with rapid and sustained effects throughout the trial. Haduvio was generally well tolerated, with similar discontinuation rates due to adverse events in both Haduvio and placebo groups. Encouraged by these findings, Trevi plans to request an End-of-Phase 2 meeting with the FDA later this year and aims to initiate a Phase 3 program in early 2026.
Read Announcement- Drug:
- Haduvio (nalbuphine ER).
- Announced Date:
- June 1, 2025
- Estimated Event Date Range:
- June 2, 2025 - June 2, 2025
- Target Action Date:
- June 02, 2025
- Indication:
- IPF Chronic Cough
Announcement
Trevi Therapeutics, announced a conference call and live webcast taking place tomorrow, Monday, June 2nd, 2025, at 8:30 a.m. ET, to share topline results from the Phase 2b CORAL trial of Haduvio in patients with IPF chronic cough.
AI Summary
Trevi Therapeutics, Inc. has announced a conference call and live webcast scheduled for Monday, June 2, 2025, at 8:30 a.m. ET. During the event, the company will share topline results from the Phase 2b CORAL trial, which evaluated Haduvio (oral nalbuphine ER) in patients suffering from chronic cough associated with idiopathic pulmonary fibrosis (IPF). This trial focuses on a group that experiences severe, persistent coughing—up to 1,500 times per day—and where no approved treatments currently exist.
The live session will provide access to audio and presentation slides through the company’s website, and interested parties can also join by dialing in via the provided domestic and international phone numbers. A replay of the webcast will be available on Trevi’s website for 30 days after the event, allowing investors and interested viewers to review the data and insights from the trial.
Read Announcement- Drug:
- Haduvio (nalbuphine ER).
- Announced Date:
- May 20, 2025
- Indication:
- IPF Chronic Cough
Announcement
Trevi Therapeutics, announced additional analyses from the Phase 2a RIVER trial of Haduvio for the treatment of patients with RCC (N=66).
AI Summary
Trevi Therapeutics announced additional analyses from its Phase 2a RIVER trial for Haduvio in patients with refractory chronic cough (RCC). The trial, which enrolled 66 participants, showed that patients treated with Haduvio reached statistically significant reductions in 24‑hour cough frequency at thresholds of 30%, 50%, and 75% across all doses. Additionally, patients taking the highest dose (108 mg twice daily) had significant improvement on the patient-reported Leicester Cough Questionnaire after 21 days (p<0.0001). The study also found no significant effects from the crossover design on the primary efficacy endpoint. Adverse events were more common during the initial week at lower doses and tended to lessen over time, with most discontinuations occurring in the first two weeks due to Central Nervous System and gastrointestinal issues. Trevi remains optimistic about Haduvio’s potential and looks forward to further data from upcoming studies.
Read Announcement- Drug:
- Haduvio (nalbuphine ER).
- Announced Date:
- March 18, 2025
- Indication:
- IPF Chronic Cough
Announcement
Trevi Therapeutics, provided business updates.
AI Summary
Trevi Therapeutics provided key business updates focused on the development of Haduvio for chronic cough conditions. The company announced positive topline data from the Phase 2a RIVER trial in patients with refractory chronic cough, showing a statistically significant reduction in 24-hour cough frequency. Additionally, the Phase 2b CORAL trial for idiopathic pulmonary fibrosis (IPF) patients completed enrollment in February 2025, with promising sample size re-estimation results that confirmed the original enrollment target. Topline data for this trial is expected in the second quarter of 2025. The updates underscore the potential of Haduvio as a best-in-class therapy for unmet chronic cough needs. Trevi also reported ending 2024 with $107.6 million in cash, cash equivalents, and marketable securities, providing sufficient funds through the second half of 2026. The company will discuss these developments further during its conference call and webcast.
Read Announcement- Drug:
- Haduvio (nalbuphine ER).
- Announced Date:
- March 10, 2025
- Indication:
- IPF Chronic Cough
Announcement
Trevi Therapeutics, Inc. announced positive topline results from its Phase 2a RIVER trial of Haduvio for the treatment of patients with RCC (N=66).
AI Summary
Trevi Therapeutics, Inc. announced positive topline results from its Phase 2a RIVER trial evaluating Haduvio (oral nalbuphine ER) for treating refractory chronic cough (RCC) in 66 patients. The study met its primary endpoint by demonstrating a statistically significant 67% reduction in the 24-hour cough frequency from baseline and a 57% placebo-adjusted reduction (p<0.0001). These results were consistent across patients with both moderate and severe cough counts, and additional patient-reported outcomes also showed significant improvement. The positive findings offer a promising outlook for addressing RCC, a condition with no approved therapies in the United States. Trevi Therapeutics plans to discuss the next steps with the FDA and looks forward to initiating further studies based on these robust Phase 2a trial outcomes.
Read Announcement- Drug:
- Haduvio (nalbuphine ER).
- Announced Date:
- March 9, 2025
- Indication:
- IPF Chronic Cough
Announcement
Trevi Therapeutics, announced a conference call and live webcast taking place tomorrow, Monday, March 10th, 2025, at 8:30 a.m. ET, to share topline results from the Phase 2a RIVER trial of Haduvio in patients with refractory chronic cough.
AI Summary
Trevi Therapeutics, a clinical-stage biopharmaceutical company, announced it will host a conference call and live webcast tomorrow, Monday, March 10, 2025, at 8:30 a.m. ET. During the call, the company plans to share topline results from its Phase 2a RIVER trial, which investigated Haduvio™ (oral nalbuphine ER) in patients suffering from refractory chronic cough. The webcast will feature audio and presentation slides and is designed to provide insight into the performance of this investigational therapy, which aims to help patients with a challenging condition that lacks approved treatment options. Participants can join the discussion via phone using the provided domestic or international numbers, and an archived replay of the webcast will be available on the company’s website for 30 days after the event.
Read Announcement- Drug:
- Haduvio (nalbuphine ER).
- Announced Date:
- February 25, 2025
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- IPF Chronic Cough
Announcement
Trevi Therapeutics, announced that Topline results continue to be expected in the first half of 2025.
AI Summary
Trevi Therapeutics, a clinical-stage biopharmaceutical company, announced an important milestone in its development of Haduvio™, an investigational treatment for chronic cough in patients with idiopathic pulmonary fibrosis (IPF). The company has completed enrollment in its Phase 2b CORAL trial, which tests three different doses of Haduvio against a placebo to find the most effective regimen for reducing chronic cough. Trevi Therapeutics expects to report the topline results of this trial in the first half of 2025. These upcoming results are critical as they will help guide the design and dosing strategy for the planned Phase 3 program, potentially offering a new therapeutic option for IPF patients. The trial’s outcome could address a significant unmet need, improving the quality of life for patients who endure persistent and disruptive coughing symptoms.
Read Announcement- Drug:
- Haduvio (nalbuphine ER).
- Announced Date:
- February 25, 2025
- Indication:
- IPF Chronic Cough
Announcement
Trevi Therapeutics, announced that it has completed enrollment in its Phase 2b CORAL trial of Haduvio for the treatment of chronic cough in patients with IPF.
AI Summary
Trevi Therapeutics announced that it has completed enrollment in its Phase 2b CORAL trial, marking a major milestone in the development of Haduvio for treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF). The study is a double-blind, randomized, placebo-controlled trial that enrolled around 160 IPF patients. It tests three different doses of Haduvio (27mg, 54mg, and 108mg taken twice daily) over a six-week period, including a two-week titration phase followed by four weeks of fixed dosing.
The company aims to determine the optimal dose for a future Phase 3 program. Topline results are expected in the first half of 2025. This trial is important because current treatments for chronic cough in IPF patients are limited and often ineffective, leaving a significant unmet medical need.
Read Announcement- Drug:
- Haduvio (nalbuphine ER).
- Announced Date:
- December 12, 2024
- Indication:
- IPF Chronic Cough
Announcement
Trevi Therapeutics, Inc announced the positive outcome from the planned sample size re-estimation (SSRE) for the ongoing Phase 2b CORAL trial in IPF patients with chronic cough, which requires no change to the current sample size for the trial (N=160).
AI Summary
Trevi Therapeutics, Inc. announced a positive outcome from its planned sample size re-estimation (SSRE) for the ongoing Phase 2b CORAL trial. The trial, which focuses on treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF), has maintained its current sample size at 160 participants. The SSRE, conducted on the highest dose (108mg twice daily) after 50% of the intended enrollment completed six weeks of treatment, confirmed that no adjustments to the sample size are needed. This outcome supports a pre-specified conditional power of 80% or greater, reflecting stable and robust trial design assumptions.
With approximately 75% of the enrollment target reached, the full trial results are expected in the first half of 2025. This milestone reassures researchers and investors of the underlying efficacy observed in previous studies and the trial's potential to address an unmet need in treating IPF-related chronic cough.
Read Announcement- Drug:
- Haduvio (nalbuphine ER).
- Announced Date:
- December 12, 2024
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- IPF Chronic Cough
Announcement
Trevi Therapeutics, Inc. announced that topline results continue to be expected in the first half of 2025
AI Summary
Trevi Therapeutics, Inc. announced that their Phase 2b CORAL trial for Haduvio™ (oral nalbuphine ER) in IPF patients with chronic cough is making strong progress. A recent sample size re-estimation confirmed that the initial target of 160 patients remains adequate, with 75% of enrollment now complete. This result supports the trial design and key powering assumptions, ensuring the study continues as planned.
The company reiterated its confidence in Haduvio’s potential as a best-in-class treatment. Importantly, Trevi Therapeutics stated that topline results from the full trial are expected in the first half of 2025. This upcoming milestone is seen as a crucial step toward advancing their investigational therapy for patients suffering from chronic cough associated with idiopathic pulmonary fibrosis.
Read Announcement- Drug:
- Haduvio (nalbuphine ER).
- Announced Date:
- December 3, 2024
- Indication:
- IPF Chronic Cough
Announcement
Trevi Therapeutics, Inc. announced positive results from the human abuse potential (HAP) study of oral nalbuphine.
AI Summary
Trevi Therapeutics, Inc. recently announced positive results from its human abuse potential study of oral nalbuphine. The study, designed as a randomized, double-blind, double-dummy, placebo-controlled, five-way crossover trial in recreational drug users, found that the clinical doses of 81mg and 162mg of oral nalbuphine produced a statistically significant lower “Drug Liking” compared to 6mg intravenous butorphanol. This outcome was measured using a 100-point visual analog scale where drug liking scores were noticeably lower for the oral nalbuphine doses, indicating a reduced potential for abuse.
The study also assessed secondary endpoints, which supported the primary findings. There were no serious adverse events reported, reinforcing the promising safety profile of oral nalbuphine for further development. These findings are important as they suggest that oral nalbuphine may address a significant health need while posing fewer public safety risks compared to other opioids.
Read Announcement- Drug:
- Haduvio (nalbuphine ER).
- Announced Date:
- September 26, 2024
- Indication:
- IPF Chronic Cough
Announcement
Trevi Therapeutics, Inc. announced that data from the Phase 2a CANAL trial will be presented at CHEST 2024 held in Boston, Massachusetts from October 6-9.
AI Summary
Trevi Therapeutics, Inc. announced that data from its Phase 2a CANAL trial will be presented at CHEST 2024 in Boston, Massachusetts, from October 6-9. The trial, which focused on patients with idiopathic pulmonary fibrosis (IPF), showed promising results with the investigational therapy Haduvio™, an oral nalbuphine ER formulation intended to relieve chronic cough. At the meeting, Professor Alyn Morice, Head of Respiratory Medicine at HYMS and leader of the Hull Cough Clinic, will share key findings from the study. These include a significant increase in cough-free periods and decreased overall cough time and intensity among the 38 IPF patients who participated in the trial. This presentation highlights the potential of Haduvio to provide relief for patients suffering from chronic cough in IPF, a condition with limited current treatment options.
Read Announcement- Drug:
- Haduvio (nalbuphine ER).
- Announced Date:
- September 4, 2024
- Indication:
- IPF Chronic Cough
Announcement
Trevi Therapeutics, Inc announced that data from the Phase 2a CANAL trial will be presented at the European Respiratory Society (ERS) Congress 2024 being held in Vienna, Austria from September 7-11. The presentation will take place on September 8th.
AI Summary
Trevi Therapeutics, Inc. announced that data from its Phase 2a CANAL trial will be presented at the European Respiratory Society (ERS) Congress 2024 in Vienna, Austria, from September 7-11. The presentation, set for September 8, will highlight the correlation between changes in objective cough counts and improvements in patient-reported outcomes in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough. Professor Jacky Smith from the University of Manchester will deliver the findings, emphasizing the potential impact of the investigational therapy Haduvio™ (oral nalbuphine ER) on chronic cough treatment. The study addresses a major unmet need in managing chronic cough in IPF patients, where cough significantly affects daily life and overall health. This presentation is a key event that could inform future treatment strategies and improve quality of life for patients suffering from severe chronic cough.
Read Announcement
Trevi Therapeutics FDA Events - Frequently Asked Questions
As of now, Trevi Therapeutics (TRVI) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Trevi Therapeutics (TRVI) has reported FDA regulatory activity for Haduvio (nalbuphine ER)..
The most recent FDA-related event for Trevi Therapeutics occurred on June 2, 2025, involving Haduvio (nalbuphine ER).. The update was categorized as "Top-line results," with the company reporting: "Trevi Therapeutics, Inc. is pleased to announce today positive topline results from its Phase 2b CORAL trial of Haduvio for the treatment of chronic cough in patients with IPF (N=165)."
Currently, Trevi Therapeutics has one therapy (Haduvio (nalbuphine ER).) targeting the following condition: IPF Chronic Cough.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:TRVI) was last updated on 7/13/2025 by MarketBeat.com Staff
