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Trevi Therapeutics, Inc. (TRVI)

Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the advancement and commercialization of Haduvio, a potential treatment for debilitating neurologically mediated conditions. This orally administered, extended-release formulation of nalbuphine is currently undergoing Phase IIb/III clinical trials for chronic pruritus (severe itching) and persistent cough experienced by patients with idiopathic pulmonary fibrosis. Trevi Therapeutics also possesses a licensing agreement with Endo Pharmaceuticals Inc., granting it the rights to develop and market products containing nalbuphine hydrochloride in various formulations. Established in 2011, the company maintains its corporate headquarters in New Haven, Connecticut.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Trevi Therapeutics, Inc. logo

Trevi Therapeutics, Inc.

NASDAQ:TRVIHealthcare
-1.81%$13.56
AH$13.56+0.00%vs close
Mkt Cap$1.93B
Float111.4M
O/S142.48M
Vol
$ Vol
RVOL
Inst Own-
SI14.4%
Earnings
Dilution
Trevi Therapeutics, Inc. logoNASDAQ:TRVI$13.56-1.81%
Phase Distribution
17 lead-sponsored trials·3 active·14 completed
Phase 16
Phase 24
Phase 2/35
Phase 32
Status Overview
Recruiting3
Completed14

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Status
Phase
  • Phase 3
    Recruiting

    Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets

    NAL ER, Placebo

    Idiopathic Pulmonary Fibrosis

    Enrollment
    306
    Start
    Jun 2026
    Primary Completion
    Jun 2028est.
    Completion
    Jul 2028est.
    NCT07671911
  • Phase 3
    Recruiting

    Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine (NAL) Extended-Release (ER) Tablets

    NAL ER, Placebo

    Idiopathic Pulmonary Fibrosis

    Enrollment
    201
    Start
    Sep 2026
    Primary Completion
    Aug 2027est.
    Completion
    Oct 2027est.
    NCT07868419
  • Phase 2/3
    Completed

    Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

    nalbuphine HCl ER tablets 60 mg BID, nalbuphine HCl ER tablets 120mg BID

    Uremic Pruritus, Pruritus

    Enrollment
    373
    Start
    Jun 2014
    Primary Completion
    Jul 2015
    Completion
    Jul 2015
    NCT02143648
  • Phase 2/3
    Completed

    Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus

    nalbuphine HCl ER

    Uremic Pruritus, Pruritus

    Enrollment
    167
    Start
    Sep 2014
    Primary Completion
    Jan 2016
    Completion
    Jan 2016
    NCT02143973
  • Phase 2/3
    Completed

    Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

    nalbuphine HCl ER tablets 90 mg BID, nalbuphine HCl ER tablets 180 mg BID

    Prurigo Nodularis, Nodularis Prurigo +2

    Enrollment
    62
    Start
    Mar 2015
    Primary Completion
    Aug 2016
    Completion
    Aug 2016
    NCT02174419
  • Phase 2/3
    Completed

    Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis

    nalbuphine HCl ER

    Prurigo Nodularis, Nodularis Prurigo +1

    Enrollment
    36
    Start
    Aug 2015
    Primary Completion
    Sep 2017
    Completion
    Sep 2017
    NCT02174432
  • Phase 2/3
    Completed

    PRISM Study-Pruritus Relief Through Itch Scratch Modulation

    Nalbuphine ER Tablets, Placebo Tablets

    Prurigo Nodularis

    Enrollment
    353
    Start
    Aug 2018
    Primary Completion
    May 2022
    Completion
    Feb 2023
    NCT03497975
  • Phase 2
    Completed

    A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough

    NAL ER, Placebo

    Idiopathic Pulmonary Fibrosis

    Enrollment
    42
    Start
    Oct 2019
    Primary Completion
    May 2022
    Completion
    May 2022
    NCT04030026
  • Phase 2
    Completed

    Refractory Chronic Cough Improvement Via NAL ER (RIVER)

    NAL ER, Placebo

    Refractory Chronic Cough

    Enrollment
    66
    Start
    Nov 2023
    Primary Completion
    Jan 2025
    Completion
    Jan 2025
    NCT05962151
  • Phase 2
    Completed

    Cough Reduction in IPF With Nalbuphine ER

    NAL ER, Placebo

    Idiopathic Pulmonary Fibrosis

    Enrollment
    165
    Start
    Feb 2024
    Primary Completion
    Apr 2025
    Completion
    Apr 2025
    NCT05964335
  • Phase 2
    Recruiting

    The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)

    NAL ER, Placebo

    Refractory Chronic Cough

    Enrollment
    100
    Start
    Jun 2026
    Primary Completion
    Sep 2027est.
    Completion
    Sep 2027est.
    NCT07671924
  • Phase 1
    Completed

    Phase 1 Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

    Nalbuphine HCL ER

    Uremic Pruritus

    Enrollment
    22
    Start
    Apr 2013
    Primary Completion
    Nov 2013
    Completion
    Nov 2013
    NCT02373215
  • Phase 1
    Completed

    Oral Abuse Potential Study of Nalbuphine

    Nalbuphine HCl solution, Placebo solution

    Nalbuphine, Opioid Abuse

    Enrollment
    56
    Start
    May 2018
    Primary Completion
    Dec 2018
    Completion
    Jun 2020
    NCT04018664
  • Phase 1
    Completed

    Study of Nalbuphine ER in Participants With Hepatic Impairment

    Nalbuphine ER

    Hepatic Impairment

    Enrollment
    28
    Start
    Jun 2019
    Primary Completion
    Feb 2020
    Completion
    Feb 2020
    NCT04020016
  • Phase 1
    Completed

    A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants

    NAL ER, Pirfenidone

    Healthy Participants

    Enrollment
    132
    Start
    Jun 2025
    Primary Completion
    Sep 2025
    Completion
    Sep 2025
    NCT07015398
  • Phase 1
    Completed

    NAL ER IPF Respiratory Function and Safety Study

    NAL ER, Placebo

    Idiopathic Pulmonary Fibrosis

    Enrollment
    9
    Start
    Aug 2025
    Primary Completion
    Jun 2026
    Completion
    Jun 2026
    NCT07036029
  • Phase 1
    Completed

    A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants

    NAL ER

    Healthy Participants

    Enrollment
    60
    Start
    Feb 2026
    Primary Completion
    May 2026
    Completion
    May 2026
    NCT07487740
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