NAL ER

Phase 3Small molecule

TTrevi Therapeutics

NAL ER is one of 73 small molecule programs targeting Idiopathic Pulmonary Fibrosis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Idiopathic Pulmonary FibrosisNot yet recruiting

Chronic CoughActive, not recruiting

Refractory Chronic CoughNot yet recruiting

Idiopathic Pulmonary FibrosisPhase 3

Not yet recruiting

Chronic CoughPhase 2

Active, not recruiting

Refractory Chronic CoughPhase 2

Not yet recruiting

Competition

Competitive Landscape

179 competitors in Idiopathic Pulmonary Fibrosis

#DrugCompanyPhaseTrials

Thalomid

Bristol-Myers Squibb

Phase 3

2 2

Tracleer

Johnson & Johnson

Phase 3

2 3

Prevacid

Takeda

Phase 3

1 4

Letairis

Gilead

Phase 3

1 5

Gleevec

Novartis

Phase 3

1 6

MS Contin

Jascayd

1 8

Cytoxan

BBaxter Healthcare Corporation

Phase 3

1 9

Coumadin

AAbbott

Phase 3

1 10

Minocin

TTriax

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 2Recruiting

Refractory Chronic Cough

NCT07671924

Q3 2028

Phase 3Recruiting

Idiopathic Pulmonary Fibrosis

NCT07671911

Clinical

Trials by Indication[1]

Idiopathic Pulmonary Fibrosis3 trials

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

Completed·TTrevi Therapeutics·Phase 2·NCT04030026·42 enrolled

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Chronic Cough in Participants With Idiopathic Pulmonary Fibrosis

Recruiting·TTrevi Therapeutics·Phase 3·NCT07671911·306 enrolled

A Randomized, Double-Blind, Placebo-Controlled, Parallel, 4-Arm Dose Ranging Study of the Safety and Efficacy of Nalbuphine Extended-Release Tablets (NAL ER) for the Treatment of Cough in Idiopathic Pulmonary Fibrosis (IPF)

Completed·TTrevi Therapeutics·Phase 2·NCT05964335·165 enrolled

ART1 trial

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

Recruiting·TTrevi Therapeutics·Phase 1·NCT07487740·60 enrolled

Interaction1 trial

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

Completed·TTrevi Therapeutics·Phase 1·NCT07015398·132 enrolled

Chronic Cough1 trial

Refractory Chronic Cough Improvement Via NAL ER (RIVER)

Completed·TTrevi Therapeutics·Phase 2·NCT05962151·66 enrolled

Function1 trial

NAL ER IPF Respiratory Function and Safety Study

Recruiting·TTrevi Therapeutics·Phase 1·NCT07036029·10 enrolled

1 more indication

Refractory Chronic Cough1 trial

A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Participants With Refractory Chronic Cough

Recruiting·TTrevi Therapeutics·Phase 2·NCT07671924·100 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for NAL ER. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — NAL ER compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for NAL ER. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Trevi Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: TTrevi Therapeutics

NAL ER

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q3 2028

Trials by Indication[1]

Idiopathic Pulmonary Fibrosis3 trials

ART1 trial

Interaction1 trial

Chronic Cough1 trial

Function1 trial

Refractory Chronic Cough1 trial

References

Drug Info

Quick Facts

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