Nalbuphine clinical trials
Nalbuphine is named as an intervention in 7 current clinical trials in our USA, China, Egypt, UK and Canada registers. 6 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Trevi Therapeutics (3). The most-studied condition is Idiopathic Pulmonary Fibrosis. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Nalbuphine is approved
All regulators →Of the three regulators tracked here, the first to approve Nalbuphine was the US, on 15 May 1979.
- 1 EU orphan designation, most recently for treatment of uraemic pruritus (27 Feb 2015, negative)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Nalbuphine
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Nalbuphine works
All drug targets →- Opioid receptors; mu/kappa/delta agonist AgonistTarget: Opioid receptors; mu/kappa/delta✓ In ChEMBL and the Guide to Pharmacology
- Prurigo nodularisPhase 2/3
- CoughPhase 2
- CataractPhase 2
- Idiopathic pulmonary fibrosisPhase 2
- Post operative nausea and vomitingPhase 2
- Total hip arthroplastyPhase 2
- PruritusPhase 1
- Cesarean sectionPhase 1
- Liver disorderPhase 1
- Gastrointestinal diseaseEarly phase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL895, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 1663, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Nalbuphine
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Nalbuphine
- ATC code
- N02AF02
- ChEMBL
- CHEMBL895
- DrugBank
- DB00844
- PubChem CID
- 5311304
- CAS number
- 20594-83-6
- FDA UNII
- L2T84IQI2K
- Wikidata
- Q277979
- Wikipedia
- Nalbuphine
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Nalbuphine
7 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Nalbuphine in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Nalbuphine. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
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 (IPF) (OCEAN-1)
2026-525877-38-00 · CTIS ↗ · Respiratory Tract Diseases
|
Phase 3 | Authorised | Trevi Therapeutics Inc | Spain, Poland |
|
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
2026-526087-20-00 · Respiratory Tract Diseases
|
Phase 2 | Authorised | Trevi Therapeutics Inc | Poland |
Conditions studied with Nalbuphine
11 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Trevi Therapeutics | 3 |
| Zhongshan Ophthalmic Center, Sun Yat-sen University | 1 |
| Hairong Chen | 1 |
| Assiut University | 1 |
| National Cancer Institute, Egypt | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in USA | 2 | 2 |
| Clinical trials in China | 2 | 2 |
| Clinical trials in Egypt | 2 | 1 |
| Clinical trials in UK | 1 | 1 |
| Clinical trials in Canada | 1 | 1 |
| EU register (CTIS) | 2 | — |
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Nalbuphine trials
How many clinical trials are testing Nalbuphine?
7 current trials in our USA, China, Egypt, UK and Canada registers name Nalbuphine as a drug or biological intervention, as of the registry sync on 11 November 2026. Completed and withdrawn studies are not counted.
Are Nalbuphine trials recruiting patients?
Yes. 6 of the 7 trials are recruiting: 2 with sites in USA, 2 with sites in China, 1 with sites in Egypt, 1 with sites in UK and 1 with sites in Canada. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Nalbuphine clinical trials?
Trevi Therapeutics (3), Zhongshan Ophthalmic Center, Sun Yat-sen University (1), Hairong Chen (1) and Assiut University (1), among 5 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Nalbuphine works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Nalbuphine works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Nalbuphine (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 11 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.