Lubiprostone clinical trials
Lubiprostone is named as an intervention in 2 current clinical trials in our USA and China registers. 2 are recruiting patients now. The most common phase is Observational. The sponsor with the most trials is BioDelivery Sciences International (1). The most-studied condition is Opioid-induced Constipation.
Where Lubiprostone is approved
All regulators →Of the three regulators tracked here, the first to approve Lubiprostone was the US, on 31 Jan 2006. It is approved in 2 of the 3 regulators tracked here.
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.
Lubiprostone patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Lubiprostone, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 3 listed patents; the last listed expires 25 Oct 2027 (US 8026393).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Lubiprostone
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 Lubiprostone works
All drug targets →- Chloride channel protein 2 opener OpenerTarget: CLCN2 chloride voltage-gated channel 2✓ In ChEMBL and the Guide to Pharmacology
- Bowel dysfunctionPhase 3
- Non-alcoholic fatty liverPhase 3
- Chronic constipationPhase 2/3
- HIV infectious diseasePhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201134, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 4242, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Lubiprostone
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Lubiprostone.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Lubiprostone for treating chronic idiopathic constipation NICE TA318 | Recommended | 23 Jul 2014 | Withdrawn |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Lubiprostone
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 Lubiprostone
- ATC code
- A06AX03
- ChEMBL
- CHEMBL1201134
- DrugBank
- DB01046
- PubChem CID
- 157920
- CAS number
- 333963-40-9
- FDA UNII
- 7662KG2R6K
- Wikidata
- Q6695342
- Wikipedia
- Lubiprostone
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 Lubiprostone
2 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation
NCT07277907 · ClinicalTrials.gov ↗ · Slow Transit Constipation, Pharmacotherapy
|
Phase 3 | Recruiting | Third Military Medical University | China |
|
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
NCT03720613 · Opioid-induced Constipation
|
Observational | Recruiting | BioDelivery Sciences International | USA |
Registers 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.
Conditions studied with Lubiprostone
3 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| BioDelivery Sciences International | 1 |
| Third Military Medical University | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in USA | 1 | 1 |
| Clinical trials in China | 1 | 1 |
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Lubiprostone trials
How many clinical trials are testing Lubiprostone?
2 current trials in our USA and China registers name Lubiprostone as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Lubiprostone trials recruiting patients?
Yes. 2 of the 2 trials are recruiting: 1 with sites in USA and 1 with sites in China. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Lubiprostone clinical trials?
BioDelivery Sciences International (1) and Third Military Medical University (1). 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 Lubiprostone 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 Lubiprostone 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 Lubiprostone (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 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.