Hexvix is named as an intervention in 2 current clinical trials in our USA and Italy registers. 2 are recruiting patients now. The most common phase is Observational. The sponsor with the most trials is Photocure (1). The most-studied condition is Bladder Cancer. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Of the three regulators tracked here, the first to approve Hexvix was the US, on 28 May 2010. 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.
Protections still running for marketed products containing Hexvix, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
Reproduced from the FDA Orange Book and Purple Book (checked 28 Sep 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.
| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Vesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to Avoid Secondary Resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs)
NCT05962541 · ClinicalTrials.gov ↗ · Non-muscle-invasive Bladder Cancer, Non-Muscle Invasive Bladder Urothelial Carcinoma, High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma
|
Phase 4 | Recruiting | University of Roma La Sapienza | Italy |
|
Blue Light Cystoscopy With Cysview® Registry
NCT02660645 · ClinicalTrials.gov ↗ · Bladder Cancer
|
Observational | Recruiting | Photocure | 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.
Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Hexvix. 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 |
|---|---|---|---|---|
|
Hex-SUB1-IPC 2025-067 - PROOF OF CONCEPT: FEASIBILITY OF PHOTODYNAMIC DIAGNOSIS IN BLADDER CANCER PATIENTS WITH SUB-ONE-HOUR INSTILLATION TIME OF HEXAMINOLEVULINATE (HEXVIX®)
2026-526917-27-00 · Neoplasms
|
Phase 2 | Authorised | Institut Paoli Calmettes | France |
| Lead sponsor | Trials |
|---|---|
| Photocure | 1 |
| University of Roma La Sapienza | 1 |
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in USA | 1 | 1 |
| Clinical trials in Italy | 1 | 1 |
| EU register (CTIS) | 1 | — |
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.
2 current trials in our USA and Italy registers name Hexvix as a drug or biological intervention, as of the registry sync on 1 October 2026. Completed and withdrawn studies are not counted.
Yes. 2 of the 2 trials are recruiting: 1 with sites in USA and 1 with sites in Italy. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Photocure (1) and University of Roma La Sapienza (1). The number in brackets is how many trials each organisation leads.
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Hexvix works or whether it is effective, and it is not medical advice.
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Hexvix works or whether it is effective. Each trial links to its own record so you can check it yourself.
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Hexvix (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 1 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.