Valganciclovir clinical trials
Valganciclovir is named as an intervention in 6 current clinical trials in our Taiwan, China, France, Sweden, Norway, Canada and Mexico registers. 4 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is First Affiliated Hospital Xi'an Jiaotong University (1). The most-studied condition is Kidney Transplant.
Where Valganciclovir is approved
All regulators →Of the three regulators tracked here, the first to approve Valganciclovir was the US, on 29 Mar 2001. It is approved in 2 of the 3 regulators tracked here.
- 2 EU orphan designations, most recently for treatment of diffuse large B-cell lymphoma (13 Jan 2023, withdrawn)
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.
Valganciclovir patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Valganciclovir, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 2 listed patents; the last listed expires 11 Dec 2027 (US 9642911).
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 Valganciclovir
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 Valganciclovir works
All drug targets →- Human herpesvirus 1 DNA polymerase inhibitor InhibitorChEMBL only
- Intellectual disabilityPhase 3
- Cytomegalovirus infectionPhase 3
- Cytomegalovirus retinitisPhase 3
- Hearing loss disorderPhase 3
- Sensorineural hearing loss disorderPhase 3
- Ulcerative colitisPhase 3
- Anterior uveitisPhase 2/3
- TuberculosisPhase 2/3
- Hodgkins lymphomaPhase 2
- Immunoblastic LymphadenopathyPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201314, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 4716, 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 Valganciclovir
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- 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 Valganciclovir
- ATC code
- J05AB14
- ChEMBL
- CHEMBL1201314
- DrugBank
- DB01610
- PubChem CID
- 135413535
- CAS number
- 175865-60-8
- FDA UNII
- GCU97FKN3R
- Wikidata
- Q423384
- Wikipedia
- Valganciclovir
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 Valganciclovir
6 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.
Valganciclovir across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
3 single-substance products containing Valganciclovir on the HPRA medicines list.
- Valcyte 450 mg film-coated tabletsCHEPLAPHARM Arzneimittel GmbH · PA2239/023/001 · Marketed
- Valcyte 50 mg/ml powder for oral solutionCHEPLAPHARM Arzneimittel GmbH · PA2239/023/002 · Marketed
- Valganciclovir Accord 450 mg film-coated tabletsAccord Healthcare Ireland Ltd. · PA2315/179/001 · Marketed
Supply shortages
- Valgapan 50 mg/ml Pulver zur Herstellung einer Lösung zum EinnehmenGermany (BfArM) · Other reason · 17 Sep 2026 to 1 Dec 2026
Recent approvals
- Valganciclovir HydrochlorideFDA · 26 Oct 2026 · Generic (ANDA) · Alembic
- Valganciclovir HydrochlorideFDA · 18 Jul 2016 · Generic (ANDA) · Actavis Labs Fl Inc
Conditions studied with Valganciclovir
12 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| First Affiliated Hospital Xi'an Jiaotong University | 1 |
| Assistance Publique - Hôpitaux de Paris | 1 |
| Cecilia Soderberg-Naucler | 1 |
| Duke University | 1 |
| National Taiwan University Hospital | 1 |
| University of California, San Francisco | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in Taiwan | 2 | 1 |
| Clinical trials in China | 1 | 1 |
| Clinical trials in France | 1 | 1 |
| Clinical trials in Sweden | 1 | 0 |
| Clinical trials in Norway | 1 | 0 |
| Clinical trials in Canada | 1 | 1 |
| Clinical trials in Mexico | 1 | 1 |
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Valganciclovir trials
How many clinical trials are testing Valganciclovir?
6 current trials in our Taiwan, China, France, Sweden, Norway, Canada and Mexico registers name Valganciclovir (also registered as J05AB14) as a drug or biological intervention, as of the registry sync on 13 November 2026. Completed and withdrawn studies are not counted.
Are Valganciclovir trials recruiting patients?
Yes. 4 of the 6 trials are recruiting: 1 with sites in Taiwan, 1 with sites in China, 1 with sites in France, 1 with sites in Canada and 1 with sites in Mexico. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Valganciclovir clinical trials?
First Affiliated Hospital Xi'an Jiaotong University (1), Assistance Publique - Hôpitaux de Paris (1), Cecilia Soderberg-Naucler (1) and Duke University (1), among 6 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Valganciclovir licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Valganciclovir, for example Valcyte 450 mg film-coated tablets (CHEPLAPHARM Arzneimittel GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Valganciclovir shortage?
The registers we track list 1 entry for Valganciclovir: 1 German notice. Shortages are product- and country-specific; check with a pharmacist.
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 Valganciclovir 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 Valganciclovir 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 Valganciclovir (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 13 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.