Posaconazole clinical trials
Posaconazole is named as an intervention in 11 current clinical trials in our USA, UK, China, France, South Korea, Germany, Italy, Australia, Canada, Belgium, Spain, Denmark, Japan, Poland, Mexico, Israel, India, Switzerland and Brazil registers. 7 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is BeOne Medicines (1). The most-studied condition is Acute Myeloid Leukemia. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Posaconazole is approved
All regulators →Of the three regulators tracked here, the first to approve Posaconazole was the EU, on 25 Oct 2005. It is approved in 3 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.
Posaconazole patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Posaconazole, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- Exclusivity I-984: New indication: treatment of invasive aspergillosis in patients 2 years of age and older who weigh 10 kg to 40 kg, until 27 Jan 2029.
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 Posaconazole
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 Posaconazole works
All drug targets →- Cytochrome P450 51 inhibitor InhibitorChEMBL only
- HistoplasmosisPhase 3
- American trypanosomiasisPhase 2
- Tinea unguiumPhase 2
- Triple-negative breast carcinomaPhase 2
- Acute leukemiaPhase 1/2
- Acute myeloid leukemiaPhase 1/2
- LeukemiaPhase 1/2
- Myelodysplastic syndromePhase 1/2
- CancerPhase 1
- GlioblastomaEarly phase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1397, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 11428, 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 Posaconazole
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 9 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Noxafil, Posaconazole AHCL (generic), Posaconazole Accord (generic)EMA product information: package leaflet and summary of product characteristics in every EU language.
- 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.
Trials by status
Trials by phase
Clinical trials of Posaconazole
11 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.
Posaconazole in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Posaconazole. 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 Phase 1/2, Multicenter, First-in-Human, Dose Escalation and Expansion Study Evaluating CHM-029, as Monotherapy and in Combination with Standard Therapies in Participants with Relapsed or Refractory, or Newly Diagnosed Acute Myeloid Leukemia (AML) with NPM1 Mutations, KMT2A or NUP98 Rearrangements
2026-526409-14-00 · Neoplasms
|
Phase 1 | Authorised | Charm Therapeutics Limited | France, Germany, Spain + 2 more |
|
A Phase 1/2, Open-Label, Multicenter, Multi-cohort Study of S241656 as Monotherapy or in Combination with other Antileukemic Agents in participants with Selected Myeloid Malignancies
2025-525128-88-00 · Neoplasms
|
Phase 1 | Authorised | Institut De Recherches Internationales Servier IRIS | Netherlands, Spain, Germany + 3 more |
Posaconazole 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)
9 single-substance products containing Posaconazole on the HPRA medicines list.
- Posaconazole Clonmel 100 mg gastro-resistant tabletsClonmel Healthcare Ltd · PA0126/307/001 · Marketed
- Posaconazole Teva 100 mg gastro-resistant tabletsTeva B.V. · PA1986/091/001 · Marketed
- Posaconazole Viatris 100 mg gastro-resistant tabletsViatris Limited · PA23266/030/001 · Marketed
- Noxafil 100 mg gastro-resistant tabletsMerck Sharp & Dohme BV, · EU/1/05/320/002-003
- Noxafil 300 mg concentrate for solution for infusionMerck Sharp & Dohme BV, · EU/1/05/320/004
Supply shortages
- Posaconazole InjectionUS (FDA) · Resolved · updated 2 Dec 2025
Conditions studied with Posaconazole
21 conditionsAll 21 conditions
| Condition (as registered) | Trials |
|---|---|
| Acute Myeloid Leukemia | 2 |
| Acute Myeloid Leukaemia | 2 |
| Myelodysplastic Syndromes | 1 |
| Myelodysplastic/Myeloproliferative Neoplasm | 1 |
| High Risk Myelodysplastic Syndrome | 1 |
| Acute Lymphoblastic Leukaemia | 1 |
| Higher-risk Myelodysplastic Syndromes | 1 |
| Invasive Fungal Infection | 1 |
| Chronic Pulmonary Aspergillosis | 1 |
| Breast Cancer | 1 |
| Invasive Fungal Disease | 1 |
| Graft Versus Host Disease | 1 |
| Hematopoietic Stem Cell Transplantation | 1 |
| Hematologic Malignancy | 1 |
| Candidiasis | 1 |
| Fungal Infection | 1 |
| Genetic Predisposition | 1 |
| Brain Tumor, Recurrent | 1 |
| Cancer, Advanced | 1 |
| Glioma of Brain | 1 |
| Histoplasmosis | 1 |
Sponsors
lead sponsor per trialBy country register
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 Posaconazole trials
How many clinical trials are testing Posaconazole?
11 current trials in our USA, UK, China, France, South Korea, Germany, Italy, Australia, Canada, Belgium, Spain, Denmark, Japan, Poland, Mexico, Israel, India, Switzerland and Brazil registers name Posaconazole (also registered as MK-5592) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Posaconazole trials recruiting patients?
Yes. 7 of the 11 trials are recruiting: 4 with sites in USA, 3 with sites in UK, 2 with sites in China, 3 with sites in France, 3 with sites in South Korea, 2 with sites in Germany, 2 with sites in Italy, 2 with sites in Australia, 1 with sites in Canada, 2 with sites in Belgium, 1 with sites in Spain, 1 with sites in Denmark, 1 with sites in Japan, 1 with sites in Poland, 1 with sites in Mexico, 1 with sites in Israel and 1 with sites in Switzerland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Posaconazole clinical trials?
BeOne Medicines (1), Amphista Therapeutics Ltd (1), AstraZeneca (1) and Merck Sharp & Dohme LLC (1), among 11 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Posaconazole licensed in Ireland?
Yes. The HPRA medicines list includes 9 single-substance products containing Posaconazole, for example Posaconazole Clonmel 100 mg gastro-resistant tablets (Clonmel Healthcare Ltd). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Posaconazole shortage?
The registers we track list 1 entry for Posaconazole: US FDA: resolved. 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 Posaconazole 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 Posaconazole 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 Posaconazole (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 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.