Leniolisib is named as an intervention in 4 current clinical trials in our USA and UK registers. None are recruiting at the moment. The most common phase is Phase 2. The lead sponsor is Pharming Technologies B.V. The most-studied condition is APDS.
| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Pediatric Patients Aged 4 to 11 Years With APDS
NCT05438407 · ClinicalTrials.gov ↗ · APDS
|
Phase 3 | Active, closed | Pharming Technologies B.V. | USA |
|
Pediatric Patients Aged 1 to 6 Years With APDS
NCT05693129 · ClinicalTrials.gov ↗ · APDS
|
Phase 3 | Active, closed | Pharming Technologies B.V. | UK, USA |
|
Leniolisib for Immune Dysregulation in PIDs
NCT06549114 · ClinicalTrials.gov ↗ · Primary Immunodeficiency Disorders (PIDs)
|
Phase 2 | Active, closed | Pharming Technologies B.V. | USA |
|
Long-term Safety and Efficacy of Leniolisib in PIDs With Immune Dysregulation
NCT06990529 · ClinicalTrials.gov ↗ · PIDs Linked to PI3K
|
Phase 2 | Active, closed | Pharming Technologies B.V. | UK, 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.
The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
1 single-substance product containing Leniolisib on the HPRA medicines list.
No entry for Leniolisib in the EMA, FDA or German BfArM shortage lists we track.
| Lead sponsor | Trials |
|---|---|
| Pharming Technologies B.V. | 4 |
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in USA | 4 | 0 |
| Clinical trials in UK | 2 | 0 |
A trial with sites in more than one country appears in each of those registers.
4 current trials in our USA and UK registers name Leniolisib as a drug or biological intervention, as of the registry sync on 25 September 2026. Completed and withdrawn studies are not counted.
Not at the moment. None of the 4 trials in our registers is recruiting; they are active but closed to enrolment, not yet open, or enrolling by invitation. Only the study team can confirm whether a patient is eligible.
The lead sponsor is Pharming Technologies B.V. The number in brackets is how many trials each organisation leads.
Yes. The HPRA medicines list includes 1 single-substance product containing Leniolisib, for example Joenja 70 mg film-coated tablets (Pharming Technologies B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Not in the lists we track: Leniolisib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Leniolisib 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 Leniolisib 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 Leniolisib (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 25 Sep 2026.