Leniolisib clinical trials
Leniolisib is named as an intervention in 3 current clinical trials in our USA, UK, Spain, Japan, Portugal and France registers. None are recruiting at the moment. The most common phase is Phase 3. The lead sponsor is Pharming Technologies B.V. The most-studied condition is APDS.
Where Leniolisib is approved
All regulators →Of the three regulators tracked here, the first to approve Leniolisib was the US, on 24 Mar 2023. It is approved in 3 of the 3 regulators tracked here.
- 2 EU orphan designations, most recently for treatment of common variable immunodeficiency (CVID) (22 Aug 2025, positive)
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.
Leniolisib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Leniolisib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 1 listed patent; the last listed expires 19 Feb 2032 (US 8653092).
- Latest patent on the drug substance itself: 19 Feb 2032 (US 8653092).
- Exclusivity ODE-430: Orphan drug exclusivity: treatment of activated phosphoinositide 3-kinase delta (pi3k delta) syndrome (apds) in adult and pediatric patient…, until 24 Mar 2030.
- Exclusivity ODE*: FDA has not recognized orphan-drug exclusivity (ode) for this drug, but it contains the same active moiety or moieties as another drug(s) t…, until 24 Mar 2030.
- Exclusivity NPP: New patient population, until 11 Sep 2029.
- Exclusivity NS: New strength, until 11 Sep 2029.
- Exclusivity NCE: New chemical entity, until 24 Mar 2028.
- Joenja for treatment of activated phosphoinositide 3-kinase delta syndrome: until 22 May 2036. Union Register
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 Leniolisib
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 Leniolisib works
All drug targets →- PI3-kinase p110-delta subunit inhibitor InhibitorTarget: PIK3CD phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit delta✓ In ChEMBL and the Guide to Pharmacology
- Immunodeficiency diseasePhase 2/3
- Sjogren syndromePhase 2
- Autoimmune lymphoproliferative syndromePhase 2
- Common variable immunodeficiencyPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3643413, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 9424, 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 Leniolisib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: JoenjaEMA 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.
Reference identifiers for Leniolisib
- ChEMBL
- CHEMBL3643413
- DrugBank
- DB16217
- PubChem CID
- 57495353
- CAS number
- 1354690-24-6
- FDA UNII
- L22772Z9CP
- Wikidata
- Q27282602
- Wikipedia
- Leniolisib
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 Leniolisib
3 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Pediatric Patients Aged 4 to 11 Years With APDS
NCT05438407 · APDS
|
Phase 3 | Active, closed | Pharming Technologies B.V | USA, France, Japan |
|
Pediatric Patients Aged 1 to 6 Years With APDS
NCT05693129 · APDS
|
Phase 3 | Active, closed | Pharming Technologies B.V | UK, USA, Spain, Portugal, Japan |
|
Long-term Safety and Efficacy of Leniolisib in PIDs With Immune Dysregulation
NCT06990529 · PIDs Linked to PI3K
|
Phase 2 | Active, closed | Pharming Technologies B.V | UK, USA, Spain |
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.
Leniolisib 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)
1 single-substance product containing Leniolisib on the HPRA medicines list.
- Joenja 70 mg film-coated tabletsPharming Technologies B.V. · EU/1/26/2034/001
Supply shortages
No entry for Leniolisib in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
- JoenjaEMA · 21 May 2026 · Pharming Technologies B.V.
- JoenjaFDA · 24 Mar 2023 · New Drug (NDA) · Pharming
Conditions studied with Leniolisib
2 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Pharming Technologies B.V | 3 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in USA | 3 | 0 |
| Clinical trials in UK | 2 | 0 |
| Clinical trials in Spain | 2 | 0 |
| Clinical trials in Japan | 2 | 0 |
| Clinical trials in Portugal | 1 | 0 |
| Clinical trials in France | 1 | 0 |
A trial with sites in more than one country appears in each of those registers.
Questions about Leniolisib trials
How many clinical trials are testing Leniolisib?
3 current trials in our USA, UK, Spain, Japan, Portugal and France registers name Leniolisib as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Leniolisib trials recruiting patients?
Not at the moment. None of the 3 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.
Who sponsors Leniolisib clinical trials?
The lead sponsor is Pharming Technologies B.V. The number in brackets is how many trials each organisation leads.
Is Leniolisib licensed in Ireland?
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.
Is there a Leniolisib shortage?
Not in the lists we track: Leniolisib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
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 Leniolisib 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 Leniolisib 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 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 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.