Leniolisib clinical trials
Also written CDZ173 and Joenja.
How each study uses leniolisib is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
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Approvals
The first approval found in each region, with its record
- United States
- 24 Mar 2023 · JOENJA · NDA 217759 (FDA, Drugs@FDA)
- European Union
- 21 May 2026 · Joenja · EMEA/H/C/005927 (EMA)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
9 studies that test it; most in 2023 (3)
| Year | Studies |
|---|---|
| 2015 | 1 |
| 2016 | 2 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 2 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 9 · Other 0
Pharming Technologies B.V. (7) · Novartis Pharmaceuticals (2)
Related medicines
As reviewed, each with the page that says it.
- One of Protein Kinase Inhibitors source
Coming up
From the study records. Dates are the sponsors’ own estimates and often move.
Reaching primary completion within a year · 1, 1 in phase 3
Studies that test leniolisib, phase 3 first.
- Nov 2026Pediatric Patients Aged 4 to 11 Years With APDSPhase 3 · Pharming Technologies B.V.
Studies
Open first, then newest update. How each study uses leniolisib is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 9
- An Open-Label Study to Assess the Safety & Efficacy of Leniolisib in Japanese Patients With APDSRecruitingPhase 3Pharming Technologies B.V.NCT06249997Written as Leniolisib
- Leniolisib for Immune Dysregulation in PIDsCompletedPhase 2Pharming Technologies B.V.NCT06549114Written as Leniolisib
- Leniolisib for Immune Dysregulation in CVIDCompletedPhase 2Pharming Technologies B.V.NCT06897358Written as Leniolisib
- Long-term Safety and Efficacy of Leniolisib in PIDs With Immune DysregulationActive, not recruitingPhase 2Pharming Technologies B.V.NCT06990529Written as Leniolisib
- Pediatric Patients Aged 1 to 6 Years With APDSActive, not recruitingPhase 3Pharming Technologies B.V.NCT05693129Written as Leniolisib
- Pediatric Patients Aged 4 to 11 Years With APDSActive, not recruitingPhase 3Pharming Technologies B.V.NCT05438407Written as Leniolisib
- Extension to the Study of Efficacy of CDZ173 in Patients With APDS/PASLITerminatedPhase 2/3Pharming Technologies B.V.NCT02859727Written as CDZ173
- Study of Efficacy of CDZ173 in Patients With APDS/PASLICompletedPhase 2/3Novartis PharmaceuticalsNCT02435173Written as CDZ173
- Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's SyndromeCompletedPhase 2Novartis PharmaceuticalsNCT02775916Written as CDZ173
Codes
What other systems call leniolisib · ClinicalTrials.gg INT000852
- MeSH (NLM) C000625376leniolisibConfirmed ClinicalTrials.gov, NLM
- UNII (FDA) L22772Z9CPLENIOLISIBConfirmed FDA, Wikidata
- Wikidata Q27282602leniolisibConfirmed FDA, Wikidata
- NCI Thesaurus C170103LeniolisibOne source FDA
- DrugBank DB16217One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000625376 | leniolisib | Confirmed ClinicalTrials.gov, NLM |
| UNII (FDA) | L22772Z9CP | LENIOLISIB | Confirmed FDA, Wikidata |
| Wikidata | Q27282602 | leniolisib | Confirmed FDA, Wikidata |
| NCI Thesaurus | C170103 | Leniolisib | One source FDA |
| DrugBank | DB16217 | — | One source Wikidata |
Also registered as leniolisib phosphate (UNII 3700M1H39Q).
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.