Leniolisib
Trade name: Joenja
Small moleculeapprovedOrphan Drug FDA
Approved
Mar 24, 2023
Clinical trial activity
9 trials · 10 clinical orgs · 1 marketing orgs
Phase 1
0
Phase 2
7
Phase 3
5
Phase 4
0
Earliest trial started Aug 25, 2015 (NCT02435173)
Timeline
2010s
- Jan 1, 2015
Earliest Phase 2 Sponsor(trial)
- Jan 30, 2018
Orphan Drug Designation
2020s
- Jan 1, 2022
Pharming Group — Earliest Phase 3 Sponsor(trial)
- Mar 24, 2023
Pharming Group — Earliest FDA Approval
- Mar 24, 2023
Pharming Group — Marketing Organization
- Mar 24, 2023
Pharming Group — NDA Secondary Org
- Mar 24, 2023
Pharming Group — NDA Organization
Indications
Mechanism of action
Approval history
- approvedPriority reviewMar 24, 2023
Chemistry & pharmacology
Loading structure…
SMILES
CCC(=O)N1CC[C@H](Nc2ncnc3c2CN(c2cnc(OC)c(C(F)(F)F)c2)CC3)C1- Mol. weight
- 450.47 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
First in class
Sources
- ChEMBLCHEMBL3989909 ↗
- ChEMBLCHEMBL3643413 ↗
Also known as
- cdz173
- cdz173
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06990529 | Phase 2 | Apr 29, 2025 | Aixial Group, Pharming Group |
| NCT06897358 | Phase 2 | Feb 12, 2025 | Pharming Group, Tufts University |
| NCT06549114 | Phase 2 | Oct 21, 2024 | National Institutes of Health (NIH), Pharming Group |
| NCT05693129 | Phase 3 | Aug 30, 2023 | Aixial Group, CMIC Co, Ltd. Japan, Fortrea, LabCorp, Pharming Group |
| NCT06249997 | Phase 3 | Aug 3, 2023 | Axial Biotech, Inc, CMIC Co, Ltd. Japan, LabCorp, Pharming Group, Tokyo Medical University |
| NCT05438407 | Phase 3 | Aug 31, 2022 | Aixial Group, CMIC Co, Ltd. Japan, Fortrea, LabCorp, Pharming Group |
| NCT02859727 | Phase 2/Phase 3 (Phase 3) | Sep 8, 2016 | Novartis |
| NCT02775916 | Phase 2 | Jun 1, 2016 | Novartis |
| NCT02435173 | Phase 2/Phase 3 (Phase 3) | Aug 25, 2015 | Novartis |
Showing 9 of 9 trials
Page 1 / 1
Organizations
Research & Development (10)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Pharming Group | For profit | 6 | 6 | 2 | 2022 |
| Aixial Group | For profit | 3 | 0 | 2 | 2022 |
| CMIC Co, Ltd. Japan | For profit | 3 | 0 | 1 | 2022 |
| LabCorp | For profit | 3 | 0 | 1 | 2022 |
| Novartis | For profit | 3 | 3 | 2 | 2015 |
| Fortrea | For profit | 2 | 0 | 1 | 2022 |
| Axial Biotech, Inc | For profit | 1 | 0 | 1 | 2023 |
| National Institutes of Health (NIH) | Government | 1 | 0 | 1 | 2024 |
| Tokyo Medical University | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Tufts University | Academic/Hospital | 1 | 0 | 1 | 2025 |
10 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Pharming Group | For profit | MKTG | Mar 24, 2023 |
| Pharming Group | For profit | NDA2 | Mar 24, 2023 |
| Pharming Group | For profit | NDA | Mar 24, 2023 |