6 completed, 1 not yet recruiting, 1 terminated. 4 Phase 3, 3 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 4 | Completed 3, Not yet recruiting 1 |
| Phase 1 | 3 | Completed 2, Terminated 1 |
| Phase 2 | 2 | Completed 1, Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Double-blind, Randomized, Placebo-controlled Trial of Ganaxolone in CDKL5 Deficiency Patients 6 Months to Less Than 2 Years Old Ganaxolone, Placebo - CDKL5 Deficiency Disorder | Phase 3 | Not yet recruiting | Immedica Pharma AB | 20 | 2027-03-01 | 2026-08-05 |
| Pegzilarginase in Subjects <24 Months Old With Arginase 1 Deficiency Pegzilarginase - Arginase 1 Deficiency | Phase 3 | Completed | Immedica Pharma AB | 3 | 2024-08-30 | 2026-05-22 |
| Long-term Safety Study of Chronocort in the Treatment of Participants With Congenital Adrenal Hyperplasia Chronocort - Congenital Adrenal Hyperplasia | Phase 3 | Completed | Immedica Pharma AB | 76 | 2022-04-01 | 2026-06-18 |
| Efficacy and Safety of Pegzilarginase in Patients With Arginase 1 Deficiency Pegzilarginase, Placebo - Arginase I Deficiency, Hyperargininemia | Phase 3 | Completed | Immedica Pharma AB | 32 | 2019-05-01 | 2026-08-21 |
| Pegzilarginase and Pembrolizumab for Extensive Disease Small Cell Lung Cancer Pegzilarginase, Pembrolizumab - Small-cell Lung Cancer | Phase 1 / Phase 2 | Terminated | Immedica Pharma AB | 42 | 2017-12-21 | 2026-10-28 |
| A Study of AEB1102 (Pegzilarginase) in Patients With Arginase 1 Deficiency AEB1102 - Arginase I Deficiency, Hyperargininemia | Phase 2 | Completed | Immedica Pharma AB | 14 | 2017-12-07 | 2026-09-24 |
| A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS Co-ArgI-PEG modified human arginase I - Acute Myeloid Leukemia, Myelodysplastic Syndrome | Phase 1 | Completed | Immedica Pharma AB | 21 | 2016-08-15 | 2026-08-13 |
| A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With Advanced Solid Tumors Co-ArgI-PEG - Advanced Cancers | Phase 1 | Completed | Immedica Pharma AB | 76 | 2015-10-22 | 2026-08-06 |
Hyperargininemia (3) · Adrenal Hyperplasia, Congenital (1) · CDKL5 deficiency disorder (1) · Leukemia, Myeloid, Acute (1) · Myelodysplastic Syndromes (1) · Small Cell Lung Carcinoma (1)
Bulk Drugs (1) · ganaxolone (1) · pembrolizumab (1)
United States (6) · Canada (3) · United Kingdom (3) · Austria (2) · France (2) · Portugal (2) · Germany (1) · Italy (1) · Japan (1) · Puerto Rico (1)
Mattias Rudebeck, PhD MSc BMedSc (6) · D Merke (1)