TheraRadar
Landscape / Rare Disease
Data updated: Jun 28, 2026

CDKL5 Deficiency Disorder Clinical Trial Landscape

CDKL5 Deficiency Disorder is being studied across 5 clinical trials registered since 2008, with 2 programs currently active. The competitive pipeline includes 2 active Phase 3 trials, 0 active Phase 2 trials, and 0 active Phase 1 trials.

Top industry sponsors include Zogenix, Inc., Immedica Pharma AB.

Trial activity

2 active / 5 total since 2008
Active by phase 2 Ph3 / 3 0 Ph2 / 2 0 Ph1 / 0 0 Ph4 / 0

Sponsor activity

Who is running trials now — green active, blue completed, red failed/terminated.

Sorted by active Active Done Failed
Zogenix, Inc. 1 0 0
Immedica Pharma AB 1 0 0

How the field has grown

New-trial starts peaked in 2018 (2 registered); 2025 saw 0. The right-hand chart shows median Phase 3 enrollment by start year — the number in parentheses is that year's Phase 3 trial count (3 in total), so single-trial years (and years with no Phase 3 starts) are obvious. Both are by trial start date; the current year is partial.

New trials started by year

2016
0
2017
0
2018
2
2019
1
2020
0
2021
0
2022
1
2023
0
2024
0
2025
0
2026
1

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Median Phase 3 enrollment by start year

2016 (0)
0
2017 (0)
0
2018 (1)
101
2019 (0)
0
2020 (0)
0
2021 (0)
0
2022 (1)
87
2023 (0)
0
2024 (0)
0
2025 (0)
0
2026 (1)
20

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Full trial pipeline

Every active and completed trial across Phase 1–4, with enrollment analytics. Sortable, filterable, exportable with Pro.

NCT05064878 ACTIVE NOT RECRUITING
A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder.
Zogenix, Inc. n=87
NCT05249556 NOT YET RECRUITING
Double-blind, Randomized, Placebo-controlled Trial of Ganaxolone in CDKL5 Deficiency Patients 6 Months to Less Than 2 Years Old
Immedica Pharma AB n=20
NCT03572933 COMPLETED
Study of Adjunctive Ganaxolone Treatment in Children and Young Adults With CDKL5 Deficiency Disorder
Marinus Pharmaceuticals n=101

Full CDKL5 Deficiency Disorder Pipeline

Every trial across Phase 1–4, plus enrollment analytics. Sortable, filterable, exportable.

Unlock with Pro

Data: ClinicalTrials.gov · Trials registered 2008 onwards · Industry sponsors only