Dravet Syndrome Clinical Landscape Report 2026: Trials, Readouts and White Space
Turn fragmented clinical intelligence into a decision-ready landscape. This report was assembled with PatSnap MCP Servers for Clinical Trials, Drug & Asset, and Company & Deal Intelligence. Explore the PatSnap MCP Marketplace to reproduce the workflow in your own AI research stack.
Data snapshot: 16 July 2026. This report is a strategic research view, not medical advice. Trial status and timing can change; confirm records before making development or investment decisions.
Executive view
Dravet Syndrome remains an active clinical development field. The field is increasingly separating symptomatic benefit from disease modification, while enrichment, digital measures and fluid or imaging biomarkers reshape trial design. The PatSnap evidence set used here contains 75 matched trial records and 81 indexed result records before the decision-focused sample below was selected.
How PatSnap MCP built this report
The workflow used Clinical Trials MCP search to define the landscape, then clinical_trial_fetch to retrieve trial design, phase, status, sponsor, geography, endpoints and timing. It separately called clinical_trial_result_fetch for indexed readouts. Drug & Asset drug_fetch supplied target and global development status, while Company & Deal Intelligence organization_fetch supplied sponsor context. This keeps trial-, asset- and company-level claims distinct and traceable.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Expected readout |
|---|---|---|---|---|---|---|
| NCT07675746 | RC-001 | Early Phase 1; Recruiting | Second Affiliated Hospital of Guangzhou Medical University | China | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (From first dose to 24 weeks after the last dose); Number of Participants With Serious Adverse Events (SAEs) (From signing informed consent to 24 weeks after the last dose) | 2027-12-31 |
| NCT07531745 | ION337 | Phase 1/2; Recruiting | Ionis Pharmaceuticals, Inc. | United States | Parts 1 and 2: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (Part 1: up to 6 months; Part 2: up to 31 months); Number of Participants With Clinically Significant Change From Baseline in Safety Laboratory Values (Part 1: up to 6 months; Part 2: up to 31 months) | 2030-12-01 |
| NCT07527754 | Intervention not normalized | Not Applicable; Not yet recruiting | Assistance Publique des Hôpitaux de Paris SA | France | Area under the ROC curve (AUROC) of S100B measurement, assessing its ability to discriminate epilepsy from other causes of transient loss of consciousness (15 Months) | 2027-07-30 |
| JPRN-jRCT2071260005 | Itraconazole + Rifampin + DSP-0378 | Phase 1; 募集中 | Sumitomo Pharma Co., Ltd. | Japan | Part A ‐ 有害事象 ‐ バイタルサイン ‐ 臨床検査（ホルモン検査を含む） ‐ 12誘導心電図 ‐ 神経学的検査 ‐ 脈拍数及び経皮的動脈血酸素飽和度（SpO2）モニター ‐ C-SSRS ‐ RASS ‐ Bond-Lader Visual Analogue Scale（BL-VAS） ‐ Profile of Mood States 2nd Edition（POMS 2） ‐ 20-item Physician Withdrawal Checklist（PWC-20） Part B DSP-0378の薬物動態パラメータ Part C DSP-0378の薬物動態パラメータ; Part A - Adverse events - Vital signs -Clinical laboratory tests (including hormone tests) - 12-lead electrocardiogram - Neurological examination - Pulse rate and percutaneous arterial oxygen saturation (SpO2) monitoring - C-SSRS - RASS - Bond-Lader Visual Analogue Scale (BL-VAS) - Profile of Mood States 2nd Edition (POMS 2) - 20-item Physician Withdrawal Checklist (PWC-20) Part B Pharmacokinetic parameters of DSP-0378 Part C Pharmacokinetic parameters of DSP-0378 | 2027-01-31 |
The table is designed for competitive decisions: endpoint selection, geographic reach and readout timing appear beside phase and sponsor. Phase alone does not reveal evidence maturity; a small study may answer a near-term biomarker question while a large pivotal program can leave a multi-year readout gap.
What indexed results say
- A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2) (Phase 3): the indexed record reports -; -; Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE) = 293 Participants.
- Zorevunersen demonstrates potential as a disease modifying therapy in patients with Dravet syndrome through durable seizure reduction and ‑ improvements in cognition, behavior, and quality of life through 36 months in open-label extension studies (Phase 1/2): the indexed record reports EQ-VAS = 6.06 %.
- A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of Soticlestat (TAK-935) as Adjunctive Therapy in Subjects With Developmental Epileptic Encephalopathies Including Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome (ENDYMION 1) (Phase 2): the indexed record reports -; -; -.
Cross-trial comparisons require caution. Population, prior therapy, baseline risk, endpoint definition, follow-up and analysis set can all change the apparent signal. The strategic value lies in identifying what each readout resolves—and which uncertainty remains.
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Asset and sponsor context
PatSnap Drug & Asset records add mechanism and global development status for the sampled programs, including RC-001 (Preclinical; Nav1.1), ION337 (Phase 1/2; Nav1.1), Itraconazole (Approved; fungal CYP51A1), Rifampin (Approved; RNAP), DSP-0378 (Phase 1). Company & Deal Intelligence records identify sponsor context for Second Affiliated Hospital of Guangzhou Medical University, Ionis Pharmaceuticals, Inc. (IONS), Assistance Publique des Hôpitaux de Paris SA, Sumitomo Pharma Co., Ltd. (4506). Together, those layers show whether a study sits inside a scaled portfolio, an emerging specialist strategy or an academic development path.
Where the white space is
- Validated biomarkers that bridge biological activity to meaningful function.
- Longer follow-up that distinguishes transient symptom change from altered disease trajectory.
- Decentralized and digital measures that reduce noise without increasing patient burden.
- Trials designed around genetically or biologically defined subgroups.
Strategic implications
For sponsors, differentiation is more credible when the evidence package resolves a known decision gap: an active comparator, a better-defined responder population, a safer or easier delivery model, a clinically meaningful outcome, or a defensible sequencing strategy. Business-development teams can use the same landscape to separate crowded mechanisms from differentiated evidence architectures. Investors should track endpoint maturity and operational feasibility alongside nominal phase.
What to monitor next
Track status changes, protocol amendments, primary-completion dates, newly indexed results, ownership changes and multinational expansion. Re-run the MCP queries on a schedule and compare deltas. Pay particular attention when a program moves from a surrogate endpoint to a clinical outcome or when a specialist sponsor adds a scaled development partner.
Bottom line
Dravet Syndrome has meaningful clinical activity and equally meaningful evidence gaps. A useful landscape connects trial design, results, mechanism and sponsor rather than listing studies in isolation.
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