Developmental and Epileptic Encephalopathies Drugs Market 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Medication, Statistics, Revenue, Therapies and Companies by DelveInsight

Developmental and Epileptic Encephalopathies Drugs Market

(Albany, USA) DelveInsight’s Developmental and Epileptic Encephalopathy Market Insights report includes a comprehensive understanding of current treatment practices, developmental and epileptic encephalopathy emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan].

The Developmental and Epileptic Encephalopathies market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Developmental and Epileptic Encephalopathies market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Developmental and Epileptic Encephalopathies treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Developmental and Epileptic Encephalopathies market.

Key Takeaways from the Developmental and Epileptic Encephalopathy Market Report

• As per DelveInsight analysis, the developmental and epileptic encephalopathy market size in the 7MM was approximately USD 2100 million in 2023.
• According to the assessment done by DelveInsight, the estimated total DEE diagnosed prevalent cases in the 7MM were approximately 235K in 2021.
• In May 2025, Capsida Biotherapeutics (“Capsida”) today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for CAP-002, its wholly owned first-in-class, intravenously (IV) administered gene therapy to enter clinical trials for syntaxin-binding protein 1 developmental and epileptic encephalopathy (STXBP1-DEE). This is the first program entering a human clinical trial utilizing an IV-administered, blood brain barrier-crossing engineered capsid that also is detargeted from off-target tissues, like liver and dorsal root ganglia (DRG). CAP-002 is enabled by one of Capsida’s proprietary engineered capsids and optimized cargo. In addition, Capsida uses a proprietary manufacturing process and CAP-002 is manufactured in Capsida’s state-of-the-art wholly owned Good Manufacturing Practice (GMP) facility.
• In February 2025, NICE approved FINTEPLA (fenfluramine) for people with Lennox- Gastaut Syndrome (LGS). It is the first licensed non-cannabis medication for this type of epilepsy. Prior to its approval in 2019, the only treatment for LGS that NICE recommended was EPIDYOLEX (cannabidiol) combined with clobazam. This is the second indication for which the NHS will provide FINTEPLA. Since 2022, the NHS has commissioned FINTEPLA to treat people with Dravet syndrome.
• In February 2025, Immedica Pharma AB announced the successful completion of the previously announced transaction to acquire all of the outstanding shares of Marinus Pharmaceuticals. Through this transaction, Immedica acquires Marinus’ FDA-approved seizure medication ZTALMY.
• Zorevunersen, a first-in-class disease-modifying medication, will be made available to Dravet patients in all countries outside of the US, Canada, and Mexico thanks to a partnership between Stoke Therapeutics and Biogen in February 2025. Following successful alignment with regulatory agencies in the United States, Europe, and Japan, Stoke Therapeutics recently announced plans to initiate a global Phase III registrational trial of zorevunersen (EMPEROR). Commencement of the study is scheduled for the second quarter of 2025, and a pivotal data readout is planned in the second half of 2027 to support global regulatory filings.
• In January 2025, Takeda made the announcement to end the soticlestat development program. This decision comes after it was revealed in June 2024 that the soticlestat Phase III SKYLINE study in Dravet syndrome and SKYWAY study in LGS failed to meet their primary endpoints. Takeda therefore, stopped working on the soticlestat LGS development program and consulted with the US FDA over the overall data supporting soticlestat treatment for Dravet syndrome. The FDA notified Takeda that, to support a New Drug Application (NDA) for soticlestat in Dravet syndrome, the existing clinical data package would not be able to provide significant evidence of efficacy.
• In December 2024, Orion Corporation and Marinus Pharmaceuticals decided to mutually terminate their European-wide marketing and distribution agreement for ZTALMY. In Europe, ZTALMY is approved for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age.
• In December 2024:- Longboard Pharmaceuticals- The objective of this study is to assess the long-term safety, tolerability, and efficacy of adjunctive therapy of LP352 in subjects with developmental and epileptic encephalopathies who completed participation in Study LP352-201.
• Leading developmental and epileptic encephalopathy companies working in the treatment market are Takeda, Eisai, SK Life Science, Stoke Therapeutics, Harmony Biosciences/Epygenix, Longboard Pharmaceuticals, Praxis Precision Medicines, Neurocrine Biosciences, Bright Minds Biosciences, Cerecin, Encoded Therapeutics, Bloom Science, IAMA Therapeutics, Ultragenyx Pharmaceutical, Neuroene Therapeutics, Regel Therapeutics, Jazz Pharmaceuticals, Biocodex, Zogenix (Acquired by UCB), Lundbeck, Marinus Pharmaceuticals, Novartis, Aquestive Therapeutics, Supernus Pharmaceuticals, Eisai Pharmaceuticals, GlaxoSmithKline, Meda Pharmaceuticals, Roche, Mallinckrodt Pharmaceuticals, Xenon Pharmaceuticals, Ovid Therapeutics, BioPharm Solutions and others.
• The promising developmental and epileptic encephalopathy therapies in the pipeline include EPX-100, EPX-200, EPX-300, XEN 496, LP 352, STK-001, JBPOS0101, Soticlestat (OV935/TAK-935), Carisbamate, NBI-921352, NBI-827104, PRAX-562, and others.
• The current therapeutic landscape of DEE in the United States is driven by current treatment practices which includes anti-epileptic drugs (AEDs), Epidiolex/Epidyolex (cannabidiol), Fintepla (Fenfluramine), Afinitor/Votubia (Everolimus), and others.

Discover which therapies are expected to grab the major developmental and epileptic encephalopathy market share @ Developmental and Epileptic Encephalopathy Market Forecast

Developmental and Epileptic Encephalopathy Overview

Developmental and Epileptic Encephalopathy (DEE) refers to a group of severe neurological disorders characterized by early-onset seizures and significant developmental impairments. Developmental and Epileptic Encephalopathy often begins in infancy or early childhood and includes syndromes such as Dravet syndrome, Lennox-Gastaut syndrome, and West syndrome. Developmental and Epileptic Encephalopathy is caused by genetic mutations in genes like SCN1A, CDKL5, and STXBP1. Developmental and Epileptic Encephalopathy leads to cognitive, motor, and behavioral deficits due to both epileptic activity and abnormal brain development.

Developmental and Epileptic Encephalopathy symptoms include frequent, treatment-resistant seizures and developmental delays. Developmental and Epileptic Encephalopathy diagnosis involves genetic testing, EEG, and MRI to identify underlying causes and seizure patterns. Developmental and Epileptic Encephalopathy treatment may involve anti-seizure medications, dietary therapies like the ketogenic diet, and in some cases, surgical interventions. Developmental and Epileptic Encephalopathy remains a therapeutic challenge due to limited response to conventional treatments. Developmental and Epileptic Encephalopathy research is focusing on gene therapy, precision medicine, and novel antiepileptic drugs.

Developmental and Epileptic Encephalopathy requires a multidisciplinary care approach involving neurologists, geneticists, and therapists. Developmental and Epileptic Encephalopathy awareness is vital for early diagnosis and better long-term outcomes. Developmental and Epileptic Encephalopathy is a rare but life-altering condition that demands continuous medical innovation and support.

Developmental and Epileptic Encephalopathy Epidemiology Segmentation

DelveInsight estimates that there were approximately 235K diagnosed prevalent cases of DEE in the 7MM in 2021.

Among the EU-4 countries, the diagnosed prevalent population of DEE was maximum in Germany in 2021.

The developmental and epileptic encephalopathy market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

• Diagnosed Prevalent Population of developmental and epileptic encephalopathy
• Treated pool of developmental and epileptic encephalopathy

Download the report to understand which factors are driving developmental and epileptic encephalopathy epidemiology trends @ Developmental and Epileptic Encephalopathy Prevalence

Developmental and Epileptic Encephalopathy Treatment Market

Some of the general principles and approach to pediatric epilepsy treatment can be found in the epileptic encephalopathy treatment. The best anti-epileptic treatment is chosen based on the type of epilepsy syndrome. Although anti-seizure medications are commonly used, some types of seizures are notoriously difficult to control. It is the primary method of controlling epileptic seizures and is almost always the first class of therapy medications.

Some of the FDA-approved drugs used for DEE treatment include Epidiolex (Jazz Pharmaceuticals), Diacomit (Biocodex), Fintepla (Zogenix), Sabril (Lundbeck), Ztalmy (Marinus Pharmaceuticals), Afinitor Disperz/Votubia (Novartis), Sympazan (Aquestive Therapeutics), Trokendi XR (Supernus Pharmaceuticals), Onfi (Lundbeck), Banzel (Eisai Pharmaceuticals), Lamictal (GlaxoSmithKline), and others.

In some children, steroid therapy with adrenocorticotropic hormone (ACTH) or prednisone has been beneficial. When medications do not work well, a vagus nerve stimulator or the ketogenic diet may be considered in patients. Moreover, in children with seizures that begin in one area or involve only one side of the brain, epilepsy surgery may be an option. In these cases, a focal resection (removal of a single area) or a hemispherectomy (removal of the majority of one side of the brain) may be considered.

To know more about developmental and epileptic encephalopathy treatment options, visit @ Developmental and Epileptic Encephalopathy Treatment Market

Developmental and Epileptic Encephalopathy Pipeline Therapies and Key Companies

• XEN496: Xenon Pharmaceuticals
• Soticlestat: Takeda/Ovid Therapeutics
• Carisbamate: SK Life Science
• EPX-100 (Clemizole HCl): Epygenix
• NBI-921352: Neurocrine Biosciences
• STK-001: Stoke Therapeutics
• NBI-827104: Neurocrine Biosciences
• JBPOS0101: BioPharm Solutions
• PRAX-562: Praxis Precision Medicines
• EPX-200 (Lorcaserin): Epygenix
• EPX-300: Epygenix
• LP352: Longboard Pharmaceuticals

Learn more about the DEE FDA-approved drugs @ Developmental and Epileptic Encephalopathy Drugs Market

Developmental and Epileptic Encephalopathy Market Dynamics

The dynamics of developmental and epileptic encephalopathy market is anticipated to change in the coming years. Ztalmy, the first licensed therapy for CDKL5 deficiency disorder, was recently approved in the United States, boosting the developmental and epileptic encephalopathy market growth. Moreover, the void left by a lack of licensed medications will be filled by further R&D advancement. In addition, Epidiolex and Fintepla continue to add new prescribers and expand their existing prescriber base due to their strong uptake.

Furthermore, the current competitive scenario for DEE is limited to a few therapies. Currently, the DEE market appears to be an unexplored area by pharmaceutical companies, and thus the companies have a significant opportunity to capture the potential developmental and epileptic encephalopathy market space. Emerging drugs with improved seizure control may positively impact the developmental and epileptic encephalopathy market landscape and patients’ quality of life.

However, several factors are impeding the growth of the DEE market. Rare epileptic syndromes, such as LGS, Dravet Syndrome, and CDKL5 deficiency disorder, are extremely complex and heterogeneous diseases with multiple etiologies, posing several diagnostic challenges as the disease progresses.

Scope of the Developmental and Epileptic Encephalopathy Market Report

• Study Period: 2020–2034
• Coverage: 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]
• Developmental and Epileptic Encephalopathy Market Size in 2023: USD 2100 million
• Key Developmental and Epileptic Encephalopathy Companies: Neuroene Therapeutics, BioPharm Solutions, Jazz Pharmaceuticals (NASDAQ: JAZZ), Roche (SWX: ROG), Stoke Therapeutics (NASDAQ: STOK), Aquestive Therapeutics (NASDAQ: AQST), Bloom Science, Biocodex, Zogenix (Acquired by UCB), Praxis Precision Medicines (NASDAQ: PRAX), Eisai Pharmaceuticals (TYO: 4523), Marinus Pharmaceuticals (NASDAQ: MRNS), Takeda (TYO: 4502), Meda Pharmaceuticals (Acquired by Mylan), GlaxoSmithKline (LSE: GSK), Regel Therapeutics, Supernus Pharmaceuticals (NASDAQ: SUPN), Neurocrine Biosciences (NASDAQ: NBIX), Harmony Biosciences (NASDAQ: HRMY), Epygenix, Lundbeck (CPH: LUN), Longboard Pharmaceuticals (NASDAQ: LBPH), Xenon Pharmaceuticals (NASDAQ: XENE), Cerecin, Novartis (SWX: NOVN), Ovid Therapeutics (NASDAQ: OVID), Mallinckrodt Pharmaceuticals (NYSE: MNK), IAMA Therapeutics, Bright Minds Biosciences (NASDAQ: DRUG), Encoded Therapeutics, Ultragenyx Pharmaceutical (NASDAQ: RARE), SK Life Science (Subsidiary of SK Biopharmaceuticals, KRX: 326030), Eisai (TYO: 4523) and others.
  • Key Developmental and Epileptic Encephalopathy Therapies: XEN496, Soticlestat, Carisbamate, Carisbamate, EPX-100, NBI-921352, STK-001, NBI-827104, JBPOS0101, PRAX-562, EPX-200 (Lorcaserin), EPX-300, LP352, and others
  • Therapeutic Assessment: Developmental and Epileptic Encephalopathy current marketed and emerging therapies
  • Developmental and Epileptic Encephalopathy Market Dynamics: Developmental and Epileptic Encephalopathy market drivers and barriers
  • Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
  • Unmet Needs, KOL’s views, Analyst’s views, Developmental and Epileptic Encephalopathy Market Access and Reimbursement

Discover more about DEE drugsin development @ Developmental and Epileptic Encephalopathy Clinical Trials and FDA Approvals

Table of Contents

1. Key Insights

2. Developmental and Epileptic Encephalopathy Report Introduction

3. Executive Summary

4. Key Events

5. Developmental and Epileptic Encephalopathy SWOT Analysis

6. Developmental and Epileptic Encephalopathy Epidemiology and Market Methodology

7. Developmental and Epileptic Encephalopathy (DEE) Market Overview at a Glance

7.1. Developmental and Epileptic Encephalopathy Market Share (%) Distribution by Therapies in 2021

7.2. Developmental and Epileptic Encephalopathy Market Share (%) Distribution by Therapies in 2034

8. Developmental and Epileptic Encephalopathy Background and Overview

8.1. West Syndrome

8.2. Dravet Syndrome

8.3. Lennox–Gastaut Syndrome

8.4. Landau–Kleffner Syndrome (LKS) (Acquired Epileptic Aphasia)

8.5. Epilepsy with Continuous Spike-and-Waves during Slow-Wave Sleep

8.6. Doose Syndrome (myoclonic atonic epilepsy)

8.7. CDKL5 deficiency disorder (CDD)

8.8. Tuberous sclerosis complex (TSC)

8.9. Genetic Epilepsy

8.10. Biomarkers of epileptic encephalopathies

9. Treatment of Developmental and Epileptic Encephalopathy

9.1. Antiseizure medications

9.2. Steroid therapy

9.3. Other Therapies

9.4. Epilepsy surgery

9.5. Developmental and Epileptic Encephalopathy Treatment Algorithm

10. Developmental and Epileptic Encephalopathy Treatment Guidelines

11. Developmental and Epileptic Encephalopathy Epidemiology and Patient Population of 7MM

11.1. Key Findings

11.2. Assumptions and Rationale

11.2.1. Dravet Syndrome

11.2.2. Lennox-Gastaut Syndrome

11.2.3. Ohtahara Syndrome

11.2.4. West Syndrome

11.2.5. Landau-Kleffner Syndrome

11.2.6. Tuberous Sclerosis Complex

11.2.7. CDKL5 deficiency disorder

11.2.8. Others

11.3. Diagnosed Prevalent Population of DEE in 7MM

11.4. United States

11.4.1. Diagnosed Prevalent Population of DEE in the United States

11.5. EU-4 and UK

11.5.1. Diagnosed Prevalence of DEE in the EU-4 and the UK

11.6. Japan

11.6.1. Diagnosed Prevalent Population of Developmental and Epileptic Encephalopathy in Japan

12. Marketed Developmental and Epileptic Encephalopathy Drugs

12.1. Key Competitor

13. Emerging Developmental and Epileptic Encephalopathy Drugs

13.1. Key Competitors

14. Developmental and Epileptic Encephalopathy (DEE): 7MM Market Analysis

14.1. Key Findings

14.2. Developmental and Epileptic Encephalopathy Market Outlook

14.3. Key Market Forecast Assumptions

14.4. Attribute Analysis

14.5. Total Market Size of Developmental and Epileptic Encephalopathy in the 7MM

14.6. Developmental and Epileptic Encephalopathy Market Size by Current and Emerging Therapies in the 7MM

14.7. United States Market Size

14.7.1. Total Market Size of DEE in the United States

14.7.2. Market Size of DEE by Current and Emerging Therapies in the United States

14.8. EU-4 and UK Market Size

14.8.1. Total Market size of DEE in the EU-4 and the UK

14.8.2. Market Size of DEE by Current and Emerging Therapies in EU-4 and the UK

14.9. Japan

14.9.1. Total Market size of DEE in Japan

14.9.2. Market Size of DEE by Current and Emerging Therapies in Japan

15. Developmental and Epileptic Encephalopathy Market Drivers

16. Developmental and Epileptic Encephalopathy Market Barriers

17. Developmental and Epileptic Encephalopathy Unmet Needs

18. Developmental and Epileptic Encephalopathy Market Access and Reimbursement

19. Appendix

19.1. Bibliography

19.2. Report Methodology

20. DelveInsight Capabilities

21. Disclaimer

22. About DelveInsight

About DelveInsight

DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

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