CLINICAL TRIALS PROFILE FOR FINTEPLA

All Clinical Trials for FINTEPLA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05560282 ↗	Fenfluramine for Adult Dravet Patients	Not yet recruiting	Zogenix, Inc.	Phase 3	2022-10-10	Full Title: Fenfluramine for the treatment of refractory Epilepsy in Adult Dravet patients Short Title: Fenfluramine for Adult Dravet patients Clinical Phase: Phase III Sample Size: A total of 15 participants will be included in the study. Study Population: Adult patients (18 years and older) with drug-resistant epilepsy (maintained on their existing medications, with exception of cannabidiol) and genetically confirmed Dravet syndrome will be recruited to participate in the study. Accrual Period: 12 months Study Design: Open label, non-randomized and uncontrolled add-on trial in adults (18 years of age and older) residing in Ontario, with refractory motor seizures and maintained on their existing antiepileptic medications, with exception of cannabidiol. Study Duration: • Treatment period: 12 months Study duration: 28 months Study Agent/ Intervention/ Procedure: Name of study drug: fenfluramine (FINTEPLA) Dose and frequency: starting at 0.1 mg/kg twice daily, maximum 26 mg/day, in patients not taking concomitant stiripentol; starting at 0.1 mg/kg twice daily, maximum of 17 mg/day in patients taking concomitant stiripentol. All doses are divided to twice a day. Duration: Baseline phase: 4 weeks (no study drug) Titration phase: 2 weeks (if not taking stiripentol) to 3 weeks (if the patient is taking stiripentol) Treatment phase: 12 weeks Extension phase: up to 38 weeks, for patients who had at least a 50% decrease in seizure frequency Post-trial washout phase: 2 weeks (if not taking stiripentol) to 3 weeks (if the patient is taking stiripentol) Route of administration: Oral Efficacy and safety points of interest - Monthly convulsive seizure frequency (MCSF) reduction ≥ 50% - Improvement in motor function - Improvement in Cognition and Behavior - Improvement in Quality of Sleep - Improvement in Quality of life - Determination of Cardiovascular safety in adults - Responder analysis (≥25%, ≥75%, or 100% reduction in mean MCSF) - Longest period of seizure freedom - Number of Emergency room visits - Use of rescue medication (number of days in 28 day-periods) - Duration of post-ictal stage - Frequency of other seizure types - Body weight changes - Patient's global functioning prior to and after study (Clinical Global Impressions Scale) Trial registration: www.clinicaltrials.gov
NCT05560282 ↗	Fenfluramine for Adult Dravet Patients	Not yet recruiting	University Health Network, Toronto	Phase 3	2022-10-10	Full Title: Fenfluramine for the treatment of refractory Epilepsy in Adult Dravet patients Short Title: Fenfluramine for Adult Dravet patients Clinical Phase: Phase III Sample Size: A total of 15 participants will be included in the study. Study Population: Adult patients (18 years and older) with drug-resistant epilepsy (maintained on their existing medications, with exception of cannabidiol) and genetically confirmed Dravet syndrome will be recruited to participate in the study. Accrual Period: 12 months Study Design: Open label, non-randomized and uncontrolled add-on trial in adults (18 years of age and older) residing in Ontario, with refractory motor seizures and maintained on their existing antiepileptic medications, with exception of cannabidiol. Study Duration: • Treatment period: 12 months Study duration: 28 months Study Agent/ Intervention/ Procedure: Name of study drug: fenfluramine (FINTEPLA) Dose and frequency: starting at 0.1 mg/kg twice daily, maximum 26 mg/day, in patients not taking concomitant stiripentol; starting at 0.1 mg/kg twice daily, maximum of 17 mg/day in patients taking concomitant stiripentol. All doses are divided to twice a day. Duration: Baseline phase: 4 weeks (no study drug) Titration phase: 2 weeks (if not taking stiripentol) to 3 weeks (if the patient is taking stiripentol) Treatment phase: 12 weeks Extension phase: up to 38 weeks, for patients who had at least a 50% decrease in seizure frequency Post-trial washout phase: 2 weeks (if not taking stiripentol) to 3 weeks (if the patient is taking stiripentol) Route of administration: Oral Efficacy and safety points of interest - Monthly convulsive seizure frequency (MCSF) reduction ≥ 50% - Improvement in motor function - Improvement in Cognition and Behavior - Improvement in Quality of Sleep - Improvement in Quality of life - Determination of Cardiovascular safety in adults - Responder analysis (≥25%, ≥75%, or 100% reduction in mean MCSF) - Longest period of seizure freedom - Number of Emergency room visits - Use of rescue medication (number of days in 28 day-periods) - Duration of post-ictal stage - Frequency of other seizure types - Body weight changes - Patient's global functioning prior to and after study (Clinical Global Impressions Scale) Trial registration: www.clinicaltrials.gov
NCT06118255 ↗	A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome	Recruiting	UCB BIOSCIENCES, Inc.	Phase 3	2024-05-21	The primary purpose of this study is evaluate the safety and tolerability of fenfluramine hydrochloride (HCl) 0.2 to 0.8 mg/kg/day in infants 1 year to less than 2 years of age with Dravet syndrome.

Clinical Trial Conditions for FINTEPLA

Condition Name

Condition Name for FINTEPLA
Intervention	Trials
Dravet Syndrome	2
Dravet Syndrome, Intractable	1

Condition MeSH

Condition MeSH for FINTEPLA
Intervention	Trials
Syndrome	2
Epilepsies, Myoclonic	2

Clinical Trial Locations for FINTEPLA

Trials by Country

Trials by Country for FINTEPLA
Location	Trials
Canada	1
United States	1
United Kingdom	1

Trials by US State

Trials by US State for FINTEPLA
Location	Trials
Tennessee	1

Clinical Trial Progress for FINTEPLA

Clinical Trial Phase

Clinical Trial Phase for FINTEPLA
Clinical Trial Phase	Trials
Phase 3	2

Clinical Trial Status

Clinical Trial Status for FINTEPLA
Clinical Trial Phase	Trials
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for FINTEPLA

Sponsor Name

Sponsor Name for FINTEPLA
Sponsor	Trials
Zogenix, Inc.	1
University Health Network, Toronto	1
UCB BIOSCIENCES, Inc.	1

Sponsor Type

Sponsor Type for FINTEPLA
Sponsor	Trials
Industry	2
Other	1

FINTEPLA Market Analysis and Financial Projection

Last updated: April 25, 2026

FINTEPLA (fenfluramine): What’s the clinical status, market reality, and forward revenue outlook?

What is FINTEPLA and where is it used clinically?

FINTEPLA is fenfluramine, a centrally acting anti-seizure therapy. Its core marketed use is pediatric and adult epilepsy driven by Dravet syndrome and Lennox-Gastaut syndrome (LGS) indications, with regulatory labeling shaped by seizure-frequency endpoints and safety monitoring requirements. The drug is sold under the brand name FINTEPLA. FDA approvals and label scope are tied to specific patient populations and add-on therapy use.

Key branded position in the US is anchored to:

• Dravet syndrome: adjunctive treatment of seizures associated with Dravet syndrome in patients age 2 years and older, with dosing and monitoring aligned to risk controls.
• Lennox-Gastaut syndrome: adjunctive treatment of seizures associated with LGS in patients age 2 years and older (regulatory labeling includes criteria for seizure types and treatment context).
• Safety monitoring: label includes cardiac risk controls and echocardiography guidance consistent with the drug’s mechanism and class history.

US label and FDA history (anchor points)

• FDA approval: FINTEPLA approved in 2020 for Dravet syndrome; later expanded to LGS (timeline reflected in FDA package insert updates). FDA labeling is the authoritative boundary for marketable populations. [1–3]

What do the latest clinical trials and evidence signals indicate?

A full “latest trials” picture depends on public trial registries and sponsor updates; however, the available high-level picture for FINTEPLA’s ongoing clinical relevance is that it already has established approval cohorts and clinical endpoints. Business impact comes from:

• whether new trials are aimed at expanding labeled age bands, seizure types, or earlier lines of therapy
• whether evidence is aimed at reducing discontinuations via optimized dosing and monitoring
• whether real-world utilization is shifting toward broader add-on adoption

Public evidence repeatedly ties FINTEPLA value to seizure reduction outcomes in Dravet and LGS cohorts (core pivotal programs plus post-approval evidence). Commercially, that means trial readouts matter most when they:

• extend efficacy claims into additional subgroups or seizure categories within or adjacent to labeled populations
• reduce safety friction through clearer monitoring thresholds and operational protocols

Where clinical development tends to land commercially For FINTEPLA, development that can move the needle typically falls into four buckets:

• Label expansion within pediatric neurology (age or seizure-type expansion)
• Durability evidence (continued seizure control over longer observation)
• Optimization (dose titration protocols and management of AEs)
• Combination strategy (positioning versus other add-on agents in LGS and Dravet care pathways)

The drug’s marketed footprint makes “incremental” development less about proving it works and more about widening access and improving tolerability and dosing operations for patients, prescribers, and payers.

Primary public clinical anchor programs FINTEPLA’s approval was supported by pivotal trials in Dravet and LGS populations, and post-marketing label management aligns with safety monitoring needs described in the FDA label. [1–3]

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What is FINTEPLA’s market reality: size, pricing, payer friction, and competition?

How big is the addressable market?

Addressable prevalence is driven by:

• prevalence of Dravet syndrome and LGS
• proportion of patients treated with add-on therapy at centers that prescribe specialty anti-seizure drugs
• pediatric neurology population size in the US and major EU markets
• payer acceptance and prior authorization burden

Even without a full epidemiologic re-estimation in this note, business reality is that FINTEPLA is a niche specialty product with a concentrated patient base. That typically produces:

• meaningful revenue per patient when coverage is secured
• high operational friction when coverage requires documentation of prior therapies or specific seizure patterns

What are pricing and reimbursement dynamics?

FINTEPLA pricing is payer-state dependent and tends to be dominated by:

• specialty pharmacy distribution and formulary placement
• prior authorization (PA) with disease documentation requirements
• step therapy and “medical necessity” justification
• utilization management for add-on therapy criteria

In the US, revenue tracks closely with:

• formulary access in large pharmacy benefit managers and payer formularies
• growth in the number of treated patients, not just net pricing
• specialty pharmacy effectiveness at driving therapy initiation after diagnosis

What competition matters and why?

In Dravet and LGS, the competitive set is anchored to other anti-seizure medications and, in some contexts, disease-modifying or broad-spectrum adjunctive therapies. Competitive pressure shows up through:

• payer preference for lower-cost alternatives or established agents
• clinical preference and dosing convenience
• safety and monitoring burden comparisons
• patient-level tolerability differences

Commercially, FINTEPLA’s differentiation is seizure-frequency reduction in these specific syndromes paired with long-term dosing patterns. Competitors that force substitution or create payer steer affect share even when clinical profiles are similar.

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What does the revenue projection for FINTEPLA look like?

Projection framework

A credible forecast for FINTEPLA’s future revenue is driven by:

1. Patient growth in labeled populations (new starts)
2. Retention and treatment duration (less discontinuation)
3. Net price evolution (rebates, discounts, payer mix)
4. Competitive intensity (formulary tier movements, steered alternatives)
5. Regulatory and label changes that broaden access

Given this note’s constraint on citing only verifiable public sources, the projection below uses a business-logic approach grounded in FDA label scope and typical specialty epilepsy commercialization dynamics rather than speculative numeric market sizing without source backing.

Forward outlook (directional but actionable)

Base case drivers

• If payer access remains stable and prescriber adoption continues, revenue grows primarily through additional patient initiations in the LGS and Dravet populations already cleared by label.
• Ongoing clinical evidence that clarifies long-term tolerability and real-world effectiveness supports persistence, reducing churn.

Upside drivers

• Any verified label expansion (age/seizure type) increases the covered pool.
• Better operational protocols for safety monitoring reduce discontinuations and “therapy abandonment.”

Downside drivers

• Increased formulary exclusion or tighter PA criteria reduce starts.
• Competitive entrants with easier dosing, lower monitoring burden, or better payer economics displace share.

Near-term business focus points

For investors or R&D planners, the commercial questions are practical:

• Will treated patient counts keep rising at a rate sufficient to outpace competitive substitutions?
• Will cardiac-monitoring compliance and AE management keep persistence high enough to support LTV-based forecasting?
• Will any new evidence consolidate FINTEPLA’s place as a preferred add-on rather than a later-line option?

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What are the key risk and compliance elements that affect adoption and forecast?

Safety monitoring and operational burden

FINTEPLA’s label includes cardiac risk management requirements. This impacts:

• prescribing workflows (cardiac assessments scheduling)
• continuity of therapy for patients with monitoring delays
• payer confidence where safety documentation is required

The operational burden is not theoretical; it shows up as initiation delays and discontinuation risks when monitoring capacity is limited. The net effect is slower uptake versus drugs without similarly intensive monitoring.

FDA label language and safety controls are foundational to all commercialization plans in the US. [1–3]

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What should R&D and investment teams track next for FINTEPLA?

Commercial KPIs

• New patient starts in Dravet and LGS labeled cohorts
• Persistence rate by dosing cohort (dose optimization can affect discontinuation)
• PA approval rate (proxy for payer friction)
• Specialty pharmacy fill and refill continuity
• AE-driven discontinuation patterns tied to label compliance

Regulatory and evidence milestones

• Any trial outcomes that expand or refine labeled subgroups
• Real-world evidence on persistence, seizure reductions in clinical practice, and safety outcomes
• Label supplement updates that change monitoring operational requirements

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Key Takeaways

• FINTEPLA (fenfluramine) is an approved add-on anti-seizure therapy for Dravet syndrome and Lennox-Gastaut syndrome populations in line with FDA labeling, with adoption influenced by pediatric specialty treatment workflows and safety monitoring requirements. [1–3]
• Clinical evidence matters commercially most when it expands access or improves tolerability and persistence, not when it merely re-confirms seizure reduction in already-cleared cohorts.
• Revenue trajectory in forward periods is primarily driven by treated-patient growth, retention, and net pricing, with payer policy and cardiac monitoring operational burden acting as adoption constraints. [1–3]

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FAQs

1) What is FINTEPLA’s main indication base in the US?
FINTEPLA is indicated as adjunctive therapy for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients aged 2 years and older, per FDA labeling. [1–3]

2) Does FDA labeling impose cardiac monitoring requirements for FINTEPLA?
Yes. The FDA label includes cardiac safety controls and monitoring guidance tied to risk management. [1–3]

3) What most affects FINTEPLA growth: price or patient starts?
For specialty epilepsy brands like FINTEPLA, growth is typically more sensitive to patient initiations and persistence than to list price changes, because net price and rebating move with formulary access and contract structure. (Label-constrained access determines the addressable base.) [1–3]

4) What clinical trial outcomes would be most commercially meaningful?
Evidence that expands eligible populations (age/seizure-type) or improves tolerability and persistence has the strongest path to incremental revenue by increasing starts and reducing discontinuation. [1–3]

5) Who is the competitive threat in Dravet and LGS?
Competition comes from other anti-seizure therapies used as adjuncts in Dravet and LGS, with payer and prescriber choice shaped by efficacy, safety/monitoring burden, and access. (FINTEPLA’s differentiation is tightly linked to label-specific efficacy and safety management.) [1–3]

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References (APA)

1. U.S. Food and Drug Administration. (2020). FDA approves FINTEPLA (fenfluramine) for Dravet syndrome. [Press release].
2. U.S. Food and Drug Administration. (n.d.). FINTEPLA (fenfluramine) prescribing information.
3. U.S. Food and Drug Administration. (n.d.). Drug trials snapshots: FINTEPLA (fenfluramine). [FDA database entries].