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
United States	1
United Kingdom	1
Canada	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
Recruiting	1
Not yet recruiting	1

Clinical Trial Sponsors for FINTEPLA

Sponsor Name

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

Sponsor Type

Sponsor Type for FINTEPLA
Sponsor	Trials
Industry	2
Other	1

Last updated: July 25, 2026

FINTEPLA (fenfluramine) clinical trials update, market analysis, and revenue projection (US and key markets)

Fenfluramine (FINTEPLA) remains commercially anchored in rare pediatric epilepsies. Post-launch evidence continues to be driven by dosing optimization and lifecycle expansions across Dravet syndrome and Lennox-Gastaut syndrome (LGS), with regulatory standing supported by FDA labeling that ties efficacy to seizure reductions in defined age bands. Commercial upside depends on (1) continued penetration in eligible pediatric patients, (2) retention after year 1, and (3) any label expansion into broader LGS subpopulations or additional disease-modifying claims that convert adoption from “last-line” to earlier-line prescribing.

What clinical trials support FINTEPLA’s current and next label in Dravet and LGS?

Which pivotal trials are the basis of FINTEPLA’s FDA approval

Dravet syndrome

• Study 1 (fenfluramine versus placebo; Dravet): core evidence for seizure-frequency reduction in Dravet patients on background antiseizure therapy.
• Study 2 (longer-term safety/efficacy follow-on): supports durability and safety profile across extended exposure.

Lennox-Gastaut syndrome

• Study 3 (fenfluramine versus placebo; LGS): key trial supporting seizure-reduction outcomes relevant to LGS endpoints.
• Study 4 (longer-term follow-on): supplies maintenance of effect and adverse-event profile with chronic dosing.

What post-approval trials are most likely to matter to commercialization

Post-approval development for fenfluramine typically concentrates on:

• Durability endpoints (12 to 24 months seizure control maintenance; responder rates).
• Subgroup confirmation (age strata, baseline seizure frequency tiers, prior antiseizure drug exposure).
• Real-world evidence generation for payer and formulary adoption.
• Pediatric dosing refinement to reduce tolerability friction and improve persistence.

What endpoints and regulatory signals typically move prescribing

For FINTEPLA uptake, trials that strengthen:

• magnitude and consistency of reduction in seizure frequency,
• responder-rate stability (eg, at 50% responder thresholds),
• safety tolerance with chronic use,
• and endpoints aligned to clinical practice (drop in convulsive seizures, LGS seizure types), tend to drive formulary approvals and physician confidence.

How does FINTEPLA’s efficacy profile compare across Dravet vs Lennox-Gastaut?

Dravet syndrome: adoption dynamics

In Dravet, clinicians often treat FINTEPLA as a high-impact option after inadequate control with standard antiseizure regimens. The market consequence is that penetration is sensitive to pediatric neurologist “referral center” behavior and to payer authorization speed.

Lennox-Gastaut syndrome: broader adoption constraints

In LGS, prescribing depends on:

• seizure-type mix,
• baseline severity,
• co-medication tolerance,
• and how strongly the trial endpoints translate to caregiver-visible outcomes.

The commercial implication is that uptake can be slower than Dravet unless evidence and access reduce perceived risk and improve treatment persistence.

When do FINTEPLA clinical trials translate into revenue growth?

Revenue acceleration usually follows a predictable lag structure:

1. Regulatory milestone or label-reinforcing dataset enters awareness.
2. Formulary and prior authorization protocols adjust.
3. Neurologist prescribing increases after payer coverage stabilizes.
4. Persistence determines net revenue trajectory over quarters.

Because fenfluramine is a chronic pediatric therapy, sustained retention after initial use frequently drives annualized revenue more than short-term spikes from new data releases.

What is the current market size for pediatric rare epilepsy where FINTEPLA competes?

US addressable population framing (commercial relevance)

Fenfluramine competes within pediatric epilepsies defined by:

• Dravet syndrome
• LGS

Commercial TAM is constrained by diagnosis rates, referral patterns to tertiary centers, and treatment-line position (second-line vs later-line). Within that, FINTEPLA’s effective TAM is further narrowed by:

• pediatric age windows in labeling,
• background therapy tolerability,
• and payer access barriers.

Where demand tends to concentrate

• High neurologist density regions and specialized pediatric epilepsy centers
• Plans that accept novel therapies with structured prior authorization
• Patients with high seizure burden where caregiver and physician urgency is greatest

Who are FINTEPLA’s competitive threats in Dravet and LGS?

Competitive set

FINTEPLA’s competitive landscape spans antiseizure medicines with pediatric indications and also includes newer entrants targeting broader seizure-control objectives. Key competitive pressure comes from:

• therapies with simpler administration or fewer monitoring burdens,
• therapies with payer-preferred contracting,
• and therapies positioned earlier in treatment algorithms.

What differentiates FINTEPLA

Commercial differentiation is driven by:

• seizure reduction magnitude in labeled populations,
• responder rates and durability,
• and a safety profile that is acceptable for chronic pediatric use under routine monitoring.

Market share is typically won or lost at the intersection of efficacy confidence and access feasibility.

What is the market forecast for FINTEPLA through 2030?

Base-case growth logic

A defensible base-case projection generally rests on three drivers:

1. Penetration: incremental share among eligible pediatric patients
2. Persistence: proportion of patients continuing therapy after year 1
3. Price/mix: net price stability and any pediatric dosing changes affecting reimbursed volume

Without verified, up-to-date financial disclosures for FINTEPLA revenue in the user prompt, numeric revenue forecasts cannot be produced to a standard suitable for high-stakes business decisions.

What pricing, reimbursement, and access factors will determine FINTEPLA uptake?

Payer mechanics

• Prior authorization approvals and evidence submission requirements
• Step edits requiring proof of inadequate response to background therapy
• Specialty pharmacy distribution constraints
• Patient assistance programs that reduce abandonment risk

Access friction points

Fenfluramine’s pediatric use makes authorization sensitive to:

• documentation of age and diagnosis coding,
• seizure burden metrics,
• and prescriber specialty.

Commercial risk increases when payers tighten criteria faster than clinical evidence updates.

How many patients can realistically start FINTEPLA each year?

Patient flow constraints

Annual initiations are limited by:

• diagnosis identification pipeline,
• availability of pediatric epilepsy specialists,
• and payer authorization throughput.

Initiation rates often track the speed of formulary acceptance, not only clinical trial strength.

What are the key clinical and safety considerations impacting sales?

Safety monitoring

Chronic pediatric fenfluramine use requires ongoing safety surveillance. Any pattern of tolerability issues affects:

• dosing persistence,
• caregiver willingness to continue,
• and physician comfort.

Adverse event management as a commercial lever

If adverse events can be managed with predictable dose adjustments, persistence improves and sales follow.

What would a label expansion or new indication do to the FINTEPLA market?

Scenario impact

A new or expanded indication typically moves the curve by:

• increasing the eligible pool,
• enabling earlier treatment-line adoption,
• and improving payer willingness to cover due to broader evidence sets.

But the conversion to revenue is mediated by formulary processes and physician behavior.

Key trials update checklist to monitor (commercially actionable)

To track whether clinical development is likely to shift revenue, monitor:

• publication or presentation of longer-term efficacy and durability
• subgroup analyses that strengthen guideline-relevant use
• real-world studies tied to persistence and discontinuation rates
• safety signal updates that affect monitoring protocols
• any expansion that changes dosing eligibility or seizure-type coverage

Key Takeaways

• FINTEPLA commercial performance depends on pediatric epilepsy penetration, treatment persistence, and payer access mechanics across Dravet and LGS.
• Clinical trial value for revenue is highest when it improves durable efficacy confidence and reduces tolerability and authorization friction.
• Market growth through 2030 is driven primarily by persistence and access, not by short-cycle trial readouts.
• Numeric revenue projections cannot be produced from the information provided in the prompt to meet high-stakes forecasting standards.

FAQs

1. What phase 3 or follow-on studies drive FINTEPLA’s long-term efficacy claims?
2. How does FINTEPLA’s dosing persistence in real-world cohorts compare with pivotal trial responder rates?
3. What payer prior authorization documentation most affects FINTEPLA initiation in pediatric epilepsy?
4. Which competitive therapies most threaten FINTEPLA share in Lennox-Gastaut syndrome?
5. What clinical trial signals would most likely support FINTEPLA moving earlier in treatment algorithms?

References

1. FDA prescribing information for FINTEPLA (fenfluramine).
2. Published pivotal studies of fenfluramine in Dravet syndrome and Lennox-Gastaut syndrome.