Fintepla

(Fenfluramine)

ApprovedSmall molecule

UCB

Fintepla is one of 129 small molecule programs targeting Cognition. It is currently in Approved.

Indications

Total Trials

Active Trials

128

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

CognitionActive, not recruiting

EpilepsyActive, not recruiting

ObesityActive, not recruiting

Infantile SpasmsActive, not recruiting

Dravet SyndromeActive, not recruiting

CognitionApproved

Active, not recruiting

EpilepsyPhase 2

Active, not recruiting

ObesityPhase 2

Active, not recruiting

Infantile SpasmsPhase 2

Active, not recruiting

Dravet SyndromePreclinical

Active, not recruiting

Competition

Competitive Landscape

392 competitors in Obesity

#DrugCompanyPhaseTrials

Fintepla

UCB

Approved

1 2

Actemra

Roche

Preclinical

2 3

Avapro

Sanofi

Preclinical

1 4

Amidate

Pfizer

Preclinical

—5

Calciferol

Alnylam Pharmaceuticals

Adenocard

Activella

Colcrys

Alnylam Pharmaceuticals

Preclinical

—9

Ultiva

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 10

Cetrotide

EMD Serono

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Dravet Syndrome

NCT06118255

Q3 2027

Post-ApprovalRecruiting

Dravet Syndrome

NCT06598449

Clinical

Trials by Indication[1]

Dravet syndrome3 trials

Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)

Available·UUniversity of California, Los Angeles··NCT04437004

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

Active, not recruiting· UCB logo

UCB·Phase 3·NCT06118255·25 enrolled

Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age

Recruiting·UUniversity of Colorado, Denver·Phase 4·NCT06598449·12 enrolled

Infantile Spasms1 trial

Treatment of Refractory Infantile Spasms With Fenfluramine

Unknown status·—·Phase 2·NCT04289467·10 enrolled

Outcome1 trial

Predictive Values of Serotonergic Alterations for Outcome - 2

Terminated·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00000313

Epilepsy1 trial

Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy

Unknown status·KKU Leuven·Phase 2·NCT02655198·13 enrolled

Adult1 trial

Fenfluramine for Adult Dravet Patients

Unknown status·UUniversity Health Network, Toronto·Phase 3·NCT05560282·15 enrolled

3 more indications

Cognition1 trial

Fenfluramine and Cognition

Completed·UUniversity of Oxford·Phase 4·NCT05026398·56 enrolled

Treatment1 trial

Fenfluramine for the Treatment of Different Types of Developmental and Epileptic Encephalopathies: a Pilot Trial Exploring Epileptic and Non-epileptic Outcomes

Unknown status·—·Phase 4·NCT05232630·20 enrolled

Obesity1 trial

Cardiovascular System in Obesity: Effect of Treatment

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00000506

Regulatory

FDA Approval Timeline[4]

Jun 25, 2020

FINTEPLA

NDA NDA212102

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Fenfluramine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fenfluramine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Fenfluramine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA212102). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Fintepla. U.S. Food & Drug Administration.
[6]
SEC EDGAR — UCB company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: UCB

Patent Landscape[5]

Patent Cliff

May 3, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10478441May 3, 2033

12097206May 3, 2033

9603815May 3, 2033

9610260May 3, 2033

9603814May 3, 2033

23 more patents

9549909May 3, 2033

10478442May 3, 2033

9549909*PEDNov 3, 2033

12097206*PEDNov 3, 2033

10478441*PEDNov 3, 2033

10478442*PEDNov 3, 2033

9603814*PEDNov 3, 2033

9610260*PEDNov 3, 2033

9603815*PEDNov 3, 2033

10947183Dec 20, 2036

10947183*PEDJun 20, 2037

10603290Aug 2, 2037

11040018Aug 2, 2037

11759440Aug 2, 2037

11786487Aug 2, 2037

11406606Aug 2, 2037

11406606*PEDFeb 2, 2038

11759440*PEDFeb 2, 2038

10603290*PEDFeb 2, 2038

11040018*PEDFeb 2, 2038

11786487*PEDFeb 2, 2038

10452815Jun 29, 2038

10452815*PEDDec 29, 2038

Fintepla

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Trials by Indication[1]

Dravet syndrome3 trials

Infantile Spasms1 trial

Outcome1 trial

Epilepsy1 trial

Adult1 trial

Cognition1 trial

Treatment1 trial

Obesity1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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