Fintepla

(Fenfluramine)

ApprovedSmall molecule

UCB

Fintepla is one of 58 small molecule programs targeting Dravet syndrome. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Dravet SyndromeRecruiting

CognitionCompleted

Dravet SyndromeApproved

Recruiting

CognitionApproved

Completed

Competition

Competitive Landscape

88 competitors in Cognition

#DrugCompanyPhaseTrials

Lyrica

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

Approved

1 2

Zocor

OOrganon and Co

Approved

1 3

Tylenol

Namenda

3 5

Metaxalone

VViking Therapeutics, Inc.

Approved

1 6

Fintepla

UCB

Approved

1 7

Epidiolex

Jazz Pharmaceuticals

Phase 2

2 8

Nuplazid

AACADIA Pharmaceuticals Inc.

Phase 2

1 9

Remimazolam Tosilate

FFujian Shengdi Pharmaceutical Co., Ltd.

Phase 3

1 10

Psilocybin

COMPASS Pathways

Phase 2

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

Timeline

Expected Milestones

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

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

Open-Label, Single-Arm, Phase 3 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome

Completed· UCB logo

UCB·Phase 3·NCT06118255·25 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

Adult1 trial

Fenfluramine for Adult Dravet Patients

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

Outcome1 trial

Predictive Values of Serotonergic Alterations for Outcome - 2

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

Obesity1 trial

Cardiovascular System in Obesity: Effect of Treatment

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

3 more indications

Epilepsy1 trial

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

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

Infantile Spasms1 trial

Treatment of Refractory Infantile Spasms With Fenfluramine

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

Cognition1 trial

Fenfluramine and Cognition

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

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

Q3 2027

Trials by Indication[1]

Dravet syndrome3 trials

Treatment1 trial

Adult1 trial

Outcome1 trial

Obesity1 trial

Epilepsy1 trial

Infantile Spasms1 trial

Cognition1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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