Dexedrine Spansule

(Dextroamphetamine)

ApprovedSmall molecule

Innovent Biologics (Suzhou) Co. Ltd.

Dexedrine Spansule is one of 45 small molecule programs targeting Substance Abuse. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Substance AbuseActive, not recruiting

Attention Deficit Hyperactivity DisorderActive, not recruiting

ApathyActive, not recruiting

Substance AbusePreclinical

Active, not recruiting

Attention Deficit Hyperactivity DisorderApproved

Active, not recruiting

ApathyApproved

Active, not recruiting

Competition

Competitive Landscape

34 competitors in Attention Deficit Hyperactivity Disorder

#DrugCompanyPhaseTrials

Ritalin

Novartis

Approved

27 2

Strattera

MMap77

Approved

26 3

Revia

Teva

Approved

2 4

Vyvanse

Takeda

Approved

2 5

Nicorette

Pfizer

Approved

1 6

Intuniv

PPromius Pharma, LLC

Approved

6 7

Brintellix

Buspar

Northera

Rocaltrol

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

Clinical

Trials by Indication[1]

Schizophrenia2 trials

Imaging Dopamine D2 Agonist Binding Sites in Schizophrenia

Withdrawn·NNYU Langone Health··NCT03999190

Pharmacologically-augmented Cognitive Therapies (PACTs) for Schizophrenia.

Completed·UUniversity of California, San Diego·Phase 2·NCT02634684·82 enrolled

AIN1 trial

Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000306·140 enrolled

Substance Abuse1 trial

A Study on Suicidality, Psychosis or Substance Abuse With Methylphenidate, Atomoxetine, Amphetamine/Dextroamphetamine or Lisdexamfetamine

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT04132557·430,000 enrolled

Methamphetamine Dependence1 trial

A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence

Completed·—·Phase 2·NCT00630682·60 enrolled

Apathy1 trial

Apathy Associated With Alzheimer's Disease

Completed·SSunnybrook Health Sciences Centre·Phase 4·NCT00254033·40 enrolled

10 more indications

Withdrawal1 trial

Studying Amphetamine Withdrawal in Humans

Completed·UUniversity of Arkansas·Phase 2·NCT01215929·35 enrolled

Refractory Depression1 trial

Sequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression

Terminated·NNew York State Psychiatric Institute·Phase 4·NCT00296686·31 enrolled

Imaging1 trial

Spectroscopic Imaging at 4T: A Drug Challenge Study

Terminated·MMclean Hospital·N/A·NCT01577706·7 enrolled

Treatment1 trial

Dextroamphetamine as an Adjunct in Cocaine Treatment - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000304·120 enrolled

Attention Deficit Hyperactivity Disorder1 trial

Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder

Completed·SStony Brook University·Phase 4·NCT00228046·40 enrolled

Interaction1 trial

Amphetamine Cocaine Interaction Study - 2

Terminated·TThe University of Texas Health Science Center, Houston·Phase 1·NCT00000305

Oral1 trial

Dextroamphetamine-Cocaine Behavioral Intervention - 5

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000308·54 enrolled

Adult1 trial

Decision Making Study in Young and Middle-Aged Adults: Part II

Completed·VVanderbilt University·Phase 1·NCT03512171·65 enrolled

Children1 trial

Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD

Completed·OOstfold Hospital Trust·Phase 4·NCT01220440·36 enrolled

Stroke1 trial

Amphetamine-Enhanced Stroke Recovery

Completed·—·Phase 2·NCT01905371·99 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

DEXEDRINE SPANSULE

NDA NDA017078

Mar 22, 2022

XELSTRYM

NDA NDA215401

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Dextroamphetamine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Dextroamphetamine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Dextroamphetamine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA215401). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Dexedrine Spansule. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Innovent Biologics (Suzhou) Co. Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Innovent Biologics (Suzhou) Co. Ltd.

Patent Landscape[5]

Patent Cliff

Oct 24, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9456993Oct 24, 2033

9474722Oct 24, 2033

12678504Mar 11, 2034

11559501Jan 6, 2042

Dexedrine Spansule

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Schizophrenia2 trials

AIN1 trial

Substance Abuse1 trial

Methamphetamine Dependence1 trial

Apathy1 trial

Withdrawal1 trial

Refractory Depression1 trial

Imaging1 trial

Treatment1 trial

Attention Deficit Hyperactivity Disorder1 trial

Interaction1 trial

Oral1 trial

Adult1 trial

Children1 trial

Stroke1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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