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Nuvigil

(Armodafinil)

ApprovedSmall molecule

NNuvo Research GmbH

Armodafinil is a wakefulness-promoting medication used to treat excessive daytime sleepiness caused by conditions like narcolepsy, shift work sleep disorder, and sleep apnea. It works by affecting brain chemicals that control sleep and wakefulness to help patients stay alert during the day.[2] Nuvigil is currently approved and in use across 18 indications[4].[1]

Nuvigil is one of 342 small molecule programs targeting Depressive Disorder. It is currently in Approved.

18

Indications

47

Total Trials

0

Active Trials

341

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Depressive DisorderApproved

HypersomniaApproved

Childhood CancerActive, not recruiting

Sleep DisorderActive, not recruiting

ObesityApproved

Chronic Myelogenous LeukemiaActive, not recruiting

Narcolepsy-Cataplexy SyndromeActive, not recruiting

Attention Deficit Hyperactivity DisorderActive, not recruiting

Sleep ApneaApproved

LymphomaActive, not recruiting

Depressive DisorderApproved

Approved

HypersomniaApproved

Approved

Childhood CancerApproved

Active, not recruiting

Sleep DisorderApproved

Active, not recruiting

ObesityApproved

Approved

Chronic Myelogenous LeukemiaPreclinical

Active, not recruiting

Narcolepsy-Cataplexy SyndromeApproved

Active, not recruiting

Attention Deficit Hyperactivity DisorderApproved

Active, not recruiting

Sleep ApneaApproved

Approved

LymphomaPreclinical

Active, not recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

Nuvigil

NNuvo Research GmbH

Zofran

Cabenuva

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Kenalog

BBausch Health Americas, Inc.

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Decadron

QQuince Therapeutics S.p.A.

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Systemic Therapy

Bristol-Myers Squibb

Antibody-Drug Conjugate

MMBrace Therapeutics

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

Clinical

Trials by Indication[1]

Bipolar I Disorder5 trials

Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Completed·CCephalon·Phase 3·NCT01072630·492 enrolled

Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Completed·CCephalon·Phase 3·NCT01305408·399 enrolled

A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Completed·CCephalon·Phase 3·NCT01072929·433 enrolled

Show 2 more trials

Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Completed·CCephalon·Phase 2·NCT00481195·257 enrolled

Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Terminated·CCephalon·Phase 3·NCT01121536·867 enrolled

Fatigue5 trials

Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors

Completed·WWake Forest University Health Sciences·Phase 2·NCT01032200·54 enrolled

Single Agent Armodafinil for Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT01330446·26 enrolled

Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT01781468·328 enrolled

Show 2 more trials

Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS

Completed·NNew York State Psychiatric Institute·Phase 4·NCT00737204·70 enrolled

Effect of Nuvigil on Fatigue

Completed·MMassachusetts General Hospital·Phase 4·NCT01460628·25 enrolled

Adult2 trials

Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss

Completed· Takeda logo

Takeda·Phase 2·NCT01096680·135 enrolled

PET Study Examining the Dopaminergic Activity of Armodafinil in Adults

Completed·MMassachusetts General Hospital·Phase 1/2·NCT00592943·12 enrolled

Brain Injury2 trials

Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury

Terminated·CCephalon·Phase 3·NCT00893789·117 enrolled

Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury

Terminated·CCephalon·Phase 3·NCT00983437·49 enrolled

Small Cell Lung Cancer2 trials

Reducing Symptom Burden - Non Small Cell Lung Cancer (NSCLC)

Withdrawn·MM.D. Anderson Cancer Center·Phase 1/2·NCT01048983

A Study for Reducing Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer by Minocycline and Armodafinil

Completed·MM.D. Anderson Cancer Center·N/A·NCT01317550·14 enrolled

26 more indications

Narcolepsy2 trials

Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy

Completed· Teva logo

Teva·Phase 1·NCT01624480·40 enrolled

Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy

Completed·CCephalon·Phase 3·NCT00078377·196 enrolled

Excessive Sleepiness2 trials

Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder

Completed·CCephalon·Phase 3·NCT00758498·427 enrolled

Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder

Completed·CCephalon·Phase 4·NCT01080807·385 enrolled

Dementia2 trials

Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies

Withdrawn·NNYU Langone Health·N/A·NCT01256905

"Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies"

Completed·MMayo Clinic·Phase 4·NCT01023672·20 enrolled

Insomnia2 trials

Cognitive Behavioral Therapy With or Without Armodafinil in Treating Cancer Survivors With Insomnia and Fatigue After Chemotherapy

Completed·—·Phase 2·NCT01019187·226 enrolled

Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy

Completed·UUniversity of Rochester·Phase 2·NCT01091974·138 enrolled

Obstructive Sleep Apnea2 trials

Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression

Completed·CCephalon·Phase 4·NCT00518986·249 enrolled

Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

Completed·CCephalon·Phase 3·NCT00228566·247 enrolled

Schizophrenia1 trial

Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia

Completed·CCephalon·Phase 2·NCT00772005·287 enrolled

Hepatitis C1 trial

Armodafinil for Patients Starting Hepatitis C Virus Treatment

Terminated·RResearch Foundation for Mental Hygiene, Inc.·Phase 4·NCT01470651·26 enrolled

Memory1 trial

Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance

Completed·CCephalon·Phase 4·NCT00711516·40 enrolled

Lymphoma1 trial

Evaluate the Efficacy of Armodafinil for Patients With B-cell Lymphoma and Severe Fatigue

Withdrawn·WWashington University School of Medicine·N/A·NCT01044004

Stroke1 trial

Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke

Completed·—·Phase 2·NCT01896128·19 enrolled

Eating Disorder1 trial

Armodafinil in Binge Eating Disorder (BED)

Completed·LLindner Center of HOPE·Phase 3·NCT01010789·60 enrolled

Multiple Myeloma1 trial

A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma

Completed·OOncotherapeutics·Phase 3·NCT01160380·50 enrolled

Myeloid Leukemia1 trial

Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia Patients

Terminated·MM.D. Anderson Cancer Center·N/A·NCT01169753·1 enrolled

Esophageal Cancer1 trial

A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01746043·22 enrolled

Breast Cancer1 trial

Management of Insomnia in Breast Cancer Patients

Completed·SStanford University·Phase 2·NCT01011218·70 enrolled

Sleep Disorder1 trial

The Treatment of Insomnia Comorbid With Sleep Disordered Breathing Using Armodafinil and/or Cognitive Behavioral Therapy for Insomnia

Completed·UUniversity of Pennsylvania·N/A·NCT02552303·39 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Armodafinil as Adjunctive Therapy in Schizophrenic Adults With Cognitive Deficits

Completed·CCephalon·Phase 2·NCT00487942·60 enrolled

Schizoaffective Disorder1 trial

Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder

Completed·NNorthwestern University·Phase 4·NCT00373672·58 enrolled

Concentration1 trial

Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL

Completed·CCephalon·Phase 3·NCT00236080·136 enrolled

Treatment1 trial

Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia

Completed·—·Phase 2/3·NCT02151253·81 enrolled

Head and Neck Cancer1 trial

Symptom Burden in Head and Neck Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT01219673·1 enrolled

Driving1 trial

Effect of Armodafinil on Simulated Driving

Completed·UUniversity of Florida·Phase 1·NCT02468856·12 enrolled

Sarcoidosis1 trial

Use of Armodafinil for Fatigue in Sarcoidosis

Completed·UUniversity of Cincinnati·Phase 2/3·NCT00555347·20 enrolled

Fibromyalgia1 trial

An Eight Week, Double-Blind Efficacy Study of Armodafinil Augmentation to Alleviate Fibromyalgia Fatigue

Completed·SState University of New York - Upstate Medical University·Phase 4·NCT00678691·55 enrolled

Multiple Sclerosis1 trial

Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS)

Completed·UUniversity of Missouri, Kansas City·Phase 2/3·NCT00981084·33 enrolled

Malignant Glioma1 trial

A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas

Completed·—·Phase 2·NCT00766467·81 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 15, 2007

NUVIGIL

NDA NDA021875

Sources

References

[1]
ClinicalTrials.gov — 47 trial records for Armodafinil. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Nuvigil drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Armodafinil compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Armodafinil. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021875). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Nuvo Research GmbH company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dopamine Transporter Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: NNuvo Research GmbH

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