Drugs / Armodafinil
Armodafinil
also known as
CEP-10953 · Nuvigil · Armodafinilo · CEP-10952 · CRL-40982 · NSC-751850 · NSC-758711 · NuvigilTM · +1 more
Small molecule targets SLC6A3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | NUVIGIL | — | 2007-06-15 | fda.gov ↗ |
Trials 42 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01624480 | Jul 2012 → Sep 2015 | narcolepsy | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT01219673 | Mar 2013 → Jan 2014 | head and neck cancer | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT01330446 | May 2011 → Dec 2022 | head and neck cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT01746043 | Feb 2013 → Jan 2017 | esophageal cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01011218 | Jan 2011 → Jul 2016 | insomnia | Stanford University | Completed | No outcome recorded |
| Phase 2 | NCT01032200 | Aug 2010 → Jan 2013 | cognitive disorder, primary brain neoplasm | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01019187 | Jun 2009 → Aug 2013 | cancer of unknown primary site | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 2 | NCT00766467 | Sep 2008 → Jul 2014 | malignant glioma | Eudocia Quant Lee, MD | Completed | No outcome recorded |
| Phase 2 | NCT01091974 | Feb 2008 → Apr 2013 | breast cancer, insomnia | University of Rochester | Completed | No outcome recorded |
| Phase 2 | NCT01896128 | Jan 2008 → Jul 2015 | hemiplegia, stroke disorder | Burke Rehabilitation Hospital | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT02151253 | May 2011 → Sep 2015 | sleep-wake disorder | Duke University | Completed | No outcome recorded |
| Phase 2/3 | NCT00981084 | Sep 2009 → Apr 2011 | multiple sclerosis | University of Missouri, Kansas City | Completed | No outcome recorded |
| Phase 319 trials | ||||||
| Phase 3 | NCT01781468 | Jun 2013 → May 2019 | — | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 3 | NCT02478580 | Aug 2011 → Sep 2013 | obesity disorder | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT01305408 | Mar 2011 → Jul 2013 | bipolar depression | Cephalon | Completed | No outcome recorded |
| Phase 3 | NCT01160380 | Jun 2010 → Jun 2013 | plasma cell myeloma | Oncotherapeutics | Completed | No outcome recorded |
| Phase 3 | NCT01121536 | Apr 2010 → Oct 2013 | bipolar depression | Cephalon | Terminated | No outcome recorded |
| Phase 3 | NCT01072630 | Mar 2010 → Nov 2012 | depressive disorder | Cephalon | Completed | No outcome recorded |
| Phase 3 | NCT01072929 | Jan 2010 → Mar 2012 | depressive disorder | Cephalon | Completed | No outcome recorded |
| Phase 3 | NCT01010789 | Nov 2009 → Nov 2014 | binge eating disorder, obesity disorder | Lindner Center of HOPE | Completed | No outcome recorded |
| Phase 3 | NCT00983437 | Aug 2009 → Jan 2011 | traumatic brain injury | Cephalon | Terminated | No outcome recorded |
| Phase 3 | NCT00893789 | Apr 2009 → Jan 2011 | traumatic brain injury | Cephalon | Terminated | No outcome recorded |
| Phase 3 | NCT00758498 | Sep 2008 → Feb 2009 | hypersomnia | Cephalon | Completed | No outcome recorded |
| Phase 3 | NCT00228566 | Oct 2005 → Jul 2006 | hypersomnia, narcolepsy, obstructive sleep apnea syndrome | Cephalon | Completed | No outcome recorded |
| Phase 3 | NCT00236080 | Aug → Dec 2005 | circadian rhythm sleep disorder, shift work type | Cephalon | Completed | No outcome recorded |
| Phase 3 | NCT00228553 | May 2004 → Jul 2006 | circadian rhythm sleep disorder, shift work type, hypersomnia, narcolepsy, obstructive sleep apnea syndrome | Cephalon | Completed | No outcome recorded |
| Phase 3 | NCT00078377 | Mar 2004 → Jan 2005 | narcolepsy | Cephalon | Completed | No outcome recorded |
| Phase 3 | NCT00080288 | Mar → Dec 2004 | circadian rhythm sleep disorder, shift work type, hypersomnia | Cephalon | Completed | No outcome recorded |
| Phase 3 | NCT00079677 | Mar → Oct 2004 | obstructive sleep apnea syndrome | Cephalon | Completed | No outcome recorded |
| Phase 3 | NCT00078325 | Feb → Nov 2004 | obstructive sleep apnea syndrome | Cephalon | Completed | No outcome recorded |
| Phase 3 | NCT00078312 | Jan 2004 → Jul 2006 | circadian rhythm sleep disorder, shift work type, narcolepsy, obstructive sleep apnea syndrome | Cephalon | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT01460628 | Oct 2011 → May 2013 | — | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01470651 | Oct 2011 → Jun 2014 | hepatitis C virus infection | Research Foundation for Mental Hygiene, Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT01080807 | Mar → Oct 2010 | hypersomnia | Cephalon | Completed | No outcome recorded |
| Phase 4 | NCT01023672 | Nov 2009 → Mar 2012 | Lewy body dementia | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT00711516 | Sep 2008 → Sep 2009 | hypersomnia | Cephalon | Completed | No outcome recorded |
| Phase 4 | NCT00737204 | Jun 2008 → Apr 2010 | HIV infectious disease | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 4 | NCT00678691 | Aug 2007 → Jun 2009 | fibromyalgia | State University of New York - Upstate Medical University | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT01317550 | Jul 2011 → Feb 2016 | lung cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| — | NCT01169753 | May 2011 → Feb 2013 | chronic myeloid leukemia | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| — | NCT01256905 | Jan → Aug 2011 | Lewy body dementia, Parkinson disease | NYU Langone Health | Withdrawn | No outcome recorded |
| — | NCT01044004 | Mar 2010 → Jun 2012 | B-cell non-Hodgkin lymphoma | Washington University School of Medicine | Withdrawn | No outcome recorded |
Also used as a comparator or background therapy in 13 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02468856 Comparator | May → Nov 2017 | — | University of Florida | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT00592943 Comparator | Oct 2007 → May 2008 | — | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT01048983 Comparator | — | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT01400958 Comparator | Dec 2010 → Dec 2012 | malignant glioma | H. Lee Moffitt Cancer Center and Research Institute | Terminated | No outcome recorded |
| Phase 2 | NCT01096680 Comparator | Apr → Jul 2010 | — | Shire | Completed | No outcome recorded |
| Phase 2 | NCT00825227 Comparator | Dec 2008 → Oct 2009 | chemotherapy-induced toxicity | Cephalon | Terminated | No outcome recorded |
| Phase 2 | NCT00772005 Comparator | Sep 2008 → Mar 2010 | schizophrenia | Cephalon | Completed | No outcome recorded |
| Phase 2 | NCT00487942 Comparator | Jul → Dec 2007 | schizophrenia | Cephalon | Completed | No outcome recorded |
| Phase 2 | NCT00481195 Comparator | Jun 2007 → Dec 2008 | bipolar depression | Cephalon | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00555347 Comparator | Oct 2007 → Aug 2010 | sarcoidosis | University of Cincinnati | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT00518986 Comparator | Oct 2007 → Mar 2009 | dysthymic disorder, major depressive disorder, obstructive sleep apnea syndrome | Cephalon | Completed | No outcome recorded |
| Phase 4 | NCT00373672 Comparator | Aug 2006 → Jan 2010 | schizoaffective disorder, schizophrenia | Northwestern University | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02552303 Comparator | Apr 2014 → Jul 2015 | insomnia, obstructive sleep apnea syndrome | University of Pennsylvania | Completed | No outcome recorded |
Press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2014-06-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Reaches Settlements In NUVIGIL® Patent Case tevapharm.com ↗ |
| 2013-08-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Reports Top-Line Results from Final Phase III Study of Armodafinil (NUVIGIL®) in Patients with Major Depression Associated with Bipolar I Disorder tevapharm.com ↗ |
| 2013-01-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Reports Top-Line Results from Second Phase III Study of Armodafinil (NUVIGIL®) in Patients with Major Depression Associated with Bipolar 1 Disorder tevapharm.com ↗ |
| 2012-04-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva settles Nuvigil litigation with Mylan tevapharm.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Armodafinil | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01746043 ↗52 |
| Known as | Armodafinilo | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201192 ↗ |
| Known as | CEP-10952 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201192 ↗ |
| Known as | CEP-10953 | “A 12-Month, Open-Label, Flexible-Dosage (100 to 250 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients With Excessive...” NCT00228553 ↗4“The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment” NCT00080288 ↗ “Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome” NCT00079677 ↗ “Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy” NCT00078377 ↗ “CEP-10953 (Armodafinil)” NCT00078312 ↗ |
| Known as | CRL-40982 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201192 ↗ |
| Known as | NSC-751850 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201192 ↗ |
| Known as | NSC-758711 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201192 ↗ |
| Known as | Nuvigil | “Subjects will be randomized to take armodafinil (Nuvigil) or placebo along with their current antipsychotic and tested at baseline and week 6 for differences in memory,...” NCT00373672 ↗ |
| Known as | NuvigilTM | “Armodafinil (NuvigilTM) is an isomer of a drug currently approved by the FDA for the treatment of fatigue secondary to narcolepsy, sleep apnea, and shift work sleep disorder...” NCT00678691 ↗ |
| Known as | R-(-)-modafinil | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201192 ↗ |
| Action | Inhibit | “Dopamine transporter inhibitor” CHEMBL1201192 ↗ |
| Modality | Small molecule | — CHEMBL1201192 ↗ |
| Route | Oral | “Armodafinil (po) 100 to 250 mg/day up to 12 months” NCT00078312 ↗ |
| Target | SLC6A3 | “Dopamine transporter inhibitor” CHEMBL1201192 ↗ |