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
| 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 Stop: Enrollment |
| Phase 1/2 | NCT01330446 | May 2011 → Dec 2022 | head and neck cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 27 trials · 1 met primary · 1 missed | ||||||
| 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 | Missed primary |
| Phase 2 | NCT01091974 | Feb 2008 → Apr 2013 | breast cancer, insomnia | University of Rochester | Completed | Met primary |
| 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 | Mixed |
| Phase 319 trials · 3 met primary · 5 missed | ||||||
| Phase 3 | NCT01781468 | Jun 2013 → May 2019 | — | Alliance for Clinical Trials in Oncology | Completed | Missed primary |
| 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 | Missed primary |
| Phase 3 | NCT01160380 | Jun 2010 → Jun 2013 | plasma cell myeloma | Oncotherapeutics | Completed | Missed primary |
| Phase 3 | NCT01121536 | Apr 2010 → Oct 2013 | bipolar depression | Cephalon | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT01072630 | Mar 2010 → Nov 2012 | depressive disorder | Cephalon | Completed | Missed primary |
| Phase 3 | NCT01072929 | Jan 2010 → Mar 2012 | depressive disorder | Cephalon | Completed | Met primary |
| Phase 3 | NCT01010789 | Nov 2009 → Nov 2014 | binge eating disorder, obesity disorder | Lindner Center of HOPE | Completed | Missed primary |
| Phase 3 | NCT00983437 | Aug 2009 → Jan 2011 | traumatic brain injury | Cephalon | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT00893789 | Apr 2009 → Jan 2011 | traumatic brain injury | Cephalon | Terminated | Mixed Stop: Business |
| Phase 3 | NCT00758498 | Sep 2008 → Feb 2009 | hypersomnia | Cephalon | Completed | Mixed |
| 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 | NCT00079677 | Mar → Oct 2004 | obstructive sleep apnea syndrome | Cephalon | Completed | Met primary |
| Phase 3 | NCT00080288 | Mar → Dec 2004 | circadian rhythm sleep disorder, shift work type, hypersomnia | Cephalon | Completed | Met primary |
| Phase 3 | NCT00078377 | Mar 2004 → Jan 2005 | narcolepsy | 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 · 2 met primary · 1 missed | ||||||
| Phase 4 | NCT01470651 | Oct 2011 → Jun 2014 | hepatitis C virus infection | Research Foundation for Mental Hygiene, Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT01460628 | Oct 2011 → May 2013 | — | Massachusetts General Hospital | Completed | 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 | Missed primary |
| Phase 4 | NCT00737204 | Jun 2008 → Apr 2010 | HIV infectious disease | New York State Psychiatric Institute | Completed | Met primary |
| Phase 4 | NCT00678691 | Aug 2007 → Jun 2009 | fibromyalgia | State University of New York - Upstate Medical University | Completed | Met primary |
| 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 Stop: Enrollment |
| — | 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 |
| Comparator or background therapy13 trials | ||||||
| Phase 1 | NCT02468856 Comparator | May → Nov 2017 | — | University of Florida | Completed | No outcome recorded |
| 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 Stop: Enrollment |
| Phase 2 | NCT01400958 Comparator | Dec 2010 → Dec 2012 | malignant glioma | H. Lee Moffitt Cancer Center and Research Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01096680 Comparator | Apr → Jul 2010 | — | Shire | Completed | Met primary |
| 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 2/3 | NCT00555347 Comparator | Oct 2007 → Aug 2010 | sarcoidosis | University of Cincinnati | Completed | No outcome recorded |
| 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 |
| — | NCT02552303 Comparator | Apr 2014 → Jul 2015 | insomnia, obstructive sleep apnea syndrome | University of Pennsylvania | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2016-11-28 | Lupin Limited | Regulatory Lupin Receives FDA Approval for Generic Nuvigil® Tablets lupin.com ↗
Lupin Limited (Lupin) announced today that its US subsidiary Lupin Pharmaceuticals, Inc. (LPI) has received final approval for its Armodafinil Tablets 50 mg, 150 mg, 200 mg and 250 mg from the United States Food and Drug Administration (FDA) to market a generic version of Cephalon, Inc’s Nuvigil® Tablets 50 mg, 150 mg, 200 mg and 250 mg. |
| 2013-08-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Results 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 ↗
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced top-line results of its final Phase III clinical study for armodafinil (NUVIGIL®) as adjunct therapy in adults with major depression associated with bipolar I disorder. |
| 2013-01-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Results 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 ↗
Teva Pharmaceutical Industries Ltd. today announced top-line results of its Phase III clinical program for armodafinil (NUVIGIL®) as adjunct therapy in adults with major depression associated with bipolar 1 disorder. |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-02-05 | Apotex Inc. | Apotex acquires US rights to PROVIGIL® (modafinil) and NUVIGIL® (armodafinil) apotex.com ↗ |
| 2016-11-28 | Lupin Limited | Lupin Receives FDA Approval for Generic Nuvigil® Tablets lupin.com ↗ |
| 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 NCT00228566 ↗ |
| 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 ↗ |