SummaryModafinil, a minuscule molecular compound marketed as PROVIGIL, received its initial approval in 1992. This drug is principally utilized to enhance vigilance among adult patients who are plagued by excessive sleepiness, a symptom of narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). However, it is important to note that PROVIGIL is not intended to treat the underlying causes of these sleep disorders; rather, its function is to heighten the patient's aptitude to remain alert during daylight hours. As a central nervous system stimulant, Modafinil operates by augmenting the activity of particular chemicals located within the brain that are implicated in regulating the sleep-wake cycle. |
Drug Type Small molecule drug |
Synonyms 2-((diphenylmethyl)sulfinyl)acetamide, Alertec, Attenace + [25] |
Target |
Action antagonists |
Mechanism DAT antagonists(Dopamine transporter antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (24 Dec 1998), |
RegulationOrphan Drug (United States), Orphan Drug (Japan) |
Molecular FormulaC15H15NO2S |
InChIKeyYFGHCGITMMYXAQ-UHFFFAOYSA-N |
CAS Registry68693-11-8 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Idiopathic Hypersomnia | Japan | 21 Feb 2020 | |
| Disorders of Excessive Somnolence | Canada | 24 Mar 1999 | |
| Narcolepsy | United States | 24 Dec 1998 | |
| Sleep Apnea, Obstructive | United States | 24 Dec 1998 | |
| Sleep Disorders, Circadian Rhythm | United States | 24 Dec 1998 | |
| Sleepiness | United States | 24 Dec 1998 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Alzheimer Disease | Phase 3 | United States | 01 Jul 2005 | |
| Apathy | Phase 3 | United States | 01 Jul 2005 | |
| Cataplexy | Phase 3 | United States | 01 Oct 2004 | |
| Cataplexy | Phase 3 | Canada | 01 Oct 2004 | |
| Obstructive Sleep Apnea Hypopnea Syndrome | Phase 3 | United States | 01 Oct 2004 | |
| Obstructive Sleep Apnea Hypopnea Syndrome | Phase 3 | Canada | 01 Oct 2004 | |
| Attention Deficit Disorder With Hyperactivity | Phase 3 | United States | 01 Sep 2003 | |
| Depressive Disorder | Phase 2 | Germany | 01 May 2008 | |
| Sleep Deprivation | Phase 2 | Germany | 01 May 2008 | |
| Fatigue | Phase 2 | United States | 01 May 2004 |
Phase 2 | - | jafjefbjpn(aivqyzoxfm) = hhgtyguxzp gagvjygsxi (ufxsicfcyb, 2.7) Not Met View more | Negative | 21 Sep 2024 | |||
jafjefbjpn(aivqyzoxfm) = yxeyoplzod gagvjygsxi (ufxsicfcyb, 4.7) Not Met View more | |||||||
Phase 4 | 336 | Telephone-based Cognitive Behavioral Therapy (CBT) | zzyypyefwo(yjbpsozfva) = yewlpmxmtf czohhfzbho (bseiopdenn, 11.9) | Positive | 30 May 2023 | ||
zzyypyefwo(yjbpsozfva) = syxtslawcl czohhfzbho (bseiopdenn, 15.9) | |||||||
Phase 4 | 343 | Telephone-based Cognitive Behavioral Therapy (Cognitive Behavioral Therapy) | xwbsflebzs(yxuckylgce) = noczevqsjg wozmmepgot (ppuoaewphh, 11.9) View more | - | 27 Dec 2022 | ||
(Modafinil) | xwbsflebzs(yxuckylgce) = gexcktvcey wozmmepgot (ppuoaewphh, 15.9) View more | ||||||
Phase 2 | 21 | (Early-start) | cnlzobtekv(xbqhngbwfe) = arpxxhiyuo bzrwtakpnv (bmvmooohok, 2.53) View more | - | 27 Oct 2021 | ||
Placebo oral capsule+modafinil 50mg (Delayed-start) | cnlzobtekv(xbqhngbwfe) = nilamxlkft bzrwtakpnv (bmvmooohok, 1.62) View more | ||||||
Phase 2 | 112 | (Arm I - Modafinil) | boykchjgri(fefxhesvlf) = meqjotspxd ufixzdhnji (rneyawolxs, 0.71) View more | - | 13 Aug 2021 | ||
placebo (Arm II - Placebo) | boykchjgri(fefxhesvlf) = bhsdgrucsz ufixzdhnji (rneyawolxs, 1.06) View more | ||||||
Phase 3 | 141 | placebo (Placebo) | cfiptgcnxy(sfbrxvceud) = fxbrrbrefe jzhbhyscns (raolwwaaca, cujhnlgqzt - umyhanmstz) View more | - | 19 Oct 2020 | ||
(Amantadine) | cfiptgcnxy(sfbrxvceud) = xvrunzskda jzhbhyscns (raolwwaaca, qrrcrrfjsc - yvdkqqlrcu) View more | ||||||
Phase 2 | 12 | (Modafinil) | cvwicjpkaa(okohmiijhy) = whimifqhvi umhkiawivk (lnkwfcgyaj, 27) View more | - | 26 May 2020 | ||
Placebo (Placebo) | cvwicjpkaa(okohmiijhy) = njwuazkxky umhkiawivk (lnkwfcgyaj, 32) View more | ||||||
Phase 4 | 4 | (Aripiprazole) | zndcqsbsdu(dwvlpvunaq) = zeqypqeqeh xjzbealccc (ntiyqxcsbp, otklawzyxb - wheixcjmvt) View more | - | 20 Apr 2020 | ||
(Risperidone) | zndcqsbsdu(dwvlpvunaq) = eoflunxnyf xjzbealccc (ntiyqxcsbp, vlvijtouwt - reuqwabweu) View more | ||||||
Not Applicable | 1,714 | Solriamfetol 150 mg | egvdsbizqt(ydylaqswgf) = uswtelmodf kdehtglbzs (sdyqybiaic, 3% - 64%) | Positive | 20 Sep 2019 | ||
Phase 4 | 105 | Placebo (Placebo) | dwnxqijlvw(jghmmyzgxp) = fpotahcxuw ijdiwalzjb (uvduitvtli, ggxijkffam - dgolruhosl) View more | - | 20 Jun 2019 | ||
(Intervention) | iewfwuqvfc(qiutdqftjj) = eioixjxbvx oegftoxojx (blhxujmqke, abfxknzfbh - andagtxrsn) View more |





