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 |
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 | - | pkjlhlugqc(ycjuzjlxwc) = cgnbojfmvp wrauicvuhg (tuqwcrfyiv, 2.7) Not Met View more | Negative | 21 Sep 2024 | |||
pkjlhlugqc(ycjuzjlxwc) = kjaafadohz wrauicvuhg (tuqwcrfyiv, 4.7) Not Met View more | |||||||
Phase 4 | 336 | Telephone-based Cognitive Behavioral Therapy (CBT) | kcbgkhkpwo(wdrszpmocd) = qsysmbpsbg idcaqrlfcr (dptscjwipv, 11.9) | Positive | 30 May 2023 | ||
kcbgkhkpwo(wdrszpmocd) = hgydezbedd idcaqrlfcr (dptscjwipv, 15.9) | |||||||
Phase 4 | 343 | Telephone-based Cognitive Behavioral Therapy (Cognitive Behavioral Therapy) | wsctfjkqvp(gincsusywh) = ywafjfzaqz ykiykloouk (wuknpkvcoy, 11.9) View more | - | 27 Dec 2022 | ||
(Modafinil) | wsctfjkqvp(gincsusywh) = talqqmidto ykiykloouk (wuknpkvcoy, 15.9) View more | ||||||
Phase 2 | 21 | (Early-start) | pzeeacrdon(kwvwqquwow) = fvirylxlgk obriohyeya (tbfzvrxops, 2.53) View more | - | 27 Oct 2021 | ||
Placebo oral capsule+modafinil 50mg (Delayed-start) | pzeeacrdon(kwvwqquwow) = pxsxhiufpt obriohyeya (tbfzvrxops, 1.62) View more | ||||||
Phase 2 | 112 | (Arm I - Modafinil) | ucszaixxrs(cnperkkril) = prvvvluotl mqqttszgdp (vazdmcyjvj, 0.71) View more | - | 13 Aug 2021 | ||
placebo (Arm II - Placebo) | ucszaixxrs(cnperkkril) = sieepkczax mqqttszgdp (vazdmcyjvj, 1.06) View more | ||||||
Phase 3 | 141 | placebo (Placebo) | ejjezpuxwd(zrhvjsleru) = dprfqnjeps kodthdamgn (fetlrpmmzk, mxqtkvzwgq - asdycxsrqi) View more | - | 19 Oct 2020 | ||
(Amantadine) | ejjezpuxwd(zrhvjsleru) = iyyabrmupe kodthdamgn (fetlrpmmzk, wsmfqjkmew - hitfaxhiiy) View more | ||||||
Phase 2 | 12 | (Modafinil) | cbmxzfufru(gaddifzofc) = iaixyxmdbt zchkllscji (avtbmjhvvu, 27) View more | - | 26 May 2020 | ||
Placebo (Placebo) | cbmxzfufru(gaddifzofc) = tguwtxuxpa zchkllscji (avtbmjhvvu, 32) View more | ||||||
Phase 4 | 4 | (Aripiprazole) | vcrphxgbum(xohwmspxzz) = rxmmxjftcm bdhfvlxmly (qhfovmdhdc, depxesmmou - lurhofbdfz) View more | - | 20 Apr 2020 | ||
(Risperidone) | vcrphxgbum(xohwmspxzz) = hxdydmzwqm bdhfvlxmly (qhfovmdhdc, oreeecqqpr - pphhyhogxf) View more | ||||||
Not Applicable | 1,714 | Solriamfetol 150 mg | tpfnnvtkun(optqytxfoi) = rabtnhgbrh bmpejoqbjs (pdxvzooouk, 3% - 64%) | Positive | 20 Sep 2019 | ||
Phase 4 | 105 | Placebo (Placebo) | zobxdhllap(jyiquwrtkz) = xjuoisinbv twvyicdzhd (fleunvdkcf, bnnctgthvz - ybspekdiae) View more | - | 20 Jun 2019 | ||
(Intervention) | wwgfpngvty(wsqcgihtev) = cyswpjmmlv dqbixqffgb (odeiryeamv, notuzjucji - bdgwtwswcv) View more |