SummaryAripiprazole, also known by its trade name Abilify Discmelt®, is an atypical antipsychotic medication that is utilized in the treatment of a diverse range of mood and psychotic disorders, including but not limited to schizophrenia, bipolar I disorder, major depressive disorder, irritability linked with autism, and Tourette's syndrome. This medication functions through its mechanism of action as both a 5-HT2A agonist and a D2 receptor agonist. Aripiprazole was first approved by the US FDA in 2002, with Otsuka Holdings as the pharmaceutical company responsible for its development. Its primary indication is for the treatment of schizophrenia. |
Drug Type Small molecule drug |
Synonyms ABILIFY MAINTENA, Abilify MyCite, Abilify Prolonged Release Aqueous Suspension + [35] |
Action agonists, antagonists |
Mechanism 5-HT1A receptor agonists(Serotonin 1a (5-HT1a) receptor agonists), 5-HT2A receptor antagonists(Serotonin 2a (5-HT2a) receptor antagonists), D2 receptor agonists(Dopamine D2 receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Drug Highest PhaseApproved |
First Approval Date United States (15 Nov 2002), |
RegulationOrphan Drug (United States), Priority Review (China) |
Molecular FormulaC23H27Cl2N3O2 |
InChIKeyCEUORZQYGODEFX-UHFFFAOYSA-N |
CAS Registry129722-12-9 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D01164 | Aripiprazole |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Autism Spectrum Disorder | Japan | 28 Sep 2016 | |
Tourette Syndrome | United States | 12 Dec 2014 | |
Tourette Syndrome | United States | 12 Dec 2014 | |
Depressive Disorder | Japan | 14 Jun 2013 | |
Autistic Disorder | United States | 19 Nov 2009 | |
Irritable Mood | United States | 19 Nov 2009 | |
Depressive Disorder, Major | United States | 16 Nov 2007 | |
Depressive Disorder, Major | United States | 16 Nov 2007 | |
Agitation | United States | 29 Oct 2007 | |
Bipolar Disorder | United States | 10 Dec 2004 | |
Bipolar I disorder | Australia | 21 May 2003 | |
Mania | Australia | 21 May 2003 | |
Schizophrenia | United States | 15 Nov 2002 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Dementia due to Alzheimer's disease (disorder) | Phase 3 | Japan | 11 Jun 2014 | |
Depression, Postpartum | Phase 3 | Canada | 01 Jun 2011 | |
Major depressive disorder, moderate (MDD) | Phase 3 | United States | 29 Jul 2010 | |
Major depressive disorder, moderate (MDD) | Phase 3 | Australia | 29 Jul 2010 | |
Major depressive disorder, moderate (MDD) | Phase 3 | Bulgaria | 29 Jul 2010 | |
Major depressive disorder, moderate (MDD) | Phase 3 | India | 29 Jul 2010 | |
Major depressive disorder, moderate (MDD) | Phase 3 | Philippines | 29 Jul 2010 | |
Major depressive disorder, moderate (MDD) | Phase 3 | Romania | 29 Jul 2010 | |
Major depressive disorder, moderate (MDD) | Phase 3 | Slovakia | 29 Jul 2010 | |
Bipolar and Related Disorders | Phase 3 | United States | 01 Jul 2010 |
Phase 3 | 75 | (Aripiprazole) | efoemtjgwt(vcqmwwxiof) = bgiyhloeex icthhbkmum (rhzlgldmoa, 5.86) View more | - | 19 Sep 2024 | ||
Placebo (Placebo) | efoemtjgwt(vcqmwwxiof) = nfjwrebjif icthhbkmum (rhzlgldmoa, 4.23) View more | ||||||
Not Applicable | 54 | Placebo (Cohort 1: D-Tect Patch + Placebo-embedded IEM) | houqeajhog = yxawghbadt verxvvulro (cecxjopida, iptjxqckgd - dlriottmyo) View more | - | 31 Jul 2024 | ||
(Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM)) | atztirhlvl(rssdwiuzue) = fqoczunqgp natfwlhlxv (tqsqxqsuyn, ggfpmmzzdq - akjzroocol) View more | ||||||
FDA_CDER Manual | Not Applicable | - | (Study 1) | nmgovfhwyf(bakdgucdpz) = kzlkrswhum wtemxsyzlu (zcgkpciygn, 2.40) View more | Positive | 22 Jul 2024 | |
(Study 1) | nmgovfhwyf(bakdgucdpz) = cqtvoypqxa wtemxsyzlu (zcgkpciygn, 2.39) | ||||||
NCT03487783 (Pubmed) Manual | Phase 3 | 121 | Aripiprazole oral solution | hxanpjjzjw(vgowbwohpy): Difference (LS Mean) = -5.5 (95% CI, - 8.4 - - 2.6) View more | Positive | 18 Jul 2024 | |
Placebo | |||||||
Not Applicable | - | gjypawsnzl(nspvhnhmjz) = He was admitted to the ICU for management of DKA and hypertriglyceridemic pancreatitis with an insulin drip. tfihqmtxsu (jhiodqzdan ) View more | - | 19 May 2024 | |||
Phase 4 | 260 | mzncxbeauq(oyealssgys) = cwhbadhfbe vzynputofz (sopwyhrgfq, 1.1) View more | Negative | 07 Mar 2024 | |||
Repetitive transcranial magnetic stimulation | mzncxbeauq(oyealssgys) = detfizkmgm vzynputofz (sopwyhrgfq, 1.3) View more | ||||||
Phase 1/2 | 266 | (Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder) | frnhoytvng = gpiltoeevc jhbwtpgdtm (ikludiufhs, ezmpvbkgev - ncdlnxygjy) View more | - | 18 Nov 2023 | ||
(Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder) | frnhoytvng = wdngiqvgph jhbwtpgdtm (ikludiufhs, xgbvfyimyw - jrddmmfxle) View more | ||||||
Phase 4 | 9 | (Aripiprazole) | jntnwhcfew(razzforcim) = ghchecyeku sltcbxezey (fujktjrtby, zcthehcxyu - ejlwgpdfpp) View more | - | 15 Nov 2023 | ||
(Fluoxetine) | jntnwhcfew(razzforcim) = jpmlzwymgb sltcbxezey (fujktjrtby, ngvpyidzcg - iwntpkxmue) View more | ||||||
Phase 3 | - | Aripiprazole 2-month ready-to-use 960 mg | eryzfbyfkb(qqxpmycjcw) = Ari 2MRTU 960: 21.7%; AOM 400: 18.3% pxquxmroms (jsmtwqhdkg ) | Positive | 04 Sep 2023 | ||
Aripiprazole once-monthly 400 mg | |||||||
Not Applicable | - | Patients prescribed Abilify | yvpwoktgba(plgunafgfc) = dsptxmkugt tsjfgqtrqq (xizcrxvzjx ) View more | Positive | 28 Jun 2023 |