Rexulti, Rxulti(brexpiprazole)
Brexpiprazole, Rexulti, Rxulti (brexpiprazole) is a small molecule pharmaceutical. Brexpiprazole was first approved as Rexulti on 2015-07-10. It is used to treat major depressive disorder, schizophrenia, and schizophrenia spectrum and other psychotic disorders in the USA. It has been approved in Europe to treat schizophrenia. It is known to target D(2) dopamine receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| mental disorders | D001523 |
Trade Name
FDA
EMA
Brexpiprazole, Rexulti (discontinued: Brexpiprazole)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| brexpiprazole | ANDA | 2022-12-13 |
| rexulti | New Drug Application | 2026-09-18 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BREXPIPRAZOLE, REXULTI, OTSUKA | |||
| 2026-05-10 | I-913 | ||
| 2024-12-27 | NPP | ||
HCPCS
No data
Clinical
Clinical Trials
101 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Schizophrenia | D012559 | EFO_0000692 | F20 | 13 | 5 | 17 | 1 | 3 | 37 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | 4 | 20 | 4 | 2 | 30 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 1 | 3 | 20 | 4 | 2 | 29 |
| Depression | D003863 | — | F33.9 | 1 | 3 | 18 | 5 | 1 | 27 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 1 | — | 4 | 1 | — | 6 |
| Psychotic disorders | D011618 | — | F20.81 | 2 | — | — | 1 | 1 | 4 |
| Treatment-resistant depressive disorder | D061218 | — | — | — | — | 1 | 1 | — | 2 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mental disorders | D001523 | EFO_0000677 | F91.9 | 1 | — | 7 | — | 1 | 9 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | 6 | — | 2 | 8 |
| Dementia | D003704 | EFO_0003862 | F03 | — | 1 | 5 | — | 2 | 7 |
| Psychomotor agitation | D011595 | — | — | — | 1 | 6 | — | 1 | 7 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | 1 | 2 | 3 | — | — | 6 |
| Traumatic stress disorders | D040921 | — | — | 1 | 2 | 3 | — | — | 6 |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | — | — | 5 | — | — | 5 |
| Nervous system diseases | D009422 | — | G00-G99 | 1 | — | 2 | — | 1 | 4 |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | 1 | — | 2 | — | — | 3 |
| Borderline personality disorder | D001883 | — | F60.3 | — | 3 | 1 | — | — | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | 1 | — | — | 1 | 2 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 1 | — | — | — | 1 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | 1 | — | — | — | 1 |
| Hyperkinesis | D006948 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Central nervous system diseases | D002493 | — | G96.9 | 1 | — | — | — | — | 1 |
| Conduct disorder | D019955 | EFO_0004216 | F91 | 1 | — | — | — | — | 1 |
| Attention deficit and disruptive behavior disorders | D019958 | — | F91.3 | 1 | — | — | — | — | 1 |
| Oppositional defiant disorder | D000096865 | — | — | 1 | — | — | — | — | 1 |
| Problem behavior | D000066553 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 1 | 1 |
| Tic disorders | D013981 | — | F95 | — | — | — | — | 1 | 1 |
| Aggression | D000374 | EFO_0003015 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Brexpiprazole |
| INN | brexpiprazole |
| Description | Brexpiprazole is a N-arylpiperazine. |
| Classification | Small molecule |
| Drug class | antiulcer agents (benzimidazole derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=c1ccc2ccc(OCCCCN3CCN(c4cccc5sccc45)CC3)cc2[nH]1 |
Identifiers
| PDB | — |
| CAS-ID | 913611-97-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2105760 |
| ChEBI ID | — |
| PubChem CID | 11978813 |
| DrugBank | DB09128 |
| UNII ID | 2J3YBM1K8C (ChemIDplus, GSRS) |
Target
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Safety
Black-box Warning
Black-box warning for: Brexpiprazole, Rexulti
Adverse Events
Top Adverse Reactions
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15,123 adverse events reported
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