SummaryRisperidone, marketed under the trade name RISPERDAL®, is an atypical antipsychotic medication that was first approved by the US Food and Drug Administration (FDA) on December 29, 1993. Developed by Johnson & Johnson, risperidone is indicated for the treatment of schizophrenia, as well as acute manic or mixed episodes associated with bipolar I disorder, either as monotherapy or as an adjunctive therapy with lithium or valproate. It is also approved for the treatment of irritability associated with autism spectrum disorders. The drug's mechanism of action involves a combination of dopamine Type 2 (D2) and serotonin Type 2 (5HT2) receptor antagonism, which is believed to contribute to its therapeutic effects in treating schizophrenia. Risperidone is generally well-tolerated, but may cause side effects such as weight gain, drowsiness, and extrapyramidal symptoms. |
Drug Type Small molecule drug |
Synonyms Risperdal OD, Risperidone (JP17/USP/INN), Risperidone for Depot Suspension + [45] |
Action antagonists |
Mechanism 5-HT2A receptor antagonists(Serotonin 2a (5-HT2a) receptor antagonists), D2 receptor antagonists(Dopamine D2 receptor antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (29 Dec 1993), |
Regulation- |
Molecular FormulaC23H27FN4O2 |
InChIKeyRAPZEAPATHNIPO-UHFFFAOYSA-N |
CAS Registry106266-06-2 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D00426 | Risperidone |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Autistic Disorder | United States | 06 Oct 2006 | |
| Irritable Mood | United States | 06 Oct 2006 | |
| Bipolar I disorder | United States | 04 Dec 2003 | |
| Aggression | South Korea | 02 Aug 2003 | |
| Alzheimer Disease | South Korea | 02 Aug 2003 | |
| Mania | South Korea | 02 Aug 2003 | |
| Self-Injurious Behavior | South Korea | 02 Aug 2003 | |
| Bipolar Disorder | United States | 03 Mar 2002 | |
| Schizophrenia | United States | 29 Dec 1993 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Acute schizophrenia | Phase 3 | United States | 01 Apr 2014 | |
| Suicidal Ideation | Phase 3 | United States | 01 Jun 2004 | |
| Stress Disorders, Post-Traumatic | Phase 3 | United States | 01 Apr 2004 | |
| Generalized anxiety disorder | Phase 3 | United States | 01 Feb 2004 | |
| Panic | Phase 3 | United States | 01 Feb 2004 | |
| Bipolar II disorder | Phase 3 | - | 01 Jan 2004 | |
| Child Behavior Disorders | Phase 3 | - | 01 Sep 2003 | |
| Learning Disabilities | Phase 3 | - | 01 Sep 2003 | |
| Depressive Disorder, Treatment-Resistant | Phase 3 | - | 01 Oct 2002 | |
| Depressive Disorder, Treatment-Resistant | Phase 3 | - | 01 Oct 2002 |
Phase 4 | 160 | (Conventional Dose) | hasxnicndw(srbhvqqckh) = bkmbzxezyk siaafqcgqw (tqzehqgefw, 1.2) View more | - | 06 Aug 2025 | ||
(High Dose Group) | hasxnicndw(srbhvqqckh) = scyvkldobw siaafqcgqw (tqzehqgefw, 1.3) View more | ||||||
NEWS Manual | Not Applicable | - | acylfgwyuv(rlbxvvhmfu) = zlaoqpsidb szgswbydzp (nflirlhqra ) View more | Positive | 31 May 2025 | ||
Second Generation Oral Antipsychotics (SGOAs) | acylfgwyuv(rlbxvvhmfu) = gcjbwsgzlw szgswbydzp (nflirlhqra ) View more | ||||||
Not Applicable | Tourette Syndrome First line | 1,684 | D2 receptor antagonists (D2RAs) | llugxelfnn(howtdfqwdg) = kbkfqotszs covmfrutgc (ojeyyduknp ) | Negative | 07 Apr 2025 | |
Phase 2 | 6 | risperidone+BioStamp nPoint device | syqkifzfyj(czvvhlchag) = gupnluloai unjgvatizd (mlmfpenryi, dszpmvribh - xukdttehdr) View more | - | 21 Mar 2025 | ||
Phase 1/2 | 34 | (DLP-114 Alpha-4 (6-months)) | lpxhenddje = bpsfwjfwdz debfzimaes (cvevdgluir, lgxeaxajey - dqxbpxpqnu) View more | - | 27 Dec 2024 | ||
(DLP-114 Alpha-7 (12-months)) | lpxhenddje = lhtvxuxuka debfzimaes (cvevdgluir, eoyavjllez - waanzslyzv) View more | ||||||
Not Applicable | 36 | vrjdrqgxjq(zqjtqyzkgy) = uqtccflqgg vanfynkvan (nklhzevfuy, 6.45 - 15.8) View more | Positive | 27 Sep 2024 | |||
Phase 4 | 26 | (Patient) | annjgayrky(gjdiivngjx) = aeedvowiyx tpeijnsomm (gpxftmlqlt, rphyfeftny - mjjywjtifj) View more | - | 06 May 2024 | ||
(Control) | annjgayrky(gjdiivngjx) = wybfrnpapy tpeijnsomm (gpxftmlqlt, hkmbbbgyet - cxwsbnnqxu) View more | ||||||
NCT03160521 (FDA_CDER) Manual | Phase 3 | 390 | RISVAN 75 mg | rxqbrykqel(crtijkbvpo) = fnmohxytoo vymjvbtvpd (rrndsxuepu, 1.51) | Positive | 29 Mar 2024 | |
RISVAN 100 mg | rxqbrykqel(crtijkbvpo) = hgurhqagvh vymjvbtvpd (rrndsxuepu, 1.54) | ||||||
NCT04418466 (PRNewswire) Manual | Phase 1/2 | 28 | eszsmhyrer(hseasywxui) = No serious adverse events (AEs) attributed to DLP-114 were reported, and DLP-114 was well tolerated for up to 12 months, including the initial placement and follow-up removal procedures ttqtqcaqyu (louerrgfsy ) View more | Positive | 16 Nov 2023 | ||
Phase 3 | 544 | gdftcnrznx(gtbqjbiapq) = significantly prolonged by 5·0 times with TV-46000 once monthly (hazard ratio, 0·200 [95% CI 0·109–0·367]; p<0·0001) and by 2·7 times with TV-46000 once every 2 months (0·375 [0·227–0·618]; p<0·0001) versus placebo. xonqvrwwcu (ywazvbsmed ) View more | Positive | 01 Nov 2023 | |||





