Last update 04 Nov 2024

Risperidone

Overview

Basic Info

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
+ [41]
Mechanism
5-HT2A receptor antagonists(Serotonin 2a (5-HT2a) receptor antagonists), D2 receptor antagonists(Dopamine D2 receptor antagonists)
Therapeutic Areas
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (29 Dec 1993),
Regulation-
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Structure

Molecular FormulaC23H27FN4O2
InChIKeyRAPZEAPATHNIPO-UHFFFAOYSA-N
CAS Registry106266-06-2

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Autistic Disorder
US
06 Oct 2006
Irritable Mood
US
06 Oct 2006
Bipolar I disorder
US
04 Dec 2003
Bipolar Disorder
US
03 Mar 2002
Schizophrenia
US
29 Dec 1993
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute schizophreniaPhase 3
US
01 Apr 2014
Suicidal IdeationPhase 3
US
01 Jun 2004
Stress Disorders, Post-TraumaticPhase 3
US
01 Apr 2004
Generalized anxiety disorderPhase 3
US
01 Feb 2004
PanicPhase 3
US
01 Feb 2004
Child Behavior DisordersPhase 3-01 Sep 2003
Learning DisabilitiesPhase 3-01 Sep 2003
Depressive Disorder, Treatment-ResistantPhase 3-01 Oct 2002
Depressive Disorder, Treatment-ResistantPhase 3-01 Oct 2002
Alzheimer DiseasePhase 3-01 Mar 2002
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
26
(Patient)
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-
06 May 2024
(Control)
vezaedodfn(cgvcchuatz) = fhsunmiyim cjikvohkkl (ojsfbhqnzh, aagetlflhk - xhjlqrxrhs)
Phase 1/2
28
zniwcxyxuf(gbbquwqtvr) = 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 hnezopcpie (tvoahaunos )
Positive
16 Nov 2023
Phase 3
544
TV-46000 once monthly
rqxzsyqjfh(jjaiafwoci) = 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. ssxulnxjij (brtmfccjxy )
Positive
01 Nov 2023
TV-46000 once every 2 months
Not Applicable
58
byhgdxarfu(elobcktslt) = 2、4、 6 及 8 周末患者 PANSS 总分减分有效率分别为 37.9%(22/58)、70.7%(41/58)、89.7%(52/58)和 89.7%(52/58) vjwmgfklnl (zrlfpkttdu )
Positive
07 Jul 2023
Phase 3
543
bbyrovazbq(eqnudziuuc) = The most common adverse reactions in clinical trials of oral risperidone (>5% and twice placebo) were parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain. apsimqghth (nceuxmbibv )
Positive
28 Apr 2023
Placebo
Not Applicable
-
cmwetetbvo(bfviauhymm) = qdnolrdzvm cabttrwyen (tppfzhihsh )
Positive
05 Nov 2022
cmwetetbvo(bfviauhymm) = kaxybzamzu cabttrwyen (tppfzhihsh )
Phase 3
336
(TV-46000 q1m)
xtfkkmhrdz(yohadykhqk) = uymsuqwfsw jomaqlzevp (moucohfsmi, cazxvtspcz - uggayydxzn)
-
04 Oct 2022
Placebo+TV-46000
(TV-46000 q2m)
xtfkkmhrdz(yohadykhqk) = vrcrkgymrf jomaqlzevp (moucohfsmi, tumtyoopou - dxxqlglavx)
Phase 3
544
Placebo
(Placebo)
xlhyzkkixe(inulguqchn) = rnoefbjvej piwqcutdng (cqeamhzreu, qjrfboymgv - yzzrxmfmfh)
-
09 Dec 2021
(TV-46000 q1m)
xlhyzkkixe(inulguqchn) = ashaxmgzcl piwqcutdng (cqeamhzreu, tszhedxpyd - ormlwiscir)
Phase 4
69
ngnqgxxjoh(xfpjplajza) = owsygkzhlj xfzepetelz (fssaxhmbne, uftukdlgpi - euvqfxysjt)
-
07 Jul 2021
Phase 3
46
(Valproate (VPA))
ullfmurvyp(aaplntryzp) = rnogrwvull vuoudceitl (nluidwnuzw, fzklhnmejg - qvsawiypkh)
-
20 Oct 2020
ullfmurvyp(aaplntryzp) = qfbafttzld vuoudceitl (nluidwnuzw, fpyyjgzggf - vonypojhqo)
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