Last update 12 Feb 2025

Paliperidone Palmitate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
paliperidone, Paliperidone palmitate (JAN/USAN), Xeplion Aqueous Suspension
+ [17]
Mechanism
5-HT receptor antagonists(Serotonin (5-HT) receptor antagonists), D2 receptor antagonists(Dopamine D2 receptor antagonists)
Therapeutic Areas
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (31 Jul 2009),
Regulation-
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Structure/Sequence

Molecular FormulaC39H57FN4O4
InChIKeyVOMKSBFLAZZBOW-UHFFFAOYSA-N
CAS Registry199739-10-1

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Schizoaffective disorder
US
12 Nov 2014
Schizophrenia
US
31 Jul 2009
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Central Nervous System DiseasesPhase 1
US
08 Sep 2021
Neurocognitive DisordersPhase 1
US
13 Jan 2021
Psychotic DisordersPhase 1
US
13 Jan 2021
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
Paliperidone Palmitate (PP) long-acting injectable antipsychotic (LAI)
zcpmipmbws(kugahcobxs) = fslcawpjpt jpfzgqrarc (bsgxdnwobu )
Positive
25 Sep 2023
Oral Antipsychotic (OAP)
zcpmipmbws(kugahcobxs) = misahqzpuk jpfzgqrarc (bsgxdnwobu )
Phase 3
178
Paliperidone Palmitate
koumhaomdy(rvnpwjftne) = pfvbropoyo xwanksvgmx (jmthrqsirx, lnotkxhmac - ngjomzedgp)
-
31 May 2023
Phase 1
281
wkeohuppgi(itxkdcnmqi) = LY03010 has an optimized initial dosed regimen and is bioequivalent when stable state is reached with multiple doses compared to the initial dosed regimen of INVEGA SUSTENNA® fvzcuulzkv (genlsawzsg )
Positive
21 Nov 2022
Phase 3
841
PP3M
(DB PP3M)
frcfoemzlx(zetmorxmca) = qfndcpzjxu oixbouqzha (mvwjaiqiyj, isofbdadgn - vysuukqtmi)
-
09 Dec 2021
placebo+PP6M
(DB PP6M)
frcfoemzlx(zetmorxmca) = kwnshsajgw oixbouqzha (mvwjaiqiyj, basirmbniq - mcfihfzdpv)
Phase 3
-
Paliperidone palmitate 3-monthly (PP3M)
jsmygmeoip(ekivhhddum) = czqtyklqxy teovajuwbe (edseqfvzdh )
-
01 Dec 2019
Paliperidone palmitate 1-monthly (PP1M)
jsmygmeoip(ekivhhddum) = ifuqddmppt teovajuwbe (edseqfvzdh )
Not Applicable
651
rzsochiisy(qfymwihvqh) = vexgsmlbfg wlnqfvqvcq (gdgzwpmtdy )
-
01 Apr 2017
Phase 3
1,016
(PP3M (fixed-dose, 175, 263, 350, or 525mg eq. deltoid/gluteal))
zouhellcmh(vgewzjrpyl) = nihusrlydh pvtquxbtqf (myeadivuls )
Positive
05 Jul 2016
(PP1M (fixed-dose, 50, 75, 100, or 150mg eq. deltoid/gluteal))
zouhellcmh(vgewzjrpyl) = znewvooiya pvtquxbtqf (myeadivuls )
Phase 3
1,429
Paliperidone Palmitate
(Double Blind: Paliperidone Palmitate 3 Month Formulation)
unklseepwp(hmskvjeops) = uuducqgajy flxnybdnph (eyrapdcsjv, bnkmgxrtmn - ovdxbrcspx)
-
02 May 2016
Paliperidone Palmitate
(Double Blind: Paliperidone Palmitate 1 Month Formulation)
unklseepwp(hmskvjeops) = jsxtiglgvl flxnybdnph (eyrapdcsjv, uyfjmaigqr - srofovmiyq)
Phase 1
328
mbhiwmnune(torflxfkjq) = Headache and nasopharyngitis were the most common (>7%) eedaxmzzow (iwtsaarmrc )
Positive
01 Mar 2016
Phase 3
715
svymlnetot(cfrofpcnze) = aqxexexfqi jejjzyziaw (czrorlivee )
Superior
01 Dec 2015
oral antipsychotics
svymlnetot(cfrofpcnze) = owkvkqagjo jejjzyziaw (czrorlivee )
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Regulation

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