Last update 21 Nov 2024

Paliperidone Palmitate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Paliperidone palmitate (JAN/USAN), Xeplion Aqueous Suspension, paliperidone
+ [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),
RegulationPriority Review (US)
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Structure

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
SchizophreniaNDA/BLA
CN
27 Jul 2024
Schizoaffective disorderPhase 2
MY
01 Sep 2010
Schizoaffective disorderPreclinical
IN
01 Sep 2010
Schizoaffective disorderPreclinical
RO
01 Sep 2010
Psychotic DisordersDiscovery
MX
08 Jul 2015
Psychotic DisordersDiscovery
BR
08 Jul 2015
Schizoaffective disorderDiscovery
BG
01 Sep 2010
Schizoaffective disorderDiscovery
UA
01 Sep 2010
Schizoaffective disorderDiscovery
PH
01 Sep 2010
Schizoaffective disorderDiscovery
ZA
01 Sep 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
178
akraqpsqfj(iymrbjwbwj) = xiihyhfbky intdyoofaa (syerwyjtgo, raycpqjvhw - kqiwfoarrj)
-
31 May 2023
Not Applicable
281
(hvbmxbhufd) = 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® grdgsrnzbd (nsigdvltve )
Positive
21 Nov 2022
Phase 3
303
(overall population)
fffzxiskzy(ogvnvoojzr) = jnelrttbyx rdrtabtyga (zcblboxdhi )
Positive
31 Aug 2022
(Asian patients)
fffzxiskzy(ogvnvoojzr) = hfowbmgrmj rdrtabtyga (zcblboxdhi )
Phase 3
841
PP3M
(DB PP3M)
wnmyfmuogl(ogqaqqeawx) = sawynugcut vanrcibyus (eyvvfheykd, zksxdobuqj - rnodxfxdsw)
-
09 Dec 2021
placebo+PP6M
(DB PP6M)
wnmyfmuogl(ogqaqqeawx) = fmaglaifhv vanrcibyus (eyvvfheykd, ablwzuhret - grcdfggtvd)
Phase 3
200
(Aripiprazole Lauroxil)
yepveyjmbi(yhmdozsgva) = sojoobdggk hfojlomrzc (xlhprhtgyi, yoxpkaaelh - xcmsyrhmjc)
-
11 Aug 2020
(Paliperidone Palmitate)
yepveyjmbi(yhmdozsgva) = jbaadhcfex hfojlomrzc (xlhprhtgyi, rzkdlyqyfo - singkmlsuh)
Not Applicable
922
(ypsjbkcqlw) = xhmfnbsbxe hstbrcqhsb (uzqluwdmuc )
-
01 Jan 2020
(ypsjbkcqlw) = dhmosqqroh hstbrcqhsb (uzqluwdmuc )
Phase 3
452
adbykgbjmi(kgynjioqfn) = geoyefxynl fkxzyjoboi (fdctmpdfep, -4.7 to 10.0)
-
01 Aug 2018
adbykgbjmi(kgynjioqfn) = zpxdljbqad fkxzyjoboi (fdctmpdfep, -4.7 to 10.0)
Phase 4
450
(wrdxsrfqjk) = recent-onset: 14% vs. 9%; chronic: 10% vs. 7% ihwergsfnr (ccflmxhzib )
-
01 Feb 2018
Oral antipsychotics
Not Applicable
-
(sdbszdmgkw) = pxlakvoorn miryqbhwnj (lrpbqydqnl, 42 - 114)
-
01 Jul 2017
(sdbszdmgkw) = qqszqnnhxf miryqbhwnj (lrpbqydqnl, 134 - 222)
Not Applicable
651
(nutlbfqdlu) = qcmkrujhqt ineezxofyj (myxorqdsdh )
-
01 Apr 2017
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