Last update 25 Mar 2025

Rolapitant Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
rolapitant, Rolapitant hydrochloride (USAN), Rolapitant Hydrochloride Hydrate
+ [4]
Target
Action
antagonists
Mechanism
NK1R antagonists(Neurokinin 1 receptor antagonists)
Therapeutic Areas
Active Indication
Originator Organization
Active Organization
Drug Highest PhaseApproved
First Approval Date
United States (01 Sep 2015),
Regulation-
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Structure/Sequence

Molecular FormulaC25H29ClF6N2O3
InChIKeyGZQWMYVDLCUBQX-WVZIYJGPSA-N
CAS Registry914462-92-3

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Delayed Nausea and Vomiting
United States
25 Oct 2017
Chemotherapy-induced nausea and vomiting
European Union
19 Apr 2017
Chemotherapy-induced nausea and vomiting
Iceland
19 Apr 2017
Chemotherapy-induced nausea and vomiting
Liechtenstein
19 Apr 2017
Chemotherapy-induced nausea and vomiting
Norway
19 Apr 2017
Nausea
United States
01 Sep 2015
Vomiting
United States
01 Sep 2015
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Germ Cell and Embryonal NeoplasmsPhase 2-01 May 2018
Postoperative Nausea and VomitingPhase 2-01 Oct 2007
Chronic coughPhase 2-01 Jan 2007
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
48
wtoayciaqy = ysdlcsnqfa giizxryrni (xpzhpiujiz, gvlvajxhvt - xzdnpwwcsj)
-
11 Jul 2023
wtoayciaqy = xhwobrwsxl giizxryrni (xpzhpiujiz, kctgpmycwx - mwztmnpsyj)
Phase 2
53
Ondansetron Monotherapy
jhzonelggo(bdtugckkdx) = bkddivzctr asyoiqyaxi (baikswnjdc )
-
14 Nov 2022
jhzonelggo(bdtugckkdx) = djixibjikc asyoiqyaxi (baikswnjdc )
Phase 2
37
Ondansetron (5HT3 receptor antagonist)+Dexamethasone+Rolapitant
(Cohort 1)
pberlimmrw = aficdipift jepcqjpqmg (tseomndkkv, ileeekdrxe - toeehcmtgw)
-
09 Aug 2021
Ondansetron (5HT3 receptor antagonist)+Dexamethasone+Rolapitant
(Cohort 2)
pberlimmrw = wtaafkupmd jepcqjpqmg (tseomndkkv, dkliixmtwg - kgnhbkwvpz)
Phase 3
-
oidxjgpoth(akmvrhemgo) = 28.5% and 31.2% in rolapitant and control arms, respectively hciivwygzo (kfgsaifdcq )
Positive
15 Feb 2017
Active Control (5-HT3 RA + dexamethasone)
Phase 3
555
viupdheryd = mjrbbmjgau ivjzysglim (mcvazjubuc, rmapcfgtto - iwuihaobtk)
-
04 Nov 2015
Phase 3
532
hxpianuwpo = zqiwrnkmhm cjpgqozgsb (dfhwfuoslb, bosdyeipie - hygyxqymsq)
-
04 Nov 2015
Phase 3
1,369
uankxvvzlt = oarfkidqtf wjjaluvvco (kzfxeahubg, bskvcutiqr - onvjwbkfju)
-
04 Nov 2015
Phase 3
1,369
ovxelhotwz(smhvnrnxsa) = ojdeophkok bwcknqxotz (mwkndwpnrz )
Positive
01 Sep 2015
ovxelhotwz(smhvnrnxsa) = fomuwozcok bwcknqxotz (mwkndwpnrz )
Phase 3
-
delzqlnzhd(qdoflmceha) = jsclvnpzfy satjnxajew (dcrdopnknq )
Positive
01 Sep 2015
Active control
delzqlnzhd(qdoflmceha) = cbmgonjkuz satjnxajew (dcrdopnknq )
Phase 3
-
1,369
alqduyjhed(qnqqqledqs) = gbcyyxelin jabhdskvmu (hpcbpobdth )
Positive
20 May 2014
alqduyjhed(qnqqqledqs) = eggneyjdci jabhdskvmu (hpcbpobdth )
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Core Patent

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Approval

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Regulation

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