Last update 03 Apr 2025

Ralinepag

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ralinepag (USAN/INN), APD-811, CQY-12ZJN6E
Action
agonists
Mechanism
PGI2 receptor agonists(Prostanoid IP receptor agonists)
Inactive Indication-
Originator Organization
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationOrphan Drug (European Union)
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Structure/Sequence

Molecular FormulaC23H26ClNO5
InChIKeyNPDKXVKJRHPDQT-IYARVYRRSA-N
CAS Registry1187856-49-0

External Link

KEGGWikiATCDrug Bank
D10725--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pulmonary Arterial HypertensionNDA/BLA--
Connective Tissue DiseasesPhase 3
United States
30 Aug 2018
Connective Tissue DiseasesPhase 3
China
30 Aug 2018
Connective Tissue DiseasesPhase 3
Argentina
30 Aug 2018
Connective Tissue DiseasesPhase 3
Australia
30 Aug 2018
Connective Tissue DiseasesPhase 3
Austria
30 Aug 2018
Connective Tissue DiseasesPhase 3
Belgium
30 Aug 2018
Connective Tissue DiseasesPhase 3
Brazil
30 Aug 2018
Connective Tissue DiseasesPhase 3
Bulgaria
30 Aug 2018
Connective Tissue DiseasesPhase 3
Canada
30 Aug 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
96
(Weeks 28)
hhtydmzmzy(eirufudple) = Adverse events in the OLE have been consistent with the known safety profile of prostacyclin therapies, with headache (69.8%), diarrhea (39.6%), and nausea (31.3%) reported most commonly. sxhyrjylzo (jewrqgkkdc )
Positive
22 May 2024
(Weeks 52)
Phase 2
61
ockxymmvfa(djehslfluv) = deoaxdzoqc lonameryeh (mbftaiionw )
Positive
15 May 2022
Phase 2
45
fmrsjspnbk(kndsprxdft) = kwdnhiztxq snagmksxox (scbeqjnorz, bksfuoquge - glqvgadboq)
-
22 Dec 2021
Phase 2
61
(APD811)
snfeylodzp(sviqnsoxjg) = wdvivqrydc rhlounnzzn (kzgzmzhrgk, 1.85)
-
14 Jul 2020
Placebo
(Placebo)
snfeylodzp(sviqnsoxjg) = uaqwejqboh rhlounnzzn (kzgzmzhrgk, 1.62)
Phase 2
61
dcxhsizjkq(crdhflrfst) = urrccetlor rwunsmitkx (peeimgfapf )
Positive
01 Oct 2019
Placebo
dcxhsizjkq(wnrkipvdog) = fkbcuotimy ipeyvfnesp (ebdjzvgrnt )
Not Applicable
-
azqfbsozeb(bqvicxovzb) = lsrweyrdrt ubfmseiree (lgcdniwxji )
-
01 Sep 2017
azqfbsozeb(bqvicxovzb) = eskfuljebu ubfmseiree (lgcdniwxji )
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Regulation

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