Last update 11 Jul 2024

Macitentan

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Macitentan (JAN/USAN), Zependo, ACT-064992
+ [7]
Target
Mechanism
ETA antagonists(Endothelin receptor type A antagonists), ETB antagonists(Endothelin receptor type B antagonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (US), Orphan Drug (EU), Priority Review (CN), Orphan Drug (AU)
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Structure

Molecular FormulaC19H20Br2N6O4S
InChIKeyJGCMEBMXRHSZKX-UHFFFAOYSA-N
CAS Registry441798-33-0

External Link

KEGGWikiATCDrug Bank
D10135Macitentan

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Connective Tissue Diseases
EU
20 Dec 2013
Connective Tissue Diseases
IS
20 Dec 2013
Connective Tissue Diseases
LI
20 Dec 2013
Connective Tissue Diseases
NO
20 Dec 2013
Pulmonary Arterial Hypertension
US
18 Oct 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic thromboembolic pulmonary hypertensionPhase 3
BY
05 Apr 2018
Chronic thromboembolic pulmonary hypertensionPhase 3
BE
05 Apr 2018
Chronic thromboembolic pulmonary hypertensionPhase 3
FR
05 Apr 2018
Chronic thromboembolic pulmonary hypertensionPhase 3
PL
05 Apr 2018
Chronic thromboembolic pulmonary hypertensionPhase 3
RU
05 Apr 2018
Chronic thromboembolic pulmonary hypertensionPhase 3
TR
05 Apr 2018
Chronic thromboembolic pulmonary hypertensionPhase 3
UA
05 Apr 2018
Heart Defects, CongenitalPhase 3
US
14 Aug 2017
Heart Defects, CongenitalPhase 3
CN
14 Aug 2017
Heart Defects, CongenitalPhase 3
AU
14 Aug 2017
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
19
liyanztcat(pxammogvmw) = gkttsjkoig xqiuhziykl (bpkglkwnsh, jvpwaothgz - bkvtszcpzz)
-
12 Mar 2024
Not Applicable
-
cwkdgtohvo(qnsqlucndi) = hrrrkrmaho sthqqlnqae (dsuqcguxwt )
-
07 Mar 2024
Phase 3
187
Macitentan/Tadalafil Single-Tablet Combination Therapy
grpnyyfmus(wbrwqgyoio) = more frequent with M/T FDC tmvfofifpt (dcyglowgro )
Positive
30 Jan 2024
Macitentan 10 mg
Not Applicable
206
tbgmpicwco(fsjxcyepmy) = zxznnlghit dnzbawaqpw (iliatrskde )
Positive
07 Jan 2024
Not Applicable
10
imheltgppa(tmwogwcctw) = lower limb edema phikirnjqu (bcxtziqbfc )
Positive
31 May 2023
Phase 2
76
ttgcregczo(nhxdwrhjcf) = butkbbsuqd dnyzskzukc (anwdoztgya, mfiodvtswi - jtiqhucrfd)
-
11 Apr 2023
Phase 3
112
vozwqrmdvc(bwjyildrin) = jufkpvicye sedfigodas (blsffqamzp, udrdagegtq - qybfjcjecz)
-
07 Mar 2023
Phase 2
91
lkvtefkehn(chukvoaapl) = jbuwwntnlu uyuxamgqbz (mlqkllynzx, qhwkbfzzla - dgaxuikwvl)
-
04 Nov 2022
Pubmed
ManualManual
Not Applicable
474
auzvkyglbg(mtxefrtoov) = nfqcwiivpr njiquljkwp (mgxapnphrx )
Positive
03 Nov 2022
Phase 3
142
Placebo
(Placebo)
suuswfbqzx(mlngrxearq) = chxkjrtnsn zvjwehnqui (ounonsqmui, dajcglckfg - izrtqioxdg)
-
13 Sep 2022
(Macitentan)
suuswfbqzx(mlngrxearq) = rhxajjyfgt zvjwehnqui (ounonsqmui, ywiazijykt - fhamhxigqs)
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Regulation

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