Drug

Sitaxentan

Approved medicine

ClassEndothelin receptor, ET-A/ET-B antagonistResearchOngoing clinical research

Also known as Sitaxsentan.

RxNorm659161 ChEMBLCHEMBL282724 ATCC02KX03UNIIJ9QH779MEM

Protein targets

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

SELECTIVE ENDOTHELIN TYPE A RECEPTOR INHIBITION IN CARDIAC SURGERY SUBJECTS WITH PRE-EXISTING CARDIOVASCULAR RISK FACTORS: A DOSE CONFIRMATION STUDY

Clinical trial2022-09-08Results posted · ClinicalTrials.gov

Drug Safety Update: Sitaxentan (Thelin▼): worldwide withdrawal from the market

Regulatory2014-12-11MHRA

A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension

Clinical trial2011-07-01Terminated · ClinicalTrials.gov

A Phase 3, Multi-Center, Randomized, Double-Blind, Efficacy And Safety Study Of Monotherapy Sitaxsentan Sodium Versus Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension Who Have Completed Study B1321001 (NCT00795639)

Clinical trial2011-03-01Terminated · ClinicalTrials.gov

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety And Efficacy Study Of Sitaxsentan Sodium In Subjects With Pulmonary Arterial Hypertension

Clinical trial2011-03-01Terminated · ClinicalTrials.gov

A Phase 1, Open Label, Randomized, Multiple Dose Study To Assess The Two-Way Drug Interaction Between Sitaxsentan And Low Dose Ritonavir In Healthy Subjects

Clinical trial2011-02-01Withdrawn · ClinicalTrials.gov

A Phase 1, Open Label, Fixed Sequence Design, Multiple Dose Study To Assess The Effect Of Rifampin On The Pharmacokinetics Of Sitaxsentan In Healthy Subjects

Clinical trial2011-01-01Withdrawn · ClinicalTrials.gov

A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension

Clinical trial2011-01-01Terminated · ClinicalTrials.gov

A Phase 1, Open Label, Randomized, Four Period, Crossover, Multiple Dose Study To Assess The Pharmacokinetic Interaction Between Sitaxsentan and Tadalafil and The Effect Of Sildenafil On Sitaxsentan PK In Healthy Subjects

Clinical trial2010-12-01Terminated · ClinicalTrials.gov

A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension

Clinical trial2010-12-01Terminated · ClinicalTrials.gov

Effect of a Receptor Antagonist of Endothelin 1 (Sitaxsentan, Thelin) on Bronchial Remodeling in Severe Asthma With Fixed Bronchial Obstruction

Clinical trial2010-12-01Terminated · ClinicalTrials.gov

A Phase 3, Multi-Center, Open Label Study To Evaluate The Safety And Efficacy Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension

Clinical trial2010-11-01Terminated · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Sitaxentan

Aliases & brands

Sitaxsentan

RxNorm CUI

659161

ChEMBL ID

CHEMBL282724

ATC codes

C02KX03

UNII

J9QH779MEM

Primary mechanism

Endothelin receptor, ET-A/ET-B antagonist

Regulatory jurisdictions

mhra

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Endothelin receptor type B

EDNRB · P24530

ANTAGONISTEndothelin receptor, ET-A/ET-B antagonist

Endothelin-1 receptor

EDNRA · P25101

ANTAGONISTEndothelin receptor, ET-A/ET-B antagonist

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities

MHRA

Total events

mhraMedicines and Healthcare products Regulatory Agency· 1 event

2014-12-11Safety communicationSafety

Drug Safety Update: Sitaxentan (Thelin▼): worldwide withdrawal from the market

Evidence ↗

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).