Drugs / Sitaxentan
Sitaxentan
also known as
Sitaxsentan · Thelin · IPI-1040 · SITAXENTAN SODIUM · sitaxsentan sodium · Sitaxsentan sodium salt · TBC-11251 · TBC-11251 SODIUM · +2 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Thelin | — | 2011-01-06 | europa.eu ↗ |
| Approved | EU (EMA) | Thelin | — | 2006-08-10 | europa.eu ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01100736 | Jan → Sep 2009 | isoproterenol-mediated vasodilatation, pulmonary arterial hypertension | University of Edinburgh | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT01251835 | Dec 2010 → Jan 2011 | pulmonary arterial hypertension | Pfizer | Withdrawn | No outcome recorded |
| Phase 1 | NCT01244620 | Nov → Dec 2010 | pulmonary arterial hypertension | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT00981968 | Sep → Nov 2009 | — | Pfizer | Completed | No outcome recorded |
| Phase 24 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT00817037 | Jul 2007 → Jul 2009 | chronic kidney disease, hypertensive disorder, proteinuria | University of Edinburgh | Completed | No outcome recorded |
| Phase 2 | NCT00810732 | May 2007 → Mar 2009 | chronic kidney disease | Pfizer | Completed | Met primary |
| Phase 2 | NCT00838383 | Aug 2006 → Mar 2008 | — | Pfizer | Completed | Missed primary |
| Phase 2 | NCT00303498 | Mar 2006 → May 2008 | diastolic heart failure | Pfizer | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00034307 | — | pulmonary hypertension | ICOS-Texas Biotechnology | Unknown | No outcome recorded |
| Phase 36 trials · 1 met primary | ||||||
| Phase 3 | NCT01210443 | Nov → Dec 2010 | pulmonary arterial hypertension | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT01204853 | Aug → Nov 2010 | pulmonary arterial hypertension | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00796510 | Jul 2010 → Jan 2011 | pulmonary arterial hypertension | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00795639 | Dec 2008 → Mar 2011 | pulmonary arterial hypertension | Pfizer | Terminated | Met primary |
| Phase 3 | NCT00080457 | May 2003 → Jan 2005 | pulmonary hypertension | Encysive Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00811018 | Mar 2003 → Jul 2011 | pulmonary arterial hypertension | Pfizer | Terminated | No outcome recorded |
| Phase not applicable1 trial · 1 met primary | ||||||
| — | NCT00744211 | Jul 2008 → Jun 2011 | heart disorder | VA Office of Research and Development | Completed | Met primary |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT01251848 Comparator | Jan → Feb 2011 | pulmonary arterial hypertension | Pfizer | Withdrawn | No outcome recorded |
| Phase 2 | NCT01050491 Comparator | Nov 2009 → Dec 2010 | — | French National Institute of Health and Medical Research | Terminated | No outcome recorded |
| Phase 3 | NCT00796666 Background | May 2009 → Mar 2011 | pulmonary arterial hypertension | Pfizer | Terminated | Missed primary |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sitaxentan | “randomly assigned to receive 6 weeks dosing with placebo, the selective ETA receptor antagonist, sitaxentan, or long-acting nifedipine.” PMID 31177906 ↗ Jun 2019 |
| Known as | IPI-1040 | ChEMBL registry synonym — accepted as the source's own label CHEMBL282724 ↗ |
| Known as | SITAXENTAN SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL282724 ↗ |
| Known as | Sitaxsentan | “The purpose of this study was to evaluate the efficacy and safety of the selective endothelin type A (ETA) receptor antagonist sitaxsentan in patients who have heart failure...” PMID 24720918 ↗ Feb 201413“Effect of a Receptor Antagonist of Endothelin 1 (Sitaxsentan, Thelin) on Bronchial Remodeling in Severe Asthma” NCT01050491 ↗ |
| Known as | sitaxsentan sodium | “The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan sodium) compared to placebo (sugar pill) in the treatment of patients with pulmonary...” NCT00080457 ↗ |
| Known as | Sitaxsentan sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL282724 ↗ |
| Known as | TBC-11251 | ChEMBL registry synonym — accepted as the source's own label CHEMBL282724 ↗ |
| Known as | TBC-11251 SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL282724 ↗ |
| Known as | TBC-11251NA | ChEMBL registry synonym — accepted as the source's own label CHEMBL282724 ↗ |
| Known as | TBC-11251Z | ChEMBL registry synonym — accepted as the source's own label CHEMBL282724 ↗ |
| Known as | Thelin | “The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan sodium) compared to placebo (sugar pill) in the treatment of patients with pulmonary...” NCT00080457 ↗2“Effect of a Receptor Antagonist of Endothelin 1 (Sitaxsentan, Thelin) on Bronchial Remodeling in Severe Asthma” NCT01050491 ↗ “sitaxsentan (Thelin)” NCT00838383 ↗ |
| Action | Inhibit | “the selective endothelin type A (ETA) receptor antagonist sitaxsentan” PMID 24720918 ↗ Feb 2014 |
| Modality | Small molecule | — CHEMBL282724 ↗ |
| Route | Oral | “sitaxsentan 100 mg (target dose) 0rally once daily” NCT00303498 ↗ |