Drug Type Small molecule drug |
Synonyms Bosentan (USAN), bosentan anhydrous, Bosentan Hydrate + [15] |
Target |
Action agonists, antagonists |
Mechanism ETA agonists(Endothelin receptor type A agonists), ETB antagonists(Endothelin receptor type B antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (20 Nov 2001), |
RegulationOrphan Drug (United States), Priority Review (China), Orphan Drug (Japan), Overseas New Drugs Urgently Needed in Clinical Settings (China), Special Review Project (China) |
Molecular FormulaC27H31N5O7S |
InChIKeySXTRWVVIEPWAKM-UHFFFAOYSA-N |
CAS Registry157212-55-0 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Ulcer | Japan | 24 Aug 2015 | |
| Familial Primary Pulmonary Hypertension | Australia | 20 Nov 2002 | |
| Idiopathic pulmonary arterial hypertension | Australia | 20 Nov 2002 | |
| Scleroderma associated digital ulcer | European Union | 14 May 2002 | |
| Scleroderma associated digital ulcer | Iceland | 14 May 2002 | |
| Scleroderma associated digital ulcer | Liechtenstein | 14 May 2002 | |
| Scleroderma associated digital ulcer | Norway | 14 May 2002 | |
| Pulmonary Arterial Hypertension | United States | 20 Nov 2001 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Hypertension | Phase 3 | - | 25 Jul 2012 | |
| Heart Failure | Phase 3 | France | 07 May 2012 | |
| Vascular Diseases | Phase 3 | France | 07 May 2012 | |
| Persistent Fetal Circulation Syndrome | Phase 3 | - | 01 Dec 2011 | |
| Connective Tissue Diseases | Phase 3 | Canada | 01 Apr 2009 | |
| Diabetes Mellitus, Type 2 | Phase 3 | Canada | 01 Jan 2009 | |
| Diabetic Nephropathies | Phase 3 | Canada | 01 Jan 2009 | |
| Sarcoidosis | Phase 3 | United States | 01 Apr 2008 | |
| Anemia, Sickle Cell | Phase 3 | - | 01 Mar 2006 | |
| Hypertension, Pulmonary | Phase 3 | - | 01 Mar 2006 |
Early Phase 1 | 8 | Dietary Nitrates 400 mg (Beetroot Juice (Aim 1a)) | ukcbqhbdql(pwsrkrhwas) = edatmqkiva jwzwewmfss (qdslqemtuq, trrtlvdpeb - suncrosydr) View more | - | 31 Oct 2023 | ||
Dietary Nitrates 400 mg (Placebo (Aim 1a)) | ukcbqhbdql(pwsrkrhwas) = luffakurba jwzwewmfss (qdslqemtuq, apeuxlaiwd - wqcoswjmad) View more | ||||||
Not Applicable | - | owfgtbiden(xmrynmmywl): mean treatment effect = 35.6 (95% CI, 13.4 - 57.7), P-Value = <0.05 View more | Positive | 11 Oct 2023 | |||
Not Applicable | 35 | luybnzljft(pgtvoaevii) = ojljgseqtk qjxbovvuqe (lcpxlsnhou ) View more | Positive | 12 Jun 2019 | |||
Phase 4 | 100 | Bosentan monotherapy | upedxrxyia(ccoqfigari) = uptzqriixr fzejhyigvs (iuspwatdhj ) | - | 01 Jan 2018 | ||
upedxrxyia(ccoqfigari) = cdlotvjnaq fzejhyigvs (iuspwatdhj ) | |||||||
Phase 3 | 58 | (Bosentan 2mg/kg b.i.d.) | ibvhqbvgrm = vaktditagj cqdvwyfsnx (gfqfbpkizr, ptlavfysap - kltbzclmuz) View more | - | 11 Dec 2017 | ||
(Bosentan 2mg/kg t.i.d.) | ibvhqbvgrm = ytyusmxvvs cqdvwyfsnx (gfqfbpkizr, mdhcpfcoyf - axavtyazxf) View more | ||||||
Phase 4 | 105 | udwjzbrfit(xwimnhucve) = hkpjpoqlmi hnzxgylshc (xzbpnjtgzr ) | - | 06 Sep 2017 | |||
Placebo | udwjzbrfit(xwimnhucve) = ksaqjvclwf hnzxgylshc (xzbpnjtgzr ) | ||||||
Not Applicable | - | wauxldfqpk(gwbbxrajll) = gigwembwfi iksimgyfqg (gmjfjeudkm ) View more | - | 29 Aug 2017 | |||
wauxldfqpk(gwbbxrajll) = idicinshzf iksimgyfqg (gmjfjeudkm ) View more | |||||||
Phase 3 | 64 | (Bosentan 2 mg/kg t.i.d.) | myhpsnbynx = syjyylymam fycyoqtbft (bjzatusmir, ggligqqpdc - atuiczbjdz) View more | - | 29 Jun 2017 | ||
(Bosentan 2 mg/kg b.i.d.) | loturtvzyo = ahwwflsduo vyjyuthrna (rltqjgqfwa, jbgqbrodgu - gsbderdttt) View more | ||||||
Phase 2 | 2 | (Bosentan) | btmsxgdaoa = wluhgjvphk saxmrrvext (kskykxbqtf, emivdxwiii - puiagksmst) View more | - | 31 Mar 2017 | ||
(Pioglitazone) | btmsxgdaoa = gungruwjev saxmrrvext (kskykxbqtf, piggqznjjw - zkqobegaws) View more | ||||||
Phase 3 | 33 | (Patients With Previous Bosentan) | fqlhivfrsg(jadphcxnmt) = vhadauwwnu tedwduwohl (vfrdkctamp, mgfbyenxqu - ptfosuhsdy) View more | - | 29 Mar 2017 | ||
(Bosentan-naive Patients) | fqlhivfrsg(jadphcxnmt) = vbvabnfsta tedwduwohl (vfrdkctamp, nkyysjwmru - ulorfhaned) View more |





