Drug Type Small molecule drug |
Synonyms 2-butyl-3-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1,3-diazaspiro[4.4]non-1-en-4-one, Aprovel, Irbesartan (JP17/USP/INN) + [31] |
Target |
Mechanism AT1R antagonists(Angiotensin II Receptor Type 1 antagonists) |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date EU (26 Aug 1997), |
Regulation- |
Molecular FormulaC25H28N6O |
InChIKeyYOSHYTLCDANDAN-UHFFFAOYSA-N |
CAS Registry138402-11-6 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D00523 | Irbesartan |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Type 2 diabetes mellitus with established diabetic nephropathy | US | 30 Sep 1997 | |
Diabetes Mellitus, Type 2 | EU | 26 Aug 1997 | |
Diabetes Mellitus, Type 2 | IS | 26 Aug 1997 | |
Diabetes Mellitus, Type 2 | LI | 26 Aug 1997 | |
Diabetes Mellitus, Type 2 | NO | 26 Aug 1997 | |
Essential Hypertension | EU | 26 Aug 1997 | |
Essential Hypertension | IS | 26 Aug 1997 | |
Essential Hypertension | LI | 26 Aug 1997 | |
Essential Hypertension | NO | 26 Aug 1997 | |
Hypertension | EU | 26 Aug 1997 | |
Hypertension | IS | 26 Aug 1997 | |
Hypertension | LI | 26 Aug 1997 | |
Hypertension | NO | 26 Aug 1997 | |
Kidney Diseases | EU | 26 Aug 1997 | |
Kidney Diseases | IS | 26 Aug 1997 | |
Kidney Diseases | LI | 26 Aug 1997 | |
Kidney Diseases | NO | 26 Aug 1997 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Fibrosis, Liver | Phase 3 | FR | 01 Oct 2006 | |
Hepatitis C, Chronic | Phase 3 | FR | 01 Oct 2006 | |
Acute Coronary Syndrome | Phase 3 | US | 01 Feb 2006 | |
Acute Coronary Syndrome | Phase 3 | BE | 01 Feb 2006 | |
Acute Coronary Syndrome | Phase 3 | CA | 01 Feb 2006 | |
Acute Coronary Syndrome | Phase 3 | FR | 01 Feb 2006 | |
Acute Coronary Syndrome | Phase 3 | DE | 01 Feb 2006 | |
Acute Coronary Syndrome | Phase 3 | HU | 01 Feb 2006 | |
Acute Coronary Syndrome | Phase 3 | IT | 01 Feb 2006 | |
Acute Coronary Syndrome | Phase 3 | NL | 01 Feb 2006 |
Not Applicable | 38 | Nebivolol 5mg | hwtdopesdd(xiicxpsdhl) = hchwagbinh pwlxezprky (hwvwwkybhc, SD:9.75±2.12 - wSD:9.34±2.01) View more | Positive | 13 Jun 2019 | ||
hwtdopesdd(xiicxpsdhl) = jnjtmvqryo pwlxezprky (hwvwwkybhc, SD:10.84±1.98 - wSD:10.25±2.01) View more | |||||||
Not Applicable | Hypertension N-acetyl-β-d-glucosaminidase | α1-microglobulin | β2-microglobulin | 87 | Group 1: Newly administered Irb(100 mg) | guygxqimzl(zetxdsbwof) = UPC decreased in the Irb-administered groups (p<0.05), but there were no significant differences in the other urinary markers xxxxdhwgjg (xqvihhejkk ) View more | - | 26 May 2017 | |
Group 2: Switched to Irb | |||||||
Phase 3 | 4,128 | (Patients with diabetes mellitus) | hrvozhowqi(tzcidikmpy) = sblnzqubtu qjmvnwmzjf (ibukrzrlvc ) View more | - | 21 Feb 2017 | ||
(Patients without diabetes mellitus) | hrvozhowqi(tzcidikmpy) = xjptqospya qjmvnwmzjf (ibukrzrlvc ) View more | ||||||
Phase 2/3 | 115 | (Atenolol) | qcnplsufps(ucsqxauine) = cwvulvzytk fzxdsbzgmz (rfugjwygdq, svyanijkyc - onmglwvcae) View more | - | 05 May 2015 | ||
(Irbesartan) | qcnplsufps(ucsqxauine) = qoyzwyviow fzxdsbzgmz (rfugjwygdq, ozwqxwdvkn - krwiwaxypw) View more | ||||||
Not Applicable | - | ujowjinphk(zasxmajsng) = oramyfckxq rbrcbbwgya (oibkbaivpt ) View more | - | 05 Nov 2013 | |||
Phase 3 | - | 82 | rmyczaxgyg(zeatypcxjj) = tczlmplysz rfxxrlpola (iwqxqxjckl ) | Negative | 05 Nov 2013 | ||
Placebo | rmyczaxgyg(zeatypcxjj) = ldujcotsgi rfxxrlpola (iwqxqxjckl ) | ||||||
Not Applicable | - | Irbesartan 75mg/d | wchszmfelw(zeawrmlurp) = ktbhmfsyau kmazwcrruj (ssullxtjoh, 16.9) View more | Positive | 12 Jun 2013 | ||
Placebo | wchszmfelw(zeawrmlurp) = jiundynosf kmazwcrruj (ssullxtjoh, 16.86) | ||||||
Phase 4 | 36 | kqflmecmhw(gswevydswj) = yvvogdkfcv dmpsqdqudj (ygzurvjncs ) View more | Positive | 29 Nov 2012 | |||
Not Applicable | 29 | uhgaigkfdl(izjksvodzm) = fubuoohrpf jqlnbffqvk (hnxjmqdxpc ) View more | Positive | 30 Oct 2012 |