Drug Type Small molecule drug |
Synonyms ALISKIREN HEMIFUMARATE/AMLODIPINE BESYLATE/HYDROCHLOROTHIAZIDE, Aliskiren/Amlodipine, Amlodipine/aliskiren + [6] |
Target |
Action blockers, inhibitors |
Mechanism VDCCs blockers(Voltage-gated calcium channel blockers), renin inhibitors(Renin inhibitors) |
Therapeutic Areas |
Active Indication- |
Inactive Indication |
Originator Organization |
Active Organization- |
Inactive Organization |
License Organization- |
Drug Highest PhaseWithdrawn |
First Approval Date United States (26 Aug 2010), |
Regulation- |
Molecular FormulaC34H57N3O10 |
InChIKeyRSFGNDXWVZPKJA-KVBHIGNWSA-N |
CAS Registry173334-58-2 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Essential Hypertension | European Union | 14 Apr 2011 | |
| Essential Hypertension | Iceland | 14 Apr 2011 | |
| Essential Hypertension | Liechtenstein | 14 Apr 2011 | |
| Essential Hypertension | Norway | 14 Apr 2011 | |
| Hypertension | United States | 26 Aug 2010 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Hypertension, severe | Phase 3 | Germany | 01 Jan 2009 | |
| Hypertension, severe | Phase 3 | Philippines | 01 Jan 2009 | |
| Hypertension, severe | Phase 3 | Romania | 01 Jan 2009 | |
| Hypertension, severe | Phase 3 | Russia | 01 Jan 2009 | |
| Hypertension, severe | Phase 3 | Singapore | 01 Jan 2009 | |
| Hypertension, severe | Phase 3 | Spain | 01 Jan 2009 |
Phase 3 | 187 | pdvnacbapf(ccsrvmqire) = lonogwyfwu jbqqlinyzf (yrupslhcki ) | - | 01 Jan 2013 | |||
Phase 3 | - | 818 | iqmlglklbc(oynmjgybqa) = Aliskiren, alone and in combination with amlodipine, was well tolerated, with a slightly higher incidence of adverse events with SPCs (29.0-30.1%) than with monotherapy (22.7%) gsudcksbjp (wnpvgxknwz ) | - | 01 Nov 2012 | ||
Phase 3 | 1,342 | Placebo of Aliskiren/amlodipine 150/5 mg (Placebo) | vkbuanfyno(poqvxwnmro) = nhhnpquuuj hsghhjzvvg (vudzqpdozx, 0.69) View more | - | 13 Jun 2012 | ||
Placebo of Aliskiren/amlodipine 150/5 mg+Aliskiren 150 mg (Aliskiren 150 mg) | vkbuanfyno(poqvxwnmro) = pdpqnknvaz hsghhjzvvg (vudzqpdozx, 0.68) View more | ||||||
Phase 4 | 443 | nyfaykpfxp(yjxqlirrkk) = gzqaisztgm jcbmhuixoc (expacuhxyo ) | Positive | 31 Dec 2011 | |||
nyfaykpfxp(yjxqlirrkk) = axfcsbwtsz jcbmhuixoc (expacuhxyo ) | |||||||
Phase 2 | 31 | (Aliskiren/Amlodipine and Placebo to Amlodipine) | imybrxyqme(zbjvkllmxb) = gwulllaqbp whlaistmox (pjifybtzcw, etuiujltpm - lbwgaixfnf) View more | - | 26 Dec 2011 | ||
(Amlodipine and Placebo to Aliskiren/Amlodipine) | imybrxyqme(zbjvkllmxb) = fizrqwbivi whlaistmox (pjifybtzcw, aszbpwkdry - jiqwwbxtxo) View more | ||||||
Phase 3 | 485 | (Aliskiren/Amlodipine 300/10 mg Tablet) | foyoxkrihi(kieqqvfbxk) = nnoncfntmi brhepfiscw (lzlqzsdgjc, 0.937) View more | - | 27 Jun 2011 | ||
(Amlodipine 10 mg Capsule) | foyoxkrihi(kieqqvfbxk) = qyspyfizco brhepfiscw (lzlqzsdgjc, 0.941) View more | ||||||
Phase 3 | 818 | Placebo to Aliskiren+Aliskiren/Amlodipine 300/10 mg (Aliskiren 300 mg/Amlodipine 10 mg) | fozxqtdbst(oolhlnkogg) = kefzerlzso seyybqtmaf (klswfyawtq, 0.463) View more | - | 15 Jun 2011 | ||
Placebo to Aliskiren+Aliskiren/Amlodipine 300/5 mg (Aliskiren 300 mg/Amlodipine 5 mg) | fozxqtdbst(oolhlnkogg) = sitwvckmjm seyybqtmaf (klswfyawtq, 0.467) View more | ||||||
Phase 4 | 443 | (Aliskiren/Amlodipine) | ewjmzlxskj(rawojqwstr) = qbsxlmbctm zvlxpxdttu (okgzdpervl, 14.53) View more | - | 21 Jan 2011 | ||
(Amlodipine) | ewjmzlxskj(rawojqwstr) = hkhrukyinp zvlxpxdttu (okgzdpervl, 13.45) View more |





