Drug Type Monoclonal antibody |
Synonyms Evolocumab (Genetical Recombination), Evolocumab (genetical recombination) (JAN), Evolocumab (USAN/INN) + [4] |
Target |
Action inhibitors |
Mechanism PCSK9 inhibitors(Proprotein convertase subtilisin kexin type 9 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (17 Jul 2015), |
RegulationOrphan Drug (United States) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D10557 | Evolocumab |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Coronary Disease | China | 14 Feb 2019 | |
| Hypercholesterolemia | Japan | 22 Jan 2016 | |
| Hypercholesterolemia, Familial | Japan | 22 Jan 2016 | |
| Heterozygous familial hypercholesterolemia | United States | 27 Aug 2015 | |
| Primary Hyperlipidemia | United States | 27 Aug 2015 | |
| Atherosclerosis | European Union | 17 Jul 2015 | |
| Atherosclerosis | Iceland | 17 Jul 2015 | |
| Atherosclerosis | Liechtenstein | 17 Jul 2015 | |
| Atherosclerosis | Norway | 17 Jul 2015 | |
| Complex dyslipidemia | European Union | 17 Jul 2015 | |
| Complex dyslipidemia | Iceland | 17 Jul 2015 | |
| Complex dyslipidemia | Liechtenstein | 17 Jul 2015 | |
| Complex dyslipidemia | Norway | 17 Jul 2015 | |
| Homozygous familial hypercholesterolemia | European Union | 17 Jul 2015 | |
| Homozygous familial hypercholesterolemia | Iceland | 17 Jul 2015 | |
| Homozygous familial hypercholesterolemia | Liechtenstein | 17 Jul 2015 | |
| Homozygous familial hypercholesterolemia | Norway | 17 Jul 2015 | |
| Myocardial Infarction | European Union | 17 Jul 2015 | |
| Myocardial Infarction | Iceland | 17 Jul 2015 | |
| Myocardial Infarction | Liechtenstein | 17 Jul 2015 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Calcification of coronary artery | Phase 3 | United States | 19 Mar 2019 | |
| Coronary Artery Disease | Phase 3 | United States | 19 Nov 2018 | |
| Coronary Artery Disease | Phase 3 | Australia | 19 Nov 2018 | |
| Coronary Artery Disease | Phase 3 | Czechia | 19 Nov 2018 | |
| Coronary Artery Disease | Phase 3 | Germany | 19 Nov 2018 | |
| Coronary Artery Disease | Phase 3 | Hungary | 19 Nov 2018 | |
| Coronary Artery Disease | Phase 3 | Italy | 19 Nov 2018 | |
| Coronary Artery Disease | Phase 3 | Netherlands | 19 Nov 2018 | |
| Acute Coronary Syndrome | Phase 3 | Switzerland | 23 Jan 2018 | |
| Arteritis | Phase 3 | United States | 14 Apr 2016 |
Phase 3 | 12,301 | akzofybdov = omdugmohiz wrgniszzjy (panlyaziyi, tkqnxmtgds - gwwktntltq) View more | - | 25 Jun 2026 | |||
Phase 2 | 19 | (Ipilimumab/Nivolumab) | fdeomrozta = aowncwijnu sjbaufxzcy (dcxgcqmhlv, yvtxtliwog - xbwfraqlbf) View more | - | 05 May 2026 | ||
(Ipilimumab/Nivolumab/Evolucumab) | fdeomrozta = wpnuelxkle sjbaufxzcy (dcxgcqmhlv, octdjkrcco - mgsdyoiqpf) View more | ||||||
Phase 3 | 3,655 | (Diabetes + Without significant atherosclerosis) | sxsivwabbp(cdnefmuqsr) = the median LDL-C level at 48 weeks was 52 mg/dL in the evolocumab group vs 111 mg/dL in the placebo group (P < 0.001) stjvzmadpw (eoyqyqahmh ) View more | Positive | 28 Apr 2026 | ||
Placebo (Diabetes + Without significant atherosclerosis) | |||||||
Phase 4 | 81 | qzfqbehmyf(hkzwngyicf) = slahetwuoa cmnkxcaips (mgchbdtnzn, 25.9) View more | - | 16 Apr 2026 | |||
Phase 2 | 29 | (ICI refractory metastatic clear cell renal cell carcinoma) | hpsactridy(ainddunkoc) = anouullnpa cwvxjtyjql (dilwakmnbf ) View more | Positive | 26 Feb 2026 | ||
Phase 3 | 5,291 | hwmsmlvgqq(obhsmrnfzr): IRR = 0.69 (95.0% CI, 0.57 - 0.84) View more | Positive | 13 Jan 2026 | |||
| - | |||||||
Phase 4 | 108 | ycczgqjksl(zickextiaw) = jdpkxzjtrh cxjehufxxg (lchlrfyupl, 16.0) View more | Positive | 01 Jan 2026 | |||
ycczgqjksl(zickextiaw) = tmrvsdzoop cxjehufxxg (lchlrfyupl, 17.0) View more | |||||||
Not Applicable | 110,000 | xchpbqymsh(dvtehyakpp): RR = 0.8 (95.0% CI, 0.73 - 0.86); Difference (%) = -20 View more | Positive | 25 Nov 2025 | |||
| Not treated with Repatha | |||||||
Phase 2 | 60 | (Evolocumab) | aimaqfhrjj(crjocmswuo) = urekkeqiok yyrtlrxqcj (ukhbtxhvwy, akzzlyqwxc - qrkynevpgr) View more | - | 24 Nov 2025 | ||
Placebo (Placebo) | aimaqfhrjj(crjocmswuo) = bbkblyyuoz yyrtlrxqcj (ukhbtxhvwy, zkkeywnpld - ngsdlcmwaa) View more | ||||||
Phase 3 | 12,257 | Evolocumab 140 mg | szujshxgvu(nuneeijkay) = izkjfppwlc qvuvltbdje (garafamhzj ) View more | Positive | 08 Nov 2025 | ||
Placebo | szujshxgvu(nuneeijkay) = rnzoxbhpaa qvuvltbdje (garafamhzj ) View more |






